Long-term treatment outcomes from a large-scale programmatic implementation of Dolutegravir-based antiretroviral therapy for people with HIV: An observational cohort study from India

Abstract Background Dolutegravir (DTG)-based regimens are the most commonly used antiretroviral therapy (ART) for people with HIV (PWH). However, there are limited real-world data on long-term outcomes. Methods We followed a cohort of 115,520 treatment-naïve and treatment-experienced PWH initiated or transitioned to DTG-based ART in Andhra Pradesh, India, and assessed retention and viral suppression. We performed Cox proportional hazards regression and multivariable logistic regression to determine factors associated with deaths and viral non-suppression. Findings At 48 months, 91.9% PWH were retained in care (92.9% among treatment-experienced and 75.7% among treatment-naïve), 1.8% were lost to follow-up, and 6.3% died. Of the 110,287 PWH with a documented viral load test, 97.1% were virally suppressed, including 10,698 of 11,956 (89.5%) PWH who achieved viral suppression with enhanced adherence counselling after initial viral non-suppression on DTG. For treatment-experienced PWH, viral suppression was 87.8% among those with viral non-suppression at transition, and 93.2% among those without a VL test at transition, and highest when tenofovir/lamivudine was recycled with DTG. Factors associated with increased risk of death and viral non-suppression included being male, treatment-naïve, CD4 count<200 cells/mm3 at transition, and current or past tuberculosis (TB). Additionally, age ≥50, receiving an abacavir/protease-inhibitor containing regimen, and viral non-suppression were associated with a higher risk of death. Similarly, key populations, adolescents, young adults (20–29 years), receiving a zidovudine-containing regimen, not receiving multi-month dispensation, and being LTFU (specifically>3 times during the last 12 months) were significantly associated with higher odds of viral non-suppression. Conclusion DTG was associated with high treatment retention and viral suppression, including treatment-experienced PWH with recycled tenofovir/lamivudine. Tailored differentiated services could further optimise DTG impact on viral suppression and mortality, particularly among PWH with advanced HIV disease, TB-coinfection, age >50 years, or adolescents.