Poor adherence to antiretroviral therapy (ART) predicts virologic failure (VF). Self-reported adherence and health-related quality of life (QoL) have been associated with 1st-line ART failure in resource-limited settings (RLS). Our objective was to assess whether QoL metrics add to self-reported adherence data at 4 weeks after starting 2nd-line ART in predicting early VF.
ACTG A5273 was a randomized clinical trial conducted between 2012 and 2014, which showed non inferior virologic efficacy of lopinavir/ritonavir (LPV/r) + raltegravir compared to LPV/r + nucleos(t)ide reverse transcriptase inhibitors as 2nd-line ART in participants failing non-nucleoside reverse transcriptase inhibitor ART at 15 sites in 9 RLS. Early 2nd-line VF was defined as HIV-1 RNA >400 c/mL at week 24 with subsequent confirmation. At baseline and week 4, participants completed the ACTG SF-21, which has 8 QoL domains each scored between 0 (worst) and 100 (best). Adherence was dichotomized as incomplete (self-report of any dose missed in the first 4 weeks of 2nd-line ART) and complete (no missed dose). Logistic regression was used to assess whether QoL at week 4, categorized in each domain as high (score 100), medium (75-<100) and low (<75), enhanced prediction of early 2nd-line VF in addition to adherence.
512 eligible adults (49% male, median age 39 years) were included including 500 with assessments for QoL and adherence at week 4 and for early VF; 7.4% (n=37/500) had early VF and 20.6% (103/500) reported incomplete adherence at week 4. Mean QoL improved (p<0.04) from baseline to week 4 in all domains: from 67 to 72 (general health perceptions), 91 to 93 (physical functioning), 80 to 83 (role functioning), 91 to 93 (social functioning), 91 to 94 (cognitive functioning, CF), 83 to 84 (pain, 85 to 89 (mental health), and 80 to 83 (energy/fatigue, E/F). Early VF was more common among participants who self-reported incomplete (14/103, 13.6%) versus complete adherence (23/397, 5.8%) at week 4 (OR: 2.56; 95%CI: 1.27-5.17; p=0.009). In analyses (both unadjusted and adjusted for adherence), lower QoL in CF and E/F categories at week 4 were associated with significantly higher odds of early 2nd-line VF (overall p<0.04) (Table).
Poorer QoL, particularly CF and E/F, adds to self-reported incomplete adherence after 4 weeks of 2nd-line ART in predicting VF at week 24. Evaluation is needed to assess whether patients with poorer QoL might be targeted for greater support to reduce risk of VF.