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

AIDS CareFeb 2, 2026 (epub)
Clinical ResearchInfectious Diseases

Lucas Dolatto Milléo, Erildo Vicente Muller, Camila Marinelli Martins et al.

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In 30 seconds

This systematic review and meta-analysis assessed PrEP efficacy and safety across populations, including studies published in English, Portuguese, or Spanish from 2018 to 2023. Of 1,855 studies identified, 21 met the inclusion criteria. In studies with a control group, PrEP was associated with a 76% lower HIV infection rate than control (RR 0.24, 95% CI 0.19 - 0.30). Among PrEP users in studies without a control group, 179 infections occurred among 19,982 participants, an approximate infection rate of 1% (95% CI: 0.00 - 0.02). The review also reported adverse-event proportions across several categories.

Key findings

  • Compared with control, PrEP reduced the HIV infection rate by 76% (RR 0.24, 95% CI 0.19 - 0.30).
  • Among 19,982 PrEP users in studies without a control group, 179 infections were reported; the approximate infection rate was 1% (95% CI: 0.00 - 0.02).
  • Reported proportions were 34% for general and gastrointestinal symptoms, 69% for STIs, 32% for other infections, and 5% for dermatological adverse events.

Why it matters

The pooled findings support PrEP’s role in HIV prevention across the populations represented in the included studies. The comparative estimate indicates substantially lower HIV incidence with PrEP, while the review also summarises reported adverse events. Together, these results provide clinicians with evidence on both prevention benefit and safety outcomes when discussing PrEP for primary HIV prevention.

What to keep in mind

The review included studies published from 2018 to 2023 in three languages; the abstract does not describe the populations or study designs contributing to each pooled estimate.

Source

Published in AIDS Care. This summary was written by xxcode from the publication's abstract and metadata. It is not peer reviewed and is not a substitute for the original article. For clinical decisions, review the original publication.

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