PrEP Works for Transgender Women According to New Analysis
A recently published report in the Lancet HIV describes an unplanned analysis of Truvada PrEP’s effectiveness and use among transgender women included in the iPrEx randomized controlled and open-label studies. Transgender women remain disproportionately affected by HIV and may benefit from the HIV protection afforded by PrEP. Although transgender women have been included in PrEP studies, most PrEP research thus far has focused on cisgender men who have sex with men.
The iPrEx study was a phase 3 clinical trial completed between 2007 and 2011 in six countries including the U.S. For this new analysis, University of California, San Francisco researchers along with the iPrEx study team examined data collected from 339 transgender women who participated in the iPrEx randomized controlled portion of the study and 151 who participated in the open-label extension.
“Transgender women played a large role in proving that PrEP is safe and effective. The iPrEx study team is happy to have worked with the UCSF Transgender Center for Excellence who helped create a clear view of the experience that more than 300 transgender women had with PrEP,” said iPrEx lead investigator Robert M. Grant, MD, of the Gladstone Institutes, the University of California at San Francisco and chief medical officer of San Francisco AIDS Foundation.
Eleven transgender women taking PrEP became HIV-positive (seroconverted) during the randomized controlled portion of the study as compared to 10 in the placebo group. None of the 11 transgender women who seroconverted had detectable drug levels in their blood at the time of infection. The HIV incidence was zero among people with detectable drug levels and 4.9 per 100 years (a standard measurement of risk in clinical studies) if no drug was detected.
During the open-label extension portion of the study, two transgender women seroconverted out of the 151 transgender women who took PrEP during the open-label study period. One had levels of drug below measurable levels and the other had levels of drug corresponding to less than two pills taken per week. No seroconversions happened among transgender women taking doses equivalent to four or more doses per week or between two and three doses per week.
Overall, transgender women were less likely to take PrEP at least four times a week than men who have sex with men. A minimum of four doses per week is the level thought to provide adequate HIV protection. The U.S. Federal Drug Administration has only approved the use of Truvada for PrEP as part of a daily regimen (i.e. seven times per week).
“PrEP works when it is taken. This is true for men and women, including transgender women. We learned that transgender women are like cisgender women in that worrying about taking PrEP tablets is harder when people are worrying about a lot of other stuff, like discrimination, gender affirmation, and violence,” said Grant.
“We learned that transgender women want HIV prevention services that occur with cultural humility and gender affirmation. Services should include hormone therapy when desired and careful monitoring of feminization. We look forward to working to meet people’s desires and expectations for care while ending the transmission of HIV, HIV related disease and HIV stigma. Part of this is to celebrate our sisters whose courage and creativity bring so many treasures,” he said.
Deutsch, M. and others. HIV pre-exposure prophylaxis in transgender women: A subgroup analysis of the iPrEx trial. The Lancet HIV. November, 2015.
For more information about PrEP, visit prepfacts.org.