Pharmaco-economic profile, effectiveness, and safety of a dolutegravir based first line ART regimen among people living with HIV in South Gujarat.

Abstract

Background and objectives Dolutegravir (DTG)-based first line antiretroviral therapy (ART) is preferred globally due to its high efficacy, and tolerability. In India, data on evaluation of its pharmacoeconomic impact with effectiveness and safety remains limited. This study aimed to assess the pharmacoeconomic variables, effectiveness, and safety of the dolutegravir based first line ART regimen among people living with HIV (PLHIV) in south Gujarat. Methods This prospective, and observational study was conducted at an ART centre in a tertiary care hospital. Adults (≥18 yr) receiving first-line ART for ≥6 months were enrolled (n=204) following the informed consent. Pharmacoeconomic outcomes were evaluated using analysis of cost-effectiveness, cost minimisation, cost-utility, and cost-benefit. For effectiveness, CD4 count and plasma viral load (PVL) were recorded at baseline and 6 months. The safety was assessed using causality, severity, and preventability assessment of adverse drug reactions. Results Among 204 participants, 102 received TLD (tenofovir/lamivudine/dolutegravir) and 102 TLE (tenofovir/lamivudine/efavirenz). The TLD regimen demonstrated significantly better cost effectiveness (median CER 45.7 vs. 84.7; P<0.001) and lower mean annual treatment cost [INR (₹)17,074 vs. ₹19,283; P<0.001]. Quality-adjusted life years (QALY) and disability-adjusted life years (DALY) values were comparable between regimens. Both groups showed significant CD4 improvement over 6 months; inter-regimen differences were non-significant (P=0.386). Viral suppression at 6 months was higher with TLD (99% vs. 92.2%; P=0.019). Fourteen ADRs were reported for TLD group. Interpretation and conclusions Dolutegrevir-based regime demonstrated better cost effectiveness, lower annual cost, and more consistent viral load suppression, with comparable immunological recovery and a favourable safety profile, as compared to standard ART regime.