Healthcare providers should consider advising the use of oral antiretroviral therapy for HIV-uninfected patients who are at high risk for HIV infection, say clinical guidelines released today by the Centers for Disease Control and Prevention (CDC).
When taken daily as directed, preexposure prophylaxis (PrEP) can reduce the risk for HIV infection by more than 90%, according to the CDC. However, inconsistent use results in much lower levels of protection.
"While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the US HIV epidemic today," Jonathan Mermin, MD, MPH, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said in a statement.
"These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances," Dr. Mermin added.
The guidelines, announced today in the Morbidity and Mortality Weekly Report, say PrEP should be considered for HIV-uninfected people with any of the following indications:
Anyone who is in an ongoing sexual relationship with an HIV-infected partner.
A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past 6 months and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.
A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (eg, injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.
Anyone who has, within the past 6 months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.
Adherence, Regular Testing Important
In the United States, it is estimated that as many as 275,000 uninfected gay and bisexual men and 140,000 uninfected partners in HIV-discordant heterosexual couples could benefit from PrEP.
Clinicians "have the power to increase awareness and uptake of this new prevention intervention, and to ensure that your patients who are currently uninfected with HIV have a greater chance to remain so," Dr. Mermin said in a CDC Expert Video Commentary on Medscape. "The added protection afforded by PrEP is dependent on both clinicians and patients."
The guidelines provide specific advice on how to help patients adhere to PrEP. They encourage providers to promote PreEP in appropriate patients in combination with condoms and other proven risk-reduction strategies.
A supplement to the guidelines includes checklists and interview guides to assist clinicians with PrEP prescribing and counseling.
The guidelines build on interim guidance issued by the CDC in 2012 and reported by Medscape Medical News at that time. The interim guidelines followed the release of study results showing substantial efficacy and safety of PrEP with a daily, fixed-dose combination of tenofovir and emtricitabine (Truvada, Gilead).
"The adverse effects of PrEP are mostly mild nausea and vomiting in the first month. Mild reductions in creatinine clearance have also occurred infrequently," Dr. Mermin notes.
The guidelines stress the importance of HIV testing before PrEP is prescribed and at 3-month intervals while a patient is using PrEP.
"If PrEP is given to a person with HIV, there is a risk of developing an antiretroviral therapy-resistant virus," Dr. Mermin said. "This highlights the benefits of testing for HIV with a test that detects antigen, or viral RNA, as well as antibodies, before initiating PrEP. You should also ask your patients about any symptoms of a recent or current viral illness that may be a sign of acute HIV infection. Patients should be retested every 2 to 3 months to confirm that they do not have HIV."
"PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling, and testing," said Dawn K. Smith, MD, MPH, an epidemiologist in CDC's Division of HIV/AIDS Prevention who led development of the guidelines. "Individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection."
The CDC and other organizations are conducting pilot implementation studies and demonstration projects to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection.
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Cite this: CDC Updates HIV Preexposure Prophylaxis Guidelines - Medscape - May 14, 2014.