Early Virological Response with Consensus Interferon and Ribavirin in HCV Genotype 3 Non-Responders and Relapsers to Pegylated Interferon Based Therapy

Abstract

Purpose: Data regarding effectiveness of consensus interferon (CIFN) among HCV genotype 3 patients who failed to respond to pegylated interferon and ribavirin is scarce. The aim of this study was to assess the efficacy, safety and tolerability of CIFN and ribavirin in these patients. Methods: This ongoing open label investigators' initiated clinical study includes consecutive patients of age ≥ 18 years. All eligible patients who agreed to participate in the study are receiving CIFN 15mcg/day (INFERGEN; Three Rivers Pharmaceuticals, LLC, USA) plus ribavirin 800-1200 mg daily. If the patients have complete early virological response (EVR) at week 12, the dose of CIFN is reduced to 15 mcg thrice a week for a further 36 weeks. However, the patients are considered “non-responder” and treatment discontinued if there is a < 2 log10 reduction in HCV RNA. Patients with partial EVR will continue to receive daily CIFN plus RBV for further 12 weeks. These partial responders who will have undetectable HCV RNA at week 24 will continue to receive CIFN 15 μgm daily + ribavirin for further 24 weeks. Results: Included in this interim analysis are 46 patients; 26 (57%) were nonresponders and 20 (43%) relapsers to previous pegylated interferon and ribavirin therapy. Median age 44 years (range 25-61), males 27 (59%). The median baseline quantitative HCV PCR 424668 IU/ml (range 647-1.9 x 107). Ten patients were clinically cirrhotic Child Class A. Twenty patients underwent a liver biopsy, with majority of patients(n=9) having stage 3 fibrosis. A total of 37 patients have completed 12 weeks of treatment and 9 patients dropped out during the initial 12 weeks. Out of the 37 patients (20 non-responders, 13 relapsers), 33 (89%) achieved a complete EVR and one partial EVR. Normal values of SGPT at the end of 12 weeks were observed in 11 nonresponders and 12 relapsers. Common side effects were fever, anorexia and myalgias (78%). Absolute neutropenia (count <500) was observed in 2 patients who were given G-CSF. Five patients received erythropoetin to raise the hemoglobin. Six patients received SSRIs for mild depressive symptoms. Two patients developed portosystemic encephalopathy and were dropped out of the treatment. Conclusion: Our HCV genotype 3 patients who were non-responders and relapsers to previous treatment with pegylated interferon and ribavirin have shown a good response to Consensus Interferon plus ribavirin as reflected by the achievement of early virological response in the majority of patients. It would also be interesting to observe a sustained virological response in these patients.