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Preexposure Prophylaxis for the Prevention of HIV: Updated Evidence Report and Systematic Review

An evidence report supporting revised USPSTF recommendations on preexposure prophylaxis (PrEP) for prevention of HIV (see separate PNN article) concludes that oral tenofovir alafenamide/emtricitabine (TAF/FTC) is noninferior to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and injectable cabotegravir reduced the risk of HIV infection compared with oral TDF/FTC in the populations studied.

“Thirty-two studies were included in the review (20 randomized clinical trials [N = 36,543] and 12 studies of diagnostic accuracy [N = 5,544,500]),” the authors write. “Eleven trials in the 2019 review found oral PrEP associated with decreased HIV infection risk vs placebo or no PrEP (n = 18,172; relative risk [RR], 0.46 [95% CI, 0.33-0.66]). Higher adherence was associated with greater efficacy. One new trial (n = 5,335) found oral [TAF/FTC] to be noninferior to [TDF/FTC] in men who have sex with men (RR, 0.47 [95% CI, 0.19-1.14]). Two new trials found long-acting injectable cabotegravir associated with decreased risk of HIV infection vs oral TDF/FTC (RR, 0.33 [95% CI, 0.18-0.62] in cisgender men who have sex with men and transgender women [n = 4,490] and RR, 0.11 [95% CI, 0.04-0.31] in cisgender women [n = 3,178]). Discrimination of instruments for predicting incident HIV infection was moderate in men who have sex with men (5 studies; n = 25,488) and moderate to high in general populations of persons without HIV (2 studies; n = 5,477,291).”

Editorial: “Since the US Food and Drug Administration (FDA) approval of the initial PrEP regimen in 2012, recent developments have significantly expanded PrEP options,” editorialists write. “The initial PrEP regimen was daily [TDF/FTC], with an additional oral option approved in 2019 consisting of daily [TAF/FTC]. Finally, an injectable bimonthly option with cabotegravir was proven to be highly effective and was recently approved, with more and longer-acting options being evaluated. These options for PrEP are highly effective when adhered to. Therefore, we strongly agree with the [USPSTF] statement that ‘concludes with high certainty that there is a substantial net benefit from the use of effective antiretroviral therapy to reduce the risk of acquisition of HIV infection in persons at increased risk of acquiring HIV (A recommendation).'”

Source: JAMA