Check interim guidance for PrEP in men, women

The Centers for Disease Control and Prevention (CDC) has issued new interim guidance for use of pre-exposure prophylaxis (PrEP) for in heterosexual men and women at high risk for HIV. The daily drug regimen may be used by HIV-uninfected individuals to reduce their risk of HIV infection.

The interim guidance follows the July 2012 Food and Drug Administration's approval of once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate, Gilead Sciences, Foster City, CA), with condoms and other safer-sex measures, for use for HIV prevention in men who have sex with men, persons in discordant couples, and other individuals at risk for acquiring HIV through sexual activity. [Did you receive the Contraceptive Technology Update bulletin on the FDA approval? To receive future bulletins, provide your e-mail address to AHC Media customer service at (800) 688-2421 or customerservice@ahcmedia.com.]

"With 50,000 new HIV infections every year in the United States, we urgently need additional prevention options," said Kevin Fenton, MD, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and Tuberculosis Prevention in a statement issued with publication of the interim guidance. "To facilitate the safe and effective use of PrEP as an additional tool, the guidance we're releasing today gives healthcare providers information to help them evaluate and support its use for their patients who may be considering this method."

Check key points

The new CDC guidance is similar to information issued for use of PrEP among men who have sex with men. (CTU reported on the guidance; see "Update: Use of HIV drugs shrinks infection risk in uninfected people," March 2011 STI Quarterly supplement, S1, and "Pre-exposure prophylaxis for HIV prevention under review by Food and Drug Administration," July 2011 STI Quarterly supplement," S1.)

Key points of the new guidance include the following:

  • PrEP should be targeted to individuals at very high risk for HIV infection, such as those with a partner who is HIV-positive.
  • Counseling must emphasize that it is critical that patients using PrEP take the daily medication consistently, as the level of protection has been shown to be closely related to levels of adherence.
  • For female patients who are pregnant or trying to conceive, discussion must include available information about potential risks and benefits of beginning or continuing the PrEP regimen so that an informed decision can be made. Why? While no adverse effects have been found among infants exposed to Truvada during pregnancy, most of the data comes from those children born to HIV-positive women using the drug during course of treatment in clinical trials. Data are incomplete for children of HIV-negative women who become pregnant while using PrEP. Women who are breastfeeding should not be prescribed PrEP.
  • PrEP is not considered a stand-alone solution. Clinicians should include it as part of a comprehensive package of prevention services, including counseling to reduce risk behavior and advocate adherence to the daily pill regimen, access to condoms, and management of other sexually transmitted infections.
  • Patients who are prescribed PrEP must be confirmed to be HIV negative prior to use, and their HIV status, experience of side effects, adherence, and risk behaviors must be monitored regularly during use.1

Review checklist

After determining that an individual is HIV-negative and at high risk of infection, clinicians will need to confirm that a patient's calculated creatinine clearance is at least 60 mL or above per minute before PrEP is initiated. Why? A side effect of Truvada use includes new or worsening kidney problems.2 Be sure to check serum creatinine and calculate creatinine clearance three months after drug initiation, then every six months while the patient is on PrEP medication.

All patients should be screened for hepatitis B infection, as well as other sexually transmitted infections. PrEP candidates should be vaccinated against hepatitis B if susceptible, or treated if active infection exists, regardless of the clinician's decision regarding prescribing PrEP. Testing for hepatitis B has been recommended because worsening of hepatitis B infections has been reported in those who have both HIV-1 and hepatitis B when treatment with Truvada was stopped.

The most common side effects reported with Truvada use include diarrhea, nausea, abdominal pain, headache, and weight loss.

Need more information on PrEP use? Gilead Sciences has established a dedicated web site, https://www.truvadapreprems.com. Developed as a risk evaluation and mitigation strategy site, the Internet portal provides materials to educate and inform healthcare providers and uninfected individuals at high risk for acquiring HIV-1. The CDC also has developed a provider fact sheet that encapsulates the interim guidance. It is available at http://1.usa.gov/esua27.

References

  1. Centers for Disease Control and Prevention (CDC). Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR 2012; 61:586-589.
  2. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41.