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Randomized Controlled Trial
. 2010 Jan 28;24(3):395-403.
doi: 10.1097/qad.0b013e328335cd8a.

Antiretroviral medication adherence and class- specific resistance in a large prospective clinical trial

Edward M Gardner  1 , Katherine H Hullsiek, Edward E Telzak, Shweta Sharma, Grace Peng, William J Burman, Rodger D MacArthur, Margaret Chesney, Gerald Friedland, Sharon B Mannheimer; Terry Beirn Community Programs for Clinical Research on AIDS and the International Network for Strategic Initiatives in Global HIV Trials
Affiliations
Randomized Controlled Trial

Antiretroviral medication adherence and class- specific resistance in a large prospective clinical trial

Edward M Gardner et al. AIDS. .

Abstract

Objective: To assess the association between adherence to antiretroviral therapy and the presence of class-specific antiretroviral medication resistance.

Design: Secondary analysis of prospective clinical trial data.

Methods: Participants randomized to the protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI) strategies of the Community Programs for Clinical Research on AIDS (CPCRA) Flexible Initial Retrovirus Suppressive Therapies (FIRST) Study were included. Adherence was measured by 7-day self-report. Virological failure was defined as an HIV-RNA more than 1000 at or after 4 months. The association between cumulative adherence and the development of class-specific genotypic resistance was assessed by Cox regression analysis.

Results: Included were 457 and 446 antiretroviral-naive participants on the protease inhibitor and NNRTI strategies, respectively. The median time to initial virological failure in the protease inhibitor strategy was 1.2 years; 135 (30%) individuals failed with resistance. The median time to initial virological failure in the NNRTI strategy was 3.0 years; 127 (28%) failed with resistance. No association was found between cumulative adherence and protease inhibitor resistance [hazard ratio 1.1, 95% confidence interval (CI) 0.9-1.4 per 10% lower adherence]. However, lower cumulative adherence was associated with an increased risk of NNRTI resistance at initial virological failure (hazard ratio 1.2, 95% CI 1.1-1.3 per 10% lower adherence). In both strategies, lower cumulative adherence was associated with an increased risk of nucleoside reverse transcriptase inhibitor (NRTI) resistance at initial virological failure.

Conclusion: Adherence-resistance relationships are class-specific. For NRTIs and NNRTIs, initial virological failure with resistance is more likely at lower levels of cumulative adherence.

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Figures

Figure 1
Figure 1
Risk (hazard ratio) of initial virological failure with resistance by randomized strategy and cumulative adherence categories in the CPCRA FIRST Study. *hazard ratios with 95% confidence intervals, compared to individuals with100% cumulative adherence
Figure 2
Figure 2
Class-specific resistance at initial virological failure by cumulative adherence category in the CPCRA FIRST Study, assessed in individuals experiencing virological failure during follow-up on NNRTIs (n = 136), Nonboosted PI (n = 164), and Ritonavir Boosted PI (n = 41). Panel A denotes NNRTI or PI resistance. Panel B denotes NRTI resistance.
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