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Update on Hepatitis B Virus Infection:Focus on Treatment

j.urnal of Clinical and Translational Hepatology 2014年第4期2卷 285-291页

作者： stephanos j. hadziyannis Liver Unit and its Molecular Biology Laboratory National and Kapodistrian University of Athens Evgenidion Hospital of Athens Athens Greece

This review article is an update of the current treatment strategies available for chronic hepatitis B. In addition to achieving on-therapy clinical remission and suppression of HBV replication without resistance, the ultimate goal of therapy is the development of sustained remission and HBsAg loss after discontinuation of treatment. This is the closest possible to cure outcome for hepatitis B virus (HBV) infection. These goals can be achieved by response-guided courses of pegylated interferon (peg-IFN)-alpha at rates higher than 30%, both in hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients. Review of the data regarding discontinuation of long term NA treatment in HBeAg-negative patients revealed that stopping such therapy is safe with high rates of sustained off treatment responses that appear to be immunologically induced. Decreasing hepatitis B surface antigen (HBsAg) titers under therapy to<500, particularly<100 IU/mL, and adding a course of peg-IFN to ongoing long term nucleos(t)ide analogue (NA) therapy increase the percentage of sustained responses following discontinuation of NA treatment.

关键词： HBV Treatment Chronic hepatitis Interferon NA discontinuation

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恩替卡韦治疗拉米夫定耐药性慢性乙肝患者的疗效和耐受性:一项剂量范围研究

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世界核心医学期刊文摘（胃肠病学分册） 2006年第4期2卷 21-22页

作者： Gish R.G hadziyannis S.j. 陈云茹

Background &Aims: Entecavir is a nucleoside analogue with potent in vitro activity against lamivudine-resistant hepatitis B virus (HBV). This randomized, dose-ranging, phase 2 study compared the efficacy and safety of entecavir with lamivudine in lamivudine-refractory patients. Methods: Hepatitis B e antigen (HBeAg)-positive and -negative patients (n = 182), viremic despite lamivudine treatment for ≥24 weeks or having documented lamivudine resistance substitutions, were switched directly to entecavir (1.0, 0.5, or 0.1 mg daily) or continued on lamivudine (100 mg daily) for up to 76 weeks. Results: At week 24, significantly more patients receiving entecavir 1.0 mg (79%) or 0.5 mg (51%) had undetectable HBV DNA levels by branched chain DNA assay compared with lamivudine (13%; P < .0001). Entecavir 1.0 mg was superior to entecavir 0.5 mg for this end point (P < .01). After 48 weeks, mean reductions in HBV DNA levels were 5.06, 4.46, and 2.85 log10 copies/mL on entecavir 1.0, 0.5, and 0.1 mg, respectively, significantly higher than 1.37 log10 copies/mL on lamivudine. Significantly higher proportions of patients achieved normalization of alanine aminotransferase levels on entecavir 1.0, 0.5, and 0.1 mg (68%, 59%, and 47%, respectively) than on lamivudine (6%). One vir ologic rebound due to resistance occurred (in the 0.5 mg group). Conclusions: In HBeAg-positive and HBeAg-negative lamivudine-refractory patients, treatment with entecavir 1.0 and 0.5 mg daily was well tolerated and resulted in significa nt reductions in HBV DNA levels and normalization of alanine aminotransferase le vels. One milligram of entecavir was more effective than 0.5 mg in this populati on.

关键词：恩替卡韦慢性乙肝耐药患者核苷类似物乙型肝炎 DNA 病毒血症平均下降率

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阿德福韦长期治疗HBeAg阴性的慢性乙型肝炎

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世界核心医学期刊文摘（胃肠病学分册） 2005年第11期1卷 2-3页

作者： hadziyannis S.j. Tassopoulos N.C. j.nny Heathcote E. 李明 Department of Medicine Henry Dunant Hospital 107 Mesogion Ave. Athens 11526 Greece Dr.

