Impact of Direct-Acting Antivirals on BMI, BP, Cholesterol
SAN FRANCISCO, CA—At The Liver Meeting® 2015, new data showed direct acting antiviral (DAA) therapy for HCV was associated with significant reductions in components of the metabolic syndrome, with durable effects in patients achieving sustained virologic response at 12 weeks (SVR12).
Although HCV is linked to the metabolic syndrome and "DAA is often successful in achieving SVR, pleiotropic effects on components of the metabolic syndrome have not been characterized," explained Mark Pedersen, MD, from Banner University Medical Center and the University of Arizona College of Medicine in Phoenix, AZ.
Study investigators aimed to evaluate the effect of DAA HCV therapy on components of the metabolic syndrome by conducting a prospective, cohort study of consecutively enrolled patients with monoinfected chronic HCV initiated on treatment with a DAA regimen. They compared "changes in metabolic syndrome profiles during DAA therapy between those who achieved SVR12 and those who did not."
The 218 study patients received one of the following treatments: pegylated interferon alfa 2a (IFN) + sofosbuvir (SOF) + ribavirin (RBV) (n=37); SOF + RBV (n=117); SOF + simeprevir (SMV) (n=51); ledipasvir (LDV) + SOF (n=11); and LDV + SOF + RBV (n=2).
Before and at end of treatment, body mass index (BMI), systolic blood pressure (BP), diastolic BP, fasting blood glucose, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, and triglycerides were measured. The investigators also conducted a subgroup analysis to evaluate metabolic profile changes for those achieving SVR12.
Of the patients, 61.5% were HCV genotype 1 and 56.4% were cirrhotic. The majority of patients, 63.8%, were treatment-naïve; 10.1% had relapsed and 26.1% were nonresponders.
The highest prevalence of concomitant metabolic syndrome parameter pre-treatment was hypertension (38.5%) followed by diabetes (16.5%), and hyperlipidemia (15.3%).
At end of treatment, significant reductions in BMI (P=0.002), systolic BP (P=0.047), diastolic BP (P=0.009), total cholesterol (P=0.028), and LDL (P=0.053) were noted in the entire cohort.
"Changes in BMI, total cholesterol, and LDL were driven primarily by the subgroup achieving SVR12," Dr. Pedersen noted. Although changes in blood pressure were observed at end of treatment in the entire cohort, "only those who reached SVR12 demonstrated sustained changes," he added, with diastolic BP significantly decreased (P=0.01) and systolic BP trending toward decrease (P=0.09).
One study limitation is that other markers of insulin resistance, such as glycosylated hemoglobin, were not assessed.
"Further prospective study is needed to examine direction and durability of metabolic component changes with respect to viral (eg, genotype) and host (eg, fibrosis stage) factors,” concluded Dr. Pedersen.