1 Jul 2025
“Use of doravirine-based regimens in clinical practice in Europe: a real-life retrospective observational study.”
A large real-world European study has confirmed that Doravirine (DOR)-based antiretroviral therapy is both highly effective and well-tolerated among people living with HIV (PLWH), whether newly diagnosed or switching from previous treatments, documented in the manuscript released by AIDS on the 1st of July 2025/
Doravirine is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) approved in Europe since 2018. This study adds to growing evidence from clinical trials and real-life data supporting its use in both treatment-naïve and treatment-experienced individuals. There is little data on virological, resistance and tolerability outcomes on non -research clinical use. Doravirine is recommended first line therapy in the EACS guidelines.
The retrospective DREW study, conducted across 16 clinical sites in the UK, France, Spain, Belgium, and the Netherlands, evaluated outcomes in nearly 400 adults living with HIV, who either started or switched to a DOR-containing regimen. 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. 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-up and 13 (3.3%) discontinued the DOR regimen, four (1%) due to adverse events. The results show high levels of efficacy and low levels of side effects in DOR-containing regimens in both treatment-naive and treatment-experienced PWH.
Professor Anton Pozniak, Chief Investigator of DREW, stated “The study generated important data on Doravirine and showed its utility in first line and in switch patients.”
Dr Agathe Rami, First Author, stated “Our findings reinforce the high real-world effectiveness and tolerability of Doravirine-based regimens, supporting their role as a valuable option in routine clinical practice for both newly diagnosed and treatment-experienced people living with HIV across Europe.”
Contributing sites: Chelsea and Westminster (UK), St Antoine (France), CHU De Nantes (France), Guys Hospital (UK), Lariboisiere Hospital (France), Bichat-Claude Bernard Hospital (France), University Hospitals Pitié Salpêtrière (France), Institute Of Tropical Medicine Antwerp (Belgium), St Louis Hospital (France), Mortimer Market Centre (UK), CHU Nice (France), CHU St Pierre (Belgium), Erasmus University Medical Center (Netherlands), Southmead Hospital (UK), CHU de Montpellier (France), University Hospital Clínic de Barcelona (Spain).
This study is sponsored by NEAT ID and funded by MSD.
Notes to editors:
1. NEAT ID's mission is to support and develop Clinical Research on Infectious Diseases and spread expertise, resources and funds. NEAT ID provides training and mobility of scientists at all levels and foster lasting research collaborations Internationally. Please visit our website for more details: https://www.NEAT-ID.org
2. Professor Anton Pozniak is a consultant physician in HIV Medicine at the Chelsea and Westminster Hospital, Professor in the Department of Clinical Research at the London School of Hygiene & Tropical Medicine, Past President of the International AIDS Society and NEAT ID. Anton has been an advisor on HIV and AIDS to the UK Government Health Select Committee and a member of the expert advisory group on AIDS for the UK Department of Health. He has published more than 400 peer-reviewed papers, mainly on clinical aspects of HIV treatment and care and HIV-associated tuberculosis.
3. Dr Agathe Rami is a French physician specialized in HIV medicine with expertise in clinical research. Based in the Department of Infectious Diseases at the Lariboisière and Saint-Louis hospitals in Paris, France, she has been involved in numerous national and international collaborative studies in the field of HIV and other infectious diseases.