Adult hepatitis C virus treatment systematic review; supporting evidence

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection [Internet]. Geneva: World Health Organization; 2018 Jul.

Cover of Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection

Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection [Internet].

Show details

Contents

< Prev Next >

Web Annex 3.2Adult hepatitis C virus treatment systematic review; supporting evidence

Purpose

This ‘Supporting Document’ lists the studies that informed the pooled SVR12 estimates in the ‘all comer’ analyses for:

Sofosbuvir + daclatasvir
Sofosbuvir + velpatasvir
Glecaprevir + pibrentasvir

Refer to Web Annex 3.1 (the complete report (v3)) for a summary of all SVR12 estimates and GRADE evidence summaries for all treatments and patient populations.

Results

This Supporting Document is to accompany the main report (v3). The summaries presented in this section include a list of the studies which informed each analysis.

Efficacy outcomes (SVR12) – All comers

For each treatment in the all-comer population, the pooled proportions of patients achieving SVR12 are presented by genotype and treatment-experience. The number of treatment arms may represent subgroups of treatment arms in a single study, such as where outcomes are reported separately by prior treatment experience. The all-treatment experience analysis pools outcomes from patients who are treatment-naïve, treatment-experienced, and where previous treatment status was unclear.

Trial evidence refers to evidence coming from RCTs and other non-randomized or single-arm trials. This analysis is supplemented with an all evidence analysis, which also incorporates outcomes from observational studies.

Comparative evidence is not available and inferences on relative treatment effect should be avoided.

Daclatasvir + Sofosbuvir

All-treatment experience

In the all-treatment experience analysis of patients treated with daclatasvir + sofosbuvir, evidence was available for patients across all genotypes. The percentage of patients achieving SVR12 varied from 88% to 98%. Across outcomes, GRADE assessments varied from very low to high. A summary of the analyses is presented in Table 1.

Table 1SVR12 in all patients treated with daclatasvir + sofosbuvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence AI444-040¹⁸⁷	1	4	91	0.98 (0.96, 0.98)	⊕⊕⊕⊕
Genotype 1	All evidence Desnoyer 2016⁴¹ Foster 2016⁶¹ VASCUVALDIC 2¹⁷³^,¹⁷⁴ AI444-040¹⁸⁷ ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴ Ji 2016⁹⁸	6	19	773	0.96 (0.94, 0.98)	⊕⊕⊕⊕
Genotype 2	Trial evidence	–	–	–	–	–
Genotype 2	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴ Mangia 2016a¹³²	2	4	21	0.94 (0.86, 1.00)	⊕
Genotype 3	Trial evidence Hezode 2017⁷⁹^,⁸⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ ENDURANCE-3⁶⁰	3	4	293	0.92 (0.88, 0.97)	⊕⊕⊕⊕
Genotype 3	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴ German Hepatitis C-Registry (GT3 patients)³⁶ Foster 2016⁶¹ Mehta 2017¹³⁸ Lionetti 2017¹²⁸ Hezode 2017⁷⁹^,⁸⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ Bansal 2017¹⁹ ENDURANCE-3⁶⁰	9	16	895	0.89 (0.85, 0.94)	⊕⊕⊕
Genotype 4	Trial evidence Abdel-Aziz 2017¹⁰ Yakoot 2017²²³	2	3	180	0.97 (0.95, 1.00)	⊕⊕⊕⊕
Genotype 4	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴ Abdel-Aziz 2017¹⁰ Yakoot 2017²²³	3	5	183	0.97 (0.95, 1.00)	⊕⊕⊕⊕
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence Iwamoto 2017⁹³ VASCUVALDIC 2¹⁷³^,¹⁷⁴	2	3	8	0.88 (0.70, 1.00)	⊕
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence Iwamoto 2017⁹³	1	4	123	0.94 (0.90, 0.98)	⊕⊕
Mixed genotype	Trial evidence AI444-040¹⁸⁷ ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²²	2	5	233	0.94 (0.88, 0.99)	⊕⊕⊕
Mixed genotype	All evidence Foster 2016⁶¹ Torres 2017¹⁹⁵ AI444-040¹⁸⁷ ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² Autorisation Temporaire d’Utilisation (ATU) Program¹²⁰	5	9	591	0.92 (0.88, 0.97)	⊕⊕

Treatment-naïve patients only

In the analysis of treatment-naïve only patients treated with daclatasvir + sofosbuvir, evidence was available for patients with genotypes 1-5 infection, as well as an unknown or mixed genotype population. The percentage of patients achieving SVR12 varied from 75% to 98%. Across outcomes, GRADE assessments varied from very low to high. A summary of the analyses is presented in Table 2.

Table 2SVR12 in treatment-naive patients treated with daclatasvir + sofosbuvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence AI444-040¹⁸⁷	1	3	70	0.98 (0.96, 1.00)	⊕⊕⊕⊕
Genotype 1	All evidence Desnoyer 2016⁴¹ VASCUVALDIC 2¹⁷³^,¹⁷⁴ AI444-040¹⁸⁷ ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴	4	8	196	0.94 (0.90, 0.99)	⊕⊕⊕
Genotype 2	Trial evidence	–	–	–	–	–
Genotype 2	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴	1	1	1	0.75 (0.15, 1.00)	⊕
Genotype 3	Trial evidence Hezode 2017⁷⁹^,⁸⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ ENDURANCE-3⁶⁰	3	3	242	0.94 (0.89, 0.98)	⊕⊕⊕⊕
Genotype 3	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴ German Hepatitis C-Registry (GT3 patients)³⁶ Hezode 2017⁷⁹^,⁸⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ Bansal 2017¹⁹ ENDURANCE-3⁶⁰	6	7	470	0.93 (0.88, 0.98)	⊕⊕⊕⊕
Genotype 4	Trial evidence Abdel-Aziz 2017¹⁰	1	1	60	0.93 (0.87, 1.00)	⊕⊕⊕
Genotype 4	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴ Abdel-Aziz 2017¹⁰	2	2	61	0.93 (0.87, 0.99)	⊕⊕⊕
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴	1	1	2	0.83 (0.41, 1.00)	⊕
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence	–	–	–	–	–
Mixed genotype	Trial evidence AI444-040¹⁸⁷ ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²²	2	4	181	0.91 (0.82, 1.00)	⊕⊕⊕
Mixed genotype	All evidence	Same as trial-only evidence

Treatment-experienced patients only

In the analysis of treatment-experienced only patients treated with daclatasvir + sofosbuvir, evidence was available for patients with genotypes 1-4 infection, as well as an unknown or mixed genotype population. The percentage of patients achieving SVR12 varied from 75% to 98%. Across outcomes, GRADE assessments varied from very low to moderate. A summary of the analyses is presented in Table 3.

Table 3SVR12 in treatment-experienced patients treated with daclatasvir + sofosbuvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence AI444-040¹⁸⁷	1	1	21	0.98 (0.92, 1.00)	⊕⊕
Genotype 1	All evidence Desnoyer 2016⁴¹ VASCUVALDIC 2¹⁷³^,¹⁷⁴ AI444-040¹⁸⁷ ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴ Ji 2016⁹⁸	5	10	573	0.97 (0.95, 0.98)	⊕⊕⊕
Genotype 2	Trial evidence	–	–	–	–	–
Genotype 2	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴	1	1	1	0.75 (0.15, 1.00)	⊕
Genotype 3	Trial evidence ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹	1	1	51	0.86 (0.77, 0.96)	⊕⊕⊕
Genotype 3	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴ German Hepatitis C-Registry (GT3 patients)³⁶ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹	3	5	110	0.85 (0.78, 0.92)	⊕⊕⊕
Genotype 4	Trial evidence	–	–	–	–	–
Genotype 4	All evidence VASCUVALDIC 2¹⁷³^,¹⁷⁴	1	1	2	0.83 (0.41, 1.00)	⊕
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence	–	–	–	–	–
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence	–	–	–	–	–
Mixed genotype	Trial evidence ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²²	1	1	52	0.98 (0.94, 1.00)	⊕⊕⊕
Mixed genotype	All evidence	Same as trial-only evidence

Glecaprevir + Pibrentasvir

All-treatment experience

In the all-treatment experience analysis of patients treated with glecaprevir + pibrentasvir, evidence was available for patients across all genotypes. The percentage of patients achieving SVR12 varied from 83% to 98%. Across outcomes, GRADE assessments varied from very low to high. A summary of the analyses is presented in Table 4.

Table 4SVR12 in all patients treated with glecaprevir + pibrentasvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence MAGELLAN-1, Part 1¹⁶⁵^,¹⁶⁶ SURVEYOR-I⁶⁵^,¹¹⁸ EXPEDITION-1⁵⁶^–⁵⁸	3	6	231	0.98 (0.97, 1.00)	⊕⊕⊕⊕
Genotype 1	All evidence	Same as trial-only evidence
Genotype 2	Trial evidence CERTAIN-1, Sub-study 2³⁰^,³¹^,¹⁹⁸ SURVEYOR-II⁶⁵^,¹¹⁸ EXPEDITION-1⁵⁶^–⁵⁸ CERTAIN-2³¹^,¹⁹⁸	4	6	242	0.98 (0.96, 1.00)	⊕⊕⊕⊕
Genotype 2	All evidence	Same as trial-only evidence
Genotype 3	Trial evidence SURVEYOR-II⁶⁵^,¹¹⁸ ENDURANCE-3⁶⁰	2	7	533	0.95 (0.93, 0.97)	⊕⊕⊕⊕
Genotype 3	All evidence	Same as trial-only evidence
Genotype 4	Trial evidence EXPEDITION-1⁵⁶^–⁵⁸	1	1	16	0.97 (0.89, 1.00)	⊕
Genotype 4	All evidence	Same as trial-only evidence
Genotype 5	Trial evidence EXPEDITION-1⁵⁶^–⁵⁸	1	1	2	0.83 (0.41, 1.00)	⊕
Genotype 5	All evidence	Same as trial-only evidence
Genotype 6	Trial evidence EXPEDITION-1⁵⁶^–⁵⁸	1	1	7	0.94 (0.77, 1.00)	⊕
Genotype 6	All evidence	Same as trial-only evidence
Mixed genotype	Trial evidence EXPEDITION-2¹⁷¹ SURVEYOR-I⁶⁵^,¹¹⁸ MAGELLAN-1, Part 2¹⁶⁷^,¹⁶⁸	3	5	276	0.97 (0.93, 1.00)	⊕⊕⊕⊕
Mixed genotype	All evidence	Same as trial-only evidence

Treatment-naïve patients only

In the analysis of treatment-naïve only patients treated with glecaprevir + pibrentasvir, evidence was available only for patients with genotype 3 infection (N=419). The percentage of patients achieving SVR12 was 95%, with a GRADE assessment of high. A summary of the analyses is presented in Table 5.

Table 5SVR12 in treatment-naïve patients treated with glecaprevir + pibrentasvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence	–	–	–	–	–
Genotype 1	All evidence	–	–	–	–	–
Genotype 2	Trial evidence	–	–	–	–	–
Genotype 2	All evidence	–	–	–	–	–
Genotype 3	Trial evidence SURVEYOR-II⁶⁵^,¹¹⁸ ENDURANCE-3⁶⁰	2	3	419	0.95 (0.93, 0.97)	⊕⊕⊕⊕
Genotype 3	All evidence	Same as trial-only evidence
Genotype 4	Trial evidence
Genotype 4	All evidence	–	–	–	–	–
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence	–	–	–	–	–
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence	–	–	–	–	–
Mixed genotype	Trial evidence	–	–	–	–	–
Mixed genotype	All evidence	–	–	–	–	–

Treatment-experienced patients only

In the analysis of treatment-experienced only patients treated with glecaprevir + pibrentasvir, evidence was available only for patients with genotype 3 infection (N=24). The percentage of patients achieving SVR12 was 92%, with a GRADE assessment of very low. A summary of the analyses is presented in Table 6.

Table 6SVR12 in treatment-experienced patients treated with glecaprevir + pibrentasvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence	–	–	–	–	–
Genotype 1	All evidence	–	–	–	–	–
Genotype 2	Trial evidence	–	–	–	–	–
Genotype 2	All evidence	–	–	–	–	–
Genotype 3	Trial evidence SURVEYOR-II⁶⁵^,¹¹⁸	1	1	24	0.92 (0.81, 1.00)	⊕
Genotype 3	All evidence	Same as trial-only evidence
Genotype 4	Trial evidence
Genotype 4	All evidence	–	–	–	–	–
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence	–	–	–	–	–
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence	–	–	–	–	–
Mixed genotype	Trial evidence	–	–	–	–	–
Mixed genotype	All evidence	–	–	–	–	–

Sofosbuvir + Velpatasvir

All-treatment experience

In the all-treatment experience analysis of patients treated with sofosbuvir + velpatasvir, evidence was available for patients across all genotypes. The percentage of patients achieving SVR12 varied from 89% to 99%. GRADE assessments varied from low to high across outcomes. A summary of the analyses is presented in Table 7.

Table 7SVR12 in all patients treated with sofosbuvir + velpatasvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence Everson 2015⁴⁸ Pianko 2015¹⁶³ POLARIS-4²¹^,²⁴² ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	7	12	1011	0.96 (0.95, 0.98)	⊕⊕⊕⊕
Genotype 1	All evidence	Same as trial-only evidence
Genotype 2	Trial evidence ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² Everson 2015⁴⁸ POLARIS-4²¹^,²⁴² POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹ ASTRAL-2⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,¹⁸⁵^,²¹⁹^,²³¹	7	9	395	0.99 (0.97, 1.00)	⊕⊕⊕⊕
Genotype 2	All evidence	Same as trial-only evidence
Genotype 3	Trial evidence ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² Pianko 2015¹⁶³ Everson 2015⁴⁸ POLARIS-3⁹⁶ POLARIS-4²¹^,²⁴² ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹ POLARIS-2⁹⁶	8	15	776	0.89 (0.85, 0.93)	⊕⊕⊕
Genotype 3	All evidence	Same as trial-only evidence
Genotype 4	Trial evidence ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	4	5	184	0.99 (0.98, 1.00)	⊕⊕⊕⊕
Genotype 4	All evidence	Same as trial-only evidence
Genotype 5	Trial evidence ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	1	1	35	0.97 (0.92, 1.00)	⊕⊕
Genotype 5	All evidence	Same as trial-only evidence
Genotype 6	Trial evidence ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	3	3	51	0.99 (0.95, 1.00)	⊕⊕⊕⊕
Genotype 6	All evidence	Same as trial-only evidence
Mixed genotype	Trial evidence Everson 2015⁴⁸ POLARIS-2⁹⁶	2	4	485	0.99 (0.97, 1.00)	⊕⊕⊕⊕
Mixed genotype	All evidence Torres 2017¹⁹⁵ Everson 2015⁴⁸ POLARIS-2⁹⁶	3	5	489	0.99 (0.97, 1.00)	⊕⊕⊕⊕

Treatment-naïve patients only

In the analysis of treatment-naïve only patients treated with sofosbuvir + velpatasvir, evidence was available for patients with genotypes 1-3 infection, as well as an unknown or mixed genotype population. The percentage of patients achieving SVR12 varied from 84% to 98%. GRADE assessments varied from very low to high across outcomes. A summary of the analyses is presented in Table 8.

