Background:
Integrase inhibitor-based regimens are the standard of care for HIV post-exposure prophylaxis (PEP), but no such single tablet regimens are recommended in current guidelines. We analyzed tolerability, adherence and HIV seroconversions with bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) as HIV PEP in an ongoing clinical trial of text-messaging support versus standard of care for PEP users.
Methods:
Adults initiating a standard PEP regimen within the preceding five days for a confirmed or potential sexual exposure to HIV were randomized to either receive short message service (SMS) check-ins using the WelTel platform, or standard care. All participants underwent baseline HIV testing and were switched from their original PEP regimen (if applicable) to B/F/TAF to complete 28 days. CBC, ALT and creatinine were assessed at week 2; medication adherence at week 4; HIV serology at weeks 6 and 12; and adverse events at all visits.
Results:
Of 120 individuals screened for participation in the trial, 119 participants were enrolled and are included in this analysis; all were HIV-negative at baseline. Median (interquartile range) age was 29 (25, 34) years and 22% had previously used PEP. Most (86%) were men who have sex with men. Medication adherence was high; among 101 participants with available data, all took all 28 days of PEP except for two who stopped prematurely after 7 and 8 days respectively. B/F/TAF was well-tolerated, with only 11% experiencing adverse events of grade ≥2 severity; 38% experiencing AEs at least possibly related to study drug (Table), most often gastrointestinal. No HIV seroconversions were observed.
Conclusions:
B/F/TAF PEP was associated with high tolerability, high adherence and no HIV seroconversion in this cohort. These data support the use of this single tablet regimen as HIV PEP after sexual exposures.
