An extended two-year trial of lamivudine in Chinese patients with chronic hepatitis B / 中华医学杂志(英文版)

<p><b>OBJECTIVE</b>To evaluate the long-term efficacy and safety of lamivudine therapy for the treatment of chronic hepatitis B and the clinical influence of emergence of tyrosine methionine aspartic acid (YMDD) motif mutation of hepatitis B virus (HBV).</p><p><b>METHODS</b>This multicenter, double-blind, randomized, placebo controlled trial began in 1996. A total of 429 patients with HBsAg, HBeAg and HBV CNA positives were enrolled. They were randomized to receive either lamivudine 100 mg daily (n = 322) or placebo (n = 107) on 3 : 1 ratio for the first 12 weeks. Thereafter all patients were offered open label lamivudine treatment and assessed every 4 weeks for a total of 104 weeks.</p><p><b>RESULTS</b>After 1 year treatment 72.7% patients (285/392) had a sustained serum HBV DNA response. HBV DNA continued to be substantially suppressed at the second year, except in patients with the emergence of YMDD mutation whose mean HBV DNA levels increased to 86 Meq/ml (bDNA assay) but were much more lower than that of pre-treatment baseline level. lamivudine therapy resulted in increased HBeAg loss and HBeAg/anti-HBe seroconversion, which were correlated with both baseline alanine transaminase (ALT) levels and also with duration of lamivudine treatment. HBeAg loss was achieved in 26.8% of patients with ALT > 1-fold upper limit of normal at 2 yeas and in 35.6% and 55.6% of patients with ALT > 2-fold upper limit of normal and ALT > 5-fold upper limit of normal, respectively. For HBeAg seroconversion, these figures were 17.4%, 22.2%, and 33.3% respectively. By the end of 2 years, ALT levels were remained in normal ranges in 50.3% whose ALT were abnormal before treatment, and in 83% whose ALT were mormal before treatment. YMDD mutation were developed in 49.7% of the patients. Their serum HBV DNA levels were slightly increased to bDNA median level 86 Meq/ml and 15% of the patients they were ALT exceeded baseline levels. Four patients clinically flared-up and recovered after stop treatment. The adverse drug reactions (ADRs) of lamivudine were mild to moderate, only two patients were reported as drug related severe ADR.</p><p><b>CONCLUSION</b>Sustained HBV replication and clinical improvement could be obtained by the long-term lamivudine therapy with good tolerance and safety.</p>

Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B in China / 中华传染病杂志

Objective To evaluate the efficacy and safety of Adefovir dipivoxil in the 52-week treatment of chronic hepatitis B in China.Methods We randomly assigned 480 patients with chronic hepatitis B who were positive for hepatitis B e antigen(HBeAg)in China.During the first 12-week period,480 patients were randomly to receive either 10 mg of adefovir dipivoxil(ADV)or placebo once daily in a 2:1 ratio and in the second period,all patients were accepted ADV for 18 weeks.In the last 12-week stage,all patients treated by ADV were randomly to receive either 10 mg of ADV or placebo in a 2:1 ratio and patients treated by placebo were accepted ADV.The primary end point was serum HBV DNA change during the treatment.The secondary endpoints were ALT normalization rate,HBeAg loss rate and HBeAg seroconversion rate.Results At week 12,median serum hepatitis B virus(HBV)DNA levels of group AAA(ADV-ADV-ADV)and group AAP(ADV-ADV-Placebo) were reduced 3.4 and 3.3 log copies per milliliter,significantly greater than group PAA(Placebo- ADV-ADV)of 0.1 log copies/ml reduction(P

Investigation of the health related quality of life in patients with chronic hepatitis C / 中华传染病杂志

Objective To evaluate the health related quality of life (HRQOL) of patients with chronic hepatitis C(CHC) and the improvement after interferon therapy. Methods Using the SF 36 questionnaire and the hepatitis specific scale derived from the Medical Outcomes Study (MOS), the HRQOL in 67 non cirrhotic patients with chronic HCV infection were evaluated, 38 patients of which were treated with IFN ?2a 3MU( n=31) and CIFN 15 ?g ( n =7), three times a week for 6 months. 12 patients had a sustained viral response (undetectable serum HCV RNA and normal ALT level at 24 weeks post treatment) to interferon therapy. 26 patients had no response. Live biopsies were performed in 23 patients and the diagnosis of chronic hepatitis proved. These scales were self administered by patients at baseline and at 24 weeks post treatment. Patients with chronic hepatitis C were compared with healthy volunteers ( n =40) who were selected as normal controls, the age, sex, education profession were matched between them. Results Compared with healthy controls, patients with chronic hepatitis C at baseline had lower HRQOL on all eight scales of the SF 36 ( P