Table 8SVR12 in treatment-naïve patients treated with sofosbuvir + velpatasvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence Everson 2015⁴⁸	1	4	114	0.95 (0.90, 1.00)	⊕⊕
Genotype 1	All evidence	Same as trial-only evidence
Genotype 2	Trial evidence Everson 2015⁴⁸	1	2	52	0.84 (0.73, 0.95)	⊕
Genotype 2	All evidence	Same as trial-only evidence
Genotype 3	Trial evidence Everson 2015⁴⁸ POLARIS-3⁹⁶ ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹	3	4	337	0.98 (0.96, 0.99)	⊕⊕⊕⊕
Genotype 3	All evidence	Same as trial-only evidence
Genotype 4	Trial evidence	–	–	–	–	–
Genotype 4	All evidence	–	–	–	–	–
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence	–	–	–	–	–
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence	–	–	–	–	–
Mixed genotype	Trial evidence Everson 2015⁴⁸	1	2	45	0.96 (0.90, 1.00)	⊕
Mixed genotype	All evidence	Same as trial-only evidence

Treatment-experienced patients only

In the analysis of treatment-experienced only patients treated with sofosbuvir + velpatasvir, evidence was available for patients with genotypes 1-3 infection. The percentage of patients achieving SVR12 varied from 85% to 97%. GRADE assessments varied from low to high across outcomes. A summary of the analyses is presented in Table 9.

Table 9SVR12 in treatment-experienced patients treated with sofosbuvir + velpatasvir, arranged by genotype

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Genotype 1	Trial evidence Pianko 2015¹⁶³ POLARIS-4²¹^,²⁴²	2	3	120	0.96 (0.92, 1.00)	⊕⊕⊕⊕
Genotype 1	All evidence	Same as trial-only evidence
Genotype 2	Trial evidence POLARIS-4²¹^,²⁴²	1	1	33	0.97 (0.91, 1.00)	⊕⊕
Genotype 2	All evidence	Same as trial-only evidence
Genotype 3	Trial evidence Pianko 2015¹⁶³ POLARIS-3⁹⁶ POLARIS-4²¹^,²⁴² ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹	4	7	312	0.85 (0.78, 0.92)	⊕⊕⊕
Genotype 3	All evidence	Same as trial-only evidence
Genotype 4	Trial evidence	–	–	–	–	–
Genotype 4	All evidence	–	–	–	–	–
Genotype 5	Trial evidence	–	–	–	–	–
Genotype 5	All evidence	–	–	–	–	–
Genotype 6	Trial evidence	–	–	–	–	–
Genotype 6	All evidence	–	–	–	–	–
Mixed genotype	Trial evidence	–	–	–	–	–
Mixed genotype	All evidence	–	–	–	–	–

Safety outcomes

The number of patients experiencing each adverse event outcome category was pooled across studies, arranged by treatment. When possible, outcomes were extracted from each study based on the safety analysis set (i.e. number of patients who received ≥1 dose). Comparative evidence is not available and inferences on relative treatment effect should be avoided.

Discontinuations due to adverse events

Evidence on the number of patients who experienced a DAE was available for every treatment. The analyses for daclatasvir + sofosbuvir + ribavirin and sofosbuvir + ribavirin was restricted to patients with cirrhosis and genotype 2 or 3 infection. Across treatments and studies, the number of DAEs was very low, with the pooled percentages varying from 0% to 0.04%. GRADE was assessed as moderate in all cases. As very few studies blinded patients or outcome assessors, GRADE was lowered by one level due to the perceived subjectivity of labelling a discontinuation as a DAE (Risk of Bias). A summary of the analyses is presented in Table 10.

Table 10Discontinuations due to adverse events, arranged by treatment

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Daclatasvir + sofosbuvir	Trial evidence ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² Abdel-Aziz 2017¹⁰ Yakoot 2017²²³ ENDURANCE-3⁶⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹	5	8	650	0.01 (0.00, 0.01)	⊕⊕⊕
Daclatasvir + sofosbuvir	All evidence Iwamoto 2017⁹³ Mangia 2016a¹³² Lionetti 2017¹²⁸ Chen 2017³² Ji 2016⁹⁸ Abdel-Aziz 2017¹⁰ Yakoot 2017²²³ ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² ENDURANCE-3⁶⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴ Autorisation Temporaire d’Utilisation (ATU) Program¹²⁰	12	20	1955	0.01 (0.01, 0.01)	⊕⊕⊕
Glecaprevir + pibrentasvir	Trial evidence MAGELLAN-1, Part 1¹⁶⁵^,¹⁶⁶ MAGELLAN-1, Part 2¹⁶⁷^,¹⁶⁸ EXPEDITION-2¹⁷¹ CERTAIN-1, Sub-study 2³⁰^,³¹^,¹⁹⁸ Kwo 2016¹¹⁹ CERTAIN-2³¹^,¹⁹⁸ SURVEYOR-I⁶⁵^,¹¹⁸ SURVEYOR-II⁶⁵^,¹¹⁸ EXPEDITION-1⁵⁶^–⁵⁸ ENDURANCE-3⁶⁰	10	14	1333	0.01 (0.00, 0.01)	⊕⊕⊕
Glecaprevir + pibrentasvir	All evidence	Same as trial-only evidence
Sofosbuvir + velpatasvir	Trial evidence Everson 2015⁴⁸ Pianko 2015¹⁶³ ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² POLARIS-3⁹⁶ ASTRAL-2⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,¹⁸⁵^,²¹⁹^,²³¹ POLARIS-4²¹^,²⁴² ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹ POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	10	15	2445	0.00 (0.00, 0.01)	⊕⊕⊕
Sofosbuvir + velpatasvir	All evidence	Same as trial-only evidence

Serious adverse events

Evidence on the number of patients who experienced a SAE was available for every treatment with the exception of daclatasvir + sofosbuvir + ribavirin, where inclusion in this review was restricted to patients with cirrhosis and genotype 2 or 3 infection. Across treatments and studies, the number of SAEs was very low, with the pooled percentage varying 1% to 5% and GRADE assessments varying from moderate to high. A summary of the analyses is presented in Table 11.

Table 11Serious adverse events, arranged by treatment

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Daclatasvir + sofosbuvir	Trial evidence ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² Abdel-Aziz 2017¹⁰ Yakoot 2017²²³ ENDURANCE-3⁶⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹	5	8	650	0.01 (0.00, 0.02)	⊕⊕⊕⊕
Daclatasvir + sofosbuvir	All evidence Desnoyer 2016⁴¹ VASCUVALDIC 2¹⁷³^,¹⁷⁴ Ji 2016⁹⁸ ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² Abdel-Aziz 2017¹⁰ Yakoot 2017²²³ ENDURANCE-3⁶⁰ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴ Autorisation Temporaire d’Utilisation (ATU) Program¹²⁰	10	19	1875	0.03 (0.01, 0.05)	⊕⊕⊕
Glecaprevir + pibrentasvir	Trial evidence MAGELLAN-1, Part 1¹⁶⁵^,¹⁶⁶ EXPEDITION-2¹⁷¹ CERTAIN-1, Sub-study 2³⁰^,³¹^,¹⁹⁸ MAGELLAN-1, Part 2¹⁶⁷^,¹⁶⁸ SURVEYOR-I⁶⁵^,¹¹⁸ SURVEYOR-II⁶⁵^,¹¹⁸ CERTAIN-2³¹^,¹⁹⁸ EXPEDITION-1⁵⁶^–⁵⁸ ENDURANCE-3⁶⁰	9	14	1309	0.02 (0.01, 0.02)	⊕⊕⊕⊕
Glecaprevir + pibrentasvir	All evidence	Same as trial-only evidence
Sofosbuvir + velpatasvir	Trial evidence Everson 2015⁴⁸ Pianko 2015¹⁶³ ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² POLARIS-3⁹⁶ ASTRAL-2⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,¹⁸⁵^,²¹⁹^,²³¹ POLARIS-4²¹^,²⁴² ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹ POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	10	15	2445	0.03 (0.02, 0.04)	⊕⊕⊕⊕
Sofosbuvir + velpatasvir	All evidence	Same as trial-only evidence

Mortality

Evidence on mortality was available for every treatment. Incidence was very low across treatments, with the pooled morality percentage varying from 0% to 4%. GRADE assessments were high for all treatments and evidence types. A summary of the analyses is presented in Table 12.

Table 12Mortality, arranged by treatment

		Number of studies	Number of arms	Total N	Pooled proportion (95% CI)	GRADE
Daclatasvir + sofosbuvir	Trial evidence ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² Abdel-Aziz 2017¹⁰ Yakoot 2017²²³ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹	4	7	535	0.01 (0.00, 0.01)	⊕⊕⊕⊕
Daclatasvir + sofosbuvir	All evidence Iwamoto 2017⁹³ Mangia 2016a¹³² VASCUVALDIC 2¹⁷³^,¹⁷⁴ Mehta 2017¹³⁸ Ji 2016⁹⁸ ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²² Abdel-Aziz 2017¹⁰ Yakoot 2017²²³ ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹ ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴ Autorisation Temporaire d’Utilisation (ATU) Program¹²⁰	11	22	2156	0.01 (0.00, 0.01)	⊕⊕⊕⊕
Glecaprevir + pibrentasvir	Trial evidence SURVEYOR-I⁶⁵^,¹¹⁸ SURVEYOR-II⁶⁵^,¹¹⁸ EXPEDITION-1⁵⁶^–⁵⁸	3	4	539	0.01 (0.00, 0.02)	⊕⊕⊕⊕
Glecaprevir + pibrentasvir	All evidence	Same as trial-only evidence
Sofosbuvir + velpatasvir	Trial evidence Everson 2015⁴⁸ Pianko 2015¹⁶³ ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸ ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³² POLARIS-3⁹⁶ ASTRAL-2⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,¹⁸⁵^,²¹⁹^,²³¹ POLARIS-4²¹^,²⁴² ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹ POLARIS-2⁹⁶ ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	10	15	2445	0.00 (0.00, 0.00)	⊕⊕⊕⊕
Sofosbuvir + velpatasvir	All evidence	Same as trial-only evidence

Appendix A. Included studies from all analyses

Table A1List of included studies, with treatments and study design categorization

