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. 2023 Jul 19;10(8):ofad374.
doi: 10.1093/ofid/ofad374. eCollection 2023 Aug.

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP)

Alexy Inciarte  1   2   3 , Ainoa Ugarte  1 , María Martínez-Rebollar  1   3   4 , Berta Torres  1   2   3   4 , Emma Fernández  1 , Leire Berrocal  1   2 , Montserrat Laguno  1   2   3   4 , Lorena De la Mora  1   3 , Elisa De Lazzari  1   2   3   4 , Pilar Callau  2 , Iván Chivite  1 , Ana González-Cordón  1 , Estela Solbes  1 , Verónica Rico  1 , Laura Barrero  1 , José Luis Blanco  1   3   4 , Esteban Martínez  1   2   3   4 , Juan Ambrosioni  1   2   3   4 , Josep Mallolas  1   2   3   4 ; DORAVIPEP Study Group
Collaborators, Affiliations

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP)

Alexy Inciarte et al. Open Forum Infect Dis. .

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.

Keywords: HIV-1 prevention; PEP; doravirine; postexposure prophylaxis; sexual exposure.

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Conflict of interest statement

Potential conflicts of interest. A.I. has received research funding from Gilead, Janssen, and GSK. Additionally, A.I. has served on advisory boards for Almirall, Pfizer, AbbVie, and Bayer. J.A. has been granted research funding by ViiV and Gilead, and has received personal compensation from ViiV, Gilead, Janssen, and MSD. Additionally, J.A. has taken part in Advisory Boards for ViiV, Gilead, Janssen, and MSD, as well as participated in Data Safety Monitoring Boards for HIPRA and Grifols. It is important to note that these activities are separate from the current work. J.M has received research funding from ViiV and Gilead and has also been personally compensated by ViiV, Gilead, Janssen, and Amber. All authors: no conflict of interest to declare related to this work.

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