PrEP has a safety profile comparable to aspirin

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Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP) against HIV has comparable safety to aspirin, at least for the short- and medium-term. Publishing their findings, researchers compared safety data from the five major PrEP studies to data from two major aspirin safety studies, looking at the relative numbers needed to harm (NNH, or the numbers of individuals needed to take the drug to yield a specific safety outcome in one of them) between PrEP and aspirin.

Among men who have sex with men (MSM) and transgender women taking PrEP, the NNH was 114 for nausea and 96 for unintentional weight loss. Among heterosexuals, PrEP’s NNH was 68 for moderate decreased absolute neutrophil count (infection-fighting white blood cells). Participants in the PrEP trials reported no serious irreversible health problems and no hospitalisations or deaths associated with Truvada.

PrEP was associated with a mild decrease in creatinine clearance, which is an indicator of kidney function, as well as a small decrease in bone mineral density. Both of these changes reversed after individuals stopped taking Truvada. The drug has not been associated with any bone fractures, pregnancy problems or permanent kidney failure.

For aspirin, the NNH was 909 for major gastrointestinal bleeding, 123 for any gastrointestinal bleeding and 15 for any bleeding problems in men. For women, aspirin’s NNH for easy bruising was 10.

The researchers concluded that PrEP has a favorable safety profile compared to aspirin. Studies are still needed, however, to assess the long-term safety of PrEP.

Abstract
Background. The safety and effectiveness studies of emtricitabine-tenofovir disoproxil fumarate (FTC-TDF) for HIV infection pre-exposure prophylaxis (PrEP) in men and women showed that daily use reduced the risk of HIV acquisition, but there still may concerns about safety.
Methods. A narrative review was done in September 2015 comparing the five major studies on PrEP for HIV infection—Preexposure Prophylaxis Initiative (N=2,499; 3,324 person-years), Partners Preexposure Prophylaxis (N=4,747; 7,830 person-years), TDF2 (N=1,219; 1,563 person-years), Preexposure Prophylaxis Trial for HIV Prevention among African Women (N=2,056; 1,407 person-years), and Vaginal and Oral Interventions to Control the Epidemic (N=4,969; 5,509 person-years)—and the two major studies on aspirin safety—Physicians’ Health Study (N=22,071; over 110,000 person-years) and the Women Health Study (N=39,876; nearly 400,000 person-years). The numbers needed to harm (NNH) were calculated for FTC-TDF for HIV infection PrEP and aspirin.
Results. 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. For aspirin, the NNH was 909 for major gastrointestinal bleeding, 123 for any gastrointestinal bleeding, and 15 for any bleeding problems in men. In women, the NNH for easy bruising was 10.
Conclusions. We conclude that FTC-TDF for PrEP for HIV infection favorably compares to aspirin in terms of user safety. While long-term studies are needed, providers should feel reassured about the safety of short- and medium-term PrEP for HIV infection with FTC-TDF.

Poz material
Open Forum Infectious Diseases abstract


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