According to a final recommendation statement released by the US Preventive Services Task Force (USPSTF), clinicians should offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to patients at high risk of HIV acquisition (Grade A recommendation).
The recommendation was based on data from 12 randomized clinical trials that evaluated the benefits of tenofovir disoproxil fumarate (TDF) monotherapy or combined TDF/emtricitabine compared with placebo or no PrEP in patients ≥18 years of age at high risk of HIV acquisition. Duration of follow-up ranged from 4 months to 4 years.
Results showed that use of PrEP reduced the risk of HIV infection compared with placebo or no PrEP (relative risk [RR], 0.46 [95% CI, 0.33-0.66]; absolute risk reduction, −2.0% [95% CI, −2.8% to −1.2%]). “TheUSPSTF also found convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection; thus, adherence to PrEP is central to realizing its benefit,” the Task Force members noted.
Furthermore, the benefits of TDF monotherapy and combined TDF/emtricitabine were found to be relatively similar and equally effective in reducing the risk of HIV acquisition. Regarding safety, PrEP was found to be associated with an increased risk of renal (primarily elevated serum creatinine) and gastrointestinal (primarily nausea) adverse events.
Based on these findings, the USPSTF concluded that “the magnitude of benefit of PrEP with oral tenofovir disoproxil fumarate–based therapy to reduce the risk of acquisition of HIV infection in persons at high risk is substantial.”
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