A 24-week, parallel-group, open-label, randomized clinical trial comparing the early antiviral efficacy of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive chronic hepatitis B virus infection in adult Chinese patients

摘要: Abstract Background: Because drug-resistant strains of hepatitis B virus (HBV) have developed, and because serum HBV-DNA levels may rebound in patients who receive treatment with nucleoside/nucleotide analogues for up to 2 years, there remains a largely unmet clinical need agents induce potent virologic suppression the initial stage disease course HBV infection. Objective: The aim this work was compare early antiviral effectiveness telbivudine entecavir e antigen (HBeAg)-positive HBV. Methods: In parallel-group, open-label trial, adult Chinese previously untreated HBeAg-positive (HBV-DNA concentration: ≥6 log 10 copies/mL; alanine aminotransferase [ALT] level: ≥2 times upper limit normal) were randomized 600 mg or 0.5 daily 24 weeks. Blood samples collected at baseline 12 weeks after treatment. primary end point mean reduction from concentration week 24. Secondary points included 12, absence HBV-DNA, HBeAg, HBeAg seroconversion 24, normalization ALT occurrence adverse events through Results: A total 131 enrolled study: 91 men 40 women, (SD) age 32.5 (8.9) years. All ethnic Han Chinese. demographic characteristics concentrations groups well matched. Sixty-five 66 entecavir. reductions 4.99 4.69 copies/mL respectively, 6.00 5.80 (both time points, P = NS between groups). At undetectable 43.1% (28/65) group 34.8% (23/66) ( NS); it 67.7% (44/65) 57.6% (38/66) NS). rates significantly greater than (absence: 20.0% [13/65] vs 3.0% [2/66], respectively [ 0.002]; seroconversion: 13.8% [9/65] [2/66] 0.030]). However, comparable 36.9% [24/65] 28.8% [19/66] NS]; 24.6% [16/65] 13.6% [9/66] NS]). addition, observed 78.5% (51/65) 74.2% (49/66) treated entecavir, respiratory tract infection (12.3% 9.1% patients), fatigue (6.2% 7.6%), diarrhea (1.5% 3.0%), coughing (0% 1.5%), most which mild moderate. Elevated creatinine phosphokinase noted 8 telbivudine-treated (12.3%). There no statistically significant differences except phosphokinase. Conclusion: study adults infection, tolerability