Published online Jul 27, 2014. doi: 10.4254/wjh.v6.i7.520
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.
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.