DURABILITY OF THE RESPONSE TO PEGINTERFERON ALFA2b AND RIBAVIRIN IN CHRONIC HEPATITIS C PATIENTS: A COHORT STUDY IN THE ROUTINE CLINICAL SETTING.

Objectives: to evaluate whether in chronic hepatitis C-positive naïve patients recruited in the routine clinical setting and treated with pegylated-interferon-alfa2b (Peg-IFN) and ribavirin (RBV) the sustained virologic response (SVR) is durable over the long-term and if it is associated to a decrease of liver complications and incidence of glucose abnormalities. Methods: prospective long-term follow-up of 182 naïve patients enrolled in 2001-2002 and treated with Peg-IFN and RBV and followed up to December 2010 with clinical, biochemical and virological evaluations every 6-12 months. Results: none of the 115 (63.2%) sustained responders showed late viremic relapse during the follow-up. SVR was better defined at 24 weeks (16/16 relapsers, 100%) than at 12 weeks after the end of therapy (14/16 relapsers, 87.5%). At multivariable analysis, viral genotype (OR 0.16, 95% CI 0.07-0.36, p= 0.0001) and a >20% RBV reduction (OR 5.21, 95% CI 1.54-17.67, p= 0.008) independently predicted long-term response (LTR). Incidence of cirrhosis was significantly higher among non responders (21.3%) compared with long-term responders (0.9%, p≤0.0001) but risk of developing glucose abnormalities was not significantly reduced in long-term responders (HR=1.36, p= 0.363). Hepatocellular carcinoma occurred in three cases only. Conclusions: SVR obtained in patients treated in the routine clinical setting with Peg-IFN and RBV is durable over the long-term and LTR significantly reduces the risk of progression to cirrhosis; however, in a population with mild liver fibrosis the clinical impact of LTR on the risk of glucose abnormalities seems negligible.