Abstract
IntroductionDolutegravir (DTG)‐based antiretroviral therapy (ART) is recommended for first‐line HIV treatment in the US and Europe. Efavirenz (EFV)‐based regimens remain the standard of care (SOC) in India. We examined the clinical and economic impact of DTG‐based first‐line ART in the setting of India's recent guidelines change to treating all patients with HIV infection regardless of CD4 count.MethodsWe used a microsimulation of HIV disease, the Cost‐Effectiveness of Preventing AIDS Complications (CEPAC)‐International model, to project outcomes in ART‐naive patients under two strategies: (1) SOC: EFV/tenofovir disoproxil fumarate (TDF)/lamivudine (3TC); and (2) DTG: DTG + TDF/3TC. Regimen‐specific inputs, including virologic suppression at 48 weeks (SOC: 82% vs. DTG: 90%) and annual costs ($98 vs. $102), were informed by clinical trial data and other sources and varied widely in sensitivity analysis. We compared incremental cost‐effectiveness ratios (ICERs), measured in $/year of life saved (YLS), to India's per capita gross domestic product ($1600 in 2015). We compared the budget impact and HIV transmission effects of the two strategies for the estimated 444,000 and 916,000 patients likely to initiate ART in India over the next 2 and 5 years.ResultsCompared to SOC,DTG improved 5‐year survival from 76.7% to 83.0%, increased life expectancy from 22.0 to 24.8 years (14.0 to 15.5 years, discounted), averted 13,000 transmitted HIV infections over 5 years, increased discounted lifetime care costs from $3040 to $3240, and resulted in a lifetime ICER of $130/YLS, less than 10% of India's per capita GDP in 2015. DTG maintained an ICER below 50% of India's per capita GDP as long as the annual three‐drug regimen cost was ≤$180/year. Over a 2‐ or 5‐year horizon, total undiscounted outlays for HIV‐related care were virtually the same for both strategies.ConclusionsA generic DTG‐based regimen is likely to be cost‐effective and should be recommended for initial therapy of HIV infection in India.
Highlights
Dolutegravir (DTG)-based antiretroviral therapy (ART) is recommended for first-line HIV treatment in the US and Europe
We used a microsimulation of HIV disease, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)International model, to project outcomes in ART-naive patients under two strategies: (1) standard of care (SOC): EFV/tenofovir disoproxil fumarate (TDF)/lamivudine (3TC); and (2) DTG: DTG + TDF/3TC
We used the Cost-Effectiveness of Preventing AIDS Complications-International (CEPAC-I) model [15,16], a microsimulation model of HIV disease and treatment, to project and compare the clinical and economic performance of EFV/TDF/3TC, the standard of care, to DTG+TDF/3TC for treatment-na€ıve, HIV-infected patients initiating ART in India
Summary
Dolutegravir (DTG), an integrase strand transfer inhibitor, is recommended as a first-line antiretroviral drug for the treatment of HIV infection in the United States and Europe [1]. Given the improved virologic suppression and fewer side effects of DTG- compared to EFV-based regimens, implementation of DTG-based first-line ART could substantially reduce the number of people who fail first-line treatment and are lost to care or require a switch to second-line ART [2,3]. With the rollout of universal antiretroviral treatment in May 2017, cost will be an increasingly central consideration in future ART recommendations to ensure that treatment can be provided to the current population of PLHIV who are newly eligible for treatment as well as to those with new HIV diagnoses [12]. With generic DTG becoming increasingly available from multiple Indian pharmaceutical companies [14], we used simulation modelling to examine the potential cost-effectiveness and budgetary impact of a DTG-based first-line ART strategy in India
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