New CDC Guidelines: People at Risk for HIV Should Consider Truvada PrEP

Healthcare providers should advise people at "substantial risk" for HIV infection about pre-exposure prophylaxis (PrEP) using tenofovir/emtricitabine, or Truvada, according to new guidelines issued by the U.S. Centers for Disease Control and Prevention (CDC). This includes HIV negative people in an ongoing sexual relationship with HIV positive partners, gay or bisexual men who have had sex without condoms during the past 6 months, heterosexual men and women who have sex without condoms with at-risk partners, and injection drug users.

The U.S. Food and Drug Administration (FDA) approved Truvada for PrEP in July 2012. Only Truvada taken every daily has been approved for HIV prevention. Taking it sporadically before sex or as a "morning after pill" has not been proven effective. HIV testing is important before starting PrEP, as a person who already has HIV and takes Truvada without other antiretrovirals could develop drug-resistant virus.

The guidelines reflect research showing the effectiveness of PrEP for different populations. The iPrEx trial of mostly gay and bisexual men found that taking Truvada once-daily reduced the risk of HIV infection by 42% overall, rising to 92% among participants with blood drug levels indicating regular use. Similarly, the Partners PrEP and TDF2 trials, which looked at heterosexual couples in Africa, found that PrEP using Truvada or tenofovir alone reduced the risk of HIV acquisition by about 65%-75%. The Bangkok Tenofovir Study showed that daily tenofovir alone reduced HIV acquisition among people who inject drugs by about 50%. Effectiveness was lower among African women in the Fem-PrEP and VOICE due to lack of adherence.

Below is an edited excerpt from a CDC press release summarizing the new guidelines. The full guidelines are available online.

New Guidelines Recommend Daily HIV Prevention Pill for Those at Substantial Risk 

Could have significant impact on the U.S. epidemic if targeted and used as directed

Health care providers should consider advising the use of anti-HIV drugs by uninfected patients who are at substantial risk of infection, according to new clinical guidelines.

PrEP, or pre-exposure prophylaxis, could reduce HIV infection rates. When taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90 percent. Inconsistent use results in much lower levels of protection. 

"HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States," said CDC Director Tom Frieden, MD, MPH. "PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States.

The guidelines were developed by CDC in partnership with other federal health agencies, public health experts and community leaders.

The guidelines say PrEP should be considered for HIV-uninfected patients 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 six 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 (for example, 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 six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

"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 U.S. HIV epidemic today," said Jonathan Mermin, MD, MPH, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "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."

The guidelines offer providers specific advice on how to give people the support they need to take their pills regularly. Given the need for high adherence and the lack of complete protection from HIV with PrEP or any other single strategy, the guidelines encourage providers to promote and support its use in combination with condoms and other proven risk-reduction strategies. Accompanying the guidelines is a supplement that includes checklists and interview guides to assist clinicians with PrEP prescribing and counseling.

The guidelines build on interim guidance issued by CDC following the release of research findings on PrEP for men who have sex with men (MSM), heterosexuals, and people who inject drugs. In 2012, the U.S. Food and Drug Administration (FDA) approved the drug combination of 300 milligrams tenofovir disoproxil fumarate and 200 milligrams emtricitabine (TDF/FTC) for use as PrEP in combination with safer sex practices.

Consistent with FDA labeling, the guidelines stress the importance of HIV testing before PrEP is prescribed and at three-month intervals while a patient is using PrEP. Regular testing ensures that anyone on PrEP who becomes infected with HIV discontinues PrEP use in order to minimize the risk that the virus could become resistant to the drugs. Such patients then can begin receiving HIV treatment.

"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, the epidemiologist in CDC’s Division of HIV/AIDS Prevention who led the 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."

In addition to providing guidelines and tools to assist providers in effectively prescribing and supporting PrEP use, CDC and other organizations are conducting pilot implementation studies and demonstration projects throughout the country. These projects aim to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection.

The guidelines were announced today in CDC’s Morbidity and Mortality Weekly Report. The 67-page guidelines and 43-page clinical providers’ supplement are published in full at http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf and http://www.cdc.gov/hiv/pdf//guidelines/ PrEPProviderSupplement2014.pdf.

5/14/14

Reference

Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2014: A Clinical Practice Guideline. May 2014.

Other Source

Centers for Disease Control and Prevention. New Guidelines Recommend Daily HIV Prevention Pill for Those at Substantial Risk. Press release. May 14, 2014.