Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

Phase 4 Completed 52 enrolled Fenway Community Health

NaSingle-groupOpen-labelPrevention

Summary

Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)

Timeline

Start: 2019-01-24
Primary completion: 2020-03-30
Completion: 2020-03-31

Publications

Mayer KH, Gelman M, Holmes J, Kraft J, Melbourne K, Mimiaga MJ. Safety and Tolerability of Once Daily Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide for Postexposure Prophylaxis After Sexual Exposure. J Acquir Immune Defic Syndr. 2022 May 1;90(1):27-32. doi: 10.1097/QAI.0000000000002912.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bictegravir	Small molecule	—	Oral
Subject	emtricitabine	Other / unclassified	—	Oral
Subject	tenofovir alafenamide	Small molecule	—	Oral

Indications

No indication recorded.