Last yearfinallythere was exciting news about HIV prevention.
Based on the successful results of two large studies, advocates geared up to discuss the use of medication to prevent HIV. In January, based on one of those studies, the U.S. Centers for Disease Control and Prevention ( CDC ) issued interim guidelines for men who have sex with men ( MSM ) on the use of the HIV medication Truvada for PrEP, or pre-exposure prophylaxis ( prevention ) .
However, in April, 2011, Family Health International ( FHI ) announced that it was closing its FEM-PrEP study looking at whether Truvada can protect women from HIV. ( Transgender women were not included. ) FHI, a non-profit research and service organization, reported that with the results up to that date, if the study was carried out to full term it would be "highly unlikely" to statistically determine whether or not Truvada prevented HIV in the women.
The organization also noted that, "At this time, it cannot be determined whether or not Truvada works to prevent HIV infection in women."
The disappointing and unexpected results made an important point about PrEPthere's still much to be learned.
According to the U.S.-based HIV prevention advocacy organization AVAC, there are 20,000 participants in PrEP studies around the world.
Other HIV medications besides Truvada are being studied, along with different strategies, such as daily use versus at the time of exposure.
Last July, CAPRISA 004, from South Africa, reported a 39-percent drop in HIV infection in women using a vaginal gel containing tenofovir, one of the two medications found in the HIV drug Truvada. And in November, the international iPrEx study reported a 42-percent drop in HIV infections when using Truvada in gay men, men who have sex with men ( MSM ) , and transgender women ( born male ) .
In both studies, the reduction in risk of HIV infection was even greater in the people who used their regimen the most consistently. For example, there was a 68-percent drop in HIV infection for those in iPrEx who took more than 90 percent of their Truvada doses. The CORE Center here in Chicago will participate in the extension of the iPrEx study.
At the time that the FEM-PrEP trial was stopped, the same percent of women given Truvada had become infected with HIV ( 5 percent ) as in the group of women given a placebo ( fake pill ) . The women, ages 18 to 35, lived in areas of Kenya, South Africa and Tanzania where there is a high prevalence of HIV, and therefore considered to be at high risk of infection. The infection rate seen in the study showed that this was the case. In fact, 21 percent of the women screened for this study were ineligible because they were found to already be HIV-positive, and this was the main reason that women trying to enroll were ineligible. All of the women received monthly counseling sessions promoting safer sex, along with free male and female condoms.
In a press release about the FEM-PrEP results issued by the U.S. National Institute of Allergy and Infectious Diseases ( NIAID ) , the agency noted that Truvada would be compared to Viread ( brand name of the tenofovir in Truvada ) and a tenofovir vaginal gel in the VOICE study for women ( Vaginal and Oral Interventions to Control the Epidemic ) , and that continued research is "imperative."
Truvada, one of the mostly commonly used HIV medications in this country, has already been widely prescribed for the use of HIV prevention for years, through off-label use. Gilead Sciences, maker of Truvada, is preparing to get the drug approved for the use of HIV prevention, which is expected to happen by the end of this year.
Some of the many issues that need to be hashed out include the price and availability of PrEP; how it might compete with funds for HIV treatment; and how to promote adherencetaking it correctly, whether it's Truvada or anything else.
Julie Davids, director of National Advocacy and Mobilization for the AIDS Foundation of Chicago, points out that there are many emotional and social aspects as well.
"PrEP has scientific issues, it has community issues, it has personal issues," said Davids. "We're just at the first steps in the process, and it's not about PrEP vs. condoms or men who protect themselves vs. men who don't. That's a very divisive discussion and PrEP is emphasizing these tensions." Davids advocates for options, and said that while it may be counter-intuitive, PrEP research has not shown a decrease in the use of condoms, and may even help promote them.
Enid Vázquez is associate editor of Positively Aware.