Treatment of patients with chronic hepatitis b in General hospital Celje

Abstract

Background: A third of world’s population has serological evidence of a past or current infection with hepatitis B virus and 350 million people have chronic infection. Chronic hepatitis B is associated with liver cirrhosis and hepatic cancer, i.e. the diseases that cause death in over a half million people yearly. It is estimated that there are approximately 20,000 chronic hepatitis B virus carriers living in Slovenia. In our hospital, experimental use of interferon α for the treatment of patients with hepatitis B was started already in 1988, while the routine treatment with interferon α has been practised for ten years and with lamivudine for five years.

Methods: A retrospective study carried out at the Department of Infectious Diseases and Febrile Conditions of the General Hospital Celje was aimed at evaluating the effectiveness and safety of a protocol-based treatment in 35 patients (21 males and 14 females, mean age 41 years) with chronic hepatitis B (11 HBeAg positive) in the period 1994–2004 receiving interferon α and/or lamivudine and since 2003 also pegylated interferon α and adefovir.

Results: In the period 1994–2000 we treated 15 patients with chronic hepatitis B (6 HBeAg positive) using different treatment schedules: twice with interferon α, once with interferon α in combination with lamivudine and once with lamivudine alone, in one-year cycles, each cycle followed by a half-year treatment-free interval. Despite a good tolerance to medications and favorable results observed by the end of each treatment cycle, the majority of patients presented with a relatively rapid onset of recurrence (within 3–6 months) after discontinuation of therapy, with an increased virus burden and elevated blood levels of ALT while 3 patients also presented with resistance to lamivudine. Following three to four cycles of therapy, a complete response to treatment was maintained in 10 patients (66.8%), while 3 patients have been disease-free for five years. Since the year 2003, two patients with recurrent disease have been treated with pegylated interferon a, and patients resistant to lamivudine have been receiving adefovir in combination with lamivudine. After the year 2000, there were 20 naive patients (5 HBeAg positive) treated with lamivudine as well. Eight patients have not completed the treatment yet while another 8 patients have had a complete response half a year after completed one-year therapy. After the year 2003, seroconversion into anti-HBe occurred in all 11 HBeAg positive patients. In 6 of 12 patients a repeated biopsy revealed a significant progression of hepatic fibrosis, i. e. for ≥ 2 stages, after 8.5 years on average.

Conclusions: So far, our experience with different approaches to treatment of patients with chronic hepatitis B is still inconclusive and therefore we have respect the experience of foreign experts and recommendations accepted at international conferences and counsel meetings. Despite their partial effectiveness, interferon α and lamivudine are the medications that in the past decade roused a realistic hope that chronic inflammation of the liver caused by hepatitis B virus can be stopped, or at least its further progession into liver cirrhosis and hepatic cancer can be considerably delayed. The fact that, in the past, clinicians could not be but helpless observers of chronic liver disease progression into an irreversible hepatic failure should not be ignored. Although the existing treatment results are far from enviable, the prospects of pegylated interferon α, adefovir and new nucleoside analogues, presently evaluated in different stages of clinical trials, are promising and will require new strategic approaches to treatment.