Jun 12, 2013
The Centers for Disease Control and Prevention (CDC) has updated its recommendations on the use of preexposure prophylaxis (PrEP) in individuals at high risk of acquiring HIV to include its use in injection drug users (IDUs) as well as those with high-risk sexual behaviors, the agency announced today.
The recommendations follow the results of a clinical trial, published online June 12 in the Lancet, that showed that a daily oral dose of 300 mg of tenofovir disoproxil fumarate (TDF) is effective at reducing HIV infection acquisition among injection drug users.
On July 16, the US Food and Drug Administration approved the use of a fixed-dose combination of TDF 300 mg and emtricitabine (FTC) 200 mg (Truvada, Gilead Sciences) for the indication of PrEP against sexual transmission of HIV by men who have sex with men (MSM) and heterosexually active women and men. The recommendations were based on the results of clinical trials in MSM and heterosexually active men and women. Those trials did not evaluate the use of PrEP among IDUs.
On the basis of the trial results published today, the CDC recommends that PrEP be considered as one of several prevention options for persons at very high risk for HIV acquisition through the injection of illicit drugs.
Reported injection practices that place persons at very high risk for HIV acquisition include sharing of injection equipment, injecting 1 or more times a day, and injection of cocaine or methamphetamine.
PrEP Recommendation for Injection Drug Users
Daily TDF/FTC is the preferred PrEP regimen for IDUs for the following reasons:
- TDF/FTC contains the same dose of TDF (300 mg) that has been shown to be effective for IDUs,
- TDF/FTC demonstrated no additional toxicities when compared with TDF only in PrEP trials that studied both regimens,
- IDUs are at risk for sexual exposure to HIV for which TDF/FTC is indicated, and
- TDF/FTC is approved for PrEP to prevent sexual HIV transmission in the United States.
The use of TDF/FTC for prevention of HIV transmission in those without sexual acquisition risk is at present an off-label use. The CDC recommends providing services for IDUs that include PrEP as well as measures aimed at decreasing injection and risky sexual behaviors.
In all individuals, PrEP use:
- is contraindicated in those with positive or unknown HIV status or with an estimated creatinine clearance lower than 60 mL/minute,
- should be focused on adults at very high risk for HIV acquisition,
- should be given as part of comprehensive prevention services, and
- should be given with quarterly monitoring of HIV status, pregnancy status, adverse effects, medication adherence, and risk behaviors, as directed in previous interim guidance.
Adherence to daily PrEP is vital to decrease HIV infection risk, and achieving high adherence was challenging for many participants in PrEP clinical trials.
"Providing PrEP to IDUs at very high risk for HIV acquisition could contribute to the reduction of HIV incidence in the United States," the CDC notes in the statement. "In addition, if PrEP delivery is integrated with prevention and clinical care for the additional health concerns faced by IDUs (e.g., hepatitis B and C infection, abscesses, and overdose), substance abuse treatment and behavioral health care, and social services, PrEP will contribute additional benefits to a population with multiple life-threatening physical, mental, and social health challenges."
The CDC is collaborating with other federal agencies to prepare comprehensive US Public Health Service guidelines on PrEP use with MSM, heterosexually active men and women, and IDUs. Those guidelines are scheduled for release later this year.
The complete updated interim guidelines IDUs can be found here on the CDC Web site.