			Study design
Study name	Registration	Treatment arms	Trial	Observational study
Abdel-Aziz 2017¹⁰	–	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
AI444-040¹⁸⁷	NCT01359644	DAC 60 mg 24 weeks + SOF 400 mg 24 weeks	Yes	–
AI444-040¹⁸⁷	NCT01359644	DAC 60 mg 12 weeks + SOF 400 mg 12 weeks	Yes	–
AI447-017¹³⁹^,¹⁹¹^,²²⁵	NCT01051414	DAC 60 mg 24 weeks + ASV 200 mg bid 24 weeks	Yes	–
AI447-031¹⁰²	NCT01718145	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
ALLY 3+¹²⁶^,¹³⁷	NCT02319031	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), 16 weeks	Yes	–
ALLY 3+¹²⁶^,¹³⁷	NCT02319031	DAC 60 mg qd 16 weeks + SOF 400 mg qd 16 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), 16 weeks	Yes	–
ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²²	NCT02032888	DAC 60 mg qd 8 weeks + SOF 400 mg qd 8 weeks	Yes	–
ALLY-2²⁴^,¹³¹^,¹³⁷^,²²⁰^–²²²	NCT02032888	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
ALLY-3²⁵^,¹¹¹^,¹³⁷^,¹⁴⁸^,¹⁴⁹	NCT02032901	DAC 60 mg 12 weeks + SOF 400 mg 12 weeks	Yes	–
ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴	NCT01953458	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
ANRS CO22 HEPATHER⁵⁵^,¹⁶⁴	NCT01953458	DAC 60 mg qd 24 weeks + SOF 400 mg qd 24 weeks	–	Yes
ASCEND¹⁰³	–	LDV 2, 3, or 6 months + SOF 2, 3, or 6 months	Yes	–
ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	NCT02201940	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
ASTRAL-1⁴⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²²⁹	NCT02201940	PBO	Yes	–
ASTRAL-2⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,¹⁸⁵^,²¹⁹^,²³¹	NCT02220998	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
ASTRAL-2⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,¹⁸⁵^,²¹⁹^,²³¹	NCT02220998	SOF 400 mg qd 12 weeks + RBV bid 12 weeks for 1000 mg daily (body weight <75 kg) or 1200 mg daily (body weight ≥75 kg)	Yes	–
ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹	NCT02201953	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
ASTRAL-3⁵⁹^,⁷¹^,⁷³^,⁹⁴^,¹⁴⁶^,²¹⁹^,²³¹	NCT02201953	SOF 400 mg qd 24 weeks + RBV bid 24 weeks for 1000 mg daily (body weight <75 kg) or 1200 mg daily (body weight ≥75 kg)	Yes	–
ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸	NCT02201901	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
ASTRAL-4²⁹^,³⁷^,³⁸^,¹⁴⁶^,¹⁵⁷^,²²⁸	NCT02201901	SOF 400 mg qd 24 weeks + VEL 100 mg qd 24 weeks	Yes	–
ASTRAL-5¹⁰⁹^,¹⁴⁶^,²¹⁸^,²¹⁹^,²³²	NCT02480712	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
Autorisation Temporaire d’Utilisation (ATU) Program¹²⁰	–	DAC 30/60/90 qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
Autorisation Temporaire d’Utilisation (ATU) Program¹²⁰	–	DAC 30/60/90 qd 24 weeks + SOF 400 mg qd 24 weeks	–	Yes
Backus 2016¹⁸	–	LDV ≤12 weeks + SOF ≤12 weeks	–	Yes
Backus 2016¹⁸	–	PTV/r ≤12 weeks + OMV ≤12 weeks + DBV ≤12 weeks	–	Yes
Bansal 2017¹⁹	–	DAC 60 mg 12 weeks + SOF 400 mg 12 weeks	–	Yes
		DAC 60 mg 12 weeks + SOF 400 mg 12 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 12 weeks
		DAC 60 mg 24 weeks + SOF 400 mg 24 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 24 weeks
BOSON⁶²^,⁶³	–	SOF 400 mg qd 16 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 16 weeks	Yes	–
BOSON⁶²^,⁶³	–	SOF 400 mg qd 24 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 24 weeks	Yes	–
C-CORAL⁷²^,²⁰⁵^,²¹²	–	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-CORAL⁷²^,²⁰⁵^,²¹²	–	PBO 12 weeks	Yes	–
C-EDGE CO-INFECTION¹⁷²	NCT02105662	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-EDGE CO-STAR⁴⁵^,⁴⁶	NCT02105688	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-EDGE CO-STAR⁴⁵^,⁴⁶	NCT02105688	PBO	Yes	–
C-EDGE HEAD-2-HEAD¹⁷⁹^,¹⁸⁰	NCT02358044	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-EDGE IBLD⁷⁵^–⁷⁸^,¹⁸¹	NCT02252016	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-EDGE IBLD⁷⁵^–⁷⁸^,¹⁸¹	NCT02252016	PBO	Yes	–
C-EDGE Treatment-Experienced¹¹⁵^–¹¹⁷	NCT02105701	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-EDGE Treatment-Experienced¹¹⁵^–¹¹⁷	NCT02105701	ESV 50 mg qd 16 weeks + GZR 100 mg qd 16 weeks	Yes	–
C-EDGE Treatment-Naïve¹⁵²^,²²⁴^,²⁴³^–²⁴⁵	NCT02105467	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-EDGE Treatment-Naïve¹⁵²^,²²⁴^,²⁴³^–²⁴⁵	NCT02105467	PBO	Yes	–
CERTAIN-1, Sub-study 2³⁰^,³¹^,¹⁹⁸	NCT02707952	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
CERTAIN-2³¹^,¹⁹⁸	NCT02723084	GCR 300 mg qd 8 weeks + PBV 120 mg qd 8 weeks	Yes	–
Chamorro-de-Vega 2016²⁸	–	PTV/r 150/100 mg qd 12 weeks + OMV 25 mg qd 12 weeks + DBV 250 mg bid 12 weeks	–	Yes
Chen 2017³²	–	DAC 60 mg/day 12 or 24 weeks + SOF 400 mg/day 12 or 24 weeks	–	Yes
Chen 2017³²	–	LDV 90 mg/day 12 or 24 weeks + SOF 400 mg/day 12 or 24 weeks	–	Yes
Chuang 2016 - Korea³⁴^,¹²⁷^,¹⁸⁶	NCT02021656	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Chuang 2016 - Taiwan³⁴^,¹²⁷^,¹⁸⁶	NCT02021656	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
C-WORTHY⁷⁰^,¹²¹^,¹⁸⁴^,²²⁴	NCT01717326	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
C-WORTHY⁷⁰^,¹²¹^,¹⁸⁴^,²²⁴	NCT01717326	ESV 50 mg qd 18 weeks + GZR 100 mg qd 18 weeks	Yes	–
Dashtseren 2017³⁹^,⁴⁰	–	LDV 80 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Desnoyer 2016⁴¹	–	DAC 60 mg qd 12 weeks + SOF 400 mg qd or tiw 12 weeks	–	Yes
Desnoyer 2016⁴¹	–	DAC 60 mg qd 24 weeks + SOF 400 mg qd or tiw 24 weeks	–	Yes
Deterding 2015⁴²^,⁸³	–	SOF + RBV	–	Yes
ELECTRON⁶⁹	NCT01260350	SOF 400 mg 12 weeks + LDV 90 mg 12 weeks	Yes	–
ELECTRON-2⁶⁴^,⁶⁶^,⁶⁷^,¹²⁵	NCT01826981	SOF 400 mg 12 weeks + LDV 90 mg 12 weeks	Yes	–
ENDURANCE-3⁶⁰	NCT02640157	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
		DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks
		GCR 300 mg qd 8 weeks + PBV 120 mg qd 8 weeks
ERADICATE¹⁵⁸^,¹⁵⁹^,¹⁹⁶^,¹⁹⁷	NCT01878799	SOF 400 mg 12 weeks + LDV 90 mg 12 weeks	Yes	–
Everson 2015⁴⁸	NCT01858766	SOF 400 mg qd 12 weeks + VEL 25 mg qd 12 weeks	Yes	–
		SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks
		SOF 400 mg qd 8 weeks + VEL 25 mg qd 8 weeks
		SOF 400 mg qd 8 weeks + VEL 100 mg qd 8 weeks
EXPEDITION-1⁵⁶^–⁵⁸	NCT02642432	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
EXPEDITION-2¹⁷¹	NCT02738138	GCR 300 mg qd 8 weeks + PBV 120 mg qd 8 weeks	Yes	–
EXPEDITION-2¹⁷¹	NCT02738138	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
Fierer 2017⁵⁴	–	LDV 8 weeks + SOF 8 weeks	Yes	–
Foster 2016⁶¹	–	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
		LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks
		DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks + RBV Clinician discretion
FUSION²⁶^,⁵²^,¹⁴⁷^,²³⁴	NCT01604850	SOF 400 mg qd 12 weeks + RBV 1000-1200 mg/day 12 weeks	Yes	–
FUSION²⁶^,⁵²^,¹⁴⁷^,²³⁴	NCT01604850	SOF 400 mg qd 16 weeks + RBV 1000-1200 mg/day 16 weeks	Yes	–
Gane 2017⁶⁸	NCT02202980	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Gane 2017⁶⁸	NCT02202980	LDV 90 mg qd 8 weeks + SOF 400 mg qd 8 weeks	Yes	–
GARNET²¹³^,²¹⁴	NCT02582632	PTV/r 150 mg/100 mg qd 8 weeks + OMV 25 mg qd 8 weeks + DBV 250 mg bid 8 weeks	Yes	–
GECCO-01⁸⁹	–	LDV 8 weeks + SOF 8 weeks	–	Yes
German Hepatitis C-Registry (GT1 patients)²⁰²	–	LDV 12 weeks + SOF 12 weeks	–	Yes
German Hepatitis C-Registry (GT1 patients)²⁰²	–	LDV 8 weeks + SOF 8 weeks	–	Yes
German Hepatitis C-Registry (GT2 patients)¹³⁶^,¹⁹²	–	SOF 12 weeks + RBV 12 weeks	–	Yes
German Hepatitis C-Registry (GT3 patients)³⁶	–	SOF 24 weeks + RBV 24 weeks	–	Yes
		DAC 12 weeks + SOF 12 weeks
		DAC 12 weeks + SOF 12 weeks + RBV 12 weeks
		DAC 24 weeks + SOF 24 weeks
		DAC 24 weeks + SOF 24 weeks + RBV 24 weeks
GS-US-334-0118/GS-US-337-0113 (Pooled)²³⁰^,²³⁹	–	LDV 12 weeks + SOF 12 weeks	Yes	–
GS-US-337-1119 [Genotype 4]¹²^,⁶⁶	NCT02081079	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
GS-US-337-1119 [Genotype 5]¹¹^,⁶⁶	NCT02081079	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
HALLMARK DUAL¹⁰⁰^,¹⁰¹^,¹³⁵	NCT01581203	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
HALLMARK DUAL¹⁰⁰^,¹⁰¹^,¹³⁵	NCT01581203	PBO	Yes	–
HCV Research UK (HCVRUK)³³	–	DAC 12 weeks + SOF 12 weeks	–	Yes
HCV-TARGET⁵⁰^,¹⁶¹^,¹⁶⁹^,¹⁹⁴^,²¹⁵^,²²⁷	NCT01474811	SOF 400 mg qd 12 weeks + RBV Clinician discretion 12 weeks	–	Yes
		SOF 400 mg qd 16 weeks + RBV Clinician discretion 16 weeks
		SOF 24 weeks + RBV Clinician discretion 24 weeks
		LDV 90 mg qd 8, 12, or 24 weeks + SOF 400 mg qd 8, 12, or 24 weeks
		ESV + GZR
		SOF + VEL + VEL
HepNet Acute HCV IV Study⁴³^,⁴⁴	NCT02309918	LDV 90 mg qd 6 weeks + SOF 400 mg qd 6 weeks	Yes	–
Hezode 2017⁷⁹^,⁸⁰	–	DAC 60 mg qd 8 weeks + SOF 400 mg qd 8 weeks	Yes	–
Hlaing 2017⁸¹	–	SOF 400 mg qd 24 weeks + RBV 15 mg/kg/day 24 weeks	–	Yes
		LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks
		DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks + RBV 15 mg/kg/day 12 weeks
Ide 2016a⁸⁴	–	DAC 24 weeks + ASV 24 weeks	–	Yes
Ide 2016a⁸⁴	–	LDV 12 weeks + SOF 12 weeks	–	Yes
Ide 2016b⁸⁵	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Iio 2017a⁸⁶	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Iio 2017b⁸⁷	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Ikeda 2017⁸⁸	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
ION-1¹⁴^–¹⁶^,⁷⁴^,²¹⁶^,²³³^,²³⁵	NCT01701401	LDV 90 mg 12 weeks + SOF 400 mg 12 weeks	Yes	–
ION-1¹⁴^–¹⁶^,⁷⁴^,²¹⁶^,²³³^,²³⁵	NCT01701401	LDV 90 mg 24 weeks + SOF 400 mg 24 weeks	Yes	–
ION-2¹³^,¹⁵^,¹⁶^,⁷⁴^,²¹⁶^,²³³^,²³⁵	NCT01768286	LDV 90 mg 12 weeks + SOF 400 mg 12 weeks	Yes	–
ION-2¹³^,¹⁵^,¹⁶^,⁷⁴^,²¹⁶^,²³³^,²³⁵	NCT01768286	LDV 90 mg 24 weeks + SOF 400 mg 24 weeks	Yes	–
ION-3¹⁵^,¹⁶^,⁷⁴^,¹¹⁰^,²¹⁶^,²³³^,²³⁵	NCT01851330	LDV 90 mg 12 weeks + SOF 400 mg 12 weeks	Yes	–
ION-3¹⁵^,¹⁶^,⁷⁴^,¹¹⁰^,²¹⁶^,²³³^,²³⁵	NCT01851330	LDV 90 mg 8 weeks + SOF 400 mg 8 weeks	Yes	–
ION-4¹⁴⁴^,¹⁴⁵^,²³⁶	NCT02073656	SOF 400 mg 12 weeks + LDV 90 mg 12 weeks	Yes	–
Isakov 2016⁹⁰^,²⁴⁷	–	LDV 90 mg qd 8 weeks + SOF 400 mg qd 8 weeks	Yes	–
Ishigami 2017⁹¹	–	DAC + ASV	–	Yes
Itoh 2016⁹²	–	ESV qd 12 weeks + GZR qd 12 weeks	Yes	–
Iwamoto 2017⁹³	–	DAC 12 weeks + SOF 12 weeks	–	Yes
Iwamoto 2017⁹³	–	DAC 24 weeks + SOF 24 weeks	–	Yes
Jargalsaikhan 2017⁹⁷	–	LDV 12 weeks + SOF 12 weeks	Yes	–
Ji 2016⁹⁸	–	DAC 60 mg/day 12 weeks + SOF 400 mg/day 12 weeks	–	Yes
Ji 2016⁹⁸	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
Johnson 2017⁹⁹	–	LDV 8 weeks + SOF 8 weeks	–	Yes
		LDV 12 weeks + SOF 12 weeks
		LDV 24 weeks + SOF 24 weeks
Kawada 2015¹⁰⁴	–	ESV 50 mg qd 12 weeks + GZR 50 mg qd 12 weeks	Yes	–
Kawada 2015¹⁰⁴	–	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
Kawakami 2016¹⁰⁵	UMIN000015539	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	–	Yes
Korenaga 2017¹⁰⁸	–	LDV 12 weeks + SOF 12 weeks	Yes	–
Kumada 2014¹¹³^,¹³⁹^,²²⁵	NCT01497834	DAC 60 mg 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Kumada 2016a¹¹²	NCT01718145	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Kumada 2016b¹¹⁴^,¹⁹⁰	NCT02203149	ESV 50 mg qd 12 weeks + GZR 50 mg qd 12 weeks	Yes	–
Kumada 2016b¹¹⁴^,¹⁹⁰	NCT02203149	ESV 50 mg qd 12 weeks + GZR 100 mg qd 12 weeks	Yes	–
Kwo 2016¹¹⁹	–	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
Lawitz 2017¹²²^,¹²⁴	NCT02536313	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks + VOX 100 mg qd 12 weeks	Yes	–
Lionetti 2017¹²⁸	–	DAC 24 weeks + SOF 24 weeks + RBV 922 ± 200 mg/day 24 weeks	–	Yes
Lionetti 2017¹²⁸	–	DAC 24 weeks + SOF 24 weeks	–	Yes
Liu 2017¹²⁹	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Lok 2012¹³⁰	NCT01012895	DAC 60 mg 24 weeks + ASV 600 mg bid 24 weeks	Yes	–
LONESTAR¹²³	NCT01726517	LDV 90 mg 12 weeks + SOF 400 mg 12 weeks	Yes	–
LONESTAR¹²³	NCT01726517	LDV 90 mg 8 weeks + SOF 400 mg 8 weeks	Yes	–
MAGELLAN-1, Part 1¹⁶⁵^,¹⁶⁶	NCT02446717	GCR 200 mg qd 12 weeks + PBV 80 mg qd 12 weeks	Yes	–
MAGELLAN-1, Part 1¹⁶⁵^,¹⁶⁶	NCT02446717	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
MAGELLAN-1, Part 2¹⁶⁷^,¹⁶⁸	NCT02446717	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
MAGELLAN-1, Part 2¹⁶⁷^,¹⁶⁸	NCT02446717	GCR 300 mg qd 16 weeks + PBV 120 mg qd 16 weeks	Yes	–
MALACHITE-I³⁵^,⁴⁷	NCT01854697	PTV/r 150 mg/100 mg qd 12 weeks + OMV 25 mg qd 12 weeks + DBV 250 mg bid 12 weeks	Yes	–
Mangia 2016a¹³²	–	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
Mangia 2016a¹³²	–	DAC 60 mg qd 24 weeks + SOF 400 mg qd 24 weeks	–	Yes
Mangia 2017a¹³³	EUDRACT 2015-002401-1	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Mangia 2017b¹³⁴	–	SOF 400 mg qd 16 weeks + RBV 1000 or 1200 mg/day 16 weeks	–	Yes
Mangia 2017b¹³⁴	–	SOF 400 mg qd 20 weeks + RBV 1000 or 1200 mg/day 20 weeks	–	Yes
Mehta 2017¹³⁸	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
		DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks
		DAC 60 mg qd 24 weeks + SOF 400 mg qd 24 weeks
		DAC 60 mg qd 24 weeks + SOF 400 mg qd 24 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (>75 kg), divided doses 24 weeks
Mizokami 2015¹⁴⁰	NCT01975675	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Nagao 2017¹⁴³	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
Nguyen 2017¹⁵⁰^,¹⁵¹	–	LDV 90 mg qd 8 weeks + SOF 400 mg qd 8 weeks	Yes	–
Nguyen 2017¹⁵⁰^,¹⁵¹	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Ogawa 2016¹⁵⁵	–	SOF 400 mg qd 12 weeks + RBV Weight-adjusted (600-1000 mg/day) 12 weeks	–	Yes
Ogawa 2017a¹⁵⁶	UMIN000015627	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Ogawa 2017b¹⁵³^,¹⁵⁴	UMIN000024007	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
ONYX-I²⁰⁶^,²⁰⁷	–	PTV/r 12 weeks + OMV 12 weeks + DBV 12 weeks	Yes	–
ONYX-I²⁰⁶^,²⁰⁷	–	PBO 12 weeks	Yes	–
PEARL-II¹⁷^,²⁰⁸	NCT01674725	PTV/r 150/100 mg 12 weeks + OMV 25 mg 12 weeks + DBV 250 mg bid 12 weeks	Yes	–
PEARL-III⁵³^,²⁰⁸	NCT01767116	PTV/r 150/100 mg 12 weeks + OMV 25 mg 12 weeks + DBV 250 mg bid 12 weeks	Yes	–
PEARL-IV⁵³	NCT01833533	PTV/r 150/100 mg 12 weeks + OMV 25 mg 12 weeks + DBV 250 mg bid 12 weeks	Yes	–
Persico 2017¹⁶²	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
PHOTON-2¹⁴¹^,¹⁴²^,²³⁴	NCT01783678	SOF 400 mg qd 24 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 24 weeks	Yes	–
PHOTON-2¹⁴¹^,¹⁴²^,²³⁴	NCT01783678	SOF 400 mg qd 12 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 12 weeks	Yes	–
Pianko 2015¹⁶³	NCT01909804	SOF 400 mg qd 12 weeks + VEL 25 mg qd 12 weeks	Yes	–
Pianko 2015¹⁶³	NCT01909804	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
POLARIS-1²¹^,²²	NCT02607735	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks + VOX 100 mg qd 12 weeks	Yes	–
POLARIS-1²¹^,²²	NCT02607735	PBO	Yes	–
POLARIS-2⁹⁶	NCT02607800	SOF 400 mg qd 8 weeks + VEL 100 mg qd 8 weeks + VOX 100 mg qd 8 weeks	Yes	–
POLARIS-2⁹⁶	NCT02607800	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
POLARIS-3⁹⁶	NCT02639338	SOF 400 mg qd 8 weeks + VEL 100 mg qd 8 weeks + VOX 100 mg qd 8 weeks	Yes	–
POLARIS-3⁹⁶	NCT02639338	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
POLARIS-4²¹^,²⁴²	NCT02639247	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks + VOX 100 mg qd 12 weeks	Yes	–
POLARIS-4²¹^,²⁴²	NCT02639247	SOF 400 mg qd 12 weeks + VEL 100 mg qd 12 weeks	Yes	–
POSITRON²⁶^,⁹⁵	NCT01542788	SOF 400 mg qd 12 weeks + RBV 1000-1200 mg/day 12 weeks	Yes	–
Reddy 2017¹⁷⁰	–	DAC + ASV	–	Yes
Sezaki 2017¹⁷⁵	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	–	Yes
Shah 2016¹⁷⁶	NCT02074514	SOF 400 mg qd 16 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 16 weeks	Yes	–
Shah 2016¹⁷⁶	NCT02074514	SOF 400 mg qd 24 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 24 weeks	Yes	–
Shiha 2017¹⁷⁷	–	LDV 8 weeks + SOF 8 weeks	Yes	–
Shiha 2017¹⁷⁷	–	LDV 12 weeks + SOF 12 weeks	Yes	–
SIRIUS²⁰^,²³^,²⁷^,²⁰³^,²³⁷^,²³⁸	NCT01965535	SOF 400 mg 24 weeks + LDV 90 mg qd 24 weeks	Yes	–
Slash C¹⁶⁰	–	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Suda 2016¹⁸²	UMIN000016355	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	–	Yes
Suda 2017¹⁸³	UMIN000020301	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	–	Yes
Sung 2016¹⁸⁸	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	–	Yes
SURVEYOR-I⁶⁵^,¹¹⁸	NCT02243280	GCR 200 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
		GCR 200 mg qd 12 weeks + PBV 40 mg qd 12 weeks
		GCR 300 mg qd 8 weeks + PBV 120 mg qd 8 weeks
		GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks
SURVEYOR-II⁶⁵^,¹¹⁸	NCT02243293	GCR 300 mg qd 12 weeks + PBV 120 mg qd 12 weeks	Yes	–
		GCR 200 mg qd 12 weeks + PBV 120 mg qd 12 weeks
		GCR 200 mg qd 12 weeks + PBV 40 mg qd 12 weeks
		GCR 300 mg qd 8 weeks + PBV 120 mg qd 8 weeks
Suzuki 2017¹⁸⁹	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	–	Yes
SYNERGY⁶⁶^,¹⁰⁶^,¹⁰⁷^,¹⁷⁸^,¹⁹⁷^,²¹⁷	NCT01805882	LDV 90 mg qd 12 weeks + SOF 400 mg qd 12 weeks	Yes	–
Terashita 2017¹⁹³	–	DAC + ASV	Yes	–
Torres 2017¹⁹⁵	–	LDV + SOF	–	Yes
		SOF + VEL
		DAC + SOF
Toyoda 2016²⁰⁰	UMIN000017023	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Toyoda 2017¹⁹⁹	UMIN000017020	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
TURQUOISE-III⁵¹	NCT02219503	PTV/r 150/100 mg qd 12 weeks + OMV 25 mg qd 12 weeks + DBV 250 mg bid 12 weeks	Yes	–
UNITY-3²⁰¹	NCT02123654	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
VALENCE¹²⁵^,²³⁴^,²⁴¹^,²⁴⁶	NCT01682720	SOF 400 mg qd 12 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 12 weeks	Yes	–
		SOF 400 mg qd 24 weeks + RBV 1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg), twice per day 24 weeks
		PBO
VALOR-HCV ⁸²	NCT02128542	SOF 400 mg qd 12 weeks + RBV Weight-adjusted (1000-1200 mg/day divided doses) 12 weeks	Yes	–
VASCUVALDIC 2¹⁷³^,¹⁷⁴	NCT02856243	DAC 60 mg qd 12 weeks + SOF 400 mg qd 12 weeks	–	Yes
VASCUVALDIC 2¹⁷³^,¹⁷⁴	NCT02856243	DAC 60 mg qd 24 weeks + SOF 400 mg qd 24 weeks	–	Yes
Vierling 2015²⁰⁴	–	ESV 50 mg 8 weeks + GZR 100 mg 8 weeks	Yes	–
Wei 2016²¹¹	NCT01995266	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Wei 2017a²¹⁰	–	SOF 400 mg 12 weeks + RBV 1000-1200 mg divided daily dose 12 weeks	Yes	–
Wei 2017a²¹⁰	–	SOF 400 mg 24 weeks + RBV 1000-1200 mg divided daily dose 24 weeks	Yes	–
Wei 2017b²⁰⁹	–	DAC 60 mg qd 24 weeks + ASV 100 mg bid 24 weeks	Yes	–
Wei 2017b²⁰⁹	–	PBO	Yes	–
Yakoot 2017²²³	ACTRN 12617000263392	DAC (generic) 60 mg/day 12 weeks + SOF (generic) 400 mg/day 12 weeks	Yes	–
Yakoot 2017²²³	ACTRN 12617000263392	DAC (generic) 60 mg/day response-tailored duration + SOF (generic) 400 mg/day response-tailored duration	Yes	–
Younossi 2016²²⁶	–	LDV 12 weeks + SOF 12 weeks	Yes	–
Zeng 2017²⁴⁰	–	LDV (generic) 90 mg qd 8 weeks + SOF (generic) 400 mg qd 8 weeks	–	Yes

