The cost‐effectiveness and budgetary impact of a dolutegravir‐based regimen as first‐line treatment of HIV infection in India

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.

Addressing Pediatric HIV Pretreatment Drug Resistance and Virologic Failure in Sub-Saharan Africa: A Cost-Effectiveness Analysis of Diagnostic-Based Strategies in Children ≥3 Years Old

“…This finding is not surprising, as we extrapolated from adult data to assume DTG-based ART would achieve lower rates of virologic failure for all children, independent of their PDR status. Prior model-based analyses have shown similar findings in adults in LMIC [ 20 , 53 ]. We found that DTG-based ART could decrease overall costs due to lower rates of virologic failure on first-line ART and thus decreased need for PI-based ART.…”

Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries

“…(2018) modeled that DTG containing combinations is predicted to be both effective and cost-effective among sub-Saharan African countries [315]. Zheng et al (2018) also found that a generic DTG-based regimen is likely to be cost-effective in India; consequently, they believed this regimen should be recommended as initial therapy in patients newly diagnosed with HIV in India [316]. Having said this, there are still concerns regarding DTG and its combinations among LMICs.…”

Safety, Tolerability, and Efficacy of Generic Dolutegravir-containing Antiretroviral Therapy Regimens Among South Indian Human Immunodeficiency Virus-infected Patients

“…This, along with the reduced frequency of AEs and excellent efficacy, makes DTG an attractive replacement for EFV in first-line therapies in lowresource settings [12]. Our data show the potential benefits of DTG rollout among ART-naive and experienced patients; our group has already shown DTG to be cost-effective in lowresource settings [13]. Further research is needed to determine if widespread DTG implementation can have a greater impact on HIV prevention in the community due to quicker achievement of viral suppression [10,14].…”