Adherence Required On Dolutegravir

Abstract

Abstract Background Historical data from a study of non-boosted protease inhibitor-based antiretroviral therapy (ART) regimens have suggested that an average adherence threshold of 95% is the minimum necessary for viral suppression. However, dolutegravir-containing regimens, which are recommended as preferred first-line ART regimens worldwide, may be more forgiving due to their potency and high barrier to drug resistance. Methods We analyzed data from 483 ART-experienced adults in Uganda who were routinely switched from non-nucleoside reverse transcriptase inhibitor-based regimens to tenofovir-lamivudine-dolutegravir (TLD). We compared the proportion virally suppressed (\u3c 50 copies/mL) at 24- and 48-weeks post-enrollment across levels of self-reported adherence using the three-item Wilson adherence scale, with χ2 tests to determine significant differences. We also fit generalized estimating equations (GEE) with viral suppression as the outcome of interest and self-reported adherence as the predictor of interest. Results Median age was 47 (IQR 40-53), and 41% were female. Overall suppression rates were high (\u3e72%). However, we found that those reporting the lowest levels of adherence in ability and percentage had lower rates of virologic suppression than those in moderate or high adherence categories (Figure 1). When using low versus moderate to high adherence ability or percentage as a predictive measure of viral non-suppression, sensitivity and specificity were \u3c18% and \u3e93%, respectively. In regression models, lower self-reported adherence remained significantly associated with viral non-suppression after adjustment for age, sex, duration of ART, and previous ART regimen. Conclusions Individuals reporting high adherence to TLD have extremely high rates of viral suppression. However, individuals reporting poor adherence to TLD, specifically ability and percent, have significantly higher levels of viral non-suppression, which had a low sensitivity of \u3c18% due to high rates of viral suppression overall, and a specificity of \u3e93% for identifying virologic failure. Self-reported adherence questionnaires should be explored as a possible means of identifying individuals for targeted virologic monitoring and/or adherence support