Federal health officials are recommending that anyone, not just gay and bisexual men, at risk of contracting HIV should start taking a daily HIV prevention pill.
The Centers for Disease Control and Prevention today (May 14) issued new clinical guidelines to the nation’s healthcare providers that recommend they advise the use of anti-HIV drugs to their uninfected patients who are at substantial risk of infection.
Known as PrEP, for pre-exposure prophylaxis, the once-a-day pill regimen has been shown to be effective at reducing HIV infection rates. When taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90 percent, according to studies.
However, inconsistent use of the drug 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,” stated CDC Director Dr. Tom Frieden. “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 new guidelines also stress that patients be tested for HIV prior to starting PreP and be tested again at three-month intervals so if someone on PrEP does become infected with HIV they discontinue taking the drugs and begin HIV treatment.
Otherwise, warns the CDC, the virus could become resistant to the PrEP drugs.
In 2011, following an efficacy study, the CDC issued preliminary PrEP guidelines that recommended only gay and bisexual men with “substantial, ongoing, high risk” for acquiring HIV should start taking the drugs.
A year later the U.S. Food and Drug Administration (FDA) approved the drug known as Truvada, which combines 300 milligrams tenofovir disoproxil fumarate with 200 milligrams emtricitabine (TDF/FTC), for use as PrEP in combination with safer sex practices.
Last year, due to the results of another study, the CDC revised its PrEP guidelines to include its use by people at high risk for contracting HIV through injection drug use.
Based on the new guidance published this afternoon in the CDC’s Morbidity and Mortality Weekly Report, the federal agency is now advising heterosexuals at risk of contracting HIV through sex, such as not always using condoms or having sex with injection drug users, also begin taking PrEP.
In addition, anyone in an “ongoing sexual relationship” with a person who is HIV positive should consider using PrEP, according to the new advice from the CDC.
The new guidance also specifies the drug regimen should be considered by any gay or bisexual men who have had sex without a condom or have been diagnosed with a sexually transmitted disease within the last six months and is not in a “mutually monogamous relationship” with a partner who recently tested HIV negative.
“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,” stated Dr. Jonathan Mermin, director of the 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 introduction of PrEP has not been without controversy. One of the most vocal opponents has been Michael Weinstein, the president and CEO of the AIDS Healthcare Foundation based in Los Angeles, who this year called Truvada “a party drug.”
In response to today’s news from the CDC, Weinstein issued a statement saying the CDC is “ill advised” to promote Truvada, which is manufactured by Gilead, as an HIV prevention tool.
“This is a position I fear the CDC will come to regret,” stated Weinstein. “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.”
San Francisco health officials, however, have long embraced use of PrEP. The city was one of the first in the nation to test the drug and offer it to sexually active HIV negative gay and bisexual men.