A randomized controlled trial of lamivudine to treat acute hepatitis B

✍ Scribed by M. Kumar; S. Satapathy; R. Monga; K. Das; S. Hissar; C. Pande; B. C. Sharma; S. K. Sarin

• Publisher: John Wiley and Sons
• Year: 2006
• Tongue: English
• Weight: 193 KB
• Volume: 45
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.21486

✦ Synopsis

The role of antivirals in patients with acute viral hepatitis B (AVH-B) has not been evaluated in controlled trials. The aim of this study was to evaluate the efficacy of lamivudine in patients with AVH-B. AVH-B patients with serum bilirubin of more than 5 mg/dL were randomized to receive either 100 mg of lamivudine daily for 3 months (group 1, n ‫؍‬ 31) or placebo (group 2, n ‫؍‬ 40). Patients were considered to have severe AVH-B if they fulfilled 2 of 3 criteria: (1) hepatic encephalopathy; (2) serum bilirubin > 10.0 mg/dL; and (3) international normalized ratio (INR) > 1.6. At week 4, HBV DNA levels were significantly lower (P ‫؍‬ 0.037) in group 1 (median: 3.6721 log copies/mL) than group 2 (median: 4.2721 log copies/mL). Thereafter, HBV DNA levels were comparable in the 2 groups. The improvement in serum bilirubin, ALT, and INR values was similar in the 2 groups. Twenty-two patients (71%) in group 1 and 25 patients (62.5%) in group 2 had severe AVH-B. Results were similar when patients with severe AVH-B were analyzed separately. After 12 and 18 months, 93.5% and 92.5%, respectively, of patients in the lamivudine group and 96.7% and 97.5%, respectively, of patients in the placebo group lost HBsAg. There were no deaths in either group. After 1 year, 21 patients (67.7%) in group 1 and 34 patients (85%) in group 2 developed protective anti-HBs titers (P ‫؍‬ 0.096). All HBeAg-positive patients in both groups lost e antigen and anti-HBe developed in 71% and 87.5% of patients in groups 1 and 2, respectively (P ‫؍‬ 0.132). Conclusion: Though lamivudine causes a greater decrease in levels of HBV DNA, it does not cause significantly greater biochemical and clinical improvement as compared to placebo in patients with acute hepatitis B. (HEPATOLOGY 2007;45:97-101.)

Patients and Methods

From January 2002 to March 2005, 138 patients with acute hepatitis B were seen in the Liver Disease Follow-Up Clinic of G.B. Pant Hospital, New Delhi, India. Only the 71 patients who fulfilled the inclusion criteria were enrolled in this study.