References

1.: Viechtbauer W. Conducting Meta-Analyses in R with the metafor Package. Journal of Statistical Software 2010; 36(3): 48.
2.: Wallace BC, Dahabreh IJ, Trikalinos TA, Lau J, Trow P, Schmid CH. Closing the Gap between Methodologists and End-Users: R as a Computational Back-End. Journal of Statistical Software 2012; 49(5): 15.
3.: Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj 2011; 343: d5928. [PMC free article: PMC3196245] [PubMed: 22008217]
4.: Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. Bmj 2008; 336(7650): 924–6. [PMC free article: PMC2335261] [PubMed: 18436948]
5.: Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence-study limitations (risk of bias). Journal of clinical epidemiology 2011; 64(4): 407–15. [PubMed: 21247734]
6.: Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. Journal of clinical epidemiology 2011; 64(12): 1294–302. [PubMed: 21803546]
7.: Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. Journal of clinical epidemiology 2011; 64(12): 1277–82. [PubMed: 21802904]
8.: Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 8. Rating the quality of evidence-indirectness. Journal of clinical epidemiology 2011; 64(12): 1303–10. [PubMed: 21802903]
9.: Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. Journal of clinical epidemiology 2011; 64(12): 1311–6. [PubMed: 21802902]
10.: Abdel-Aziz AM, Ibrahim MA, El-Sheikh AA, et al. Effect of Sofosbuvir Plus Daclatasvir in Hepatitis C Virus Genotype-4 Patients: Promising Effect on Liver Fibrosis. Journal of Clinical and Experimental Hepatology 2017. [PMC free article: PMC5938328] [PubMed: 29743792]
11.: Abergel A, Asselah T, Metivier S, et al. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. The Lancet Infectious Diseases 2016; 16(4): 459–64. [PubMed: 26803446]
12.: Abergel A, Metivier S, Samuel D, et al. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology 2016; 64(4): 1049–56. [PubMed: 27351341]
13.: Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. New England Journal of Medicine 2014; 370(16): 1483–93. [PubMed: 24725238]
14.: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. The New England journal of medicine 2014; 370(20): 1889–98. [PubMed: 24725239]
15.: Alqahtani S, Afdahl NH, Zeuzem S, et al. Safety of ledipasvir sofosbuvir with and without ribavirin for the treatment of patients with chronic HCV genotype 1 infection an analysis of the phase 3 ion trials. Hepatology international; 9(1 SUPPL. 1): S59–S60.
16.: Alqahtani SAA, N.; Zeuzem, S.; Gordon, S. C.; Mangia, A.; Kwo, P.; Fried, M.; Yang, J. C.; Ding, X.; Pang, P. S.; McHutchison, J. G.; Pound, D.; Reddy, K. R.; Marcellin, P.; Kowdley, K. V.; Sulkowski, M. Safety and tolerability of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic hepatitis C virus genotype 1 infection: Analysis of phase III ION trials. Hepatology (Baltimore, Md) 2015; 62(1): 25–30. [PubMed: 25963890]
17.: Andreone P, Colombo MG, Enejosa JV, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology 2014; 147(2): 359–65.e1. [PubMed: 24818763]
18.: Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Comparative effectiveness of ledipasvir/sofosbuvir +/- ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin in 6961 genotype 1 patients treated in routine medical practice. Alimentary Pharmacology and Therapeutics 2016; 44(4): 400–10. [PubMed: 27291852]
19.: Bansal A, Goyal O. Treatment of Patients with Chronic Hepatitis Genotype 3 Infection with/without Cirrhosis with Sofosbuvir and Daclatasvir Therapy. Gastroenterology 2017; 152(5): S1091–S2.
20.: Bourliere M, Bronowicki JP, de Ledinghen V, et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis 2015; 15(4): 397–404. doi: 10.1016/S473-3099(15)70050-2. Epub 2015 Mar 13. [PubMed: 25773757] [CrossRef]
21.: Bourliere M, Gordon SC, Flamm SL, et al. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection. New England Journal of Medicine 2017; 376(22): 2134–46. [PubMed: 28564569]
22.: Bourliere M, Gordon SC, Ramji A, et al. Sofosbuvir/velpatasvir/voxilaprevir for 12 weeks as a salvage regimen in NS5A inhibitor-experienced patients with genotype 1-6 infection: the phase 3 POLARIS-1 study. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 102A–3A.
23.: Bourliere MB, J. P.; de Ledinghen, V.; Hezode, C.; Zoulim, F.; Mathurin, P.; Tran, A.; Larrey, D. G.; Ratziu, V.; Alric, L.; Hyland, R. H.; Jiang, D.; Doehle, B.; Pang, P. S.; Symonds, W. T.; Subramanian, G. M.; McHutchison, J. G.; Marcellin, P.; Habersetzer, F.; Guyader, D.; Grange, J. D.; Loustaud-Ratti, V.; Serfaty, L.; Metivier, S.; Leroy, V.; Abergel, A.; Pol, S. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: A randomised, double-blind, phase 2 trial (SIRIUS). The Lancet Infectious Diseases 2015; 15(4): 397–404. [PubMed: 25773757]
24.: Bristol-Myers Squibb. A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naive and Treatment- experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected with Human Immunodeficiency Virus (HIV). 2015.
25.: Bristol-Myers Squibb. A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment-Naive and Treatment-Experienced Subjects with Genotype 3 Chronic Hepatitis C Infection 2015.
26.: Carlin AFA, P.; Song, Q.; Wang, H.; Paulson, M. S.; Stamm, L. M.; Schooley, R. T.; Wyles, D. L. Temporal dynamics of inflammatory cytokines/chemokines during sofosbuvir and ribavirin therapy for genotype 2 and 3 hepatitis C infection. Hepatology 2015; 62(4): 1047–58. [PMC free article: PMC4589477] [PubMed: 26147061]
27.: Carrieri MPP, C.; Younossi, Z.; Vilotitch, A.; Fontaine, H.; Petrov-Sanchez, V.; Marcellin, F.; Carrat, F.; Hezode, C.; Bourliere, M.; Poncin, E.; Botta-Friedland, D.; Fontanges, T.; Arpurt, J. P.; Bacq, Y.; Cales, P.; Delasalle, P.; Ouzan, D.; Nousbaum, J. B.; Sylvain, C.; Ribard, D.; Gatineau-Sailliant, G.; de Montigny-Lenhardt, S.; Renard, P.; Pilette, C.; Denis, J.; Lascoux-Combe, C.; Abel, L.; Albert, M.; Chazouilleres, O.; Dubuisson, J.; Negro, F.; Pageaux, G. P.; Paradis, V.; Spire, B.; Taburet, A. M.; Trinchet, J. C.; Yazdanpanah, Y.; Dufour, C.; Frehaut, C.; Pirot, M.; Lesel, A.; Zahraa, N.; Chau, F. Health-Related Quality of Life in Chronic HCV-Infected Patients Switching to Pegylated-Interferon-Free Regimens (ANRS CO20 CUPIC Cohort Study and SIRIUS Trial). Patient 2017: 1–10. [PubMed: 28353221]
28.: Chamorro-de-Vega E, Gimenez-Manzorro A, Rodriguez-Gonzalez CG, et al. Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice. Annals of Pharmacotherapy 2016; 50(11): 901–8. [PubMed: 27422641]
29.: Charlton M, O’Leary J, Osinusi A, et al. Sofosbuvir/Velpatasvir for the treatment of HCV in patients with decompensated liver disease: the ASTRAL-4 study. Transplantation 2016; Conference: 22nd annual international congress of the international liver transplantation society, ILTS. 2016. South korea. Conference start: 20160504. Conference end: 20160507 100(5 Supplement 1): S102–S3.
30.: Chayama K, Suzuki F, Karino Y, et al. CERTAIN-1: efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis. Journal of Hepatology 2017; 66: S527. [PMC free article: PMC5866824] [PubMed: 28948366]
31.: Chayama K, Suzuki F, Sato K, et al. Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection with and without cirrhosis. Journal of Hepatology 2017; 66: S528. [PMC free article: PMC5866824] [PubMed: 28948366]
32.: Chen JH, Zeng Z, Zhang XX, et al. Efficacy and safety of combined directly acting antivirals for treatment of Chinese chronic hepatitis C patients in a real-world setting. World Journal of Gastroenterology 2017; 23(22): 4072–9. [PMC free article: PMC5473126] [PubMed: 28652660]
33.: Cheung MCM, Walker AJ, Hudson BE, et al. Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis. Journal of Hepatology 2016; 65(4): 741–7. [PubMed: 27388925]
34.: Chuang WL, Chien RN, Peng CY, et al. Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus. J Gastroenterol Hepatol 2016; 31(7): 1323–9. [PubMed: 26841930]
35.: Conway B, Janczewska E, Luo Y, et al. Malachite-I: Phase 3B trial of ombitasvir/paritaprevir/R and dasabuvir +/- ribavirin or telaprevir + peginterferon/ribavirin in treatment-naive adults with HCV genotype 1. Gastroenterology; 148(4 SUPPL. 1): S1001–S2.
36.: Cornberg MP, J.; Schober, A.; Mauss, S.; Boker, K. H. W.; Link, R.; Gunther, R.; Serfert, Y.; Pfeiffer-Vornkahl, H.; Manns, M. P.; Sarrazin, C.; Huppe, D.; Berg, T.; Niederau, C. Real-world use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection. Aliment Pharmacol Ther 2017; 45(5): 688–700. [PubMed: 28078723]
37.: Curry M, O’Leary J, Brown RS, et al. Clinical benefits of successful treatment in HCV infected patients with decompensated cirrhosis treated with sofosbuvir/velpatasvir. Transplantation 2016; Conference: 22nd annual international congress of the international liver transplantation society, ILTS. 2016. South korea. Conference start: 20160504. Conference end: 20160507 100(5 Supplement 1): S136.
38.: Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. New England Journal of Medicine 2015; 373(27): 2618–28. [PubMed: 26569658]
39.: Dashtseren B, Dendev B, Genden Z, et al. Hepatitis C treatment with sofosbuvir/ledipasvir single tablet regimen in Mongolia. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S1036–S7.
40.: Dashtseren B, Dendev B, Genden Z, et al. Hepatitis C treatment with sofosbuvir/ledispasvir single tablet regimen in Mongolia. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S1034.
41.: Desnoyer A, Pospai D, Le MP, et al. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. Journal of Hepatology 2016; 65(1): 40–7. [PubMed: 26952005]
42.: Deterding K, Honer Zu Siederdissen C, Port K, et al. Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies. Aliment Pharmacol Ther 2015; 42(7): 889–901. [PubMed: 26250762]
43.: Deterding K, Spinner CD, Schott E, et al. Ledipasvir plus sofosbuvir fixed-dose combination for 6 weeks in patients with acute hepatitis C virus genotype 1 monoinfection (HepNet Acute HCV IV): an open-label, single-arm, phase 2 study. Lancet infectious diseases 2017; 17(2): 215–22. [PubMed: 28029529]
44.: Deterding K, Spinner CD, Schott E, et al. Six weeks of sofosbuvir/ledipasvir treatment of acute hepatitis C virus genotype 1 monoinfection: final results of the The German HepNet Acute HCV IV Study. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 416A–7A.
45.: Dore GJ, Altice F, Litwin AH, et al. Elbasvir-grazoprevir to treat hepatitis C virus infection in persons receiving opioid agonist therapy a randomized trial. Annals of Internal Medicine 2016; 165(9): 625–34. [PubMed: 27537841]
46.: Dore GJ, Altice F, Litwin AH, et al. C-EDGE CO-STAR: risk of reinfection following successful therapy with elbasvir and grazoprevir in persons who inject drugs (PWID) receiving opioid agonist therapy (OAT). Journal of gastroenterology and hepatology 2016; 31: 70–1.
47.: Dore GJ, Conway B, Luo Y, et al. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. Journal of Hepatology 2016; 64(1): 19–28. [PubMed: 26321288]
48.: Everson GT, Towner WJ, Davis MN, et al. Sofosbuvir with velpatasvir in treatment-naive noncirrhotic patients with genotype 1 to 6 hepatitis c virus infection. Annals of internal medicine 2015; 163(11): 818–26. [PubMed: 26551051]
49.: Feld JJ, Jacobson IM, Hode C, et al. Sofosbuvir and velpatasvir for hcv genotype 1, 2, 4, 5, and 6 infection. New England Journal of Medicine 2015; 373(27): 2599–607. [PubMed: 26571066]
50.: Feld JJ, Maan R, Zeuzem S, et al. Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study. Clinical Infectious Diseases 2016; 63(6): 776–83. [PMC free article: PMC4996139] [PubMed: 27325691]
51.: Feld JJ, Moreno C, Trinh R, et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks. Journal of Hepatology 2016; 64(2): 301–7. [PubMed: 26476290]
52.: Feld JJ, Nelson DR, Kowdley KV, et al. All oral therapy with sofosbuvir + ribavirin for 12 or 16 weeks in treatment experienced genotype 2/3 HCV-infected patients: The fusion trial. Hepatology International 2013; 7: S436.
53.: Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014; 370(21): 1983–92. doi: 10.056/NEJMoa1402338. Epub 2014 May 4. [PubMed: 24795200] [CrossRef]
54.: Fierer DS, El Sayed A, Palaniswami P. Treatment of “acute” hepatitis C virus in human immunodeficiency virus-infected men with short-course sofosbuvir/ledipasvir. Journal of Hepatology 2017; 66: S300.
55.: Fontaine HH, C.; Roudot-Thoraval, F.; Pol, S. Safety and efficacy of the combination ombitasvir/paritaprevir/ritonavir +/- dasabuvir in HCV genotype 1-or 4-mono-infected patients from the french ANRS Co22 hepather cohort. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 453A.
56.: Forns X, Lee S, Valdes J, et al. EXPEDITION-I: efficacy and safety of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis. Journal of Hepatology 2017; 66: S3. [PubMed: 28818546]
57.: Forns X, Lee S, Valdes JM, et al. EXPEDITION-I: Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis. Gastroenterology 2017; 152(5): S1061. [PubMed: 28818546]
58.: Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. The Lancet Infectious diseases 2017. [PubMed: 28818546]
59.: Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV Genotype 2 and 3 infection. New England Journal of Medicine 2015; 373(27): 2608–17. [PubMed: 26575258]
60.: Foster GR, Gane E, Asatryan A, et al. ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis. Journal of Hepatology 2017; 66: S34.
61.: Foster GR, Irving WL, Cheung MCM, et al. Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis. Journal of Hepatology 2016; 64(6): 1224–31. [PubMed: 26829205]
62.: Foster GR, Pianko S, Brown A, et al. Efficacy of Sofosbuvir Plus Ribavirin with or Without Peginterferon-Alfa in Patients with Hepatitis C Virus Genotype 3 Infection and Treatment-Experienced Patients with Cirrhosis and Hepatitis C Virus Genotype 2 Infection. Gastroenterology 2015; 149(6): 1462–70. [PubMed: 26248087]
63.: Foster GR, Pianko S, Cooper C, et al. Sofosbuvir + peginterferon/ribavirin for 12 weeks vs sofosbuvir + ribavirin for 16 or 24 weeks in genotype 3 HCV infected patients and treatment-experienced cirrhotic patients with genotype 2 HCV: The boson study. Journal of hepatology 2015; 62(22). [PMC free article: PMC4617178] [PubMed: 26504459]
64.: Gane E, Hyland RH, An D, et al. Ledipasvir Plus Sofosbuvir With or Without Ribavirin for 12 Weeks in Patients With Hepatitis C Genotype 3 or 6 Infection. 2015. [PubMed: 26261007]
65.: Gane E, Poordad F, Wang S, et al. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology 2016; 151(4): 651–9.e1. [PubMed: 27456384]
66.: Gane E, Stedman CAM, Asselah T, et al. Ledipasvir/sofosbuvir with or without ribavirin for the treatment of patients with genotype 2-6 chronic HCV infection: Summary results from four phase ii studies. American journal of gastroenterology 2015; 110(16).
67.: Gane EJ, Hyland RH, An D, et al. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology 2015; 149(6): 1454–61.e1. [PubMed: 26261007]
68.: Gane EJ, Hyland RH, Yang Y, et al. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology 2017; 152(6): 1366–71. [PubMed: 28137593]
69.: Gane EJ, Stedman CA, Hyland RH, et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology 2014; 146(3): 736–43.e1. [PubMed: 24262278]