BACKGROUND: Treatment with adefovir dipivoxil for 48 weeks resulted in histologic, virologic, and biochemical improvement in patients with hepatitis B e antigen (HBeAg)- negative chronic hepatitis B. We evaluated the effect of continued therapy as compared with cessation of therapy. METHODS: One hundred eighty-five HBeAgnegative patients with chronic hepatitis B were assigned to receive 10 mg of adefovir dipivoxil or placebo once daily for 48 weeks (ratio, 2 ∶ 1). After week 48, patients receiving adefovir dipivoxil were again randomly assigned either to receive an additional 48 weeks of the drug or to switch to placebo. Patients originally assigned to placebo were switched to adefovir dipivoxil. Patients treated with adefovir dipivoxil during weeks 49 through 96 were subsequently offered continued therapy. The primary end points were changes in hepatitis B virus (HBV) DNA and alanine aminotransferase levels. RESULTS: Treatment with adefovir dipivoxil resulted in a median decrease in serum HBV DNA of 3.47 log copies per milliliter (on a base-10 scale) at 96 weeks and 3.63 log copies per milliliter at 144 weeks. HBV DNA levels were less than 1000 copies per milliliter in 71 percent of patients at week 96 and 79 percent at week 144. In the maj.rity of patients who were switched from adefovir dipivoxil to placebo, the benefit of treatment was lost (median change in HBV DNA levels from baseline, - 1.09 log copies per milliliter; only 8 percent of patients had levels below 1000 copies per milliliter at week 96). Side effects during weeks 49 through 144 were similar to those during the initial 48 weeks. Resistance mutations rtN236T and rtA181V were identified in 5.9 percent of patients after 144 weeks. CONCLUSIONS: In patients with HBeAg-negative chronic hepatitis B, the benefits achieved from 48 weeks of adefovir dipivoxil were lost when treatment was discontinued. In patients treated for 144 weeks, benefits were maintained, with infrequent emergence of viral resistance.

关键词：乙型肝炎 HBeAg阴性韦长慢性乙肝阿德基线水平终点指标安慰剂周和耐药基因

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拉米夫定起始的核苷酸类似物对e抗原阴性的慢性乙型肝炎长期治疗

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世界核心医学期刊文摘（胃肠病学分册） 2005年第10期1卷 42-43页

作者： Papatheodoridis G.V. Dimou E. Dimakopoulos K. S.j. hadziyannis 王志宇 Department of Medicine and Hepatology Henry Dunant Hospital 107 Messogion Ave. 11526 Athens Greece

We determined the clinical outcome of hepatitis e antigen (HBeAg)-negative chronic hepatitis B patients treated with long-term nucleos(t)ide analog therapy starting with lamivudine. We evaluated 201 such patients treated for 3.8 ±1.4 years and 2 historical similar cohorts: 1 treated with interferon-alfa (n = 209) and 1 untreated (n = 195). Virological or biochemical remission rate at 48 mon-ths under lamivudine was 34%or 36%, respectively, whereas adefovir was administered in 79 patients with virological-biochemical breakthroughs or no response. Of the lamivudine-treated patients, 4 died, 1 underwent a transplantation, and another 8 developed maj.r events, all having advanced fibrosis at baseline and all but 1 having experienced breakthroughs or no response. At 5 years, survival was 96%, and maj.r event-free survival was 93%. The maj.r event-free survival was significantly better in patients with than in those without virological remission under lamivudine. At the end of follow-up, both survival and maj.r event-free survival were independently associated with type of and response to treatment, being significantly better in patients under long-term antiviral therapy or interferon sustained responders than in interferon non-sustained responders or untreated cases (5-year survival: 96%or 98%vs. 88%or 90%, respectively). In conclusion, in HBeAg-negative chronic hepatitis B, long-term nucleos(t)ide analog therapy starting with lamivudine significantly improves survival and reduces the risk of maj.r complications, compared with interferon non-sustained responders or untreated patients. In such patients with advanced fibrosis, close follow-up for lamivudine resistance and prompt onset of additional antiviral therapy is required or the ab initio use of agent(s) with low resistance rates should be considered.

关键词： e抗原乙型肝炎类似物 α-干扰素持续应答基线水平耐药者肝脏移植应答者生化指标

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