LOW-DOSE RECOMBINANT INTERFERON THERAPY IN ANTI-HBE-POSITIVE CHRONIC HEPATITIS-B IN ASIAN INDIANS

Approximately 15% of Indian patients with hepatitis B virus (HBV)-rela ted chronic liver disease (CLD) have infection with precore mutant for ms. These patients are likely to have an aggressive course. There are equivocal reports of success with interferon therapy of mutant infecti on in the West. This therapy has not been evaluated in precore mutant- related CLD in Asian Indians. Eighteen patients (mean age 38.2 +/- 12 years, M:F: 17:1) with biopsy proven CLD and precore mutant HBV infect ion (hepatitis B surface antigen (HBsAg) positive, hepatitis B e antig en (HBeAg) negative, anti-HBe positive, HBV-DNA positive) were include d. Interferon alpha 2b was given at 3 mIU on alternate days for 4 mont hs. Serology, determination of HBV-DNA (both by dot-blot hybridization and polymerase chain reaction) and liver biopsy were repeated after c ompletion of the therapy. Response to interferon therapy was defined a s loss of HBV-DNA by dot-blot hybridization. Thirteen (72.2%) patients responded to the treatment (responders). Mean alanine aminotransferas e levels (83 +/- 12 vs 55 +/- 29 IU/L, P < 0.01) and the histological activity index (15 +/- 1.4 vs 12 +/- 1.3, P < 0.01) significantly decr eased in the responders compared with initial values. Serum albumin le vels also improved at the end of the therapy (3.5 +/- 0.4 g/dL vs 3.8 +/- 0.4 g/dL, P = 0.07). During follow up, seven of the 13 (54%) respo nders relapsed; cirrhotics relapsed more often than chronic hepatitis patients (P < 0.05). All 18 patients, however, continued to be HBV-DNA positive at the end of follow up. This study concluded that: 1. Inter feron therapy is beneficial, albeit to a limited extent, in HBV precor e mutant-related chronic liver disease in Asian Indians. 2. It is inef fective in eliminating the mutant HBV infection, which explains the hi gh relapse rate. 3. Prolonged low-dose interferon therapy alone or in combination with newer nucleoside analogues should be evaluated in the se patients.