HIV Post-exposure prophylaxis (PEP) completion rates are often low. Newer antiretroviral combinations, such as the recently approved elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide coformulation (E/C/F/TAF), may improve PEP adherence.
Prospective, open-label, single-arm trial conducted in 15 French centers (NCT02998320). Individuals with recent HIV exposure who met criteria for PEP initiation received once-daily E/C/F/TAF for 28 days. Follow-up visits were scheduled at days 14, 28, 60 and 120. The primary endpoint was PEP completion at day 28. Secondary endpoints were adherence, quality of life, adverse events and efficacy.
Ninety-eight individuals exposed to HIV received at least one dose of E/C/F/TAF (8 occupational and 90 sexual exposures, of which 64% were MSM). Participants were primarily male (77%) with a median age of 33 years (IQR, 25-39). Seventy-eight individuals (80%) completed PEP course till day 28 visit. Completion failure (n=20, 20%) was due to lost to follow-up (n=16), sexual partner or source-patient tested HIV-negative (n=2), individual’s own choice (n=1) and withdrawal of consent (n=1). No PEP interruption due to adverse events was documented. Fifteen additional participants (15%) were also lost to follow-up from day 28 to day 120. Self-reported adherence was 100%, between 90 and 99%, and <90% for 63 (76%), 18 (22%) and 2 (2%) individuals at day 14; and for 58 (75%), 13 (17%), 6 (8%) individuals at day 28, respectively. Median elvitegravir trough concentration at day 14 was 628 ng/mL (IQR, 471-934), therefore above 190 ng/mL for 96% of participants. Mean quality of life SF-12 measures of physical and mental health were of 50 and 47 on day 1, 52 and 48 on day 14, and 51 and 49 on day 28, respectively (p>0.05). Overall, 226 adverse events were reported in 58 (68%) and 43 (59%) participants, at day 14 and 28 respectively. At day 14; 93, 24 and 8 grade 1, 2 and 3 adverse events were observed, and 73, 21 and 7 on day 28, respectively. The most frequent reported adverse events were asthenia (19%), abdominal pain (16%), diarrhea (15%) and headache (14%). No renal or liver abnormalities occurred. Neither HIV seroconversion, nor acute hepatitis B infection were observed.
PEP E/C/F/TAF was well tolerated and demonstrated good completion rates. Self-reported and drug levels indicated good adherence, confirming that E/C/F/TAF could be a regimen of choice for PEP.