, Volume 17, Issue 2, pp 632-639
Date: 07 Aug 2012

Correlation Between Pill Counts and Biologic Effects in an HIV-1 Prevention Clinical Trial: Implications for Measuring Adherence

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Abstract

Clinic-based pill counts of unused study medication are frequently used to measure adherence in HIV-1 prevention trials. Monthly pill count adherence data from the Partners in Prevention HSV/HIV Transmission Study, a double-blind, placebo controlled trial of twice-daily acyclovir suppression of herpes simplex virus type 2 (HSV-2) in HIV-1 infected persons was used to compare changes between 3,381 placebo and active arm participants in two objective biologic measures of acyclovir’s drug activity: reduction in plasma HIV-1 RNA and HSV-2 genital ulcer disease (GUD). Higher acyclovir pill count adherence was associated with greater reductions in plasma HIV-1 RNA and GUD, indicating pill count data is strongly correlated with biological effects of adherence. However, when calculated adherence exceeded 102 % (i.e., fewer pills returned than expected) and when pill counts were missing because bottles were not returned, plasma HIV-1 RNA and GUD effects were diminished, likely indicating periods of non-adherence.

This study was conducted on behalf of Partners in Prevention HSV/HIV Transmission Study Team (Members of the Partners in Prevention HSV/HIV Transmission Study Team listed in the Appendix section).
Presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Rome, Italy, 17–20 July 2011. Abstract TUPE354.