Dolutegravir-Associated Dyslipidemia and Atherogenic Lipid Changes Among Treatment-Naïve People Living With HIV: A 12-Month Prospective Cohort Study From Southern India.

Background Dolutegravir (DTG)-based antiretroviral therapy (ART) is widely used for the treatment of people living with HIV (PLHIV). As cardiovascular disease risk becomes increasingly important in the long-term management of PLHIV, understanding changes in lipid parameters following initiation of DTG-based therapy is clinically relevant. Prospective data on dyslipidemia and atherogenic lipid indices among Indian PLHIV initiating tenofovir disoproxil fumarate-lamivudine-dolutegravir (TLD) remain limited. This study aimed to evaluate changes in lipid profiles and atherogenic indices over 12 months among ART-naïve PLHIV initiating TLD. Methodology We conducted a 12-month prospective cohort study at the HIV Clinic of a tertiary teaching hospital in Bengaluru, India. A total of 70 adult ART-naïve PLHIV initiating TLD were enrolled consecutively. Participants with baseline dyslipidemia, lipid-lowering therapy, pregnancy, or lactation were excluded. Fasting lipid profile, including serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides (TG), and atherogenic indices (TC/HDL-c ratio, TG/HDL-c ratio, non-HDL cholesterol) were measured at baseline and 12 months. Body mass index (BMI), fasting blood sugar (FBS), serum alanine aminotransferase (ALT), and serum creatinine were also recorded at these time points. Enrolled participants were followed up for 12 months to determine the one-year incidence of dyslipidemia and changes in lipid parameters and atherogenic indices. Results All 70 participants completed follow-up (100% retention; median age = 33 years (interquartile range = 27-40); 74.3% male). The main finding was that 24/70 (34.29%, 95% confidence interval = 23.5-46.7) developed incident dyslipidemia at 12 months, with 17/24 (70.8%) demonstrating ≥2 concurrent lipid abnormalities. Low HDL-c (24.29%) and hypertriglyceridemia (22.86%) were most frequent. Statistically significant adverse mean changes occurred in TC (157.1 → 164.6 mg/dL; t(69) = 2.23, p = 0.029), LDL-c (95.8 → 111.1 mg/dL; t(69) = 5.15, p < 0.001), TG (131.7 → 154.7 mg/dL; Z = 3.60, p < 0.001), non-HDL-c (108.9 → 119.8 mg/dL; Z = 2.45, p = 0.014), TC/HDL-c ratio (3.37 → 4.03; Z = 2.18, p = 0.029), and TG/HDL-c ratio (2.85 → 4.04; Z = 3.05, p = 0.002). HDL-c declined non-significantly (48.2 → 44.8 mg/dL; t(69) = -1.83, p = 0.071). BMI rose +0.67 kg/m² (t(69) = 3.43, p = 0.001), serum creatinine +0.11 mg/dL (t(69) = 4.86, p < 0.001), ALT increased by 12.6 IU/L (Z = -5.97, p < 0.001), and FBS +7.6 mg/dL (t(69) = 2.00, p = 0.049), without new diabetes. Conclusions DTG-based antiretroviral therapy (TLD) was associated with a 34.29% one-year incidence of dyslipidemia in ART-naïve Indian PLHIV, with significant adverse shifts in atherogenic indices. These findings support routine lipid and metabolic surveillance and consideration of statin therapy in eligible patients as essential components of monitoring care for PLHIV on DTG-based ART.