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PrEP protects adhering transgender women from HIV infection
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Recent data from the iPrEx trial suggested that pre-exposure prophylaxis treatment may effectively protect transgender women from infection with HIV.
However, rates of adherence lower than those observed among men who have sex with men appeared to result in no overall reduction in new infections, according to Madeline B. Deutsch, MD, MPH, associate physician at the School of Medicine at the University of California, San Francisco, and colleagues.
Madeline B. Deutsch
“Transgender women carry a disproportionate burden of the HIV epidemic and differ from men who have sex with men with respect to their social situation, sexual practices, use of feminizing hormones and genital anatomy,” they wrote. “Transgender women were included with MSM in many PrEP trials and demonstration projects, although the numbers of transgender participants has been low or unclear. A separate analysis of PrEP safety and efficacy among transgender women has not been reported.”
Re-examining the iPrEx trial
Deutsch and colleagues re-examined data from the iPrEx trial, a randomized, placebo-controlled phase 3 clinical trial of once daily Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences) conducted among a cohort of 2,499 MSM and transgender women from 2007 to 2011. From these enrollees, the researchers extracted a subcohort of participants who were assigned male sex at birth, but reported self-identification as a woman, transsexual or man using feminizing hormones. Participants were assigned the study drug or placebo, with the rate of new HIV infections, PrEP use, adverse events and bone mineral density compared between transgender women, MSM and their respective control groups.
Approximately 14% of those enrolled in iPrEx reported at least one of the qualifying characteristics. Characteristics of transgender women participants were similar between those receiving the intervention or placebo. Transgender women most often recruited at study sites in Peru/Ecuador or Thailand, and 20% reported the use of feminizing hormones. Compared with the MSM population recruited into iPrEx, transgender women were younger, less educated and reported more sexual partners, unprotected anal sex, STDs, cocaine or drug use, and a history of transactional sex.
Treatment adherence as determined by drug concentration testing was low among transsexual women, with protective concentrations detected only half as often as among MSM (P < .0001). Risk for infection was similar between study groups; there were 11 new infections among transgender women assigned treatment and 10 among those assigned placebo (HR = 1.1; 95% CI, 0.5-2.7); however, none of the transgender women newly infected had the study drug detected in blood. Moderate or severe adverse events were rare among transgender women, and PrEP adherence was not linked to any HIV risk behaviors.
While these findings support evidence of PrEP’s efficacy among transgender women, the researchers wrote that reduced effectiveness and adherence compared with MSM is troubling in light of the high-risk behaviors reported by this population. Further, issues of interactions between HIV medications and feminizing drugs and engagement in care provide challenges in need of further exploration, they wrote.
“PrEP is a proven method of HIV prevention controlled by the receptive partner, whether a nontransgender woman, a receptive MSM or a receptive transgender woman,” Deutsch and colleagues wrote. “Best practices for PrEP services among transgender women could arise from gender affirming clinical settings that integrate PrEP with hormone therapy and other sexual health services.”
Transgender women commonly demonstrate low ART adherence, viral suppression
These findings reflect findings reported earlier this year by Yuko Mizuno, PhD, of the CDC’s Division of HIV/AIDS Prevention, and colleagues. Using 2009-2011 data from the Medical Monitoring Project — a cross-sectional, population-based HIV surveillance system — Mizuno and colleagues investigated the clinical and behavioral characteristics of 13,167 U.S. adults who had visited medical care facilities for HIV-related issues at least once from January to April during each data collection cycle year.
Among the 1.3% of these participants self-identifying as a transgender women, 80% were nonwhite and were more likely to earn less than $20,000 annually, have no health insurance and be homeless when compared to nontransgender persons. Although there were no differences seen in time since diagnosis, stage of disease, CD4 cell count, ART prescription rates and recent viral suppression, transgender women were less likely to report 100% adherence to ART treatment within the previous 3 days. Transgender women also were less likely to report suppressed viral load for all tests during the past year, and more frequently in need of HIV case management, ART adherence support, HIV prevention counseling and other support services.
Based on these data, Mizuno and colleagues wrote that further exploration of post-ART prescription behavior among transsexual women is needed, and suspected that the poor rates of adherence and outcomes could be the result of unmet basic needs.
“We found few differences between HIV-infected transgender women and nontransgender persons in care with respect to receipt of most care, treatment and supportive services; however the noted disparities in durable viral suppression and unmet needs for basic services should be explored further,” they wrote. – by Dave Muoio
Disclosure: The researchers report no relevant financial disclosures.
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