The predictive value of ALT, HBeAg and HBV DNA levels at baseline and the degree of HBV suppression at week 12 adefovir dipivoxil treatment to the efficacy of it at week 52 in patients with HBeAg-positive chronic hepatitis B / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To study the predictive value of ALT, HBeAg and HBV DNA levels at baseline and HBV DNA levels at week 12 adefovir dipivoxil (ADV) treatment to the efficacy of it at week 52 in patients with HBeAg-positive chronic hepatitis B (CHB).</p><p><b>METHODS</b>Ninety-eight HBeAg-positive CHB patients with serum HBV DNA>or=1x10(6) copies/ml and ALT levels between 1.5 to 10 times of upper limits of normal (ULN) were enrolled in the study. Ten mg/d of ADV was administered for 52 weeks. Line serum samples were collected for measuring HBV DNA and HBV markers. The efficacy of the treatment at week 52 was evaluated in patients with different ALT, HBeAg and HBV DNA levels at baseline and HBV DNA levels at week 12 after treatment.</p><p><b>RESULTS</b>At week 52 of ADV treatment, the rates of HBV DNA<10(3) were 72.7%, 66.7% and 53.0% respectively in patients with ALT>5xULN, HBeAg<or=350 s/co and HBV DNA<or=10(8) copies/ml. Significant differences were found between them and patients with ALT<2xULN (38.0%, P<0.05), HBeAg>350 s/co (30.2%, P<0.01) and HBV DNA>10(8) copies/ml (34.4%, P<0.05) at baseline. HBeAg seroconversion rates were 42.2% and 7.5% (P<0.01) in patients with HBeAg titer<or=350 and >350 S/co at baseline. In patients with HBV DNA<10(3), 10(3)-10(5) and >10(5) copies/ml at week 12, the ratios of them with HBV DNA<10(3) less than 1000 copies/ml at week 52 were 82.6%, 57.1% and 17.5% and significant differences were found between these groups (P<0.05); HBeAg seroconversion rates were 52.2%, 25.7% and 5.0% (P<0.05); ALT normalization rates were 100%, 83% and 75%, significantly higher in patients with HBV DNA<10(3) copies/ml than those with HBV DNA>10(5) copies/ml (P<0.05) at week 12. HBV DNA and HBeAg seroconversion at week 52 correlated with HBV DNA levels at week 12 (r=0.6 and r=0.5 respectively, P<0.01).</p><p><b>CONCLUSIONS</b>In HBeAg-positive CHB patients treated with adefovir dipivoxil, HBV DNA levels at week 12 can be used to predict the efficacy at week 52. HBV DNA<10(3) copies/ml at week 12 predict a better treatment result at week 52.</p>

Specific T cell immune response in chronic hepatitis B patients treated with different doses of recombinant hepatitis B vaccine / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To study the specific cellular immunoresponse of peripheral blood lymphocytes in the chronic hepatitis B patients treated with different doses of recombinant hepatitis B vaccine.</p><p><b>METHODS</b>Seventy-two chronic hepatitis B patients who did not use any anti-HBV drugs within 6 months were randomized into 3 groups (90 micrograms, 60 micrograms, and placebo) in a ratio of 1:1:1. The patients in different groups were treated with different doses of recombinant hepatitis B vaccine in combination with IFN alpha 1b 50 micrograms with 3 times a week for 24 weeks. All patients were followed up for 24 weeks (W24). HBV DNA, HBeAg and liver functions were detected at different time points, and the number of cells that secrete IFN-gamma were detected by ELISPOT.</p><p><b>RESULTS</b>There were no significant difference in ELISPOT positive ratio among the 3 groups on baseline detection. At W24, 12 cases, 12 cases, and 7 cases showed ELISPOT positive in the group of 90 micrograms, 60 micrograms, and placebo. The proportion of patients who were ELISPOT positive was higher in the groups treated with recombinant hepatitis B vaccine (including the dose of 90 micrograms and 60 micrograms) than that in the placebo group (P=0.0446). HBV DNA turned negative in 6/24 of the patients treated with recombinant hepatitis B vaccine (at both the doses of 90 micrograms and 60 micrograms), and HBeAg/Anti-HBe seroconversion or HBeAg became negative in 7/24 of them. In the placebo group, none of the patients showed undetectable HBV DNA, HBeAg/Anti-HBe seroconversion or HBeAg disappearance. At the 24W of follow up, in the patients who were ELISPOT positive, HBV DNA became undetectable in 4 of the patients treated with recombinant hepatitis B vaccine (at doses of 90 micrograms and 60 micrograms), and HBeAg/Anti-HBe seroconversion or HBeAg disappearance were found in 9 of the cases. In the placebo group, none of the cases showed undetectable HBV DNA, and only 1 case had HBeAg/Anti-HBe seroconversion.</p><p><b>CONCLUSION</b>The recombinant hepatitis B vaccine may increase the function of specific T lymphocytes in patients with chronic hepatitis B. There were no significant differences between the patients treated with the dose of 90 micrograms and 60 micrograms hepatitis B vaccine.</p>