70.: Gane EN, R.; Luketic, V.; Asante-Appiah, E.; Hwang, P.; Robertson, M.; Wahl, J.; Barr, E.; Haber, B. Efficacy of 12 or 18 weeks of elbasvir plus grazoprevir with ribavirin in treatment-naive, noncirrhotic HCV genotype 3-infected patients. Journal of Viral Hepatitis 2017. [PubMed: 28470815]
71.: Gee Lim S, Patel K, Agarwal K, et al. Sofosbuvir/velpatasvir for 12 weeks results in high SVR12 rates in patients with indeterminate genotypes: an integrated analysis of efficacy from the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S102–S3.
72.: George J, Burnevich EZ, Sheen IS, et al. Efficacy and safety of elbasvir/grazoprevir in treatment-naive subjects with chronic HCV GT 1, GT 4 and GT 6 infection (C-CORAL): a phase III randomized multinational clinical trial. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 41A.
73.: Grebely J, Dore GJ, Zeuzem S, et al. Efficacy and safety of sofosbuvir/velpatasvir in patients with chronic hepatitis C virus infection receiving opioid substitution therapy: analysis of phase 3 ASTRAL trials. Clinical infectious diseases 2016; 63(11): 1479–81. [PMC free article: PMC5106608] [PubMed: 27553377]
74.: Grebely JM, S.; Brown, A.; Bronowicki, J. P.; Puoti, M.; Wyles, D.; Natha, M.; Zhu, Y.; Yang, J.; Kreter, B.; Brainard, D. M.; Yun, C.; Carr, V.; Dore, G. J. Efficacy and safety of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic HCV genotype 1 infection receiving opioid substitution therapy: analysis of phase 3 ION trials. Clinical infectious diseases 2016; 63(11): 1405–11. [PubMed: 27553375]
75.: Hezode C, Colombo M, Bourliere M, et al. Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study. Hepatology 2017; 03: 03. [PubMed: 28256747]
76.: Hezode C, Colombo M, Spengler U, et al. C-edge IBLD: efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in patients with chronic hepatitis C virus (HCV) infection and inherited blood disorders (IBLD). Haematologica Conference: 21st congress of the european hematology association Denmark 2016; 101: 308–9.
77.: Hezode C, Colombo M, Spengler U, et al. C-EDGE IBLD: efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in subjects with chronic hepatitis Cvirus infection and inherited blood disorders. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S753.
78.: Hezode C, Fried MW, Colombo M, et al. Efficacy and safety of elbasvir/grazoprevir in patients with chronic hepatitis c virus infection and inherited blood disorders: final data from the C-edge IBLD study. Blood Conference: 58th annual meeting of the american society of hematology, ASH 2016; 128(22).
79.: Hezode C, Leroy V, Rosa I, Pawlotsky J-M, de Ledinghen V, Bronowicki J-P. Efficacy and Safety of Sofosbuvir and Daclatasvir for 8 Weeks in Treatment-Naive Non-Cirrhotic Patients with Chronic HCV Genotype 3 Infection. Gastroenterology 2017; 152(5): S1099.
80.: Hezode C, Leroy V, Rosa I, et al. Efficacy and safety of sofosbuvir and daclatasvir for 8 weeks in treatment-naïve non-cirrhotic patients with chronic hepatitis C virus Genotype 3 Infection. Journal of Hepatology 2017; 66: S299.
81.: Hlaing NKT, Mitrani RA, Aung ST, et al. Safety and efficacy of sofosbuvir-based direct-acting antiviral regimens for hepatitis C virus genotypes 1-4 and 6 in Myanmar: Real-world experience. Journal of Viral Hepatitis 2017. [PubMed: 28475232]
82.: Ho SB, Kaplan DE, Byrne S, et al. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clinical gastroenterology and hepatology 2017; 15(2): 282–8. [PubMed: 27237429]
83.: Honer Zu Siederdissen C, Maasoumy B, Deterding K, et al. Eligibility and safety of the first interferon-free therapy against hepatitis C in a real-world setting. Liver International 2015; 35(7): 1845–52. [PubMed: 25556625]
84.: Ide T, Eguchi Y, Harada M, et al. Efficacy and safety of DAAs therapy in hepatitis C: a multicenter real-world cohort of chronic hepatitis C patients. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 459A.
85.: Ide T, Eguchi Y, Harada M, et al. Evaluation of resistance-associated substitutions in NS5A using direct sequence and cycleave method and treatment outcome with daclatasvir and asunaprevir for chronic hepatitis C genotype 1. PLoS ONE 2016; 11 (9) (no pagination)(e0163884). [PMC free article: PMC5042440] [PubMed: 27684567]
86.: Iio E, Shimada N, Abe H, et al. Efficacy of daclatasvir/asunaprevir according to resistance-associated variants in chronic hepatitis C with genotype 1. Journal of gastroenterology 2017; 52(1): 94–103. [PubMed: 27236547]
87.: Iio E, Shimada N, Takaguchi K, et al. Clinical evaluation of sofosbuvir/ledipasvir in patients with chronic hepatitis C genotype 1 with and without prior daclatasvir/asunaprevir therapy. Hepatology Research 2017. [PubMed: 28332272]
88.: Ikeda H, Watanabe T, Okuse C, et al. Impact of resistance-associated variant dominancy on treatment in patients with HCV genotype 1b receiving daclatasvir/asunaprevir. Journal of Medical Virology 2017; 89(1): 99–105. [PubMed: 27329864]
89.: Ingiliz P, Christensen S, Kimhofer T, et al. Sofosbuvir and Ledipasvir for 8 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in HCV-Monoinfected and HIV-HCV-Coinfected Individuals: results from the German Hepatitis C Cohort (GECCO-01). Clinical infectious diseases 2016; 63(10): 1320–4. [PubMed: 27535952]
90.: Isakov V, Gankina N, Salupere R, et al. Ledipasvir/Sofosbuvir for 8 weeks results in high SVR rates in treatment-naive patients with chronic HCV Infection and HIV/HCV Co-infection. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 1010A.
91.: Ishigami M, Hayashi K, Honda T, et al. Real World Data of Daclatasvir and Asunaprevir Combination Therapy for HCV Genotype 1b Infection in Patients With Renal Dysfunction. Clinical gastroenterology and hepatology 2017; 15(5): 787–8. [PubMed: 28013118]
92.: Itoh Y, Suzuki F, Karino Y, et al. Prevalence and impact of baseline resistance-associated variants on the efficacy of elbasvir / grazoprevir in hepatitis c genotype 1 infected Japanese patients. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 420A.
93.: Iwamoto M, Sonderup M, Fortas C, Maman D. Real-world effectiveness and safety of Daclatasvir/Sofosbuvir ± Ribavirin among genotype 5 and 6 patients: Medecins Sans Frontieres, 2017.
94.: Jacobson I, Brau N, Bourgeois S, et al. The tolerability of SOF/VEL for 12 weeks in >1,000 patients treated in the astral-1, astral-2, and astral-3 studies: an integrated safety analysis. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S773–S4.
95.: Jacobson I, Yoshida EM, Sulkowski M, et al. Treatment with sofosbuvir + ribavirin for 12 weeks achieves SVR12 of 78% in GT2/3 interferon-ineligible, -intolerant, or -unwilling patients: Results of the phase 3 positron trial. Journal of hepatology 2013; 58(24).
96.: Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology 2017; 153(1): 113–22. [PubMed: 28390869]
97.: Jargalsaikhan G, Dashtseren B, Dendev B, et al. Active versus passive follow-up examination of patients with chronic hepatitis C during Sofosbuvir/Ledipasvir treatment. Journal of Hepatology 2017; 66: S501.
98.: Ji D, Chen GF, Wang C, et al. Twelve-week ribavirin-free direct-acting antivirals for treatment-experienced Chinese with HCV genotype 1b infection including cirrhotic patients. Hepatology International 2016; 10(5): 789–98. [PubMed: 27443347]
99.: Johnson SW, Ammirati SR, Hartis CE, et al. Effectiveness of ledipasvir/sofosbuvir in real-world patients with chronic hepatitis C: a collaborative treatment approach. International Journal of Antimicrobial Agents 2017; 49(6): 778–81. [PubMed: 28389353]
100.: Kao JH, Lee YJ, Heo J, et al. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver International 2016; 36(10): 1433–41. [PubMed: 27009831]
101.: Kao JH, Peng CY, Chang TT, et al. All oral dual therapy with daclatasvir and asunaprevir in patients in Korea and Taiwan with HCV genotype 1B infection. Hepatology international; 9(1 SUPPL. 1): S74–S5.
102.: Karino Y, Suzuki F, Suzuki Y, et al. All oral dual combination of daclatasvir plus asunaprevir compared with telaprevir plus peginterferon alfa ribavirin in treatment naive Japanese patients chronically infected with HCV genotype 1b results from a phase 3 study. Hepatology international; 9(1 SUPPL. 1): S72.
103.: Kattakuzhy S, Emmanuel B, Gross C, et al. Adherence to prescriptions a better predictor than adherence to treatment visits for SVR among patients treated with DAA therapy in a task-shifting model. Journal of Hepatology 2017; 66: S706.
104.: Kawada N, Suzuki F, Karino Y, et al. Efficacy, safety and pharmacokinetics of grazoprevir (MK-5172) and elbasvir (MK-8742) In hepatitis C genotype 1 infected non-cirrhotic japanese patients (phase 2 portion in phase 2/3 combined study). Hepatology 2015; 62(13).
105.: Kawakami Y, Imamura M, Ikeda H, et al. Pharmacokinetics, efficacy and safety of daclatasvir plus asunaprevir in dialysis patients with chronic hepatitis C: pilot study. Journal of Viral Hepatitis 2016; 23(11): 850–6. [PubMed: 27346670]
106.: Kohli AK, R.; Sims, Z.; Nelson, A.; Sidharthan, S.; Lam, B.; Silk, R.; Kotb, C.; Gross, C.; Teferi, G.; Sugarman, K.; Pang, P. S.; Osinusi, A.; Polis, M. A.; Rustgi, V.; Masur, H.; Kottilil, S. Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study. The Lancet Infectious Diseases 2015; 15(9): 1049–54. [PMC free article: PMC4561573] [PubMed: 26187031]
107.: Kohli AO, A.; Sims, Z.; Nelson, A.; Meissner, E. G.; Barrett, L. L.; Bon, D.; Marti, M. M.; Silk, R.; Kotb, C.; Gross, C.; Jolley, T. A.; Sidharthan, S.; Petersen, T.; Townsend, K.; Egerson, D.; Kapoor, R.; Spurlin, E.; Sneller, M.; Proschan, M.; Herrmann, E.; Kwan, R.; Teferi, G.; Talwani, R.; Diaz, G.; Kleiner, D. E.; Wood, B. J.; Chavez, J.; Abbott, S.; Symonds, W. T.; Subramanian, G. M.; Pang, P. S.; McHutchison, J.; Polis, M. A.; Fauci, A. S.; Masur, H.; Kottilil, S. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Lancet 2015; 385(9973): 1107–13. [PMC free article: PMC4427052] [PubMed: 25591505]
108.: Korenaga M, Izumi N, Yokosuka O, et al. Sustained virologic response by ledipasvir/sofosbuvir reduces the incidence of hepatocellular carcinoma in Japanese patients with HCV genotype 1 infection. – Comparison with Simeprevir with peginterferon plus ribavirin. Journal of Hepatology 2017; 66: S23.
109.: Kottilil S, Wyles D, Brau N, et al. Sofosbuvir/velpatasvir fixed dose combination for 12 weeks in patients co-infected with HCV And HIV-1: the phase 3 ASTRAL-5 study. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S111.
110.: Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. New England Journal of Medicine 2014; 370(20): 1879–88. [PubMed: 24720702]
111.: Kowdley KVN, D. R.; Lalezari, J. P.; Box, T.; Gitlin, N.; Poleynard, G.; Rabinovitz, M.; Ravendhran, N.; Sheikh, A. M.; Siddique, A.; Bhore, R.; Noviello, S.; Rana, K. On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir. Liver International 2016; 36(11): 1611–8. [PubMed: 27188960]
112.: Kumada H, Suzuki F, Suzuki Y, et al. Randomized comparison of daclatasvir + asunaprevir versus telaprevir + peginterferon/ribavirin in Japanese hepatitis C virus patients. Journal of gastroenterology and hepatology 2016; 31(1): 14–22. [PubMed: 26252875]
113.: Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014; 59(6): 2083–91. [PMC free article: PMC4315868] [PubMed: 24604476]
114.: Kumada H, Suzuki Y, Karino Y, et al. The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study. Journal of gastroenterology 2016. [PMC free article: PMC5357479] [PubMed: 27873094]
115.: Kwo P, Gane E, Peng CY, et al. Efficacy and safety of grazoprevir/elbasvir +/- RBV for 12 weeks in patients with HCV G1 or G4 infection who previously failed peginterferon/RBV: C-EDGE treatment-experienced trial. Journal of hepatology 2015; 62(22).
116.: Kwo P, Gane EJ, Peng CY, et al. Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection. Gastroenterology 2017; 152(1): 164–75.e4. [PubMed: 27720838]
117.: Kwo PY, Gane E, Peng CY, et al. Efficacy and safety of grazoprevir/elbasvir +/- ribavirin (RBV) for 12 or 16 weeks in patients with HCV G1, G4, or G6 infection who previously failed peginterferon/RBV: C-EDGE treatment-experienced trial. Gastroenterology 2015; 148(4 SUPPL. 1): S1194–S5.
118.: Kwo PY, Poordad F, Asatryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. Journal of Hepatology 2017; 67(2): 263–71. [PubMed: 28412293]
119.: Kwo PY, Wyles DL, Wang S, et al. 100% SVR4 with ABT-493 and ABT-530 with or without ribavirin in treatment-naive hcv genotype 3-infected patients with cirrhosis. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S208.
120.: Lacombe K, Fontaine H, Dhiver C, et al. Real-world efficacy of daclatasvir and sofosbuvir, with and without ribavirin, in HIV/HCV coinfected patients with advanced liver disease in a French early access cohort. Journal of Acquired Immune Deficiency Syndromes 2017; 75(1): 97–107. [PMC free article: PMC5389585] [PubMed: 28272163]
121.: Lawitz E, Gane E, Pearlman B, et al. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): A randomised, open-label phase 2 trial. The Lancet 2015; 385(9973): 1075–86. [PubMed: 25467591]
122.: Lawitz E, Poordad F, Wells J, et al. Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus. Hepatology (baltimore, md) 2017; 65(6): 1803–9. [PubMed: 28220512]
123.: Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet 2014; 383(9916): 515–23. [PubMed: 24209977]
124.: Lawitz EP, F.; Wells, J.; Hyland, R. H.; Yang, Y.; Dvory-Sobol, H.; Stamm, L. M.; Brainard, D. M.; McHutchison, J. G.; Landaverde, C.; Gutierrez, J. High efficacy of sofosbuvir/velpatasvir/GS-9857 with or without ribavirin for 12 weeks in direct acting antiviral-experienced patients with genotype 1 HCV infection. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S146.
125.: Lawitz EZ, S.; Stedman, C. A.; Poordad, F.; Mir, H. M.; Seyedkazemi, S.; Hyland, R. H.; Pang, P.; Brainard, D. M.; McHutchison, J. G.; Gane, E. Sofosbuvir-based regimens for patients with hepatitis C virus genotype 3 infection: Summary results from the valence, lonestar-2, and electron-2 studies. Gastroenterology; 148(4 SUPPL. 1): S1085–S6.
126.: Leroy V, Angus P, Bronowicki JP, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+). Hepatology 2016; 63(5): 1430–41. [PMC free article: PMC5069621] [PubMed: 26822022]
127.: Lim YS, Ahn SH, Lee KS, et al. A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatology international 2016; 10(6): 947–55. [PubMed: 27198664]
128.: Lionetti R, Lenci I, Siciliano M, et al. Improved virological outcomes and excellent safety profile in genotype 3 HCV-infected cirrhotic patients after an extended 24- weeks course of daclatasvir, sofosbuvir + ribavirin: insights froma real-life multicenter study. Journal of Hepatology 2017; 66: S731.
129.: Liu CJ, Chuang WL, Sheen IS, et al. Ledipasvir/sofosbuvir for 12weeks is safe and effective in patients with chronic hepatitis C and hepatitis B coinfection: A phase 3 study in Taiwan. Journal of Hepatology 2017; 66: S56.
130.: Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. New England Journal of Medicine 2012; 366(3): 216–24. [PubMed: 22256805]
131.: Luetkemeyer AFM, C.; Ramgopal, M.; Noviello, S.; Bhore, R.; Ackerman, P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clinical Infectious Diseases 2016; 62(12): 1489–96. [PMC free article: PMC4885650] [PubMed: 27025835]
