Optimal HIV Postexposure Prophylaxis Regimen Completion With Single Tablet Daily Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine Compared With More Frequent Dosing Regimens

Abstract

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.

COVID-19-Related Disruptions to HIV Testing and Prevention Among Young Sexual Minority Men 17–24 Years Old: A Qualitative Study Using Synchronous Online Focus Groups, April–September 2020

“…In 2021, almost a decade prior to the start of COVID-19, the US Food and Drug Administration approved the use of PrEP for HIV prevention (U.S. Food and Drug Administration, 2012 ), adding another biomedical tool to combat the HIV epidemic beyond treatment as prevention and PEP. Whereas non-occupational PEP is a three- or four-drug regime of antiretrovirals administered within 72 h after a potential HIV exposure recommended by the CDC since 2005 (CDC, 2017c ; Smith et al, 2005 ) to reduce the risk of HIV seroconversion (Mayer et al, 2017 ), PrEP in its current form is a once-daily pill regime supported by CDC prescribing guidelines to be taken before HIV exposure events (CDC, 2017c ). While fewer than 12% of HIV-negative or unknown status SMM have reported taking PEP in their lifetime (John et al, 2021 ), there was a 470% increase in PrEP uptake in individuals over 16 years old, predominantly among cisgender men, between 2014 and 2016 (Ya-lin et al, 2018 ).…”

Safety and Tolerability of Once Daily Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide for Postexposure Prophylaxis After Sexual Exposure

“…The Boston community health center where the trial was conducted has maintained the largest PEP program in New England for more than 20 years, 19 and has been actively investigating new, potent, and better tolerated regimens for PEP since then. 11,12,20…”

Tolerability and Adherence of Antiretroviral Regimens Containing Long-Acting Fusion Inhibitor Albuvirtide for HIV Post-Exposure Prophylaxis: A Cohort Study in China

“…There is a demand for PEP regimens that could overcome challenges of poor adherence, severe adverse events, and dosing convenience. Two previous overseas studies using co-formulated STRs (elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine) of HIV PEP found that the majority of participants achieved a higher drug completion rate (> 70%) and favorable drug tolerance [ 11 , 12 ]. However, these studies did not include Chinese participants or cohorts, and the real-world usage of these STRs in China was low.…”