AIDS (London, England) 2017 03 15() doi 10.1097/QAD.0000000000001447
Completion rates for HIV post-exposure prophylaxis (PEP) are often low. We investigated the adherence and safety of dolutegravir (DTG 50 mg daily) with tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF-FTC) as 3-drug PEP in gay and bisexual men (GBM).
Open-label, single-arm study at 3 sexual health clinics and 2 emergency departments in Australia.
One hundred HIV-uninfected GBM requiring PEP received DTG plus TDF-FTC for 28 days. The primary endpoint was PEP failure (premature PEP cessation or primary HIV infection through Week 12). Additional endpoints were: adherence by self-report (n = 98) and pill count (n = 55); safety; and plasma drug levels at Day 28.
PEP completion was 90% (95%CI 84% to 96%). Failures (occurring at a median 9 days, IQR 3-16) comprised loss to follow-up (9%) and adverse event resulting in study drug discontinuation (headache, 1%). No participant was found to acquire HIV through Week 12. Adherence to PEP was 98% by self-report and in the 55 participants with corresponding pill count data. The most common clinical adverse events (AEs) were fatigue (26%), nausea (25%), diarrhoea (21%), and headache (10%). There were only four Grade 3-4 subjective AEs. The most common laboratory AE was raised alanine aminotransferase (22%), but there was no case of clinical hepatitis. At Day 28, the mean estimated glomerular filtration rate (eGFR) decrease was 14 mL/min/1.73m (SD 17, p = 0.001); an eGFR of <60 mL/min/1.73m occurred in 3%. CONCLUSIONS
DTG with TDF-FTC is a safe and well-tolerated option for once-daily PEP.