CDC issues guideline on prescribing HIV prophylaxis medication

A new clinical practice guideline on how to prescribe oral antiretroviral preexposure prophylaxis (PrEP) for HIV infection was issued by the CDC last week.

The guideline is based on trial data showing safety and effectiveness, as well as FDA approval, of daily oral PrEP with the fixed-dose combination of tenofovir disoproxil fumarate (TDF), 300 mg, and emtricitabine (FTC), 200 mg, to reduce the risk of HIV acquisition in adults.

According to the guideline, PrEP is recommended as a prevention option for sexually active heterosexual men and women, men who have sex with men, and injection drug users who are at substantial risk of HIV acquisition (a IA recommendation). It should also be discussed with HIV-discordant couples planning to have children as one of several options to protect the uninfected partner during conception and pregnancy (IIB recommendation). The CDC found insufficient data on use of PrEP in adolescents and suggests weighing risks and benefits in the context of local laws and regulations about health care decision making by minors (IIIB recommendation).

Before PrEP is prescribed, acute and chronic HIV infection must be excluded by symptom history and HIV testing at the time of the prescription (IA recommendation). The combination of

TDF, 300 mg, and FTC, 200 mg (Truvada), is the only FDA-approved regimen for PrEP in the mentioned populations. However, TDF alone has shown substantial efficacy and safety in injection drug users and heterosexual adults and can be considered as an alternative regimen for these populations, but not for men who have sex with men, among whom its efficacy has not been studied (IC recommendation).

The CDC guideline recommends against prescription of oral PrEP for coitally timed or other noncontinuous daily use (IIIA recommendation). Patients who take PrEP should be reassessed for HIV infection every 3 months because the drug combo is inadequate therapy for established HIV infection and its use may engender resistance to either or both drugs (IA recommendation). Renal function should also be assessed at baseline and at least every 6 months so that those in whom renal failure is developing do not continue to take PrEP (IIIA recommendation).

Finally, when PrEP is prescribed, clinicians should provide access, directly or by facilitated referral, to proven effective risk-reduction services. Because high medication adherence is critical to PrEP efficacy but was not uniformly achieved in clinical trials, patients should be encouraged to also use other effective prevention methods (IIIA recommendation). The CDC noted that this guideline will be updated based on future research.