Journal of Hepatology 1996; 24: 391-396 Printed in Denmark All rights reserved Munksgaard Copenhagen Copyright 0 European Associorion for the Study of rhe Liver 1996 Journal zyxwvutsrqponmlkjihgf of zyxwvutsrqponmlkjihgf Hepstology ISSN 0168.8278 Efficacy of low-dose alpha interferon therapy in HBV-related chronic liver disease in Asian Indians: a randomized controlled trial Shiv K. Satin, R. C. Guptan, Varsha Thakur, Shailaja Malhotra, Veena Malhotra, Kakoli Banerjee’ and Pramod Khandekar’ zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPON Department of Gastroenterology and Pathology and ‘Gene Expression Laboratory, New Delhi, India Background/Aims: Interferon therapy has been shown to be effective in Western patients with chronic hepatitis due to hepatitis B viral infection, but not in Asian Chinese. Its efficacy in Asian Indian subjects with chronic HBV infection is not known. Methods: Forty-one patients with HBV-related chronic liver disease received randomly either: (a) recombinant alpha 2b interferon (n=20) 3 MIU, subcutaneously, three times a week for 4 months, or (b) no treatment (n=21). Patients were followed up for 12 months after completion of therapy. Results: In the interferon-treated group, complete response (loss of HBV-DNA and HBeAg) was sig- nificantly higher than spontaneous clearance in the control group (50% vs. 4.8% pcO.05). Seroconver- sion to anti-HBe was seen in 35% of the treated zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHG H EPATITIS B is a major health problem; approxi- mately 300 million persons worldwide are chronically infected with hepatitis B virus (HBV). With an HBsAg carrier rate of 3%~l%, we estimate that there are about 25 million HBV carriers in India. We reported earlier that most chronic liver disease in India is due to chronic HBV infection (1,2). In several randomized controlled trials (3,4) and meta-analyses, (5) alpha interferon has been shown to be effective in inhibiting HBV replication or in clearing HBV infection in 40-50% of patients in the West. In a recent study on the long-term follow up of interferon-treated patients in USA, 87% of the responders had sustained loss of HBeAg and 65% of Received 23September 1994: revised31 March; accepted4August 1995 Correspondence: S. K. Sarin, M.D., D.M., Department of Gastroenterology, G. B. Pant Hospital, New Delhi 110002, India. and 4.8% of the control group (p-zO.05) at 4 months; it was noticeably higher in patients with chronic hepatitis than in those with cirrhosis. In the responders, alanine aminotransferase levels nearly normalized. One year after interferon ther- apy, HBeAg and HBV-DNA clearance was ob- served in 65% of patients, with HBsAg clearance in 15%. Reactivation was not seen in any patient. Side-effects were transient and minimal. Conchsion: Low-dose recombinant alpha interfer- on therapy is quite effective and safe in Asian Indi- ans with chronic liver disease due to hepatitis B in- fection. Key words: Cirrhosis; Chronic hepatitis; Hepatitis p; Interferon. them eventually lost HBsAg in 0.2-6.0 years (6). In contrast, rather disappointing results have been reported from the Far East in Asian Chinese patients (7,8). A short-term antiviral response was obtained in only 5% of patients with normal alanine aminotrans- ferase (ALT) and 38% of patients with raised ALT; overall response was 22%. Poor HBsAg clearance and high rates (24%) of reactivation were additional difficulties noticed in treating Asian Chinese patients. There is, however, no information about the use of interferon treatment in Asian patients of Indian origin with chronic HBV infection. The present study was undertaken to assess the efficacy and side-effects of interferon treatment in such a population. Materials and Methods Forty-one patients were included in the trial. The inclusion criteria were: age below 70 years, presence of hepatitis B surface antigen (HBsAg) in serum for at least 6 months, positive test for hepatitis B e anti- 391