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Effectiveness, weight changes and metabolic outcomes on switch to generic dolutegravir/lamivudine amongst people with HIV in Western India: An observational study.

Introduction We assessed the effectiveness and safety of switching to generic Dolutegravir/Lamivudine (DTG/3TC) amongst People Living with HIV (PWH) in Western India. Methods In this single-center, retrospective observational study, PWH switched to DTG/3TC were followed for virologic, immunologic, clinical effectiveness and safety including weight changes, hyperglycemia and dyslipidemia. Multivariate linear mixed effects models were used to predict average change in weight adjusted for age, sex, duration of previous ARV regimens and baseline weight. Results From May 2017 to July 2022, 304 PWH with at least 1 follow-up visit around 3 months were included. Median (IQR) age was 54 (IQR 49-61) years and 70.1% were male. Prevalence of baseline comorbidities was 57.9% (hypertension-41.5%, CKD-40.9%, DM-18.8%). Reasons for switch were proactive (81.9%) and ARV toxicity (19.1%). Median (IQR) duration of follow-up on DTG/3TC was 40 (IQR 31-49) weeks. No virologic failure were observed. Rates of virologic suppression at 12, 24, 48, 72, 96 and 120 weeks were 95.2%, 95.9%, 90%, 100%, 81.3% and 88.4% respectively. Only 9 (3%) PWH permanently discontinued DTG/3TC. Predicted adjusted mean weight gain of +2.8 kgs was observed at 96 weeks. Switching from TDF/XTC/NNRTI and duration on DTG/3TC were significantly associated with weight gain. Apart from trend in worsening hyperglycemia no clinically significant changes in lipids and eGFR were documented. Conclusions Switching to DTG/3TC is an effective and safe option amongst virologically suppressed PWH with high co-morbidity burden in India. In view of the several advantages of DTG/3TC, it may be considered for potential scale-up in the right population, both in private and public health care settings in India.

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