Evidence for the efficacy and safety of pre-exposure prophylaxis (PrEP) in all populations: a systematic review and meta-analysis

PrEP (pre-exposure prophylaxis) is a medication used to prevent HIV infection, with the combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) being the most commonly used formulation. This review aims to evaluate the efficacy and safety of PrEP across various populations based on recent studies. Studies published in English, Portuguese, or Spanish from 2018 to 2023 that provided data on HIV incidence or adverse events (AEs) associated with PrEP use were included. Two meta-analyses were conducted: one for studies with a control group and another for studies including only PrEP users. After the initial search, 1,855 studies were identified, of which 21 met the inclusion criteria. PrEP reduced the HIV infection rate by 76% (RR 0.24, 95% CI 0.19 - 0.30) compared to the control group. In studies that included only PrEP users, there were 179 cases of infection among 19,982 participants, resulting in an approximate infection rate of 1% (95% CI: 0.00 - 0.02). The proportion of general and gastrointestinal symptoms was 34%, sexually transmitted infections (STIs) 69%, other infections 32%, and dermatological AEs 5%. Overall, the findings support PrEP as an effective and safe medication for primary HIV prevention in all populations.