Emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) for HIV infection pre-exposure prophylaxis (PrEP) was comparable to aspirin use in terms of patient safety, researchers concluded in a study published in Open Forum Infectious Diseases. 

Studies have established the safety and efficacy of FTC-TDF for HIV PrEP in reducing the risk of HIV, though some safety concerns have lingered. The researchers of the latest study – from the University of California Los Angeles – reviewed 5 major studies on PrEP for HIV infection (Preexposure Prophylaxis Initiative, Partners Preexposure Prophylaxis, TDF2, Preexposure Prophylaxis Trial for HIV Prevention among African Women, Vaginal and Oral Interventions to Control the Epidemic), and 2 major studies on aspirin safety (Physicians’ Health Study, the Women Health Study). From these they calculated the numbers needed to harm (NNH) for FTC-TDF for HIV PrEP and aspirin.

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Both prevention strategies demonstrated comparable low rates of serious adverse events. The NNH for FTC-TDF in men who have sex with men and transgender women was 114 for nausea and 96 for unintentional weight loss. In heterosexual couples, the NNH was 68 for moderate decreased absolute neutrophil count. 

With aspirin use, the NNH was 909 for major gastrointestinal (GI) bleeding, 123 for any GI bleeding, and 15 for any bleeding problems in men. The NNH for easy bruising in women was 10.

Study findings may encourage efforts in making PrEP available over-the-counter like Plan B or some birth control. Researchers concluded that though long-term studies are necessary, healthcare providers “should feel reassured about the safety of short- and medium-term PrEP for HIV infection with FTC-TDF.”

For more information visit ofid.oxfordjournals.org.