Comparison of the efficacy of 48 week-Entecavir therapy with that of Adefovir therapy for chronic hepatitis B patients / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To compare the efficacy of 48 week-Entecavir therapy with that of Adefovir therapy for chronic hepatitis B patients.</p><p><b>METHODS</b>In this open-label study we randomly assigned 125 CHB patients to receive 0.5 mg of entecavir (n = 56) or 10mg of adefovir (n = 69) once daily for 48 weeks.</p><p><b>RESULTS</b>HBV DNA, ALT and HBeAg were quantified at baseline and at 0, 24, 48 weeks. At week 24 and 48, more patients in entecavir group than in adefovir group achieved undetectable serum HBV DNA level (68% vs 35%, 84% vs 49%, P < 0.05). The percentage of patients with normal ALT level in the two groups at week 48 was similar (100% vs 94%, P > 0.05). Among the HBeAg positive patients, more patients in entecavir group than in adefovir group had HBeAg loss at week 24 and 48 (23% vs 7%, 44% vs 15%, P < 0.05). The ratio of HBeAg seroconversion was similar in the two groups at week 24 (18% vs 7%, P > 0.05), but more patients in entecavir group than in adefovir group achieved HBeAg seroconversion at week 48 (33% vs 12%, P < 0.05). The retreated patients in the entecavir group had a higher chance to achieve undetectable serum HBV DNA level (79% vs 34%, P < 0.05), HBeAg loss (42% vs 17%, P > 0.05), and seroconversion (26% vs 17%, P > 0.05), than these in the adefovir group. The safety profiles and adverse event profiles were similar in the two groups.</p><p><b>CONCLUSIONS</b>Compared to adefovir, entecavir is more potent to suppress HBV replication.</p>

Analysis of spontaneous decline of HBV DNA in chronic hepatitis B patients in 12 weeks / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To analyze the spontaneous decline of HBV DNA in chronic hepatitis B patients in 12 weeks.</p><p><b>METHODS</b>Chronic hepatitis B patients not receiving antiviral treatment from 2003 to 2005 were divided into two groups according to the baseline value of ALT and TBil. Spontaneous decline of HBV DNA were retrospected, and the influence of the baseline value of ALT and TBil on spontaneous decline of HBV DNA was analyzed.</p><p><b>RESULTS</b>Total of 213 chronic hepatitis B patients (male 174, female 39, aged from 18 to 65) were recruited in this study, including 124 mild and moderate type of hepatitis B, 89 severe type of hepatitis B, and 19 patients (8.92%) were lost at the end of the 12th week. The mean baseline value of HBV DNA of all the patients was (6.66+/-1.03) log10 copies/ml, at 12 week the mean value of HBV DNA of all the patients was (5.98+/-1.53) log10 copies/ml (compared to baseline P<0.01), the decline value of HBV DNA was (0.68+/-1.46) log10 copies/ml. The mean baseline value of HBV DNA of patients with the severe type of hepatitis B was lower than that with the mild or moderate type of hepatitis B patients [(6.45+/-0.99) log10 copies/ml and (6.81+/-1.04) log10 copies/ml respectively] (P<0.05). However, there was no significant difference in the mean and the declined value of HBV DNA between these two groups at the 12th week (P<0.05). At the 12th week, the baseline values of ALT and TBil were higher in patients with HBV DNA<or=3 log10 copies/ml than those in patients with HBV DNA>3 log10 copies/ml (P>0.05); And there were no significant difference in the baseline values of ALT and TBil between patients with the declined value of HBV DNA>or=2 log10 copies/ml and patients with declined value of HBV DNA less than 2 log10 copies/ml. At the 12th week, the mean and the declined value of HBV DNA were similar between the patients with ALT<or=5xULN and the patients with ALT>5xULN at baseline. The mean baseline value of HBV DNA of patients in the group of patients whose baseline value of ALT<or=5xULN while TBil<or=5xULN was higher than that in the group of patients whose baseline value of ALT>5xULN while TBil>5xULN, ALT<or=5xULN while TBil>5xULN, ALT>5xULN while TBil<or=5xULN (P<0.05 respectively), there were no significant difference in the rate of the HBV DNA<or=3 log10 copies/ml and the rate of the declining value of HBV DNA<or=2 log10 copies/ml between the groups at 12 week (P>0.05 respectively).</p><p><b>CONCLUSIONS</b>There is spontaneous decline of HBV DNA in patients with chronic hepatitis B in 12 weeks, but the level of liver injury is not correlated with the level of spontaneous decline of HBV DNA in chronic hepatitis B patients in 12 weeks.</p>

Short-term results of telbivudine versus entecavir treatments in HBeAg-positive chronic hepatitis B patients in China / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of telbivudine (LDT) versus entecavir treatments in hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients.</p><p><b>METHODS</b>Eighty HBeAg-positive compensated CHB patients with HBV DNA more than 6 log10 copies/ml and serum ALT 2 x ULN were divided into two groups: a telbivudine treatment group, and a entecavir treatment group. HBV DNA, ALT and HBeAg were surveyed at baseline and at 12 and 24 weeks. The efficacy and safety of the two nucleoside analogues were assessed at 12 and 24 weeks.</p><p><b>RESULTS</b>Undetectable serum HBV DNA levels of the telbivudine group (50% and 80%) were similar to those of the entecavir B group (50% and 70%) according to the polymerase-chain-reaction assay at week 12 and 24. There were no significant differences in the normalization of alanine aminotransferase levels between the two groups at week 12 and 24 (52.5% vs 60.0%, 77.5% vs 75.0%). The mean reductions in serum HBV DNA from the baseline levels at week 12 and 24 were similar between the two groups [5.27 vs.5.36, 6.49 vs.6.18 log (on a base-10 scale) copies per milliliter]. More patients in the telbivudine group had HBeAg seroconversion at week 12 than those in the entecavir group (20.0% vs 5.0%, P = 0.043); however, there was no significant difference between the two groups at week 24 (27.5% vs 17.5%). No adverse reactions were found in either group.</p><p><b>CONCLUSION</b>There was no significant difference in HBV DNA undetectable rates and the ALT normalization rates between the two groups in a short-term therapy (24 weeks), but the telbivudine group had a higher rate in HBeAg seroconversion than that in the entecavir group at week 12.</p>

