US Public Health Service and CDC Endorse PrEP for Gay Men

The U.S. Public Health Service announced today that it now recommends that people who are HIV negative and at “substantial risk for HIV” take a drug designed to reduce the chance of infection.

The Public Health Service released guidelines for doctors regarding that treatment, which is called “pre-exposure prophylaxis” or PrEP.  The guidelines were prepared by a group led by representatives of the federal Centers for Disease Control and Prevention.

Those defined as being at substantial risk of contracting HIV include:

• Anyone in an ongoing relationship with an HIV positive partner.

• Anyone whose partner has recently tested HIV negative but whose relationship is not monogamous.

• Any gay or bisexual man who has had anal sex without a condom or been diagnosed with a sexually transmitted disease in the past six months.

• Any heterosexual man or woman who does not regularly use condoms and has sex with someone who is at substantial risk of contracting HIV, such as injection drug users or bisexual men.

• Anyone who has injected illegal drugs in the past six months and has shared needles or who has been treated for injection drug use in the past six months.

The guidelines also recommend that doctors discuss the use of PrEP with heterosexual couples in which one partner is HIV positive and the other HIV negative  as one of several options to protect the partner who is HIV-negative during conception and pregnancy.

The guidelines recommend that those on PrEP return to their health care provider every three months for an HIV test and other follow-up. PrEP is not used to prevent HIV after a single high-risk potential HIV exposure—such as unprotected sex, needle-sharing injection drug use or sexual assault, For that, there is another option called “post exposure prophylaxis,” or PEP.  PEP must begin within 72 hours of exposure.

The release of the guidelines comes during a major debate about PrEP.  The decision by the Public Health Department and the CDC was quickly criticized by the AIDS Healthcare Foundation, the nation’s largest non-government HIV services provider, whose president has been highly critical of PReP.  AHF has argued that Truvada, the only drug approved for PReP, is effective only if users take it every day as prescribed. AHF also has argued that by promoting PReP, the CDC is giving gay men an  excuse not to use condoms, which are 100 percent effective if used properly.

“This is a position I fear the CDC will come to regret,” said Michael Weinstein, AHF’s president.  “By recommending widespread use of PrEP for HIV prevention despite research studies amply chronicling the inability to take it as directed, and showing a limited preventive effect at best, the CDC has abandoned a science-driven, public health approach to disease prevention—a move that will likely have catastrophic consequences in the fight against AIDS in this country.

“What about other STDs like syphilis, which has seen a resurgence approaching epidemic proportions in some of the same communities that the CDC wants to target for PrEP? Despite CDC and FDA (Federal Food and Drug Administration) requirements for risk-reduction counseling and condom use while taking PrEP, the government-sanctioned widespread deployment of PrEP will be accompanied with a shift to condom-less sex.

“The CDC would be better advised to put its weight behind HIV testing and linkage to treatment for the estimated 20 percent of the 1.3 million people living with HIV in this country today who have never been tested for the disease. Finding those individuals and linking them into care and treatment would do far more to break the chain of new HIV infections and improve the public health than the CDC’s ill-advised recommendation to widely prescribe PrEP—a costly and powerful medication—to uninfected individuals.”

The only study thus far of the effect of Truvada in reducing HIV infection among gay and bisexual men, known as the IPrEx Study, found that those who were given PrEP were 44 percent less likely overall to get HIV than those who were given a placebo. Among the men with detectable levels of medicine in their blood (meaning they had taken the pill consistently), PrEP reduced the risk of infection by as much as 92 percent. Participants in that study also were encouraged to use condoms along with taking Truvada and were regularly tested and treated for sexually transmitted diseases, some of which have been shown to increase one’s risk of contracting HIV.