U.S. flag

An official website of the United States government

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

Clinical Review Report: Doravirine (Pifeltro): (Merck Canada Inc.): Indication: Doravirine (Pifeltro) is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun.

Cover of Clinical Review Report: Doravirine (Pifeltro)

Clinical Review Report: Doravirine (Pifeltro): (Merck Canada Inc.): Indication: Doravirine (Pifeltro) is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine [Internet].

Show details

References

1.
AIDSinfo. Understanding HIV/AIDS. 2019; https://aidsinfo​.nih​.gov/understanding-hiv-aids. Accessed 2019 Feb 20.
2.
Government of Canada. HIV and AIDS. 2018; https://www​.canada.ca​/en/public-health/services​/diseases/hiv-aids.html. Accessed 2019 Feb 20.
3.
4.
AidSinfo. Guidelines for the use of antiretroviral agens in adults and adolescents living with HIV. 2018 Oct 25; https://aidsinfo​.nih​.gov/guidelines/html​/1/adult-and-adolescent-arv/0. Accessed 2019 Feb 20.
5.
Clinical Study Report: P018MK1439 [DRIVE-FORWARD - week 96]. A phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial to evaluate the safety and efficacy of doravirine (MK-1439) 100 mg once daily versus darunavir 800 mg once daily plus ritonavir 100 mg once daily, each in combination with Truvada™ or Epzicom™/Kivexa™, in treatment-naïve HIV-1 infected subjects [CONFIDENTIAL internal manufacturer’s report]. Kenilworth (NJ): Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.; 2018 Jul 27.
6.
Clinical Study Report: P018V01MK1439 [DRIVE-FORWARD - week 48]. A phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial to evaluate the safety and efficacy of doravirine (MK-1439) 100 mg once daily versus darunavir 800 mg once daily plus ritonavir 100 mg once daily, each in combination with Truvada™ or Epzicom™/Kivexa™, in treatment-naïve HIV-1 infected subjects [CONFIDENTIAL internal manufacturer’s report]. Kenilworth (NJ): Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.; 2017 Oct 19.
7.
Clinical Study Report: P021MK1439A [DRIVE-AHEAD - week 96]. A phase III multicenter, double-blind, randomized, active comparator-controlled clinical trial to evaluate the safety and efficacy of MK-1439A once-daily versus Atripla™ once-daily in treatment-naïve HIV-1 infected subjects [CONFIDENTIAL internal manufacturer’s report]. Kenilworth (NJ): Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.; 2018 Oct 12.
8.
Clinical Study Report: P021V01 [DRIVE-AHEAD - week 48]. A phase III multicenter, double-blind, randomized, active comparator-controlled clinical trial to evaluate the safety and efficacy of MK-1439A once-daily versus Atripla™ once-daily in treatment-naïve HIV-1 infected subjects [CONFIDENTIAL internal manufacturer’s report]. Kenilworth (NJ): Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.; 2018 Oct 13.
9.
Clinical Study Report: P024 [DRIVE-SHIFT]. A phase III multicenter, open-label, randomized study to evaluate a switch to MK-1439A in HIV-1-infected subjects virologically suppressed on a regimen of a ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) [CONFIDENTIAL internal manufacturer’s report]. Kenilworth (NJ): Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.; 2018 Nov 6.
10.
Pifeltro (doravirine): 100 mg oral tablets [product monograph]. Kirkland (QC): Merck Canada Inc.; 2018 Oct 11.
11.
Biktarvy™ (bictegravir/emtricitabine/tenofovir alafenamide): 50 mg bictegravir, 200 mg emtricitabine, 25 mg tenofovir alafenamide; oral tablets [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc.; 2018 Jul 10: https://pdf​.hres.ca/dpd_pm/00046296.PDF. Accessed 2019 Feb 20.
12.
e-CPS. Ottawa (ON): Canadian Pharmacists Association; 2019: https://www​.e-therapeutics.ca. Accessed 2019 Feb.
13.
RxFiles drug comparison charts. HIV: human immunodeficiency virus. 11th ed. Saskatoon (SK): RxFiles; 2017 Mar: https://www​.rxfiles.ca​/rxfiles/uploads/documents​/ChartsTitlePage-11th-edition-2017-book-references​.pdf. Accessed 2019 Feb 20.
14.
Pharmacist’s Letter. Tenofovir: alafenamide vs disoproxil fumarate Stockton (CA): Therapeutic Research Center; 2016.
15.
Triumeq (dolutegravir, abacavir, and lamivudine) tablets: 50 mg dolutegravir, 600 mg abacavir, and 300 mg lamivudine [product monograph]. Laval (QC): ViiV Healthcare ULC; 2019 Jan 2: https://pdf​.hres.ca/dpd_pm/00048971.PDF. Accessed 2019 Feb 20.
16.
Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) tablets: 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, 10 mg tenofovir alafenamide [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc; 2018 Sep 17: https://pdf​.hres.ca/dpd_pm/00047410.PDF. Accessed 2019 Feb 20.
17.
Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide) tablets: 200 mg emtricitabine, 25 mg rilpivirine, 25 mg tenofovir alafenamide [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc; 2018 Dec 13: https://pdf​.hres.ca/dpd_pm/00048712.PDF. Accessed 2019 Feb 20.
18.
Juluca® (dolutegravir and rilpivirine) tablets: 50 mg dolutegravir, 25 mg rilpivirine [product monograph]. Laval (QC): ViiV Healthcare ULC; 2018 Aug 27: https://pdf​.hres.ca/dpd_pm/00047068.PDF. Accessed 2019 Feb 20.
