暴露前预防(PrEP)以预防HIV感染的暂行指南：针对注射吸毒者的PrEP

On July 16, 2012, based on the results of trials in MSM and heterosexually active women and men, the Food and Drug Administration approved a label indication for the use of the fixed dose combination of TDF 300 mg and emtricitabine (FTC) 200 mg (Truvada) as PrEP against sexual HIV acquisition by MSM and heterosexually active women and men (11). These trials did not evaluate safety and efficacy among injecting-drug users.

CDC recommends that daily TDF/FTC be the preferred PrEP regimen for IDUs for the following reasons: 1) TDF/FTC contains the same dose of TDF (300 mg) proven effective for IDUs, 2) TDF/FTC showed no additional toxicities compared with TDF alone in PrEP trials that have provided both regimens, 3) IDUs also are at risk for sexual HIV acquisition for which TDF/FTC is indicated, and 4) TDF/FTC has an approved label indication for PrEP to prevent sexual HIV acquisition in the United States. Its use to prevent parenteral HIV acquisition in those without sexual acquisition risk is currently an "off-label" use. Reported injection practices that place persons at very high risk for HIV acquisition include sharing of injection equipment, injecting one or more times a day, and injection of cocaine or methamphetamine. CDC recommends that prevention services provided for IDUs receiving PrEP include those targeting both injection and sexual risk behaviors (12).

In all populations, PrEP use 1) is contraindicated in persons with unknown or positive HIV status or with an estimated creatinine clearance <60 mL/min, 2) should be targeted to adults at very high risk for HIV acquisition, 3) should be delivered as part of a comprehensive set of prevention services, and 4) should be accompanied by quarterly monitoring of HIV status, pregnancy status, side effects, medication adherence, and risk behaviors, as outlined in previous interim guidance (9,10). Adherence to daily PrEP is critical to reduce the risk for HIV acquisition, and achieving high adherence was difficult for many participants in PrEP clinical trials.

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