Health-related quality of life (QoL) improves on first-line antiretroviral therapy (ART). However, at first-line failure, we have previously described poorer QoL among people in resource-limited settings (RLS) with higher viral load (VL). Change in QoL after starting second-line ART in RLS has not been evaluated.
ACTG A5273 was a randomized clinical trial of second-line ART comparing lopinavir/ritonavir (LPV/r) + raltegravir (RAL) with LPV/r + nucleos(t)ide reverse transcriptase inhibitors (NRTI) in participants failing a non-nucleoside reverse transcriptase inhibitor (NNRTI)-containing regimen at 15 sites in 9 RLS conducted between 2012 and 2014. The primary analysis of the trial showed no difference in virologic outcome between the two regimens. Participants completed the ACTG SF-21, which has 8 QoL domains with a standard score ranging from 0 (worst) to 100 (best): general health perceptions (GHP), physical functioning (PF), role functioning (RF), social functioning (SF), cognitive functioning (CF), pain (P), mental health (MH), and energy/fatigue (E/F). All participants were followed for at least 48 weeks. In a secondary analysis, differences in mean change in QoL between baseline (week 0) and week 48 by treatment arm and baseline VL were evaluated in intent-to-treat analysis using generalized estimating equation methods.
512 eligible adults (49% male, median age 39 years) from India (31%), Malawi (22%), South Africa (20%), Zimbabwe (9%) Kenya (9%), Tanzania (3%), Brazil (2%), Peru (2%), and Thailand (1%) were included. Median baseline CD4 count was 135 (IQR: 53; 271) cells/mm3 and VL 33,360 (IQR: 8,033; 138,153) cp/mL; 31% had VL >100,000 cp/mL. 512 and 492 participants had QoL assessments at baseline and week 48, respectively. QoL improved significantly from week 0 to 48 (p<0.05 for all domains for both treatments) with larger increases in GHP and RF. There was no significant difference between treatment arms for any domain (Table 1). Individuals with VL >100,000 cp/mL at baseline had lower mean QoL at week 0 than those with VL ≤100,000 cp/mL (3.6 to 12.1 lower; p<0.02 for each domain) but larger improvements such that mean QoL was similar at week 48 (1.3 lower to 1.7 higher across domains; p>0.2).
Improvements in QoL were similar after starting second-line ART with LPV/r + RAL or LPV/r + NRTI in RLS. QoL scores were worse among participants with higher VL prior to starting second-line, but after one year similar QoL scores were achieved.