FOROOTAN PISHBUARY H, MIRMOMEN S, ALAMDARY S, GHOFRANI H, FARAHVASH M, Y OSSEFI MASHHOOR M et al . THE EFFICACY AND SA FETY OF INTERFERON ALFA FOR THE TREATMENT OF CHRONIC HEPATITIS B INFECTED SUBJECTS IN IRAN. Med J Islam Repub Iran 2002; 16 (3) :139-134
URL:
http://mjiri.iums.ac.ir/article-1-1637-en.html
From the Digestive Disease Research Unit of Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, I.R. Iran. , emamddrc@mirmomen.com
Abstract: (4505 Views)
This preliminary study was designed to evaluate the effects of Heberon Alfa
for the treatment of chronic hepatitis B infected subjects in Iran. A single center,
open label, single treatment prospective study of Interferon Alfa (Heberon Alfa),
5 million units every other day for a period of 4 months, was performed between
1996 to 1998. A total number of 30 patients with histologically documented chronic
hepatitis and positive serum HBsAg were included in the study. Serum ALT of all
patients was greater than 1.5 times normal before start of therapy. Effect of therapy
on aminotransferase activity and HBsAg, HBeAg seroconversion was monitored
and all the patients underwent a second liver biopsy at the end of the study period.
Mean age of patients was 35.5 ± 12 (17 to 60 years old) and 73% of patients
were male. Most patients experienced adverse effects, but none warranted stopping
the treatment. No serious or unexpected adverse event was reported during
the study period. Thrombocytopenia was recorded in 2 patients. Liver biopsy
showed a decrease in hepatic inflammation in 53.5% of patients, no change in
36.70/0 and increase in hepatic inflammation in 100/0 of patients after the treatment.
Serum ALT returned to normal in 18 patients (60%), decreased in 7 patients
(23.3%) and didn't change in 5 patients (16.7%). There was a strong correlation
between serum ALT normalization and histological improvement. HBsAg
became negative in 5 patients (16.6%). 10 patients had positive HBeAg prior to
therapy, which became negative in 4 of then1 (40%) by the end of the study.
The current study confirms the result of other clinical trials and indicates that
Heberon Alfa is a safe and effective drug for the treatment of chronic hepatitis B
infected subjects with histologically documented chronic hepatitis.