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

Abstract

BACKGROUND:

Antiretroviral post-exposure prophylaxis (PEP) is recommended to prevent HIV infection after a high-risk exposure, but current regimens have presented challenges in tolerability, regimen completion, and potential drug-drug interactions. Because coformulated bictegravir, emtricitabine, and tenofovir alafenamide [BIC/FTC/tenofovir alafenamide (TAF)] is effective for HIV treatment, it was evaluated for use for PEP.

SETTING:

Boston community health center.

METHODS:

Individuals accessing PEP were enrolled in an open-label study of coformulated BIC/FTC/TAF, taken as one pill daily for 28 days. Pearson's χ2 and Fisher's exact tests were used to assess whether BIC/FTC/TAF differed with respect to side effects and regimen completion rates compared with historical PEP regimens.

RESULTS:

Between August, 2018 and March, 2020, 52 individuals enrolled 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 regimen side effects were nausea or vomiting (15.4%), fatigue (9.6%), and diarrhea/loose stools (7.7%), which were less common than historical controls using other PEP regimens, including those containing other integrase strand transfer inhibitors. Only 1 participant discontinued the regimen because of fatigue, and all other side effects were self-limited. Almost all participants (90.4%) completed the indicated regimen, which was a higher completion rate compared with earlier PEP regimens, and none became HIV-positive.

CONCLUSIONS:

BIC/FTC/TAF coformulated as a single daily pill was found to be safe, well-tolerated, and highly acceptable when used for PEP, and compared more favorably than historical PEP regimens used at an urban health center.

• Authors: Kenneth H Mayer, Marcy Gelman, Johnathon Holmes, Jessica Kraft, Kathleen Melbourne, Matthew J Mimiaga
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 90 Issue 1 Pg. 27-32 (05 01 2022) ISSN: 1944-7884 [Electronic] United States
• PMID: 34991141 (Publication Type: Journal Article)
• Copyright: Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

Chemical References

• Amides
• Anti-HIV Agents
• Heterocyclic Compounds, 3-Ring
• Heterocyclic Compounds, 4 or More Rings
• Piperazines
• Pyridones
• bictegravir
• Tenofovir
• tenofovir alafenamide
• Emtricitabine
• Adenine
• Alanine

Topics

• Adenine (adverse effects)
• Alanine
• Amides
• Anti-HIV Agents (adverse effects)
• Emtricitabine
• Fatigue (chemically induced, drug therapy)
• Female
• HIV Infections (drug therapy, prevention & control)
• Heterocyclic Compounds, 3-Ring
• Heterocyclic Compounds, 4 or More Rings (adverse effects)
• Humans
• Male
• Piperazines
• Post-Exposure Prophylaxis
• Pyridones (therapeutic use)
• Tenofovir (adverse effects, analogs & derivatives)