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QUALITY OF LIFE IMPROVEMENT DURING SECOND-LINE THERAPY IN RESOURCE-LIMITED SETTINGS
Thiago S. Torres1, Linda J. Harrison1, Alberto M. La Rosa2, Lu Zheng1, Sandra W. Cardoso3, Selvamuthu Poongulali4, McNeil Ngongondo5, Ann Collier6, Michael D. Hughes1
1Harvard Univ, Boston, MA, USA,2Asociación Civil Impacta Salud y Educación, Lima, Peru,3Inst Nacional de Infectologia (INI/Fiocruz), Rio de Janeiro, Brazil,4YRGCARE Med Cntre, Chennai, India,5UNC-Proj Malawi, Lilongwe, Malawi,6Univ of Washington, Seattle, WA, USA
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.