title: Pegylated interferon alfa-2b plus ribavirin for treatment of chronic hepatitis C.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Peginterferon alfa-2b, which was developed in India, in combination with ribavirin, is a safe and effective drug in the treatment of HCV.
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Pn
authors: P
authors: Rao
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Abraham
authors: A
authors: Koshy
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Jacob
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authors: Philip
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Narayanan
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authors: Premaletha
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Joy
authors: J
authors: Varghese
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Krishnasamy
authors: K
authors: Narayanasamy
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Samir
authors: S
authors: Mohindra
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Nitin Vikas
authors: NV
authors: Pai
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Manoj Kumar
authors: MK
authors: Agarwal
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Ashoknanda
authors: A
authors: Konar
authors: PN Rao, Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad 500082, India.
authors: Hasmukh B
authors: HB
authors: Vora
keywords: Genotype; Hepatitis C virus; Peginterferon alfa-2b; Ribavirin; Treatment