Background:  Previous studies found lower total cholesterol and low density lipoprotein (LDL) levels in HIV⁺ people with hepatitis C virus (HCV) compared to those without HCV infection. To further investigate the relationship between HCV and serum lipid levels before and after initiating ART, we studied 1440 ART-naïve HIV-infected participants of the AIDS Clinical Trials Group 5001 (ALLRT) study. All subjects received ≥3 agents in randomized, prospective ART clinical trials.

Methods:  HCV infection was defined as HCV antibody positive (ELISA) or a clinical diagnosis of HCV. ART protocols excluded those with ALT > 5X ULN and other factors. Fasting total cholesterol, non-high density lipoprotein (HDL) cholesterol, triglyceride (TG), HDL, and glucose levels were evaluated before and after 48 weeks of ART. Non-HDL cholesterol was used as LDL was not available on all subjects. Other variables examined included serum liver enzymes (ALT, AST, alkaline phosphatase), CD4, and HIV RNA before and following 48 weeks of ART. Demographics and pre-ART body mass index were also assessed. The primary analysis compared HCV⁺ with HCV^­ individuals.

Results:  HCV⁺ subjects (11%; n = 161) were older and more likely to be black (p <0.05). As expected, those with HCV were more likely to have a history of injecting drug use (IDU), and to have higher baseline ALT, AST, and alkaline phosphatase levels (p <0.05 for all). While lipid levels went up in both groups over time, unlike prior studies, week 48 fasting cholesterol levels were not different between HCV⁺ and HCV^­ subjects. Following 48 weeks of ART, changes in fasting cholesterol levels also did not differ significantly; however, 53 of the 1242 HCV^­ subjects (4.1%) received lipid-lowering drugs compared with 0 of the 161 HCV⁺ subjects (p = 0.003). A greater proportion of HCV⁺ subjects had diabetes at baseline (5% vs 2%, p = 0.07). 

Conclusions:  In contrast to prior studies, cholesterol and non-HDL lipid levels were not different over time between HCV⁺ and HCV^­ subjects in this cohort of ART-naive patients enrolled in prospective, randomized clinical trials. This may reflect the absence of ART selection bias, and also exclusion of subjects with liver enzyme elevation >5X ULN. However, significantly fewer HCV⁺ subjects required lipid-lowering agents after 48 weeks of ART, supporting a lipid-protective association with HCV infection.