Dolutegravir with tenofovir disoproxil fumarate-emtricitabine as HIV postexposure prophylaxis in gay and bisexual men.
AIDS
; 31(9): 1291-1295, 2017 06 01.
Article
em En
| MEDLINE
| ID: mdl-28301425
ABSTRACT
OBJECTIVES:
Completion rates for HIV postexposure prophylaxis (PEP) are often low. We investigated the adherence and safety of dolutegravir (DTG; 50âmg daily) with tenofovir disoproxil fumarate-emtricitabine (TDF-FTC; 300/200âmg, respectively) as three-drug PEP in gay and bisexual men.DESIGN:
Open-label, single-arm study at three sexual health clinics and two emergency departments in Australia.METHODS:
In total, 100 HIV-uninfected gay and bisexual men requiring PEP received DTG and TDF-FTC for 28 days. The primary end point was PEP failure (premature PEP cessation or primary HIV infection through week 12). Additional end points were adherence by self-report (nâ=â98) and pill count (nâ=â55), safety, and plasma drug levels at day 28.RESULTS:
PEP completion was 90% (95% confidence interval 84-96%). Failures (occurring at a median 9 days, interquartile range 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 were fatigue (26%), nausea (25%), diarrhoea (21%), and headache (10%). There were only four grade 3-4 subjective adverse events. The most common laboratory adverse event was raised alanine aminotransferase (22%), but there was no case of clinical hepatitis. At day 28, the mean estimated glomerular filtration rate decrease was 14âml/min/1.73m (SD 17, Pâ=â0.001); an estimated glomerular filtration rate of less than 60âml/min/1.73m occurred in 3%.CONCLUSIONS:
DTG with TDF-FTC is a well tolerated option for once-daily PEP.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecções por HIV
/
Quimioprevenção
/
Fármacos Anti-HIV
/
Profilaxia Pós-Exposição
/
Tenofovir
/
Emtricitabina
/
Compostos Heterocíclicos com 3 Anéis
Tipo de estudo:
Clinical_trials
Limite:
Humans
/
Male
País/Região como assunto:
Oceania
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article