PROSPECTIVE OBSERVATIONAL COHORT STUDY OF PREDICTORS OF THE EFFECTIVENESS OF PEGYLATED INTERFERON IN PATIENTS WITH HEPATITIS C IN GEORGIA.

The main objective of the study was to evaluate the predictive values of virological response at 4th and 12th weeks after treatment initiation on sustained virological response by HCV genotype in patients with hepatitis C in Georgia. Local, non-interventional, prospective, cohort study was conducted in 2011-2016. A cohort of adult peginterferon treatment naïve patients with chronic hepatitis C were observed during the complete active treatment period with PEGASYS®/COPEGUS® and 24 weeks after the end of treatment. HCV RNA titers were assessed prior to treatment, after 4, 12 weeks of treatment, at the end of treatment and 24 weeks after the end of treatment.530 men and women aged ≥18 years with serologically proven CHC (all genotypes) were enrolled in this study. Enrolles study subjects were treated with PEGASYS® 180mkg (peginterferon alfa-2a) in combination with COPEGUS® 200mg (ribavirin) according to the current standard of care and in line with current summary of product characteristics. All clinical information for this cohort study was collected from the patient's medical records. All laboratory parameters which were collected for this observational study according to the protocol were performed in study centers. All data were analyzed with descriptive and analytical statistics. Our analysis demonstrated that the early achievement of viral response predicts the higher probability of achieving sustainvirul response. The viral response itself was strongly associated with baseline liver fibrosis quantitive HCV RNA level. Early starting of treatment determines the probability of achievement higher osustain viral response.