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Fenway Institute Study Examines Safety And Tolerability Of Single Pill For PEP

A new study out of The Fenway Institute reports that the use of a single combination pill for post-exposure prophylaxis (PEP) is both safe and largely well-tolerated. The study is groundbreaking as it outlines the first demonstration of the use of a single combination pill containing bictegravir, emtricitabine, and tenofovir alafenamide for PEP.

“Data have long suggested that the prompt use of a short course of antiretroviral medication after a high risk exposure can prevent HIV transmission,” said Dr. Kenneth Mayer, Medical Research Director and Co-Chair of The Fenway Institute and lead author of this study.

Between August 2018 and March 2020, The Fenway Institute enrolled 52 individuals in the study. Most identified as cisgender gay (67.3%) or bisexual (11.5%) men, but 7.7% identified as cisgender heterosexual men and 3.8% cisgender heterosexual women. The most common side effects reported from taking this single pill were nausea or vomiting, fatigue, and diarrhea, all of which were less common than reported in historical controls using other PEP regimens. Over 90% of the study participants completed the indicated regimen, which was a higher completion rate compared with earlier PEP regimens, and none became HIV-positive.

“PEP has been used by health care workers after needle sticks and people after sexual assaults, but many of the previously used regimens either had too many side effects or involved excess pill burdens. At Fenway Health, we have provided PEP to patients for more than 25 years. In the current study, we found that taking a single pill containing tenofovir, emtricitabine, and bictegravir for PEP, was extremely well tolerated, with a 90% completion rate. The simplicity and acceptability of this regimen may help to improve PEP uptake and completion rates,” Mayer explained.

The Fenway Institute has long been a leader in research on the use of antivirals for prevention, with nearly two decades worth of experience identifying regimens that are well tolerated for PEP in addition to similar research around pre-exposure prophylaxis (PrEP).

“Safety and Tolerability of Once Daily Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide for Postexposure Prophylaxis After Sexual Exposure” is available online via the Journal of Acquired Immune Deficiency Syndromes now, and printed copies will be available starting May 1.

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