Structure
The study evaluated elvitegravir/cobicistat/tenofovir disiproxil fumarate(TDF)/emtricitabine(FTC) (“Quad pill”) for post-exposure prophylaxis (PEP).
Background
HIV-exposed individuals may benefit from PEP, but completion rates have been suboptimal because of regimen complexity and side effects. Newer antiretroviral combinations co-formulated as single daily pills may optimize PEP adherence.
Setting
One hundred HIV-uninfected individuals who presented to a Boston community health center after an acute HIV sexual exposure were enrolled and initiated PEP with the daily, single pill combination Quad pill for a 28-day course.
Methods
Side effects and medication completion rates from study participants were compared to historical controls who had used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using chi-square tests for independence.
Results
Of the 100 participants who initiated the Quad pill for PEP after a high risk sexual exposure, 71% completed the 28 day Quad pill regimen, which was significantly greater than historical controls who used TDF/FTC and raltegravir (57%, p <0.05) or AZT/3TC plus a protease inhibitor (39%, p < 0.001). The most common side effects reported by Quad pill users were: abdominal discomfort or pain, gas or bloating (42%), diarrhea (38%), fatigue (28%), nausea or vomiting (28%), headache (14%), or dizziness or lightheadedness (6%). Most symptoms were mild, limited, and did not result in medication discontinuation. No participants became HIV-infected.
Conclusions
Fixed dose combination elvitegravir/cobicistat/TDF/FTC was safe and well-tolerated for PEP, with higher regimen completion rates than more frequently dosed PEP regimens.