(RxWiki News) Should an HIV prevention pill be prescribed only to those who are at the highest risk? That's the question that doctors grapple with after the FDA approved Truvada as a preventative drug.
Only a month after Truvada's formal approval, the Centers for Disease Control and Prevention have amended their recommendations for doctors prescribing the pill.
They are now telling doctors that they should consider prescribing Truvada for heterosexual men and women at high risk for transmitting HIV, in addition to high-risk gay and bisexual men.
"If you are at high risk for HIV, speak with your doctor."
Truvada is the first HIV prevention pill to be approved by the Federal Food and Drug Administration. The pill has been on the market since 2004, as a treatment for people who already have the virus.
Its approval as part of a prevention strategy for HIV has been controversial. Critics worry that people who have been prescribed Truvada might stop using condoms, and it's not 100 percent effective.
Truvada must be taken once daily in order to provide a defense against HIV.
When it was first approved, the CDC recommended Truvada only for men who have sex with men, which is the highest-risk population for the spread of HIV.
Another high risk group is serodiscordant couples – the term for a couple in which one partner has HIV, and the other is HIV-negative. This is a situation that some heterosexual couples find themselves in, and it's a special concern when the couple wants to have a baby.
The CDC notes that studies have found mixed results in how much protection Truvada provides women. But the agency concluded that Truvada has the “potential to contribute to safe and effective HIV prevention for heterosexually active adults as well as [men who have sex with men].”
Truvada is not recommended for all sexually active heterosexual couples. But a daily dose for women and men who are at very high risk through heterosexual sex can reduce their risk, the CDC says.
The recommendations also state that Truvada “may be one of several options to help protect the HIV-negative partner in serodiscordant couples during attempts to conceive.” It added that women should take a pregnancy test before beginning the medication.
Truvada costs as much as $13,000 before insurance. It's estimated that there are 140,000 heterosexual couples in which one partner has HIV.
Condom use is still recommended as the first line of defense against HIV, and Truvada should be used in combination with this form of protection.