1. Long-term effectiveness, safety, and tolerability of doravirine in antiretroviral-experienced people with HIV in real life.
- Author
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Mejías-Trueba M, Gutierrez-Valencia A, Llaves-Flores S, Roca-Oporto C, Herrero M, Sotomayor de la Piedra C, Lopez-Cortes LF, and Espinosa N
- Subjects
- Humans, Female, Male, Adult, Middle Aged, Dideoxynucleosides therapeutic use, Dideoxynucleosides adverse effects, Dideoxynucleosides administration & dosage, Drug Combinations, Heterocyclic Compounds, 3-Ring therapeutic use, Heterocyclic Compounds, 3-Ring adverse effects, Heterocyclic Compounds, 3-Ring administration & dosage, Oxazines therapeutic use, Reverse Transcriptase Inhibitors therapeutic use, Reverse Transcriptase Inhibitors adverse effects, Spain, Treatment Outcome, Cobicistat therapeutic use, Cobicistat adverse effects, Cobicistat administration & dosage, Darunavir therapeutic use, Darunavir adverse effects, Piperazines adverse effects, Viral Load drug effects, HIV-1 drug effects, HIV-1 genetics, Cyclopropanes, Dideoxyadenosine analogs & derivatives, HIV Infections drug therapy, HIV Infections virology, Pyridones adverse effects, Lamivudine therapeutic use, Lamivudine adverse effects, Lamivudine administration & dosage, Anti-HIV Agents therapeutic use, Anti-HIV Agents adverse effects, Anti-HIV Agents administration & dosage, Triazoles therapeutic use, Triazoles adverse effects, Triazoles administration & dosage
- Abstract
Real-life data on doravirine (DOR) in different drug combinations are limited. We evaluated the effectiveness of DOR plus two nucleos(t)ide reverse transcriptase inhibitors (NRTI), mainly abacavir/lamivudine, and dual therapies in people with HIV (PWH), mostly virologically suppressed. Ambispective observational study that enrolled adults PWH who initiated a DOR-based regimen from September 2020 to February 2022 at a referral center in Spain. Participants were grouped as follows: A, received DOR plus two NRTI; B, dual therapy (DT) with DOR plus dolutegravir (DTG) or darunavir/cobicistat (DRVc); C, DOR plus ≥two antiretroviral drugs. The primary endpoints were treatment effectiveness at week 48 by intention-to-treat (ITT) and per-protocol analysis (OT). A cohort of 187 participants, 91% virologically suppressed, were analyzed after a median follow-up of 112 weeks (80-136). Group A received DOR plus abacavir/lamivudine (ABV/3TC) ( n = 109) or tenofovir/emtricitabine (TFV/3TC) ( n = 45). At week 48, the effectiveness of DOR plus ABV/3TC by ITT was 90.8% (CI
95 , 88.0-93.6), better than with TFV/FTC [73.3% (66.7-79.9); P = 0.003]. Only one virologic failure was observed. Mild adverse effects were the cause of treatment discontinuation in 7.8%, followed by switching to a single-tablet regimen. In group B, the effectiveness by ITT was 92.9% (CI95 , 88.0-97.8) at week 48. No adverse effects or virologic failure were registered in this group. DOR plus two NRTI or DT have long-term effectiveness and safety as a switching option for PWH, mostly virologically suppressed. The DOR plus ABV/3TC combination has shown even better effectiveness than TFV/FTC.IMPORTANCEDOR-based regimens have shown long-term effectiveness and safety in PWH, mostly virologically suppressed. The combination of DOR plus ABV/3TC has shown even better safety and effectiveness than TFV/FTC. DOR plus two NRTI offers cost benefits compared to other regimens., Competing Interests: L.F.L.-C. has received unrestricted research funding outside the submitted work from Gilead Sciences, Merck Sharp & Dohme, and ViiV Healthcare; consultancy fees and lecture fees from Gilead Sciences and ViiV Healthcare. N.E. has received fees as a consultant and speaker from ViiV Healthcare, Merck Sharp & Dohme, Gilead Sciences, and travel grants from Gilead Sciences and Merck Sharp for attending conferences. C.S., M.H. and A.G.-V. have received travel grants for attending conferences from Gilead Sciences.- Published
- 2024
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