From the Journals

USPSTF recommends PrEP combo for adults at high risk of HIV infection

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Tools to end HIV infection are here

To end HIV, guidelines like this one that reflect and promote advances in treatment are needed, according to Hyman Scott, MD, MPH, of the San Francisco Department of Public Health and Paul A. Volberding, MD, of the University of California, San Francisco.

With less than 10% of individuals with an indication for PrEP currently receiving the medication, it is now time to support policies aimed at broadening the access of PrEP to people at risk, the coauthors wrote. They noted that recent USPSTF guidelines show that evidence and policy in HIV medicine has matured not only in the United States but across the globe.

That said, sometimes the simplest solutions are also the best. Though the systematic review from Roger Chou, MD, and associates notes the necessity and importance of adherence, if a clinician thinks that a candidate for PrEP might be nonadherent, that clinicians should not withhold the medication, they wrote. Averting new HIV infections is the goal, and fully endorsing treatments like PrEP is an important step in that direction.*

These comments are adapted from an accompanying editorial (JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2590). Dr. Volberding reported serving on a data and safety monitoring board for Merck.

*This article was updated on 6/11/2019.



Pre-exposure prophylaxis (PrEP) plus effective antiretroviral therapy should be offered to people at high risk of HIV acquisition, according to a new recommendation from the U.S. Preventive Services Task Force (USPSTF).

“The USPSTF concludes with high certainty that the net benefit of the use of PrEP to reduce the risk of acquisition of HIV infection in persons at high risk of HIV infection is substantial,” wrote first author Douglas K. Owens, MD, of Stanford (Calif.) University and fellow members of the USPSTF. The recommendation was published in JAMA.

In various at-risk groups – including men who have sex with men, people at risk through heterosexual contact, and people who inject drugs – the USPSTF recommends a Food and Drug Adminstration–approved, once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine. In addition, tenofovir disoproxil fumarate alone can be considered an alternative regimen for high-risk heterosexually active men and women and people who inject drugs.

This recommendation was developed after a systematic review of PrEP’s effects on HIV, adherence to the treatment, and accuracy in identifying potential treatment candidates. “The findings of this review are generally consistent with those from other recent meta-analyses that found PrEP to be effective at reducing risk of HIV infection and found greater effectiveness in trials reporting higher adherence,” wrote Roger Chou, MD, of Oregon Health & Science University in Portland and coauthors. Their study was also published in JAMA.

To comprehensively assess PrEP and thus inform the USPSTF’s HIV prevention recommendations, the researchers reviewed criteria-meeting studies on oral PrEP with tenofovir disoproxil fumarate/emtricitabine or tenofovir disoproxil fumarate monotherapy; on the diagnostic accuracy of instruments to predict HIV infection; and on PrEP adherence. The final analysis included 14 randomized clinical trials, 8 observational studies, and 7 studies of diagnostic accuracy.

In 11 of the trials, PrEP was associated with reduced risk of HIV infection versus placebo or no PrEP (relative risk, 0.46; 95% confidence interval, 0.33-0.66). In 6 trials with adherence 70% or greater, the relative risk was 0.27 (95% CI, 0.19-0.39). In 7 studies on risk assessment tools for HIV infection, the instruments had moderate discrimination, though several of the studies had methodological shortcomings. As for serious adverse events, an analysis of 12 trials found no significant difference between PrEP and placebo (RR, 0.93; 95% CI, 0.77-1.12).

Dr. Chou and coauthors noted their study’s limitations, including analyzing English-language articles only and the random-effects model used to pool studies potentially returning narrow CIs. They did note, however, that the “analyses were repeated using the profile likelihood method,” which produced similar findings.

All members of the USPSTF receive travel reimbursement and an honorarium for participating in meetings. The study was funded by the Department of Health and Human Services. One of the authors reported receiving grants from the National Institutes of Health/National Institute on Drug Abuse and serving as principal investigator of NIH-funded clinical trials that received donated drugs from two pharmaceutical companies. No other conflicts of interest were reported.

SOURCE: Owens DK et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.6390; Chou R et al. JAMA. 2019 Jun 11. doi: 10.1001/jama.2019.2591.

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