Many of us were hugely disappointed when the Population Council announced last week that the microbicide they’d been testing in a huge trial in South Africa didn’t work. But buried in the trial results were some other shocking and hugely disappointing facts.
Here’s the real shocker in my opinion: Only one woman in 10 used the gel all the time. Overall, researchers estimated that women in the study used the gel in 44% of all sex acts. For years, we’ve been talking as if women were somehow better than men, somehow holier, somehow more likely to preserve their lives if given the chance. If only we had a “female controlled method” to prevent HIV and didn’t have to rely on those nasty men to use condoms, all would be well, we’ve lulled ourselves into believing. And then you give women a relatively unobtrusive product that may well protect them from HIV, and most of them don’t bother to use it most of the time.
Another disappointment was the sheer scale of infection. Over three women in every 100 became infected with HIV during the study, with no difference to speak of between the those who were assigned the candidate microbicide and those assigned a harmless but definitely ineffective gel. (Nerd Note: incidence was 3.7/100 pyo in the placebo group and 3.3/100 pyo in the microbicide group, p > 0.5). Let’s repeat that: 3.5 new infections per 100 women per year. That’s a higher rate of new HIV infections than we find among drug injectors in Bangkok, for God’s sake (and Bangkok is not exactly renowned for its effective HIV prevention for junkies). It is painfully high by any standards, and in one site the rate was close to six percent. But this isn’t what is going on in South Africa as a whole. This is what’s going on in a study where women were given fistfulls of condoms, and all were energetically urged to use them by carefully trained and highly motivated counselors. On top of that, they were screened for other sexually transmitted infections, and were treated with world-class medicines if need be, thus greatly reducing the likelihood that they’d get HIV if they did have sex with an infected partner. All the participants knew from the start that there was a 50:50 chance they might be using a “fake” microbicide, a gel which could not prevent HIV. In other words, these women had HIV prevention services that most women in South Africa could only dream of, even without the microbicide. As South Africa’s Treatment Action Campaign notes in its very sensible analysis, the rates in women without those services are likely to be higher still. That ought to be a real disappointment to everyone.
This comment from Naomi Rutenberg, who heads the Pop Council’s HIV research programmes:
The news is disappointing and the context is dismaying. The good news is that we doubled condom use and made a serious dent in STIs for women in the trial. Also encouraging that there were fewer infections in Carraguard arm. It is important and good news that women who were in the trial benefited and were in no way harmed.
Carraguard is safe and we can add an antiretroviral and try again. Adherence is a challenge but 30% of women used it all or 3 of 4 times. There is most definitely a need and a gel certainly is attractive and feasible for some women. (We’re) also working on a vaginal ring.