Efficacy and tolerability of pegylated interferon alpha 2b and ribavirin in chronic hepatitis C--a report from eastern India.

Aim: To study the efficacy and tolerability of pegylated interferon alpha 2b and ribavirin therapy in a cohort of chronic hepatitis C patients.

Methods: In a prospective, open label, uncontrolled trial pegylated interferon alpha 2b (Viraferon Peg) 1.5 microgram/ kg subcutaneously weekly plus daily ribavirin 800mg for 24 weeks in genotypes 2 & 3 and 1000mg for 48 weeks in genotypes 1 and 4 was administered to 16 patients of chronic hepatitis C. The primary end point was the sustained viral response. Therapy was prolonged by 3 months if the end of therapy response was not attained. Drug dosage was modified or temporarily discontinued if anaemia or bone marrow suppression developed.

Results: Both virological end of therapy response and sustained viral response were seen in 75% cases but not every patient who achieved end of therapy response had a sustained viral response. Relapse was seen in 31% cases and a pattern of delayed response was seen in 2 patients who later experienced a sustained viral response. Biochemical and virological responses were similar. A lower baseline viral load, genotype 3, a high ALT and the parenteral mode of viral acquisition were associated with higher sustained viral response rates. A good response was also seen in men, those over 50 years of age and those with normal baseline ALT. Most relapses occurred in genotype 3 patients whose age was less than 50 years; however the relapsing viral load was very low. 66% of previous interferon and ribavirin non-responders achieved sustained viral response. Treatment was well tolerated; temporary dose modification was required in 3 patients.

Conclusion: In Indian patients, a combination of peginterferon alpha 2b and ribavirin is safe and effective both as initial treatment of chronic hepatitis C and for use in previous non-responders.