132.: Mangia A, Arleo A, Copetti M, et al. The combination of daclatasvir and sofosbuvir for curing genotype 2 patients who cannot tolerate ribavirin. Liver International 2016; 36(7): 971–6. [PubMed: 26786792]
133.: Mangia A, Sarli R, Gamberini R, et al. Randomised clinical trial: sofosbuvir and ledipasvir in patients with transfusion-dependent thalassaemia and HCV genotype 1 or 4 infection. Aliment Pharmacol Ther 2017; 46(4): 424–31. [PubMed: 28660640]
134.: Mangia A, Susser S, Piazzolla V, et al. Sofosbuvir and ribavirin for genotype 2 HCV infected patients with cirrhosis: A real life experience. Journal of Hepatology 2017; 66(4): 711–7. [PubMed: 27965158]
135.: Manns M, Pol S, Jacobson IM, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet 2014; 384(9954): 1597–605. [PubMed: 25078304]
136.: Mauss SG, R.; Buggisch, P.; Klinker, H. H.; Schober, A.; John, C.; Lutz, T.; Pfeiffer-Vornkahl, H.; Niederau, C.; Cornberg, M.; Sarrazin, C.; Tacke, F. Treatment of HCV genotype 2 with sofosbuvir and ribavirin results in lower SVR rates in real life than expected from clinical trials. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 995A. [PubMed: 27428297]
137.: McPhee F, Hernandez D, Zhou N. Effect of minor populations of NS5A and NS5B resistance-associated variants on HCV genotype-3 response to daclatasvir plus sofosbuvir, with or without ribavirin. Antiviral Therapy 2017; 22(3): 237–46. [PubMed: 28008868]
138.: Mehta V, Mahajan R, Midha V, et al. Impact of Direct Acting Antiviral Therapy for Treatment of Hepatitis C Genotypes 1, 3 and 4: A Real Life Experience from India. Journal of Clinical and Experimental Hepatology 2017. [PMC free article: PMC5938329] [PubMed: 29743791]
139.: Miyaki E, Imamura M, Hiraga N, et al. Daclatasvir and asunaprevir treatment improves liver function parameters and reduces liver fibrosis markers in chronic hepatitis C patients. Hepatology Research 2016. [PubMed: 26574180]
140.: Mizokami M, Yokosuka O, Takehara T, et al. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. The Lancet Infectious Diseases 2015; 15(6): 645–53. [PubMed: 25863559]
141.: Molina JM, Orkin C, Iser DM, et al. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet 2015; 385(9973): 1098–106. doi: 10.16/S0140-6736(14)62483-1. Epub 2015 Feb 4. [PubMed: 25659285] [CrossRef]
142.: Molina JMO, C.; Iser, D. M.; Zamora, F. X.; Nelson, M.; Stephan, C.; Massetto, B.; Gaggar, A.; Ni, L.; Svarovskaia, E.; Brainard, D.; Subramanian, G. M.; McHutchison, J. G.; Puoti, M.; Rockstroh, J. K. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): A multicentre, open-label, non-randomised, phase 3 study. The Lancet 2015; 385(9973): 1098–106. [PubMed: 25659285]
143.: Nagao A, Hanabusa H. The impact of ledipasvir/sofosbuvir on HIV-positive and HIV-negative Japanese hemophilia patients with 1, 4, and mixed-genotype HCV. Journal of Acquired Immune Deficiency Syndromes 2017; 74(4): 418–22. [PubMed: 27984558]
144.: Naggie S, Cooper C, Saag M, et al. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. 2015. [PMC free article: PMC4892372] [PubMed: 26196665]
145.: Naggie SC, C.; Saag, M.; Workowski, K.; Ruane, P.; Towner, W. J.; Marks, K.; Luetkemeyer, A.; Baden, R. P.; Sax, P. E.; Gane, E.; Santana-Bagur, J.; Stamm, L. M.; Yang, J. C.; German, P.; Dvory-Sobol, H.; Ni, L.; Pang, P. S.; McHutchison, J. G.; Stedman, C. A.; Morales-Ramirez, J. O.; Brau, N.; Jayaweera, D.; Colson, A. E.; Tebas, P.; Wong, D. K.; Dieterich, D.; Sulkowski, M.; I. O. N. Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. New England Journal of Medicine 2015; 373(8): 705–13. [PMC free article: PMC4892372] [PubMed: 26196665]
146.: Nehra VT, E. M.; Rizza, S. A.; Temesgen, Z. Ledipasvir/sofosbuvir fixed-dose combination for treatment of hepatitis C virus genotype 4 infection. Drugs of Today 2016; 52(2): 111–7. [PubMed: 27092340]
147.: Nelson D, Feld J, Kowdley KV, et al. All Oral Therapy With Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment-Experienced Genotype 2/3 HCV-Infected Patients: Results of the Phase 3 FUSION Trial. International Liver Congress. Amsterdam; 2013.
148.: Nelson DRC, J. N.; Lalezari, J. P.; Lawitz, E.; Pockros, P. J.; Gitlin, N.; Freilich, B. F.; Younes, Z. H.; Harlan, W.; Ghalib, R.; Oguchi, G.; Thuluvath, P. J.; Ortiz-Lasanta, G.; Rabinovitz, M.; Bernstein, D.; Bennett, M.; Hawkins, T.; Ravendhran, N.; Sheikh, A. M.; Varunok, P.; Kowdley, K. V.; Hennicken, D.; McPhee, F.; Rana, K.; Hughes, E. A.; Ally- Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015; 61(4): 1127–35. [PMC free article: PMC4409820] [PubMed: 25614962]
149.: Nelson DRC, J. N.; Lalezari, J. P.; Lawitz, E.; Pockros, P. J.; Gitlin, N.; Freilich, B. F.; Younes, Z. H.; Harlan, W.; Ghalib, R.; Oguchi, G.; Thuluvath, P.; Ortiz-Lasanta, G.; Rabinovitz, M.; Bernstein, D.; Bennett, M.; Hawkins, T.; Ravendhran, N.; Sheikh, A. M.; Varunok, P.; Kowdley, K.; Hennicken, D.; McPhee, F.; Rana, K.; Hughes, E. A. All-Oral 12-wek combination treatment with Daclatasvir (DCV) and Sofosbuvir (SOF) in patients infected with HCV genotype (GT) 3: aLLY-3 phase 3 study. Canadian journal of infectious diseases and medical microbiology 2015; Conference:. 2015 CACMID-AMMI canada annual conference. Canada 26(2): e32.
150.: Nguyen MH, Trinh H, Do S, Nguyen T. Ledipasvir/sofosbuvir fixed-dose combination (LDV/SOF FDC) for 8 weeks for treatment-Naive, non-cirrhotic hepatitis C genotype 6 (HCV-6) and 12 weeks in those with cirrhosis and/or prior treatment failure: a multicenter open-labelled clinical trial. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S105.
151.: Nguyen MH, Trinh HN, Do ST, Nguyen T. Ledipasvir/sofosbuvir fixed-dose combination (LDV/SOF FDC) for 8 Weeks for treatment-naive, noncirrhotic hepatitis C genotype 6 (HCV-6) and for 12 weeks for those with cirrhosis and/or prior treatment failure: an open-labeled clinical trial. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 463A.
152.: Nicoll A, Zeuzem S, Ghalib R, et al. Final SVR24 data from the phase 3 C-EDGE treatment-naive (TN) study of elbasvir (EBR)/grazoprevir (GZR) in patients with chronic HCV genotype 1, 4 or 6 infection. Journal of gastroenterology and hepatology 2016; 31(80).
153.: Ogawa E, Furusyo N, Nomura H, et al. NS5A resistance-associated variants undermine the effectiveness of ledipasvir and sofosbuvir for cirrhotic patients infected with HCV genotype 1b. Journal of Gastroenterology 2017; 52(7): 845–54. [PubMed: 27913920]
154.: Ogawa E, Furusyo N, Nomura H, et al. Effectiveness and safety of sofosbuvir plus ledipasvir for HCV genotype 1b patients with compensated cirrhosis. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S1012.
155.: Ogawa E, Furusyo N, Nomura H, et al. Effectiveness and safety of sofosbuvir plus ribavirin for HCV genotype 2 patients 65 and over with or without cirrhosis. Antiviral research 2016; 136: 37–44. [PubMed: 27789224]
156.: Ogawa E, Furusyo N, Yamashita N, et al. Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis. Hepatology Research 2017; 47(3): E120–E31. [PubMed: 27142311]
157.: O’Leary J, Brown RS, Reddy KR, et al. Baseline clinical and laboratory parameters associated with clinical benefits of successful hcvtreatment with sofosbuvir/velpatasvir in decompensated cirrhotic patients. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S774.
158.: Osinusi A, Townsend K, Kohli A, et al. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. JAMA 2015; 313(12): 1232–9. doi: 10.001/jama.2015.1373. [PMC free article: PMC7780246] [PubMed: 25706232] [CrossRef]
159.: Osinusi AT, K.; Kohli, A.; Nelson, A.; Seamon, C.; Meissner, E. G.; Bon, D.; Silk, R.; Gross, C.; Price, A.; Sajadi, M.; Sidharthan, S.; Sims, Z.; Herrmann, E.; Hogan, J.; Teferi, G.; Talwani, R.; Proschan, M.; Jenkins, V.; Kleiner, D. E.; Wood, B. J.; Subramanian, G. M.; Pang, P. S.; McHutchison, J. G.; Polis, M. A.; Fauci, A. S.; Masur, H.; Kottilil, S. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. Jama 2015; 313(12): 1232–9. [PMC free article: PMC7780246] [PubMed: 25706232]
160.: Patrick Basu P, Shah NJ, John N, Aloysius MM, Fortuzi K. Sofosbuvir and ledipasvir in attainment of SVR12 in Sickle Cell Disease (SCD) sub-population with Chronic Hepatitis C (CHC). A single center prospective open label clinical pilot study: slash C trial. Surgical endoscopy and other interventional techniques Conference 2017; 31.
161.: Pearlman B, Lutchman G, Shiffman ML, et al. Safety and efficacy of elbasvir and grazoprevir with or without ribavirin for the treatment of hepatitis C virus genotype 1: results of the hepatitis C virus-TARGET study. Journal of Hepatology 2017; 66: S294.
162.: Persico M, Aglitti A, Caruso R, et al. Efficacy and safety of new direct antiviral agents in HCV infected patients with Diffuse Large B Cell Non-Hodgkin Lymphoma. Hepatology 2017; 17: 17. [PubMed: 28714143]
163.: Pianko S, Flamm SL, Shiffman ML, et al. Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 hepatitis c virus infection. Annals of internal medicine 2015; 163(11): 809–17. [PubMed: 26551263]
164.: Pol S, Bourliere M, Lucier S, et al. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. Journal of hepatology 2016; 10. [PubMed: 27622858]
165.: Poordad F, Felizarta F, Asatryan A, et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology 2017; (pagination). [PMC free article: PMC5573922] [PubMed: 28128852]
166.: Poordad F, Gordon SC, Asatryan A, et al. High efficacy of ABT-493 and ABT-530 in HCV genotype 1 infected patients who have failed direct-acting antiviral-containing regimens: the Magellan-i study. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S160–S1.
167.: Poordad F, Pol S, Asatryan A, et al. MAGELLAN-1, Part 2: glecaprevir and pibrentasvir for 12 or 16 weeks in patients with chronic hepatitis C virus genotype 1 or 4 and prior direct-acting antiviral treatment failure. Journal of Hepatology 2017; 66: S83.
168.: Poordad F, Pol S, Asatryan A, et al. MAGELLAN-1, Part 2: Glecaprevir and Pibrentasvir for 12 or 16 Weeks in Patients with Chronic HCV Genotype 1 or 4 and Prior Direct-Acting Antiviral Treatment Failure. Gastroenterology 2017; 152(5): S1057.
169.: Reddy KRL, J. K.; Kuo, A.; Di Bisceglie, A. M.; Galati, J. S.; Morelli, G.; Everson, G. T.; Kwo, P. Y.; Brown, R. S.; Sulkowski, M. S.; Akuschevich, L.; Lok, A. S.; Pockros, P. J.; Vainorius, M.; Terrault, N. A.; Nelson, D. R.; Fried, M. W.; Manns, M. P. All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database. Alimentary Pharmacology and Therapeutics 2017; 45(1): 115–26. [PubMed: 27790729]
170.: Reddy RK, Pol S, Thuluvath PJ, et al. A long-term, observational, follow-up study of patients treated in phase 2 and 3 clinical studies for chronic HCV infection with daclatasvir-based regimens: interim efficacy and safety outcomes. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S295–S6.
171.: Rockstroh J, Lacombe K, Viani RM, et al. Efficacy and safety of Glecaprevir/Pibrentasvir in patients coinfected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 Study. Journal of Hepatology 2017; 66: S102. [PMC free article: PMC6137115] [PubMed: 29566246]
172.: Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): A non-randomised, open-label trial. The Lancet HIV 2015; 2(8): e319–e27. [PubMed: 26423374]
173.: Saadoun D, Ferfar Y, Hezode C, et al. Sofosbuvir plus daclatasvir for hepatitis C virus-cryoglobulinemia vasculitis (HCV-CryoVas): VASCUVALDIC 2 Study. Journal of Hepatology 2017; 66: S56.
174.: Saadoun D, Pol S, Ferfar Y, et al. Efficacy and Safety of Sofosbuvir Plus Daclatasvir for Treatment of HCV-Associated Cryoglobulinemia Vasculitis. Gastroenterology 2017; 153(1): 49–52.e5. [PubMed: 28288791]
175.: Sezaki H, Suzuki F, Hosaka T, et al. The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real-life settings. Liver International 2017. [PubMed: 28178397]
176.: Shah SR, Chowdhury A, Mehta R, et al. Sofosbuvir plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 or 3 infection in India. Journal of viral hepatitis 2016; (pagination). [PubMed: 27933698]
177.: Shiha G, Waked I, Soliman R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S109.
178.: Sidharthan SK, A.; Sims, Z.; Nelson, A.; Osinusi, A.; Masur, H.; Kottilil, S. Utility of hepatitis C viral load monitoring on direct-acting antiviral therapy. Clinical Infectious Diseases 2015; 60(12): 1743–51. [PMC free article: PMC4834854] [PubMed: 25733369]
179.: Sperl J, Horvath G, Halota W, et al. C-edge head-to-head: Efficacyand safety of elbasvir and grazoprevir compared with sofosbuvir/pegylated interferon/ribavirin: A phase 3 randomized controlled trial. Journal of hepatology 2016; 64(2 SUPPL. 1): S136–S7.
180.: Sperl J, Horvath G, Halota W, et al. Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: A phase III randomized controlled trial. Journal of Hepatology 2016; 65(6): 1112–9. [PubMed: 27542322]
181.: Strasser S, Hezode C, Colombo M, et al. C-EDGE IBLD: efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in patients with chronic hepatitis C virus (HCV) infection and inherited blood disorders (IBLD). Journal of gastroenterology and hepatology 2016; 31: 82–3.
182.: Suda G, Kudo M, Nagasaka A, et al. Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C. Journal of Gastroenterology 2016; 51(7): 733–40. [PubMed: 26768604]
183.: Suda G, Nagasaka A, Yamamoto Y, et al. Safety and efficacy of daclatasvir and asunaprevir in hepatitis C virus-infected patients with renal impairment. Hepatology research 2017; (pagination). [PubMed: 27943523]
184.: Sulkowski M, Hezode C, Gerstoft J, et al. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet (London, England) 2015; 385(9973): 1087–97. [PubMed: 25467560]
185.: Sulkowski MS, Brau N, Lawitz E, et al. A randomized controlled trial of sofosbuvir/GS-5816 fixed dose combination for 12 weeks compared to sofosbuvir with ribavirin for 12 weeks in genotype 2 HCV infected patients: The Phase 3 ASTRAL-2 Study. Hepatology 2015; 62(13).
186.: Sulkowski MS, Chuang WL, Kao JH, et al. No Evidence of Reactivation of Hepatitis B Virus Among Patients Treated With Ledipasvir-Sofosbuvir for Hepatitis C Virus Infection. Clinical Infectious Diseases 2016; 63(9): 1202–4. [PMC free article: PMC6276897] [PubMed: 27486112]
187.: Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.[Erratum appears in N Engl J Med. 2014 Apr 10;370(15):1469]. New England Journal of Medicine 2014; 370(3): 211–21. [PubMed: 24428467]
188.: Sung J, Uojima H, Ohtake T, et al. A prospective, multicenter study of daclatasvir and asunaprevir combination therapy for chronic hepatitis C virus genotype 1b infection on hemodialysis. Journal of gastroenterology and hepatology 2016; 31: 354–5.
189.: Suzuki F, Hatanaka N, Bando E, Komoto A. Post marketing surveillance of daclatasvir/asunaprevir in Japanese patients with chronic hepatitis C: an interim report. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S25.
190.: Suzuki F, Karino Y, Chayama K, et al. Final results from phase 3 portion in phase 2/3 study of elbasvir / grazoprevir in hepatitis C genotype 1 infected japanese patients. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 418A–9A.
