CDC Guidance for Truvada Use in Prevention of HIV
While the best prevention of HIV and AIDS remains safe sex practices, a new study recently published in the New England Journal of Medicine revealed that prevention is also possible in the form of a once a day antiretroviral pill containing two drugs .
The Centers for Disease Control and Prevention (CDC) is offering interim guidance for the use of pre-exposure prophylaxis (PrEP) for HIV in the Jan. 28 issue of Morbidity and Mortality Weekly Report.
The CDC report notes that while the use of PrEP use of Truvada, a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, appears safe and at least partly effective, clinicians and patients need to take care to avoid possible problems.
PrEP has the potential to contribute to effective and safe HIV prevention in men who have sex with men (MSM) if:
- it is targeted to MSM at high risk for HIV acquisition
- it is delivered as part of a comprehensive set of prevention services, including risk-reduction and PrEP medication adherence counseling, ready access to condoms, and diagnosis and treatment of sexually transmitted infections;
- it is accompanied by monitoring of HIV status, side effects, adherence, and risk behaviors at regular intervals
The iPrEx study was conducted in Peru, Ecuador, Brazil, Thailand, South Africa, and the United States. Eligible participants were consenting HIV-uninfected men and male-to-female transgender adults. The study results suggests that the drug reduced the risk of catching HIV by 44%.
Truvada was generally well tolerated by the study participants and no resistance arose in the 100 participants who became HIV-positive during the study.
The CDC cautions until the safety and efficacy of PrEP is determined in trials currently under way with populations at high risk for HIV acquisition by other routes of transmission, PrEP should be considered only for MSM.
A full guidance for PrEP will take several months to develop. The interim guidance is being provided to aid in prevention of unsafe and less effective practices, including using other drugs or other dosing schedules, not screening for HIV before starting PrEP or long intervals without HIV retesting, and prescribing medication without other prevention support such as risk-reduction counseling.
Clinicians should note that PrEP should be considered only for MSM. A PrEP program should begin with screening to be sure the patient is HIV-negative, is a MSM with a substantial high risk for acquiring HIV, and has a calculated creatinine clearance is at least 60 milliliters per minute.
If the patient fits the above minimum criteria, then the PrEP medication regimen can begin. The CDC recommends:
- Prescribe 1 tablet of Truvada* (TDF [300 mg] plus FTC [200 mg]) daily.
- In general, prescribe no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV-uninfected.
- If active hepatitis B infection is diagnosed, consider using TDF/FTC for both treatment of active hepatitis B infection and HIV prevention.
- Provide risk-reduction and PrEP medication adherence counseling and condoms
The CDC noted that HIV prevention is not an approved indication for the use of the tenofovir/emtricitabine combination and that its long-term safety in people without HIV is not known.
The agency also suggested that physicians make sure that patients understand the financial implications of starting PrEP.
Truvada Shown to Prevent HIV Transmission
Centers for Disease Control and Prevention "Interim Guidance: Preexposure prophylaxis for the prevention of HIV Infection in men who have sex with men" MMWR 2011; 60: 65-68.