A 7-year study of lamivudine therapy for hepatitis B virus e antigen-positive chronic hepatitis B patients in China

Autor: Bao En Wang, Guang Bi Yao, Ji Lu Yao, Mei Zhu, Zhen Yu Cui, Ming De Zeng
Rok vydání: 2009
Předmět:
Zdroj: Journal of Digestive Diseases. 10:131-137
ISSN: 1751-2980
1751-2972
DOI: 10.1111/j.1751-2980.2009.00375.x
Popis: To evaluate the long-term efficacy and safety of lamivudine treatment for chronic hepatitis B and the impact of emergence of YMDD mutation of hepatitis B virus (HBV).A total of 429 patients with serum HBsAg, HBeAg and HBV DNA positive were randomized to receive either lamivudine 100 mg daily or a placebo in a 3:1 ratio for the first 12 weeks. Thereafter, all patients were administered with lamivudine 100 mg/d for 5 years and followed up for 2 years.After 12 weeks of the lamivudine treatment, serum HBV DNA levels decreased rapidly and HBV DNA negativity (1.6 pg/mL) was 92.2%, whereas it was only 14.1% (P0.01) in the placebo group. At the end of 5 years, serum HBV DNA continued to be substantially suppressed. The loss of HBeAg and seroconversion were significantly correlated with baseline alanine aminotransferase (ALT) levels, in patients with baseline ALT2 x upper limits of normal, the loss of HBeAg was 54% and seroconversion rate was 50%, respectively. YMDD mutation developed in 70.8% of the patients at years 5. In YMDD mutant patients, HBV DNA levels were increased moderately and with mild to moderate elevations of ALT. ALT flares (ALT5ULN) occurred in 22 patients, 16 with YMDD variants and six with non-variants. One year durability of seroconversion after stopping lamivudine was 80%.Lamivudine is effective and tolerable for chronic hepatitis B.
Databáze: OpenAIRE