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Good Adherence by 58% of Women in Maraviroc PrEP Trial--But It Works
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HIV Research for Prevention (HIVR4P), October 17-19, 2016, Chicago
Mark Mascolini
Only 58% of women enrolled in a US trial of maraviroc-based PrEP claimed good or excellent adherence to the daily regimen, usually because they simply forgot to take their pills [1]. Yet no woman taking a PrEP regimen in this phase 2 trial became infected with HIV during 48 weeks of follow-up [2]. In a parallel analysis of men in this US study, only 5 of 404 picked up HIV, and all of them had no or low drug concentrations [3].
HPTN 069/ACTG A5305 randomized participants to one of four once-daily PrEP groups: (1) maraviroc alone at 300 mg, (2) maraviroc plus FTC at 200 mg, (3) maraviroc plus TDF at 300 mg, or (4) TDF/FTC at 300/200 mg. Each study regimen contained 3 pills including placebo. The new analysis aimed to determine rates of adherence and reasons for good or poor adherence. To enter the trial, women in 12 US cities had to report condomless sex with one or more HIV-positive or HIV-status-unknown men in the past 3 months.
The 188 women enrolled had a median age of 35 years (range 18 to 61), 88% were unmarried, and 54% were unemployed. While 65% of women were black, 27% were white and 17% Hispanic. More than half of the women, 57%, had some education beyond high school. Women reported an average of 2 sex partners in the past month and an average of 1 partner with whom they used no condom.
A small majority of women, 58%, reported good or excellent adherence to PrEP, and 25% noted that they over-reported pill adherence some or all of the time. Self-reported adherence tracked closely with the finding that 60% of women had detectable drug in plasma at week 48.
The three factors women cited as most favoring adherence were commitment to preventing HIV (62%), "ownership" of the study (38%), and keeping pills visible (34%). Only 24% of women cited personal risk of becoming infected with HIV as facilitating adherence. The most frequently reported challenges to adherence were forgetting (43%), being away from home (36%), and not having pills when needed (22%). Only 12% of women listed concerns over side effects for missing a PrEP dose, and only 4% cited HIV stigma.
Study participants had a generally positive opinion of PrEP, with 76% saying they would recommend PrEP to others and 59% agreeing PrEP would be good for "anyone." About one third of women, 35%, reported a clear intention to use PrEP after the study. Only 19% of women felt they had more personal control over HIV prevention with PrEP than with condoms.
The HPTN/ACTG team noted that barriers to adherence among these women mirror those reported in previous studies. They suggested that the modest proportion of women who planned to use PrEP after the trial could reflect their low self-perceived risk of HIV infection.
References
1. Amico R, Ramirez C, Caplan M, et al. US women in the HPTN069/ACTG 5305 phase 2 PrEP study: a substudy evaluating acceptability and experiences. HIV Research for Prevention (HIVR4P 2016), October 17-19, 2016, Chicago. Abstract P24.28LB.
2. Gulick R, Wilkin T, Chen Y, et al. HPTN 069/ACTG A5305: phase II study of maraviroc-containing regimens for HIV PrEP in United States (U.S.) women. 21st International AIDS Conference (AIDS 2016). July 18-22, 2016. Durban, South Africa. Abstract TUAC0102. http://www.natap.org/2016/IAC/IAC_15.htm
3. Gulick R, Wilkin TJ, Chen Y, et al. HPTN 069/ACTG 5305: phase II study of maraviroc-based regimens for HIV PrEP in MSM. Conference on Retroviruses and Opportunistic Infections (CROI), February 22-25, 2016, Boston. Abstract 103. http://www.natap.org/2016/CROI/croi_21.htm
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