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


CONCLUSIONS
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.
Ray
Gautam
G
Gastroenterology Unit, Department of Medicine, Central, (B.R. Singh) Hospital Eastern Railway, Sealdah, Kolkata 700 014, West Bengal. gautam1910@yahoo.com
Pal
Subroto
S
Nayyar
Iqbal
I
Dey
Satyaki
S
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007194:India; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b