Compliance is high with single-tablet daily PEP regimen, prevents HIV infection

Presenter: Lijun Sun, PhD, Beijing Youan Hospital, Capital Medical University Hospital, Beijing, China

A summary of Liu A, Xin R, Zhang H, et al. A phase IV Open-label Evaluation of Safety and Tolerability of Corformulated Bictegravir/Emtricitabine/Tenofovir aAafenamide for Post-exposure Prophylaxis Following Potential Exposure to HIV-1. Late Breaker C Oral Abstract 12251. Presented at the 24th International AIDS Conference, July 29 – August 2, 2022.

A once-daily single tablet regimen of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) used as postexposure prophylaxis (PEP) taken by HIV-negative individuals after potential exposure to HIV was effective and well tolerated with a high rate of adherence and completion.

Of 112 patients enrolled in this prospective, open-label, single-arm study, self-reported adherence to the regimen was 98.9% and PEP completion was 96.4%. Through week 24, no study participants acquired HIV, according toz Lijun Sun, PhD, director, Clinic for Infection Center, Beijing Youan Hospital, Beijing, China.

While BIC/FTC/TAF has proved effective and convenient as treatment for people living with HIV (PLWH), data are limited for its use as PEP and side effects associated with PEP regimens have prevented the required 28-day completion in the past as adverse events can include cutaneous allergy, gastrointestinal disorders, and hepatorenal toxicity. Although these adverse effects are generally not severe, a meta-analysis of more than 21,000 individuals revealed that only 56.6% of PEP users complete the full standard 28-day course of therapy.1

Safety, tolerability, and adherence were evaluated in the once-daily, 28-day BIC/FTC/TAF PEP regimen of eligible patients ≥ 18 years old who presented within 72 hours after a potential sexual exposure to HIV-1.

109 (97.3%) study participants were male with sexual exposure including anal in 58 (51.8%), vaginal in 43 (38.4%), and oral in 29 (25.9%). Time from exposure was ≤ 24 hours in 54 (48.2%), 24 to 48 hours in 45 (40.2%), and 48 to 72 hours in 13 (11.6%) participants. Mean age was 30 years.

A total of 108 participants reported adherence to all expected doses. By pill count, adherence to all expected doses was 98.5%.

Four participants did not complete PEP, two because the source partner was found to be HIV negative, one for being positive for hepatitis B virus, and one due to participant’s decision.

Adverse effects were mild headache in two participants, mild diarrhea in two, and mild nausea in one. All resolved spontaneously without stopping PEP.

Reference

  1. Ford N, Irvine C, Shubber Z, et al. Adherence to HIV postexposure prophylaxis: a systematic review and meta-analysis. AIDS 2014; 28(18):2721-2727. doi: 10.1097/QAD.0000000000000505

Disclosure

The study was supported by Gilead Sciences. Lijun Sun, PhD, reported no conflicts of interest.

 

 

← Back to AIDS 2022 Summaries