Yesterday the Food and Drug Administration (FDA)'s advisory committee recommended the use of Truvada as pre-exposure prophylaxis (PreP) against HIV infection in men who have sex with men (MSM) that are between ages 18 - 30 years old. Due to the Center for Disease Control's classification of transgender women as MSM this decision will likely also provide access to PreP for transgender women regardless of sexual orientation, as well as access to PreP for transgender men who partner with men. PreP has also been recommended for use in serodiscordant MSM couples (i.e. couples in which one partner is HIV positive and the other is HIV negative).
Although the FDA is not required to follow the advisory committees' recommendations, it generally does. The final decision will be announced on June 15th.
If Gilead, the company that manufactures and sells Truvada, receives approval they have made several promises to the FDA. First, anyone who receives Truvada for PreP purposes will receive an educational guide. Second, Gildead will implement voluntary training and education for providers interested in providing PreP. Third, Gilead says it will provide vouchers for HIV testing and condoms, an opt-in reminder service for testing and enrollment in a PreP registry project to support adherence, testing and condom use in PreP users. Third, Gilead has committed to providing drug resistance testing for anyone who becomes HIV positive while taking PreP.
For more information about PreP and whether or not it may be right for you, click here.
For more details about the hearing and how the advisory committee members voted, check out this reporting by AIDSmeds.com.
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