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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.

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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].

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Abbreviations

3TC: lamivudine
BIC: bictegravir
AE: adverse event
ABC: abacavir
ART: antiretroviral therapy
ARV: antiretroviral
CI: confidence interval
CTAC: Canadian Treatment Action Council
DB: double-blind
DHHS: US Department of Health and Human Services
DTG: dolutegravir
DOR: doravirine
DRV: darunavir
DRV/r: ritonavir-boosted darunavir
DSG: delayed switch group
EFV: efavirenz
EVG: elvitegravir
EQ-5D-5L: EuroQol 5-Dimensions 5-Levels questionnaire
FAS: full-analysis set
FDC: fixed-dose combination
FTC: emtricitabine
HDL: high-density lipoprotein cholesterol
IDC: indirect comparison
InSTI: integrase strand transfer inhibitor
ISG: immediate switch group
IVRS/IVWS: interactive voice/Web response system
LDL: low-density lipoprotein cholesterol
MCID: minimal clinically important difference
NIM: noninferiority margin
NMA: network meta-analysis
NNRTI: non-nucleoside reverse transcriptase inhibitor
NRTI: nucleoside reverse transcriptase inhibitor
OL: open-label
PDVF: protocol-defined virologic failure
PI: protease inhibitor
PP: per-protocol
RCT: randomized controlled trial
RAM: resistance-associated mutation
RNA: ribonucleic acid
SAE: serious adverse event
SD: standard deviation
STR: single-tablet regimen
TAF: tenofovir alafenamide
TDF: tenofovir disoproxil fumarate
ULN: upper limit of normal
WDAE: withdrawal due to adverse event

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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. Abbreviations.
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