ANALYSIS SEXUAL HEALTH
HIV Affects Millions of Women. So Why Isn’t a New PrEP Drug Approved for Their Use?
Dec 2, 2019, 2:34pm
Anna Forbes
The FDA approved Descovy, a new drug, as safe and effective for use by the public in preventing HIV—except for people who have "receptive vaginal sex."
Descovy, with its brand new patent, could easily slip into the market niche previously occupied by Truvada, thus enabling Gilead to continue to sell a new version of PrEP for the $1,800 per month (or more) that it has been making on Truvada.
WPLG Local 10 / YouTube
When PrEP—or pre-exposure prophylaxis, a daily pill that protects against HIV—came on the U.S. market in 2012, it captured the attention primarily of men who have sex with men. According to the Food and Drug Administration, the first PrEP pill, Truvada, provides over 90 percent protection from sexually acquiring HIV when taken daily. Logically, this is a boon to women who may not be able to insist on condoms or prefer not to use them. So why did the FDA recently approve a new PrEP pill without approving it for cisgender women’s use?
Truvada isn’t cheap. Without insurance or other cost breaks, one month’s worth costs about
$1,800 in the United States. The price is much lower in countries where essential medicines’ prices are capped by government.
Given its cost and the fact that Truvada was marketed primarily to gay men, it is not surprising that
95 percent of Americans using PrEP in 2016 (the last year data was available) were men. More than two thirds (69 percent) of U.S. PrEP users were white, over half (56 percent) lived in a Western or Northeastern state, and 81 percent of all PrEP prescriptions were covered by commercial insurance. In other words, PrEP was (and still is) mostly used by affluent white men.
When PrEP was being developed more than a decade ago, two major clinical trials were conducted to assess its effectiveness: one enrolling 4,758 heterosexual couples and one enrolling 2,499 HIV-negative gay men and transgender women. High levels of protection were achieved in
both trials. Findings confirmed that Truvada is highly effective for cis women, even though it may be slightly “less forgiving” than for cis men if doses are missed.
Research shows that one of the two components in Truvada is not absorbed by vaginal tissue as readily as by rectal tissue. 
Missing doses can cause the level of this drug to drop in the vagina, possibly reducing the user’s protection. So consistent, daily use of Truvada is more important for cis women to ensure full protection