Results from a randomized controlled trial in Bangkok, Thailand, of a daily oral dose of 300 mg of tenofovir disoproxil Fumarate (TDF) showed that fewer IDUs taking TDF got HIV than those not taking TDF. The study results were released yesterday by the Thai Ministry of Health and CDC. Based on these findings, CDC recommends that PrEP be considered as one of several prevention options for people in the United States at very high risk for getting HIV through the injection of illicit drugs.
Previously, several clinical trials showed safety and efficacy of daily oral antiretroviral PrEP for the prevention of HIV among gay and bisexual men (MSM) and heterosexual men and women.IDU Risk Behaviors in the United States
Eight percent of the estimated 50,000 new HIV infections in the United States in 2010 were attributed to injection-drug use. Research has shown that both injection-drug use and sexual practices of IDUs put them at risk for getting HIV.
In a recent study of IDUs without HIV, 34% reported having shared syringes in the preceding 12 months, and 58% reported having shared injection equipment; 69% reported having unprotected vaginal sex and 23% reported having unprotected male-female anal sex. Among HIV-uninfected male IDUs, 7% reported previous male-male anal sex, and 5% reported unprotected male-male anal sex. However, only 19% of male and female IDUs reported participating in an intervention to reduce risk behaviors. These findings underscore a need to provide effective interventions to further reduce HIV infections among IDUs in the United States.
Providing PrEP to IDUs at very high risk for getting HIV could help reduce the number of new HIV cases in the United States.
CDC Recommendations on PrEP Use Among IDUsCDC recommends that PrEP use should be targeted to adults at very high risk for HIV acquisition, should be delivered as part of a comprehensive set of prevention services, and should be accompanied by quarterly monitoring of HIV status, pregnancy status, side effects, medication adherence, and both injection and sexual risk behaviors. Reported injection practices that place IDUs 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.
A single pill containing TDF 300 mg and emtricitabine (FTC) 200 mg (Truvada), is recommended as the preferred PrEP drug regimen for IDUs. In 2012, the Food and Drug Administration (FDA) approved this fixed dose combination drug, based on the results of trials in gay and bisexual men and heterosexual women and men.
Providers who wish to prescribe PrEP to IDUs should follow the same cautions and procedures in CDC’s existing interim clinical guidance on the use of PrEP to prevent sexual transmission and deliver PrEP in combination with other proven prevention services to reduce both sexual and drug-related transmission risks.
CDC is currently working to finalize full Public Health Service clinical guidelines on PrEP use, which the agency anticipates publishing later this year.