[33] DURATION OF ANTIRETROVIRAL ADHERENCE PREDICTS BIOLOGIC OUTCOMES IN CLINICAL TRIALS

1st International AIDS Society Conference on HIV Pathogenesis and Treatment

Buenos Aires, Argentina - July 8-11, 2001

[TITLE:] DURATION OF ANTIRETROVIRAL ADHERENCE PREDICTS BIOLOGIC OUTCOMES IN CLINICAL TRIALS

[AUTHOR(S):] Friedland GH, Mannheimer S, Matts J, Child C, Telzak E, Chesney M
Yale University, New Haven, CT, USA

IAS Conf HIV Pathog Treat 2001 Jul 8-11;1st: Abstract No. 33

[ABSTRACT:] Objectives: To determine the durability of adherence (adh) to antiretroviral therapy (ART) and its correlation with treatment outcome as measured by plasma HIV RNA and CD4 cell count in participants (pts) in clinical trials.

Methods: Pts were enrolled in two multicentered randomized clinical trials of ART (CPCRA 057 and 058). Adh was measured by confidential self-report 7-day recall questionnaire at baseline, 1, 4, 8 and 12 months mos of follow-up (FU). HIV RNA and CD4 cell counts were obtained at same intervals. Adh levels were calculated based on mean of the combined total of each medication taken during the previous week, and stratified for analysis as 100%, 80-99%, and <80%.

Results: 732 pts who completed 1 mo FU were evaluated. Self-reported adh predicted HIV RNA and CD4 cell count levels. Change in HIV RNA levels from baseline to 12 mos was –2.72, -2.27, and –0.65 and percent of pts with HIV RNA <50 copies was 70, 46, 19 among those reporting 100%, 80-99% and 0-79% adh, respectively. The CD4 cell count increased 152, 175 and 41 cells in the three groups. At month 1, 73 % of pts reported 100% adherence, which was significantly higher compared to 4, 8 and 12 mos. Among the 201 pts with 12 mo FU, there was a significant relationship between number of follow-up visits with 100% reported adh and virologic outcome. For pts reporting 100% adh at 4, 3, 2, 1, or 0 FU visits, change in HIV RNA from baseline to 12 mos was -3.10, -2.56, -2.03, -1.24, and -1.31 log₁₀ respectively (p = .0001). 80% of pts reporting 100% adh at all 4 FU visits, had HIV RNA <50 copies/ml; of pts reporting 100% adh at 3, 2, 1, or 0 FU visits, 73%, 43%, 28% and 13% pts had HIV RNA <50 copies (p = .0001).

Conclusions: Both the level and duration of self reported adh predicts therapeutic outcome. The maintenance of consistent high levels of adh is critical and a significant determinant of virologic outcome. Long-term interventions to maintain high levels of adh are needed.

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