Study Finds No Decrease in Health-Related QOL Among High-Risk Individuals Starting PrEP for HIV

While prior research has suggested that medication toxicity, burden of daily pill taking, and stigma associated with antiretroviral use may decrease quality of life (QOL), a new study has found that QOL in at-risk individuals starting pre-exposure prophylaxis (PrEP) for HIV prevention is similar to that in the general population and is maintained over time.

Researchers of the study used data from the HPTN 069/ACTG A5305 trial comparing 3 candidate PrEP regimens with the FDA-approved emtricitabine/tenofovir disoproxil fumarate (Truvada).

The study enrolled patients between July 2012 and December 2014 and followed up until November 2015. Participants included uninfected women, men who have sex with men, and transgender individuals considered at risk for HIV based on self-reported condomless intercourse in the past 90 days with a male partner who was either HIV-positive or of unknown status.

Data from 186 women and 405 men were analyzed. Among the women, 160 (86%) completed follow-up and 115 (62%) remained on their regimen for all 48 weeks. Among the men, 343 (84%) completed the study follow-up, and 281 (69%) remained on study regimens. Participants self-rated their health status using the EQ-5D-3L, and responses were then converted to health utilities, a preference-weighted measure of health status on a scale of 0.0 to 1.0.

Between baseline and any time during or at the end of the study, there was no significant change in QOL score. The mean QOL score among women was 0.91 at pre-PrEP baseline and 0.89 at week 48. There was even less of a change among men, dropping slightly from 0.95 at baseline to 0.94 at week 48.

“There was no significant difference in QOL at the end of the study among participants who stayed on the study regimen, participants who discontinued and restarted the regimen during the trial, and participants who discontinued the regimen early but continued study follow-up,” added the researchers.

After adjusting for age, race/ethnicity, alcohol use, marijuana use, opiate use, other substance use, or the most recent self-reported adherence assessment, there was still no significant difference in mean QOL at any time point.

Higher QOL was associated with greater self-reported ability to take the regimen as prescribed in both men and women across most time points. At week 48, both men and women with a high ability to take the regimen had a higher QOL than those without high ability.

The researchers also observed that each year of increased age was associated with lower baseline QOL in women, but not in men.

“Our findings show that QOL as a global construct is not impacted by PrEP administration, a message important for both clinicians and at-risk individuals,” noted the researchers. “Also, this finding may have implications for cost-effectiveness evaluation of PrEP regimens that include health utility as an outcome.”

Reference

Kapadia S, Wu C, Mayer K, et al. 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 [published online December 26, 2018]. PLoS One. doi: 10.1371/journal.pone.0206577.