Efficacy of low-dose alpha interferon therapy in HBV-related chronic liver disease in Asian Indians: a randomized controlled trial

J Hepatol. 1996 Apr;24(4):391-6. doi: 10.1016/s0168-8278(96)80158-9.

Abstract

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 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.

Conclusion: Low-dose recombinant alpha interferon therapy is quite effective and safe in Asian Indians with chronic liver disease due to hepatitis B infection.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alanine Transaminase / blood
  • Asia / ethnology
  • Chronic Disease
  • Dose-Response Relationship, Drug
  • Follow-Up Studies
  • Hepatitis / therapy
  • Hepatitis B / complications*
  • Humans
  • India / ethnology
  • Interferon alpha-2
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use*
  • Liver Cirrhosis / therapy
  • Liver Diseases / ethnology
  • Liver Diseases / therapy*
  • Liver Diseases / virology*
  • Recombinant Proteins
  • Treatment Outcome

Substances

  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Alanine Transaminase