PLoS ONE (Jan 2014)

Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial.

  • Steven A Safren,
  • Katie B Biello,
  • Laura Smeaton,
  • Matthew J Mimiaga,
  • Ann Walawander,
  • Javier R Lama,
  • Aadia Rana,
  • Mulinda Nyirenda,
  • Virginia M Kayoyo,
  • Wadzanai Samaneka,
  • Anjali Joglekar,
  • David Celentano,
  • Ana Martinez,
  • Jocelyn E Remmert,
  • Aspara Nair,
  • Umesh G Lalloo,
  • Nagalingeswaran Kumarasamy,
  • James Hakim,
  • Thomas B Campbell,
  • PEARLS (ACTG A5175) Study Team

DOI
https://doi.org/10.1371/journal.pone.0104178
Journal volume & issue
Vol. 9, no. 8
p. e104178

Abstract

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BACKGROUND:PEARLS, a large scale trial of antiretroviral therapy (ART) for HIV (n = 1,571, 9 countries, 4 continents), found that a once-daily protease inhibitor (PI) based regimen (ATV+DDI+FTC), but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) regimen (EFV+FTC/TDF), had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV). The present study examined non-adherence in PEARLS. METHODS:Outcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions = QOL-health, mental health = QOL-mental health), social support, substance use, binge drinking, and sexual behaviors. "Life-Steps" adherence counseling was provided. RESULTS:In both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01) and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01) non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence), worse QOL-health, age group (younger), and region were also significant predictors of treatment failure. CONCLUSION:In the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being associated with better adherence. Additionally, variables such as QOL-health, regimen, drug-use, and region play a role. Self-report and pill-count adherence, as well as additional psychosocial variables, such QOL-health, age, and region, were, in turn, associated with treatment failure.