Clinical investigation of famciclovir in chronic hepatitis B patients irresponsive to alpha interferon treatment / 中华肝脏病杂志

<p><b>OBJECTIVES</b>To evaluate the efficacy and safety of famciclovir on the decreasing levels of serum HBV-DNA and ALT and HBeAg/antiHBe seroconversion in chronic hepatitis B patients irresponsive to 3 months treatment with alpha interferon.</p><p><b>METHODS</b>Two hundred and nineteen patients with chronic HBV infection, defined as positive HBsAg, HBeAg and HBV DNA, were enrolled and randomly half-and- half put into famciclovir and placebo groups. The two groups received either famciclovir 500 mg tid or a placebo treatment for 24 weeks, and then were followed-up for another 24 weeks with no treatment.</p><p><b>RESULTS</b>At the end of 24 weeks, the log value of HBV DNA dropped from 6.54+/-1.26 to 5.70+/-2.03 in the famciclovirt group and were elevated from 6.30+/-1.32 to 6.51+/-1.65 in the placebo group (P < 0.01). The rate of cases with persistence HBV DNA dropped 2 log of quantity in the famciclovir group and was 28.28% (28/99); it was 9.47% (9/95) in the placebo group (P < 0.01). Those with persistence negative HBV DNA was 28.28% (28/99) in the flamciclovir treated group and 14.74% (14/95) in the placebo group (P < 0.05). Those persistently being HBeAg negative were 7.69% (7/91) in the famciclovir treated group and 3.33% (3/90) in the placebo group (P > 0.05). The HBeAg/antiHBe seroconversion was 4.40% (4/91) in the famciclovir group and 2.22% (2/90) in the placebo group (P > 0.05). The percentage of cases with normal of ALT level was 15.15% in the famciclovir group and 6.35% in the placebo group (P < 0.05).</p><p><b>CONCLUSION</b>Famciclovir is effective in inhibiting HBV DNA replication and in decreasing serum ALT levels. The rate of HBeAg/antiHBe seroconversion in the famciclovir treated group was similar to that of the placebo group. Famciclovir was well tolerated without severe adverse effects during our treatment.</p>

Efficacy and safety in chronic hepatitis B adolescent patients with lamivudine therapy / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To analysis the efficacy and safety of lamivudine (made in China) therapy for 52 weeks in adolescent patients with chronic hepatitis B (CHB).</p><p><b>METHODS</b>One hundred and five teenage CHB patients were treated with lamivudine 100 mg once daily for 52 weeks. Patients with elevated ALT at baseline were in group 1 and those with normal ALT were in group 2. The changes of HBV DNA, HBV seromarkers and ALT at the end of 12, 24 and 52 weeks after lamivudine therapy were compared with those at baseline. Adverse events were recorded and evaluated.</p><p><b>RESULTS</b>At the end of 52 weeks of lamivudine therapy, HBV DNA-ve, HBeAg loss and anti-HBe seroconversion were observed in 92.0%, 24.4% and 22.0% in group 1 patients and 76.1%, 14.2% and 14.2% in group 2 patients respectively. No significant differences were found between two groups. At 12, 24 and 52 weeks, normalization rates of ALT were 59.0%, 66.7% and 76.0%, normal ALT with undetectable HBV DNA were 44.9%, 64.1% and 70.7% at the same time. During 52 weeks lamivudine treatment 26 mild adverse events were observed in 18 patients.</p><p><b>CONCLUSION</b>Lamivudine can inhibit HBV replication rapidly and normalize ALT in majority adolescent CHB patients. HBeAg loss or seroconversion of anti-HBe was observed in some of these patients. All patients in this study were safety and well tolerated.</p>