Clinical Trials Study
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jul 27, 2014; 6(7): 520-526
Published online Jul 27, 2014. doi: 10.4254/wjh.v6.i7.520
Pegylated interferon alfa-2b plus ribavirin for treatment of chronic hepatitis C
PN Rao, Abraham Koshy, Jacob Philip, Narayanan Premaletha, Joy Varghese, Krishnasamy Narayanasamy, Samir Mohindra, Nitin Vikas Pai, Manoj Kumar Agarwal, Ashoknanda Konar, Hasmukh B Vora
PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India
Abraham Koshy, Department of Hepatology, Lakeshore Hospital, Kochi 682040, India
Jacob Philip, Department of Gastroenterology, Cosmopolitan Hospital, Thiruvananthapuram 695004, India
Narayanan Premaletha, Department of Gastroenterology, Medical College, Thiruvananthapuram 695011, India
Joy Varghese, Department of Hepatology, Global Hospitals and Health City, Chennai 600100, India
Krishnasamy Narayanasamy, Department of Hepatology, GGH and MMC, Chennai 600003, India
Samir Mohindra, Department of Gastroenterology, SGPGIMS, Lucknow 226014, India
Nitin Vikas Pai, Department of Gastroenterology, Pai Clinic and Diagnostic Center, Pune 411005, India
Manoj Kumar Agarwal, Department of Gastroenterology, Belle Vue Clinic, Kolkata 700017, India
Ashoknanda Konar, Department of Gastroenterology, Peerless Hospital and B.K. Roy Research Center, Kolkata 700094, India
Hasmukh B Vora, Department of Gastroenterology, Alka Hospital, Ahmedabad 380019, India
Author contributions: All eleven authors of the manuscript carried out the field research for the study in addition to contributing to the conception and design of the study; Rao PN was also instrumental in writing the paper.
Supported by Virchow Biotech Private Limited, Hyderabad, India
Correspondence to: PN Rao, MD, DM, Department of Gastroenterology, Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad 500082, India.
Telephone: +91-40-23378888 Fax: +91-40-23324255
Received: December 19, 2013
Revised: April 11, 2014
Accepted: May 28, 2014
Published online: July 27, 2014

AIM: To study the safety and efficacy of pegylated interferon alfa-2b, indigenously developed in India, plus ribavirin in treatment of hepatitis C virus (HCV).

METHODS: One-hundred HCV patients were enrolled in an open-label, multicenter trial. Patients were treated with pegylated interferon alfa-2b 1.5 μg/kg per week subcutaneously plus oral ribavirin 800 mg/d for patients with genotypes 2 and 3 for 24 wk. The same dose of peginterferon plus weight-based ribavirin (800 mg/d for ≤ 65 kg; 1000 mg/d for > 65-85 kg; 1200 mg/d for > 85-105 kg; 1400 mg/d for > 105 kg body weight) was administered for 48 wk for patients with genotypes 1 and 4. Serological and biochemical responses of patients were assessed.

RESULTS: Eighty-two patients (35 in genotypes 1 and 4 and 47 in 2 and 3), completed the study. In genotype 1, 25.9% of patients achieved rapid virologic response (RVR): while the figures were 74.1% for early virologic response (EVR) and 44.4% for sustained virologic response (SVR). For genotypes 2 and 3, all patients bar one belonged to genotype 3, and of those, 71.4%, 87.5%, and 64.3% achieved RVR, EVR, and SVR, respectively. In genotype 4, 58.8%, 88.2%, and 52.9% of patients achieved RVR, EVR, and SVR, respectively. The majority of patients attained normal levels of alanine aminotransferase by 4-12 wk of therapy. Most patients showed a good tolerance for the treatment, although mild-to-moderate adverse events were exhibited; only two patients discontinued the study medication due to serious adverse events (SAEs). Eleven SAEs were observed in nine patients; however, only four SAEs were related to study medication.

CONCLUSION: Peginterferon alfa-2b, which was developed in India, in combination with ribavirin, is a safe and effective drug in the treatment of HCV.

Keywords: Hepatitis C virus, Genotype, Peginterferon alfa-2b, Ribavirin, Treatment

Core tip: In a multicenter study, the safety and efficacy of pegylated interferon alfa-2b, indigenously developed in India, plus ribavirin was evaluated on 100 hepatitis C virus (HCV) patients with genotypes 1, 2, 3, and 4. Eighty-two patients completed the study. Most patients had mild-to-moderate adverse events, although 11 serious adverse events were reported in 9 patients. However, only 4 of these were related to study medication. The percentage of serologic response (rapid virologic response, early virologic response, and sustained virologic response rates) of patients was similar to that reported in published studies. In conclusion, peginterferon alfa-2b, developed in India, is a safe and cost-effective drug in the treatment of Indian patients with HCV infection.