Efficacy of low-dose alpha interferon therapy in HBV-related chronic liver disease in Asian Indians: a randomized controlled trial.
OBJECTIVE
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 significantly higher than spontaneous clearance in the control group (50% vs. 4.8% p < 0.05). Seroconversion to anti-HBe was seen in 35% of the treated and 4.8% of the control group (p < 0.05) 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 therapy, HBeAg and HBV-DNA clearance was observed in 65% of patients, with HBsAg clearance in 15%. Reactivation was not seen in any patient. Side-effects were transient and minimal.


CONCLUSIONS
Low-dose recombinant alpha interferon therapy is quite effective and safe in Asian Indians with chronic liver disease due to hepatitis B infection.
Sarin
S K
SK
Department of Gastroenterology and Pathology, New Delhi, India.
Guptan
R C
RC
Thakur
V
V
Malhotra
S
S
Malhotra
V
V
Banerjee
K
K
Khandekar
P
P
D000410:Alanine Transaminase / Q000097:blood; D001208:Asia / Q000208:ethnology; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006505:Hepatitis / Q000628:therapy; D006509:Hepatitis B / Q000150:complications*; D006801:Humans; D007194:India / Q000208:ethnology; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000628:therapy; D008107:Liver Diseases / Q000208:ethnology / Q000628:therapy* / Q000821:virology*; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase