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THE CLINICAL AND ECONOMIC IMPACT OF DOLUTEGRAVIR-BASED FIRST-LINE ART IN INDIA
Amy Zheng1, Nagalingeswaran Kumarasamy2, Mingshu Huang1, A. David Paltiel3, Kenneth H. Mayer4, Bharat Bhushan Rewari5, Rochelle P. Walensky1, Kenneth Freedberg1
1Massachusetts General Hosp, Boston, MA, USA,2YR Gaitonde Cntr for AIDS Rsr and Educ, Chennai, India,3Yale Univ, New Haven, CT, USA,4Fenway Hlth, Boston, MA, USA,5WHO, New Delhi, India
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.
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), from WHO-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.
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]).
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.