Annals of Hepatology (Jan 2005)
Combination of Peginterferon α-2b (12 kDa) and Lamivudine in difficult-to-treat chronic hepatitis B-an Indian experience
Abstract
Introduction: Treatment strategies for chronic hepatitis B (CHB) using either interferon or Lamivudine can achieve sustained response in 30-40 % in HBeAg positive CHB. Retreatment of treatment failure in CHB and treatment of HBeAg negative patients pose major therapeutic challenge. Because of success story of Peginterferon in hepatitis C and some preliminary data in CHB, we undertook this open-labeled prospective study to study the response of Peginterferon α-2b (PegIFN) and Lamivudine combination in patients of CHB. Materials and methods: Following 4 groups of patients of CHB with persistently elevated transaminases were treated with Lamivudine 100 mg PO daily and PegIFN 1.5 μg/ kg SC once a week-1) HBeAg negative treatment naïve patients-for 12 months 2) HBeAg negative patients who were nonresponsive to at least two treatment regimensfor 12 months, 3) HBeAg positive treatment naïve patients-for 6 months 4) HBeAg positive patients who were treatment failure at least with two regimens-for 6 months. Patients were tested for LFT, HBeAg, antiHBe, quantitative HBVDNA (only in HBeAg negative CHB) and liver biopsy when possible at inclusion. During treatment period, LFT was tested at monthly interval and HBeAg, antiHBe and HBVDNA (in HBeAg negative CHB) at 3 monthly intervals. End of treatment response (EOR) was assessed at end of treatment period and sustained response (SR) at 6 months post treatment. Treatment response was defined in HBeAg positive patients with normalization of enzymes and disappearances of HBeAg & in antiHBe positive patients with normalization of enzymes and loss of detectable HBVDNA. Results: Total 25 patients with CHB were included in this study with mean age of 37.9 ± 4.6 years (range 20-56) and male: female= 11.5:1. 1) In HBeAg negative treatment naïve patients, 4/6 patients achieved EOR (66.6%), whereas in 3/6 patients (50%) had SR. 2) In HBeAg negative treatment failure group, 4/5 patients had EOR (80%) and 3/5 patients achieved SR (60%), of which 1 patient lost HBsAg. 3) In HBeAg positive treatment naïve patients, 4/5 patients achieved EOR (80%) and 3/5 patients obtained SR (60%). One patient in this group lost HBsAg. 4) In HBeAg positive treatment failure group, 5/9 patients achieved EOR (55.5%), whereas 3/9 patients (33.3%) obtained SR. Conclusion: Overall, in difficult-to-treat patients (considering groups 1, 2 & 4-total 20 patients) with combination of PegIFN and Lamivudine, EOR was seen in 13 patients (65%), SR was obtained in 9 patients (45%) and loss of HBsAg was seen in 1 patient (5%).
