The drug Truvada was approved by the U.S. Food and Drug Administration (FDA) in July 2012 but the daily pill, for use in preventing HIV infections that lead to AIDS, has not caught on as expected among high-risk individuals. Federal officials at the Centers for Disease Control and Prevention (CDC) recommended yesterday that hundreds of thousands of Americans who are at risk take the pill, advice that could transform HIV prevention in the U.S.
Truvada is the first drug approved for pre-exposure prophylaxis, or PrEP. It costs $13,000 per year, which makes some people reluctant to take it, but most insurances and state Medicaid programs cover it, and Gilead Sciences, the drug’s manufacturer, offers a program to cover insurance co-pays and provide Truvada to the uninsured. Another problem with the wide adoption of Truvada is that the only doctors likely to prescribe it as a preventative measure are AIDS specialists, and gay men who are uninfected with HIV see little reason to see physicians other than their general practitioners. A survey of infectious disease specialists published in December showed that while 74 percent of them supported the use of Truvada, only 9 percent actually prescribe it.
Gilead Sciences does not advertise Truvada for HIV prevention, even though the FDA approved it. They do advertise it for treatment, which was a FDA approved use in 2004. Not advertising helps avoid controversy for Gilead. Some opponents consider Truvada a party drug, and say that a daily prevention pill would encourage men to avoid condom use. Michael Weinstein, AIDS Healthcare Foundation president, says that the CDC’s release of the Truvada guidelines are a shameful chapter in their history.
There is a split in the gay community among those who support the Truvada regimen, and those who have embraced the condom method of prevention. However, the CDC says that the number of HIV infections in the U.S. has stayed virtually the same for the last decade, holding at 50,000 per year in spite of 30 years of messages to use condoms to block transmission of the virus.
The PrEP medication is the only drug approved for antiretroviral use by the FDA. Three different studies since 2010 have shown that using the daily AIDS drug is 99 percent effective in protecting against HIV infection. But when analyzing pharmacy databases to determine how many Truvada prescriptions are for prevention rather than treatment they found only 2,319, 49 percent of which were for women, who are at risk if they have sex with IV drug users or infected partners.
Truvada consists of a combination of two drugs, tenofovir and emtricitabine. It is considered safe, with few side effects that may include stomach pain, weight loss, and headache. Serious side effects, including kidney and liver damage, are seen only rarely. Guidelines for use recommend that the patient have an HIV test before beginning the daily regimen to make sure they are not already infected. The recommendations for use also include retesting every three months to make sure no other sexually transmitted diseases have been picked up, that no side effects are being experienced, and that the user is still HIV negative.
Officially the CDC is endorsing the use of Truvada for prevention of HIV infection only in combination with the use of condoms. One of the concerns with the use of the daily AIDS pill for PrEP is that people will stop using condoms, which a number of gay men have already reported doing. In addition, Truvada does not protect against other sexually-transmitted diseases such as syphilis and gonorrhea.
By Beth A. Balen