A multi-center clinical study of N-acetylcysteine on chronic hepatitis B / 中华肝脏病杂志

<p><b>OBJECTIVES</b>To evaluate the effectiveness and safety of N-acetylcysteine (NAC) in treating chronic hepatitis B patients.</p><p><b>METHODS</b>144 patients with chronic hepatitis B (total bilirubin, TBil>170 mmol/L) from several centers were chosen for a randomized and double blind clinical trial. The patients were divided into a NAC group and a placebo group and all of them were treated with an injection containing the same standardized therapeutic drugs. A daily dose of 8 microgram NAC was added to the injection of the NAC group. The trial lasted 45 days. Hepatic function and other biochemistry parameters were checked at the experimental day 0 and days 15, 30, 45.</p><p><b>RESULTS</b>Each group consisted of 72 patients of similar demology and disease characteristics. During the trial, 28 cases of the 144 patients dropped out. In the NAC group, at day 0 and day 30, the TBil were 401.7 vs. 149.2 and 160.1+/-160.6. In the placebo group, the TBil on the corresponding days were 384.1+/-134.0 and 216.3+/-199.9. Its decrease in the NAC group was 62% and 42% in the placebo group. At day 0 and day 45 of treatment, the effective PTa increase rate was 72% in the NAC group and 54% in the placebo group. The total effective rate (TBil + PTa) was 90% in the NAC group and 69% in the placebo group. The parameters of the two groups showed a remarkable difference. The rate of side effects was 14% in the NAC and 5% in the placebo groups.</p><p><b>CONCLUSION</b>NAC can decrease the level of serum TBil, increase the PTa and reduce the time of hospitalization. NAC showed no serious adverse effects during the period of our treatment. We find that NCA is effective and secure in treating chronic hepatitis B patients.</p>

One year and half treatment with lamivudine in active cirrhosis resulting from chronic hepatitis B / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To study the therapy effect of long term lamivudine treatment on active cirrhosis following chronic hepatitis B, and explore the methods for abnormalities resulting from lamivudine withdrawing.</p><p><b>METHODS</b>58 patients received lamivudine 100 mg orally everyday for 18 months. The changes were observed and wrote down, including clinical symptoms and signs, aminotransferase, virology indexes, and the abnormalities after lamivudine withdrawing, then further to find out plans for the latter.</p><p><b>RESULTS</b>(1) After lamivudine treatment, there were 35 patients whose situation stabilized, life quality improved, child-pugh score declined, and liver function turned better. (2) The level of HBV DNA decreased at least 10(3) copies/ml. HBeAg of 33.3% patients (13/39) became negative. (3) Among the 10 patients who stopped lamivudine of their own accord, and came again after 3 - 6 months because of hepatitis B recurring, two were treated with interferon for one month, then turning to liver-protecting methods for deteriorating, the other eight only received liver-protecting and immune-regulating treatment, whose liver function improved.</p><p><b>CONCLUSIONS</b>Long term treatment with lamivudine for active cirrhosis following chronic hepatitis B can improve liver function and life quality, prevent exacerbation. And it is not advisable to use interferon for hepatitis B relapsing after lamivudine withdrawing.</p>

Clinical research on the treatment effect of autologous dendritic cell vaccine on the patients with chronic hepatitis B / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To investigate the treatment effect of autologous HBsAg-loaded dendritic cells (DCs) on patients with chronic hepatitis B (CHB).</p><p><b>METHODS</b>Monocytes were isolated from fresh peripheral blood of 19 CHB patients by Ficoll-Hypaque density gradient centrifugating and cultured with plastic -adherence method. DCs were induced and proliferated from the monocytes with granulocyte-macrophage clony stimulating factor (GM-CSF) and interleukin-4 (IL-4) for seven days. After being incubated with HBsAg for two hours, DCs were injected to patients subcutaneously twice at the interval of two weeks. HBV DNA level, alanine aminotransferase (ALT) level, and HBV markers in the serum of patients were tested every two months.</p><p><b>RESULTS</b>11 of the 19 (57.9%) patients responded to DC-treatment clinically. The rates of HBeAg clearance and HBeAg/anti-HBe seroconversion were 52.6% (10/19) and 26.3% (5/19) respectively, and the copies of HBV DNA decreased by 10(1.77 2.39) (t = 3.13, P < 0.01). Two patients who were treated in combination with lamivudine had complete clinical response. There was no difference in the trial effect between the DC treatment and the other two antiviral methods, and in the efficient rate between the patients whose ALT levels were high before treatment and those whose ALT levels were normal.</p><p><b>CONCLUSION</b>The autologous HBsAg-loaded DCs can effectively suppress HBV replication, reduce virus load in serum, eliminate HBeAg and promote HBeAg/ anti-HBe seroconversion. The patients whose ALT levels are high or normal can response clinically to DCs treatment. DCs in combination with lamivudine can eliminate virus more effectively.</p>