Use of doravirine-based regimens in clinical practice in Europe

作者：Agathe Rami, Anton Pozniak, Lambert Assoumou, Roya Movahedi, Karine Lacombe, François Raffi, Julie Fox, Laura Levi, Tetiana Melnyk, Debbie Roberts, Carl Fletcher, Jean‐Michel Molina, DREW Study Group · 发表于：AIDS · 年份：2025 · DOI：10.1097/qad.0000000000004151 · 被引用次数：3 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

OBJECTIVES: We evaluated antiviral effectiveness and safety of doravirine (DOR)-based regimens in people with HIV (PWH) in routine clinical practice. DESIGN: A retrospective, noninterventional study across 16 sites in five European countries [United Kingdom (UK), France, Spain, Belgium, Netherlands]. METHODS: The study was conducted in both treatment-experienced and treatment-naive PWH who either switched to, or initiated DOR-containing antiretroviral therapy (ART). The primary endpoints were virological success (defined as the percentage of participants with HIV RNA <50 copies/ml, using FDA Snapshot method) and virological failure (FDA Snapshot, HIV RNA ≥50 copies/ml) at 48 weeks after initiation of DOR regimen. RESULTS: Between August 2017 and February 2022, 394 participants were enrolled, 63 naive and 331 treatment-experienced. 75.4% were men, with a median age of 45 years, and 92.2% received DOR in combination with tenofovir disoproxil fumarate and lamivudine or emtricitabine. The proportion of participants with virological success at week 48 after initiation of DOR regimen was 90.6% [95% confidence interval (CI) 87.3-93.3] overall, 87.3% (95% CI 76.5-94.4) in the ART-naive group, and 91.2% (95% CI 87.7-94.1) in the switch group. The proportion of participants with virological failure was 3.3% (95% CI 1.8-5.6) overall, 1.6% (95% CI 0-8.5) in the ART-naive group and 3.6% (95% CI 1.9-6.2) in the switch group. Of the 394 included participants, two (0.5%) were lost to follow-...