Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients.
BACKGROUND
To evaluate the safety and effectiveness of locally produced pegylated interferon-alpha2a in treatment-naïve patients with chronic hepatitis C.


METHODS
All treatment-naïve patients diagnosed with chronic hepatitis C who referred to two university based outpatient clinics in Tehran from December 2007 to May 2008 were enrolled. Exclusion criteria included the presence of a debilitating disease, decompensated cirrhosis, or refusal to participate in the study. Patients were treated with 180 microg pegylated interferon-alpha2a (Pegaferon) weekly and 800 - 1200 mg ribavirin daily for 24 or 48 weeks depending on genotype and weight. Viral and biochemical response and adverse drug reactions were recorded.


RESULTS
A total of 108 patients were enrolled; 63 with genotype 1 and 45 with genotypes 2 and 3. The mean age of the patients was 39 years (range: 19 - 65). Ninety-seven patients completed the study and 76 achieved sustained viral response. The sustained viral response among patients completing the study was 67% for genotype 1 and 95% for genotypes 2 and 3. Adverse events were well tolerated and none led to discontinuation of treatment, however dose adjustment was necessitated in 16 patients. The most common adverse events were fatigue (73.5%), poor appetite (66.2%), and feverishness (57.4%). The mean hemoglobin drop was 2.9 g/dL.


CONCLUSIONS
Locally produced PEG-IFN in Iran is safe and effective in treatment-naïve chronic hepatitis C.
Jabbari
Hossain
H
Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Bayatian
Ayatollah
A
Sharifi
Amir Houshang
AH
Zaer-Rezaee
Hanieh
H
Fakharzadeh
Elham
E
Asadi
Reyhaneh
R
Zamini
Hediyeh
H
Shahzamani
Kiana
K
Merat
Shahin
S
Nassiri-Toosi
Mohsen
M
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004279:DNA, Viral / Q000032:analysis; D004305:Dose-Response Relationship, Drug; D004337:Drug Carriers; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000998:Antiviral Agents; D004279:DNA, Viral; D004337:Drug Carriers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a