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Dolutegravir with tenofovir disoproxil fumarate – emtricitabine as HIV post-exposure prophylaxis in gay and bisexual men.

Dolutegravir with tenofovir disoproxil fumarate – emtricitabine as HIV post-exposure prophylaxis in gay and bisexual men.
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Mcallister J, Towns JM, Mcnulty A, Pierce AB, Foster R, Richardson R, Carr A,


Mcallister J, Towns JM, Mcnulty A, Pierce AB, Foster R, Richardson R, Carr A, (click to view)

Mcallister J, Towns JM, Mcnulty A, Pierce AB, Foster R, Richardson R, Carr A,

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AIDS (London, England) 2017 03 15() doi 10.1097/QAD.0000000000001447

Abstract
OBJECTIVES
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).

DESIGN
Open-label, single-arm study at 3 sexual health clinics and 2 emergency departments in Australia.

METHODS
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.

RESULTS
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.

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