CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

Poster and Themed Discussion Abstracts

456 THE CLINICAL AND ECONOMIC IMPACT OF DOLUTEGRAVIR-BASED FIRST-LINE ART IN INDIA

Amy Zheng 1 , Nagalingeswaran Kumarasamy 2 , Mingshu Huang 1 , A. David Paltiel 3 , Kenneth H. Mayer 4 , Bharat Bhushan Rewari 5 , Rochelle P. Walensky 1 , Kenneth Freedberg 1 1 Massachusetts General Hosp, Boston, MA, USA, 2 YR Gaitonde Cntr for AIDS Rsr and Educ, Chennai, India, 3 Yale Univ, New Haven, CT, USA, 4 Fenway Hlth, Boston, MA, USA, 5 WHO, New Delhi, India Background: Dolutegravir (DTG)-based antiretroviral therapy (ART) has proven superior or non-inferior to other regimens and is recommended first-line treatment in the US. Efavirenz (EFV)-based regimens remain the standard of care (SOC) in India and other resource-limited settings, where DTG is not yet available. Anticipating generic DTG availability, we examined the clinical outcomes, cost-effectiveness, and budgetary impact of DTG-based 1st-line ART in India. Methods: We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC) International microsimulation model of HIV disease and treatment to evaluate two 1st-line ART strategies: 1) SOC: EFV/TDF/3TC; and 2) a DTG-based regimen: DTG+TDF/3TC in an HIV-infected cohort (mean age 37 years, 48%male, and median CD4 235 cells/μL). Regimen- specific model inputs included 48-week HIV RNA suppression (82% [SOC] vs. 90% [DTG]) and CD4 count increase in the first 2 months (83 vs. 107 cells/μL), from clinical trial data. Annual cost/person of SOC was USD$144; in the base case we assumed a DTG-based ART cost of $174/person/year (range $60-$264), fromWHO-projected costs of generic DTG regimens. 2nd-line PI-based ART cost was $255/person/year. Life years and costs were discounted in the ICERs; program costs were undiscounted. Strategies with incremental cost-effectiveness ratios (ICERs, $/year of life saved [YLS]) <1X Indian annual per capita GDP ($1,600) were considered cost-effective. We examined parameter uncertainty in sensitivity analysis. Results: A DTG-based regimen improved 5-year survival from 80% to 84% and extended life expectancy from 14.5 to 15.7 years, compared with SOC (Table). The proportion of patients on 1st-line ART at 5 years increased from 92% (SOC) to 96% (DTG). At a cost of $174/person/year, a DTG-based regimen had an ICER of $500/YLS compared to SOC. The ICER remained below $1,600/YLS across wide ranges of 1st-line ART cost, CD4 count increase in the first 2 months, 48-week HIV suppression rate, CD4 count at ART initiation, and 2nd-line ART cost. Program treatment costs were similar for newly ART-eligible patients at 2 years ($169 million [SOC] vs. $175 million [DTG]). Conclusion: A generic DTG-based option for 1st-line ART in India will increase survival, decrease the proportion of patients switching to 2nd-line ART, and be cost-effective, with little additional outlay over the current standard of care. DTG-based 1st-line ART, once generic pricing is available, should become the standard of care for ART initiation in India. 457 QUALITY OF LIFE IMPROVEMENT DURING SECOND-LINE THERAPY IN RESOURCE-LIMITED SETTINGS Thiago S. Torres 1 , Linda J. Harrison 1 , Alberto M. La Rosa 2 , Lu Zheng 1 , Sandra W. Cardoso 3 , Selvamuthu Poongulali 4 , McNeil Ngongondo 5 , Ann Collier 6 , Michael D. Hughes 1 , for the AIDS ClinicalTrials Group (ACTG) A5273 Study Group 1 Harvard Univ, Boston, MA, USA, 2 Asociación Civil Impacta Salud y Educación, Lima, Peru, 3 Inst Nacional de Infectologia (INI/Fiocruz), Rio de Janeiro, Brazil, 4 YRGCARE Med Cntre, Chennai, India, 5 UNC-Proj Malawi, Lilongwe, Malawi, 6 Univ of Washington, Seattle, WA, USA Background: 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. Methods: 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. Results: 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 fromweek 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). Conclusion: 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.

CROI 2017 191