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.