No change in health-related quality of life for at-risk U.S. women and men starting HIV pre-exposure prophylaxis (PrEP): Findings from HPTN 069/ACTG A5305

Abstract

Introduction: Tenofovir (TDF)-containing PrEP is effective for HIV prevention, but its effect on health-related quality of life (QOL) is unknown. Using data from HPTN 069/ACTG A5305, a randomized study of potential PrEP regimens comparing maraviroc alone, or together with TDF or emtricitabine (FTC), to TDF + FTC (control), we evaluated the impact of these regimens on QOL in at-risk HIV-uninfected U.S. women and men.

Methods: QOL was measured at baseline (before starting medications) and every 8 weeks through week 48 using the EQ-5D-3L. Responses were converted to a scale from 0.0 (death) to 1.0 (perfect health), using published valuation weights. Mean scores were compared between groups at each time point using nonparametric testing. Multivariable linear regression was used to adjust for potential confounders.

Results: We analyzed 186 women (median age 35 years, 65% black, 17% Hispanic) and 405 men (median age 30 years, 28% black, 22% Hispanic), including 9 transgender participants analyzed based on sex-at-birth. Mean baseline QOL was 0.91 for women and 0.95 for men. There were minimal changes in mean QOL over time for any regimen (women: p = 0.29; men: p = 0.14). There were no significant differences between participants who continued the regimen compared to participants who discontinued early (women: p = 0.61; men: p = 0.1). Mean QOL did not differ significantly by regimen at any time point, both unadjusted and after adjustment for age, race/ethnicity, adherence, and use of alcohol, marijuana, opiates, and other substances.

Conclusions: QOL in at-risk individuals starting candidate PrEP regimens in a clinical trial is similar to the general population and maintained over time. This finding did not vary among regimens or when adjusted for demographics, adherence, and substance use. Our findings are the first to show that starting a candidate PrEP regimen in at-risk HIV-uninfected U.S. women and men was not associated with significant changes in QOL.

Trial registration: Clinicaltrials.gov NCT01505114.

Conflict of interest statement

TJW has received research grants (to Weill Cornell) from Bristol Myers-Squibb, Gilead Sciences, and GlaxoSmithKline/Viiv Healthcare and has served as an ad hoc consultant to GlaxoSmithKline/ViiV Healthcare. KRA has received an educational grant (to the University of Michigan) and has served as an ad hoc consultant to Gilead Sciences. RJL has received drug supplies, consulting fees, and travel costs from Gilead Sciences. AA received an honorarium from Bristol Meyers Squibb for a continuing medical education program and research grants from Gilead Sciences and GlaxoSmithKline for investigatorinitiated studies. KHM has received unrestricted research grants (to Fenway Health) from Gilead Sciences and GlaxoSmithKline/ViiV Healthcare. All other authors report no potential conflicts. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Mean EQ-5D utility (Quality of life) score by PrEP study regimen over time.

Legend: Mean utility measured by EQ-5D, converted to health utility using U.S. valuation weights, where 0 is equivalent to death and 1 to perfect health. MVC = maraviroc, TDF = tenofovir disoproxil fumarate, FTC = emtricitabine.

Fig 2. Mean EQ-5D visual analogue scale (VAS) score by PrEP study regimen over time.

Mean utility measured by EQ-5D VAS, where 0 is the worst health the respondent can imagine, and 100 is the best. MVC = maraviroc, TDF = tenofovir disoproxil fumarate, FTC = emtricitabine.