19.
Symtuza™ (darunavir*/combicistat/emtricitabine/tenofovir alafenamde**): film-coated tablets 800 mg/150 mg/200 mg/100 mg (*as 867 mg darunavir ethanolate; **as 11.2 mg tenofovir alafenamide hemifumarate) [product monograph]. Toronto (ON): Janssen Inc.; 2018 Oct 3: https://pdf​.hres.ca/dpd_pm/00047627.PDF. Accessed 2019 Feb 20.
20.
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) tablets: 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, 300 mg tenofovir disoproxil fumarate [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc; 2018 Sep 17: https://pdf​.hres.ca/dpd_pm/00047408.PDF. Accessed 2019 Feb 20.
21.
Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets: 200 mg emtricitabine, 25 mg rilpivirine, 300 mg tenofovir disoproxil fumarate [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc; 2018 Dec 3: https://pdf​.hres.ca/dpd_pm/00048610.PDF. Accessed 2019 Feb 20.
22.
Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets: 600 mg efavirenz, 200 mg emtricitabine, 300 mg tenofovir disoproxil fumarate [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc; 2018 Aug 14: https://pdf​.hres.ca/dpd_pm/00046887.PDF. Accessed 2019 Feb 20.
23.
Prezcobix® (darunavir/cobicistat): film-coated tablets (800 mg/150 mg) [product monograph]. Toronto (ON): Janssen Inc; 2018 Nov 7: https://pdf​.hres.ca/dpd_pm/00048328.PDF. Accessed 2019 Feb 20.
24.
Descovy® (emtricitabine/tenofovir alafenamide) tablets: 200 mg emtricitabine, 10 mg* and 25 mg** tenofovir alafenamide (*as 11.2 mg tenofovir alafenamide hemifumarate, **as 28.0 mg tenofovir alafenamide hemifumarate) [product monograph]. Mississauga (ON): Gilead Sciences Canada, Inc; 2018 Jun 25: https://pdf​.hres.ca/dpd_pm/00046100.PDF. Accessed 2019 Feb 20.
25.
Tivicay (dolutegravir): 10, 25 and 50 mg tablets [product monograph]. Laval (QC): ViiV Healthcare ULC; 2018 Aug 27: https://pdf​.hres.ca/dpd_pm/00047067.PDF. Accessed 2019 Feb 20.
26.
Prezista® (darunavir) tablets: 75 mg, 150 mg, 600 mg, 800 mg darunavir oral suspension 100 mg/mL [product monograph]. Toronto (ON): Janssen Inc.; 2019 Mar 5: https://pdf​.hres.ca/dpd_pm/00049989.PDF. Accessed 2019 Mar 25.
27.
Norvir® (ritonavir): film-coated tablets (100 mg), oral solution (80 Mg/mL) [product monograph]. St-Laurent (QC): AbbVie Corporation; 2018 Sep 25: https://pdf​.hres.ca/dpd_pm/00047580.PDF. Accessed 2019 Feb 20.
28.
Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets: 200 mg/300 mg [product monograph]. Mississauga (ON): Gilead Sciences, Inc.; 2018 Jul 5: https://pdf​.hres.ca/dpd_pm/00046237.PDF. Accessed 2019 Feb 20.
29.
Molina JM, Squires K, Sax PE, et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018;5(5):e211–e220. [PubMed: 29592840]
30.
Orkin C, Squires KE, Molina JM, et al. Doravirine/lamivudine/tenofovir disoproxil fumarate is non-inferior to efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults with human immunodeficiency virus-1 infection: week 48 results of the DRIVE-AHEAD trial. Clin Infect Dis. 2018. [PMC free article: PMC6355823] [PubMed: 30184165]
31.
Center for Drug Evaluation and Research. Multi-discipline review(s). Pifeltro (doravirine) & Pifeltro (doravirine). Company: Merck Sharp & Dohme Corp. Application No.: 210806 & 210807. Approval date: 08/30/2018 (FDA drug approval package). Rockville (MD): U.S. Food and Drug Administration (FDA); 2018: https://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2018/210806Orig1s000,210807Orig1s000TOC.cfm. Accessed 2019 Feb 20.
32.
Health Canada reviewer’s report: Pifeltro (doravirine) [CONFIDENTIAL internal report]. Ottawa (ON): Therapeutics Products Directorate, Health Canada; 2018.
33.
van Reenen M, Janssen B. EQ-5D-5L user guide: basic information on how to use the EQ-5D-5L instrument. Rotterdam (NL): EuroQol Research Foundation; 2015: https://euroqol​.org/wp-content​/uploads/2016​/09/EQ-5D-5L_UserGuide_2015.pdf. Accessed 2019 Feb 20.
34.
Human immunodeficiency virus-1 infection: developing antiretroviral drugs for treatment. Guidance for industry. Rockville (MD): U.S. Department of Health and and Human Services, Food and Drug Administration; 2015: https://www​.fda.gov/downloads​/drugs/guidancecomplianceregulatoryinformation​/guidances/ucm355128.pdf. Accessed 2019 Feb 20.
35.
Network meta-analysis of ▬ human immunodeficiency virus type 1 (HIV-1) therapies for Pifeltro™ submission. In: CDR submission: Pifeltro (doravirine), 100 mg oral tablets. Company: Merck Canada Inc. [CONFIDENTIAL manufacturer’s submission]. Kirkland (QC): Merck Canada Inc; 2018 Nov 16.
36.
Higgins JP, Altman DG, Gøtzsche 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]
37.
Rücker R. Network meta-analysis, electrical networks and graph theory. Res Synth Methods. 2012;3(4):312–324. [PubMed: 26053424]
Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK544871

Views

  • PubReader
  • Print View
  • Cite this Page
  • PDF version of this title (1.9M)

Other titles in this collection

Related information

  • PMC
    PubMed Central citations
  • PubMed
    Links to PubMed

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...