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

Abstract

Background New regimens may provide better tolerability, convenience, and safety for non-occupational HIV post-exposure prophylaxis (PEP). For this reason, we evaluated the single-tablet regimen (STR) Doravirine/Lamivudine/Tenofovir disoproxil fumarate (DOR/3TC/TDF) for 28 days. Methods and materials Prospective, open-label, and single-arm trial. We included individuals with potential HIV-1 exposure within 72 hours. The primary endpoint was non-completion 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. The trial is registered at clinicaltrials.gov number: NCT04233372. Results Between September 2019 and March 2022, the study enrolled 399 individuals. Median age was 30 (27-36) years and 91% (n = 364) were males. 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 (13-40) hours. Non-completion of PEP was 29% (n = 114) (95%CI:24-33) and 20% (n = 72) (95%CI: 16-25) per modified ITT. Main reasons for non-completion 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 < 0.001). One hundred and twenty-three (31%) participants reported adverse events—mostly mild and self-limited (82%); discontinuation occurred in eight 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 non-occupational PEP.