191.: Suzuki Y, Ikeda K, Suzuki F, et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. Journal of Hepatology 2013; 58(4): 655–62. [PubMed: 23183526]
192.: Tacke FG, R.; Buggisch, P.; Klinker, H.; Schober, A.; John, C.; Lutz, T.; Pfeiffer-Vornkahl, H.; Niederau, C.; Cornberg, M.; Sarrazin, C.; Mauss, S. Treatment of HCV genotype 2 with sofosbuvir and ribavirin results in lower sustained virological response rates in real life than expected from clinical trials. Liver International 2017; 37(2): 205–11. [PubMed: 27428297]
193.: Terashita K, Suda G, Nakai M, et al. Safety and efficacy of direct acting antivirals (daclatasvir and asunaprevir) in hepatitis C virus infected patients with renal impairment. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S295.
194.: Terrault NA, Zeuzem S, Di Bisceglie AM, et al. Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response. Gastroenterology 2016; 151(6): 1131–40.e5. [PMC free article: PMC5300778] [PubMed: 27565882]
195.: Torres HA, Economides MP, Kyvernitakis A, et al. Sofosbuvir-based therapy in patients with chronic hepatitis C virus infection and malignancies – A prospective observational study of 136 patients. Journal of Hepatology 2017; 66: S506.
196.: Townsend KM, E. G.; Sidharthan, S.; Sampson, M.; Remaley, A. T.; Tang, L.; Kohli, A.; Osinusi, A.; Masur, H.; Kottilil, S. Interferon-Free Treatment of Hepatitis C Virus in HIV/Hepatitis C Virus-Coinfected Subjects Results in Increased Serum Low-Density Lipoprotein Concentration. AIDS Res Hum Retroviruses 2016; 32(5): 456–62. [PMC free article: PMC4845681] [PubMed: 26559180]
197.: Townsend KP, T.; Gordon, L. A.; Kohli, A.; Nelson, A.; Seamon, C.; Gross, C.; Tang, L.; Osinusi, A.; Polis, M. A.; Masur, H.; Kottilil, S. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir. AIDS 2016; 30(2): 261–6. [PMC free article: PMC10624323] [PubMed: 26691547]
198.: Toyoda H, Chayama K, Suzuki F, et al. Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients with Chronic Genotype 2 Hepatitis C Virus Infection. Hepatology 2017. [PMC free article: PMC5814891] [PubMed: 28865152]
199.: Toyoda H, Kumada T, Tada T, et al. Efficacy and tolerability of an IFN-free regimen with DCV/ASV for elderly patients infected with HCV genotype 1B. Journal of Hepatology 2017; 66(3): 521–7. [PubMed: 27890790]
200.: Toyoda H, Kumada T, Tada T, et al. Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis. Journal of Gastroenterology 2016; 51(7): 741–7. [PubMed: 26872889]
201.: Toyota J, Karino Y, Suzuki F, et al. Daclatasvir/asunaprevir/beclabuvir fixed-dose combination in Japanese patients with HCV genotype 1 infection. Journal of gastroenterology 2017; 52(3): 385–95. [PubMed: 27502287]
202.: Vermehren J, Athmann C, Gunther R, et al. Use of the 6 million viral load cut-off to guide treatment duration with ledipasvir/sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection: results from the German Hepatitis C-Registry (DHC-R). Journal of Hepatology 2017; 66: S519.
203.: Vermehren JB, M.; Pol, S.; Marcellin, P.; Hyland, R. H.; Jiang, D.; Brainard, D. M.; Zeuzem, S.; Welzel, T. M. Comparison of on-treatment HCV RNA during direct antiviral therapy using two different COBAS TaqMan HCV assays. Journal of clinical virology 2017; 89: 51–6. [PubMed: 28259054]
204.: Vierling JM, Kugelmas M, Lawitz E, et al. Efficacy of an eight-week regimen of grazoprevir plus elbasvir with and without ribavirin in treatmentnaive, noncirrhotic HCV genotype 1B infection. Journal of hepatology 2015; 62(22).
205.: Wei L, Burnevich E, Sheen IS, et al. Efficacy and Safety of elbasvir/grazoprevir in treatment-naive subjects with chronic HCV GT 1, GT 4 and GT 6 infection (CCORAL): a phase III randomized multinational clinical trial. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S161–S2.
206.: Wei L, Hou J, Luo Y, et al. ONYX-I: safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir in asian adults with genotype 1b chronic hepatitis C virus (HCV) infection: a randomized, double-blind, placebocontrolled study. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S3.
207.: Wei L, Hou J, Luo Y, et al. ONYX-I: safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir in asian adults with genotype 1b chronic hepatitis C Virus (HCV) infection-a randomized, double-blind, placebo-controlled study. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 432A–3A.
208.: Wei L, Luo Y, Chuang WL, et al. Comparison of efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin between Asian and western HCV GT1b-infected patients. Journal of Hepatology 2017: S531.
209.: Wei L, Wang FS, Zhang M, et al. A phase 3 evaluation of daclatasvir plus asunaprevir in treatmentnaive patients with chronic HCV genotype 1b infection. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S186–S7.
210.: Wei L, Xie Q, Hou J, et al. Sofosbuvir + Ribavirin-Pegylated-interferon in Genotype 1, 2, 3 or 6 HCV-infected patients: results from a phase 3 study in China. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S157–S8.
211.: Wei L, Zhang M, Xu M, et al. A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin. Journal of gastroenterology and hepatology (australia) 2016; 31(11): 1860–7. [PubMed: 27003037]
212.: Wei L, Zhdanov K, Burnevich E, et al. Efficacy and safety of elbasvir/grazoprevir in treatment-naïve patients with chronic HCVGT 1, GT 4 and GT 6 infection (C-CORAL): a phase III randomized multinational clinical trial. Journal of Hepatology 2017; 66: S529.
213.: Welzel T, Zeuzem S, Dumas EO, et al. GARNET: 98% SVR rates following eight-week treatment with ombitasvir/paritaprevir/ritonavir + dasabuvir for patients with HCV genotype 1b infection without cirrhosis. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S1002.
214.: Welzel TM, Asselah T, Dumas EO, et al. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. The Lancet Gastroenterology and Hepatology 2017; 2(7): 494–500. [PubMed: 28416221]
215.: Welzel TM, Nelson DR, Morelli G, et al. Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: Results of the real-world, clinical practice HCV-TARGET study. Gut 2016; 13. [PMC free article: PMC5595101] [PubMed: 27418632]
216.: Wilder JMJ, L. J.; Ravendhran, N.; Shiffman, M. L.; Poulos, J.; Sulkowski, M. S.; Gitlin, N.; Workowski, K.; Zhu, Y.; Yang, J. C.; Pang, P. S.; McHutchison, J. G.; Muir, A. J.; Howell, C.; Kowdley, K.; Afdhal, N.; Reddy, K. R. Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology 2016; 63(2): 437–44. [PMC free article: PMC4738375] [PubMed: 26547499]
217.: Wilson EMK, S.; Sidharthan, S.; Sims, Z.; Tang, L.; McLaughlin, M.; Price, A.; Nelson, A.; Silk, R.; Gross, C.; Akoth, E.; Mo, H.; Subramanian, G. M.; Pang, P. S.; McHutchison, J. G.; Osinusi, A.; Masur, H.; Kohli, A.; Kottilil, S. Successful Retreatment of Chronic HCV Genotype-1 Infection With Ledipasvir and Sofosbuvir After Initial Short Course Therapy With Direct-Acting Antiviral Regimens. Clinical Infectious Diseases 2016; 62(3): 280–8. [PMC free article: PMC4706633] [PubMed: 26521268]
218.: Wyles D, Brau N, Kottilil S, et al. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected with Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clinical Infectious Diseases 2017; 65(1): 6–12. [PMC free article: PMC6248627] [PubMed: 28369210]
219.: Wyles D, Brau N, Naggie S, et al. SOF/VEL single-tablet regimen in HCV mono-infected and HIV/HCV co-infected patients: comparison of efficacy and safety data from phase 3 clinical trials. Journal of the international AIDS society Conference: international congress of drug therapy in HIV infection 2016; 19: 187–8.
220.: Wyles D, Ruane P, Sulkowski M, et al. Daclatasvir in combination with sofosbuvir for hiv/HCV Coinfection: ALLY-2 Study. Top Antivir Med 2015; 23(62).
221.: Wyles DLR, P. J.; Sulkowski, M. S.; Dieterich, D.; Luetkemeyer, A.; Morgan, T. R.; Sherman, K. E.; Dretler, R.; Fishbein, D.; Gathe, J. C., Jr.; Henn, S.; Hinestrosa, F.; Huynh, C.; McDonald, C.; Mills, A.; Overton, E. T.; Ramgopal, M.; Rashbaum, B.; Ray, G.; Scarsella, A.; Yozviak, J.; McPhee, F.; Liu, Z.; Hughes, E.; Yin, P. D.; Noviello, S.; Ackerman, P.; Ally- Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. New England Journal of Medicine 2015; 373(8): 714–25. [PubMed: 26196502]
222.: Wyles DLR, P.; Sulkowski, M. S.; Dieterich, D.; Luetkemeyer, A. F.; Morgan, T. R.; Sherman, K. E.; Liu, Z.; Noviello, S.; Ackerman, P. Daclatasvir plus sofosbuvir for treatment of HCV genotypes 1-4 in HIV-HCV coinfection: The ALLY-2 study. Journal of hepatology 2015; 62(22).
223.: Yakoot M, Abdo AM, Abdel-Rehim S, Helmy S. Response Tailored Protocol Versus the Fixed 12Weeks Course of Dual Sofosbuvir/Daclatasvir Treatment in Egyptian Patients With Chronic Hepatitis C Genotype-4 Infection: A Randomized, Open-label, Non-inferiority Trial. EBioMedicine 2017; 17: 17. [PMC free article: PMC5514382] [PubMed: 28647541]
224.: Yao Y, Yue M, Wang J, et al. Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis. Can J Gastroenterol Hepatol 2017; 2017: 8186275. [PMC free article: PMC5253517] [PubMed: 28164081]
225.: Yoshimi S, Imamura M, Murakami E, et al. Long term persistence of NS5A inhibitor-resistant hepatitis C virus in patients who failed daclatasvir and asunaprevir therapy. Journal of Medical Virology 2015; 87(11): 1913–20. [PubMed: 25954851]
226.: Younossi Z, Stepanova M, Han KH, et al. Asian patients with hepatitis C (HCV) genotype 1 treated with ledipasvir and sofosbuvir (LDV/SOF) experience very high efficacy and improvement of health-related quality of life (HRQL). Journal of gastroenterology and hepatology 2016; 31(376).
227.: Younossi ZM, Park H, Gordon SC, et al. Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C. American Journal of Managed Care 2016; 22(6 Spec No.): SP205–11. [PubMed: 27266950]
228.: Younossi ZM, Stepanova M, Charlton M, et al. Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial. The lancet gastroenterology and hepatology 2016; 1(2): 122–32. [PubMed: 28404069]
229.: Younossi ZM, Stepanova M, Feld J, et al. Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: Results from ASTRAL-1 placebo-controlled trial. Journal of Hepatology 2016; 65(1): 33–9. [PubMed: 26956698]
230.: Younossi ZM, Stepanova M, Omata M, Mizokami M, Walters M, Hunt S. Quality of life of Japanese patients with chronic hepatitis C treated with ledipasvir and sofosbuvir. Medicine 2016; 95(33): e4243. [PMC free article: PMC5370780] [PubMed: 27537553]
231.: Younossi ZM, Stepanova M, Sulkowski M, et al. Ribavirin-Free Regimen With Sofosbuvir and Velpatasvir Is Associated With High Efficacy and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From Astral-2 and -3 Clinical Trials. Clinical Infectious Diseases 2016; 63(8): 1042–8. [PMC free article: PMC6276885] [PubMed: 27444413]
232.: Younossi ZM, Stepanova M, Sulkowski M, Wyles D, Kottilil S, Hunt S. Patient-reported outcomes in patients co-infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL-5 study. Liver International 2017. [PubMed: 28470938]
233.: Younossi ZMS, M.; Afdhal, N.; Kowdley, K. V.; Zeuzem, S.; Henry, L.; Hunt, S. L.; Marcellin, P. Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir. Journal of Hepatology 2015; 63(2): 337–45. [PubMed: 25795586]
234.: Younossi ZMS, M.; Sulkowski, M.; Naggie, S.; Puoti, M.; Orkin, C.; Hunt, S. L. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. Journal of Infectious Diseases 2015; 212(3): 367–77. [PMC free article: PMC5007583] [PubMed: 25583164]
235.: Younossi ZMS, M.; Marcellin, P.; Afdhal, N.; Kowdley, K. V.; Zeuzem, S.; Hunt, S. L. Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials. Hepatology (Baltimore, Md) 2015; 61(6): 1798–808. [PubMed: 25627448]
236.: Younossi ZMS, M.; Sulkowski, M.; Naggie, S.; Henry, L.; Hunt, S. Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus. Journal of Viral Hepatitis 2016; 23(11): 857–65. [PubMed: 27291391]
237.: Younossi ZMS, M.; Pol, S.; Bronowicki, J. P.; Carrieri, M. P.; Bourliere, M. The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study. Liver International 2016; 36(1): 42–8. [PubMed: 26059860]
238.: Younossi ZS, M.; Pol, S.; Bronowicki, J. P.; Carrieri, P.; Bourliere, M. The impact of ledipasvir (LDV)/sofosbuvir (SOF) combination on health-related quality of life (HRQL) and patient-reported outcomes (PROS) in cirrhotic patients with chronic hepatitis C (CH-C): The sirius study. Journal of hepatology 2015; 62(22).
239.: Younossi ZS, M.; Omata, M.; Mizokami, M.; Walters, M.; Hunt, S. Health utilities using SF-6D scores in Japanese patients with chronic hepatitis C treated with sofosbuvir-based regimens in clinical trials. Health and Quality of Life Outcomes 2017; 15 (1) (no pagination)(25). [PMC free article: PMC5282717] [PubMed: 28143559]
240.: Zeng QL, Xu GH, Zhang JY, et al. Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: A real-life observational study. Journal of Hepatology 2017; 66(6): 1123–9. [PubMed: 28189754]
241.: Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir and Ribavirin in HCV genotypes 2 and 3. New England Journal of Medicine 2014; 370(21): 1993–2001. [PubMed: 24795201]
242.: Zeuzem S, Flamm SL, Tong MJ, et al. A randomized, controlled, phase 3 trial of sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir for 12 weeks in direct acting antiviral-experienced patients with genotype 1-6 HCV infection: the POLARIS-4 study. Hepatology 2016; Conference: 67th annual meeting of the american association for the study of liver diseases: the liver meeting. 2016. United states. Conference start: 20161111. Conference end: 20161115 63(1 Supplement 1): 59A.
243.: Zeuzem S, Ghalib R, Reddy KR, et al. Final SVR24 data from the phase 3 c-edge treatment-naive study of elbasvir (EBR)/grazoprevir (GZR) in patients with chronic HCV genotype 1, 4 or 6 infection. Journal of hepatology 2016; Conference: 51st annual meeting of the european association for the study of the liver, international liver congress. 2016. Barcelona spain. Conference start: 20160413. Conference end: 20160417. Conference publication:(var.pagings) 64(2 SUPPL. 1): S821.
244.: Zeuzem S, Ghalib R, Reddy KR, et al. The phase 3 c-edge treatment-naive (TN) study of a 12-week oral regimen of grazoprevir (GZR, mk-5172)/elbasvir (EBR, mk-8742) in patients with chronic hcv genotype (GT) 1, 4, or 6 infection. Journal of hepatology 2015; 62(22).
245.: Zeuzem S, Ghalib R, Reddy KR, et al. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Annals of internal medicine 2015; 163(1): 1–13. [PubMed: 25909356]
246.: Zeuzem SD, G. M.; Colombo, M.; Flisiak, R.; Hyland, R. H.; Illeperuma, A.; Brainard, D. M.; Symonds, W. T.; McHutchison, J. G.; Weiland, O.; Reesink, H. W.; Brown, A.; Pol, S.; Hezode, C.; Esteban, R. Early viral kinetics do not predict treatment outcome with sofosbuvir + ribavirin for 12 or 24 weeks in HCV genotype 2/3 patients in the valence trial. Journal of hepatology; 60(1 SUPPL. 1): S452.
247.: Zhdanov K, Orlova-Morozova EA, Morozov V, et al. Ledipasvir/sofosbuvir in treatment-Naive patients with chronic HCV Infection and HIV/HCV co-infection and in SOFexperienced patients. Hepatology international 2017; Conference: 26th annual conference of the asian pacific association for the study of the liver, APASL. 2017. China 11(1 Supplement 1): S109–S10.

Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing.

Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user.

Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO license (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).

Under the terms of this license, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons license. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”.

Any mediation relating to disputes arising under the license shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization.

Bookshelf ID: NBK531731

Contents

< Prev Next >

PubReader
Print View
Cite this Page
Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection [Internet]. Geneva: World Health Organization; 2018 Jul. Web Annex 3.2, Adult hepatitis C virus treatment systematic review; supporting evidence.
PDF version of this page (1.0M)
PDF version of this title (952K)
Disable Glossary Links

Other titles in this collection

WHO Guidelines Approved by the Guidelines Review Committee

Related information

PMC
PubMed Central citations
PubMed
Links to PubMed

Recent Activity

Clear Turn Off Turn On

Adult hepatitis C virus treatment systematic review; supporting evidence - Guide...
Adult hepatitis C virus treatment systematic review; supporting evidence - Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

Bookshelf

Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection [Internet].

Web Annex 3.2Adult hepatitis C virus treatment systematic review; supporting evidence

Purpose

Results

Efficacy outcomes (SVR12) – All comers

Daclatasvir + Sofosbuvir

All-treatment experience

Table 1SVR12 in all patients treated with daclatasvir + sofosbuvir, arranged by genotype

Treatment-naïve patients only

Table 2SVR12 in treatment-naive patients treated with daclatasvir + sofosbuvir, arranged by genotype

Treatment-experienced patients only

Table 3SVR12 in treatment-experienced patients treated with daclatasvir + sofosbuvir, arranged by genotype

Glecaprevir + Pibrentasvir

All-treatment experience

Table 4SVR12 in all patients treated with glecaprevir + pibrentasvir, arranged by genotype

Treatment-naïve patients only

Table 5SVR12 in treatment-naïve patients treated with glecaprevir + pibrentasvir, arranged by genotype

Treatment-experienced patients only

Table 6SVR12 in treatment-experienced patients treated with glecaprevir + pibrentasvir, arranged by genotype

Sofosbuvir + Velpatasvir

All-treatment experience

Table 7SVR12 in all patients treated with sofosbuvir + velpatasvir, arranged by genotype

Treatment-naïve patients only

Table 8SVR12 in treatment-naïve patients treated with sofosbuvir + velpatasvir, arranged by genotype

Treatment-experienced patients only

Table 9SVR12 in treatment-experienced patients treated with sofosbuvir + velpatasvir, arranged by genotype

Safety outcomes

Discontinuations due to adverse events

Table 10Discontinuations due to adverse events, arranged by treatment

Serious adverse events

Table 11Serious adverse events, arranged by treatment

Mortality

Table 12Mortality, arranged by treatment

Appendix A. Included studies from all analyses

Table A1List of included studies, with treatments and study design categorization

References

Views

In this Page

Other titles in this collection

Related information

Recent Activity