Background:  Hepatic steatosis has been associated with antiretroviral therapy (ART) and, among those with HCV, with increased fibrosis progression and decreased response to HCV therapy. The study objective was to determine the prevalence and correlates of steatosis in HCV/HIV co-infected patients. 

Methods:  We randomly selected 137 HCV/HIV-co-infected, ART-exposed patients enrolled in the Johns Hopkins HIV cohort; of whom, 113 were eligible for liver biopsy.  Steatosis was evaluated by a single pathologist and scored: grade 0, none; 1, fat involving < 5% of hepatocytes; 2, 5%  to  < 30%; 3, 30%  to  60%; 4 > 60%. Clinical and laboratory data were collected from charts and the lab database.  Alcohol assessment was computer-assisted. Multivariate logistic regression analysis was performed to determine correlates of steatosis. 

Results:  The characteristics of the 113 subjects were:  median age, 38 years (interquartile range [IQR], 33 to 41); male, 65%; black race, 95%; median weight, 166 lb (IQR, 147 to 192); median CD4 count, 340 cells/mm³ (IQR 171 to  526); median HIV RNA level, 340 copies/mL (IQR 31 to 26,924); current/past alcohol use, 49%/42%; median NRTI exposure, 5.72 years (IQR 3.94 to 7.76); current D4T, 18%, D4T ever, 86%; median NNRTI exposure, 0.94 years (IQR 0.2  to  2.38); median PI exposure, 3.72 years (IQR 0.91 to 4.79).  No hepatic steatosis was observed in 67 patients (60%); among the other patients, the steatosis grade was:  1, 25 patients (22%); 2, 15 patients (13%); 3, 5 patients (4%); 4, 1 patient (1%).  No patient with >grade 2 steatosis had evidence of lactic acidosis.  The presence of steatosis was independently associated with: D4T use ever (OR 4.8, 95% CI 1.1 to 22.14, p  = 0.04); weight >190 lb (OR 4.4, 95% CI 1.6 to 11.9, p  = 0.004); Caucasian race (OR 6.3, 95% CI 0.9 to 445.4, p  = 0.07), HIV RNA undetectable <25% of measurements (OR 3.7, 1.4 to 10.2, p  = 0.01); CD4 < 200 cells/mm³ >25% of measurements (OR .27, 95% CI 0.11 to 0.70, p  = 0.007); cumulative PI exposure (OR 1.3, 95% CI 1.0 to 1.62, p  = 0.05). 

Conclusions:  Substantial hepatic steatosis (> grade 2) was detected in only 5% of a random sample of HIV/HCV-co-infected patients taking ART in this urban clinic, and 60% of patients had no steatosis.  While the associations with steatosis of body weight, HIV suppression, and cumulative ART exposure, particularly to D4T, were anticipated, research is needed to evaluate the clinical significance of steatosis, including its effect on hepatic fibrosis progression in HCV/HIV-co-infected patients.

Keywords: Steatosis; HCV; Antiretroviral therapy