Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP)
Author:
Inciarte Alexy123ORCID, Ugarte Ainoa1, Martínez-Rebollar María134, Torres Berta1234ORCID, Fernández Emma1, Berrocal Leire12, Laguno Montserrat1234, De la Mora Lorena13, De Lazzari Elisa1234, Callau Pilar2, Chivite Iván1, González-Cordón Ana1, Solbes Estela1, Rico Verónica1, Barrero Laura1, Blanco José Luis134, Martínez Esteban1234, Ambrosioni Juan1234, Mallolas Josep1234, Inciarte Alexy, Ugarte Ainoa, Torres Berta, Martínez-Rebollar María, Laguno Montserrat, Ambrosioni Juan, Agüero Daiana, Chivite Iván, Rico Verónica, Berrocal Leire, González-Cordón Ana, Puerta Pedro, de la Mora Lorena, De Lazzari Elisa, Herrera Sabina, García-Pouton Nicol, Hernández-Meneses Marta, Monzó Patricia, Rodrigo Alonso, Callau Pilar, Aguiló Raquel, Fernández Emma, Barrero Laura, Solbes Estela, Martínez Esteban, Blanco José Luis, Miró José M, Soriano Alex, Mallolas Josep,
Affiliation:
1. Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona , Barcelona , Spain 2. Fundació de Recerca Clínic Barcelona, Institut d’Investigacions Biomèdiques August Pi I Sunyer , Barcelona , Spain 3. University of Barcelona, Faculty of Medicine , Barcelona , Spain 4. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas , Madrid , Spain
Abstract
Abstract
Background
New regimens may provide better tolerability, convenience, and safety for nonoccupational human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). For this reason, we evaluated the single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for 28 days.
Methods
This was a prospective, open-label, single-arm trial including individuals with potential HIV-1 exposure within 72 hours. The primary endpoint was noncompletion of PEP at day 28. Secondary endpoints were adverse effects, adherence, and rate of seroconversion. We performed follow-up at day 7, week 4, and week 12.
Results
Between September 2019 and March 2022, the study enrolled 399 individuals. Median age was 30 (interquartile range [IQR], 27–36) years, and 91% (n = 364) were male. The mode of exposure was sex between men in 84% (n = 331) of cases; risk assessment for HIV-1 transmission was considered as “high” in 97% (n = 385) of the participants. Median time from exposure to consultation was 24 (IQR, 13–40) hours. Noncompletion of PEP was 29% (n = 114) (95% confidence interval [CI], 24%–33%) and 20% (n = 72) (95% CI, 16%–25%) per modified intention-to-treat. Main reasons for noncompletion were loss to follow-up (n = 104 [91%]) and intolerance (n = 8 [7%]). Older age was associated with a lower risk of premature discontinuation (OR, 0.94; P < .001). One hundred twenty-three (31%) participants reported adverse events, mostly mild and self-limited (82%); discontinuation occurred in 8 cases (2%). Adherence to PEP in the assessed users was 96%. There were no HIV seroconversions.
Conclusions
DOR/3TC/TDF is a well-tolerated option for nonoccupational PEP.
Clinical Trials Registration. NCT04233372.
Funder
Merck Sharp & Dohme
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Oncology
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