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Adefovir dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients:A Randomized Controlled 48-Week Trial

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Chinese Journal of Integrative Medicine 2020年第5期26卷 330-338页

作者： LI Xiao-ke ZHANG Ming-xiang SHAO Feng-zhen ZHOU Da-qiao XUE Jing-dong LIU Tie-jun CHI Xiao-ling LU Bing-jiu WANG Xian-bo LI Qin LI Jun MAO De-wen YANG Hua-sheng YANG Hong-zhi ZHAO Wen-xia LI Yong ZHANG Guo-liang ZHAO Yi-ming ZOU Jian-dong LIU Meng-yang ZHANG Ke-ke YANG Xian-zhao GAN Da-nan LI Ying ZHANG Peng LI Zhi-guo LI Shuo YE Yong-an Department of Gastroenterology Institute of Liver DiseaseDongzhimen Hospital affiliated to Beijing University of Chinese MedicineBeijing(100700)China Department of Hepatology the Sixth People's Hospital of ShenyangShenyang(110006)China Department of Hepatology the First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin(300000)China Departm ent of Hepatology Shenzhen Traditional Chinese Medicine HospitalShenzhen(518033)C hina D e pa rtm e nt of H e pa to log y Shaanxi H o spital of T radition al C hinese M edicineXi'an(710003)China Affiliated Hospital of Changchun U niversity of Chinese M edicine C hangchun(130021)China Departm ent of Hepatology Guangdong Hospital of Traditional Chinese MedicineGuangzhou(510006)China Department of Hepatology Liaoning Hospital of Traditional Chinese MedicineShenyang(110032)China Department of Hepatology Beijing Ditan HospitalBeijing(100015)China Department of Hepatology Mengchao Hepatobiliary Hospital of Fujian Medical UniversityFuzhou(350025)China Department of Hepatology the 302 Military Hospital of PLABeijing(100039)China Department of Hepatology the First Affiliated Hospital of Guangxi University of Chinese MedicineNanning(530023)China Department of Integrated Traditional Chinese Medicine and Western Medicine Beijing YouAn HospitalCapital Medical UniversityBeijing(100069)China Department of Traditional Chinese Medicine Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhou(510630)China Department of Gastroenterology the First Affiliated Hospital of Henan University of Chinese MedicineZhengzhou(450000)China Department of Hepatology Shandong Hospital of Traditional Chinese MedicineJinan(250011)China Department of Gastroenterology Anhui Hospital of Traditional Chinese MedicineHefei(230031)China Research Center of Clinical Epidemiology Peking University Third HospitalBeijing(100191)China Clinical Research Center Affiliated Hospital of Nanjing University of Traditional Chinese MedicineNanjing(210029)China

Objective:To evaluate the effects of a 48-week course of adefovir dipivoxil(ADV)plus Chinese medicine(CM)therapy,namely Tiaogan Jianpi Hexue(调肝健脾和血)and Tiaogan Jiedu Huashi(调肝解毒化湿)fomulae,in hepatitis B e antigen(HBeAg)-positive Chinese patients.Methods:A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group(EG,received ADV plus CM)and control group(CG,received ADV plus CM-placebo)for 48 weeks.The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12,24,36,48,respectively.Secondary endpoints including liver functions(enzymes and bilirubin readings)were evaluated every 4 weeks at the beginning of week 24,36,and 48.Routine blood,urine,and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations.Adverse events(AEs)were documented.Results:The combination therapy demonstrated superior HBeAg loss at 48 weeks,without additional AEs.The full analysis population was 560 and 280 in each group.In the EG,population achieved HBeAg loss on week 12,24,36,and 48 were 25(8.90%),34(12.14%),52(18.57%),and 83(29.64%),respectively;the equivalent numbers in the CG were 20(7.14%),41(14.64%),54(19.29%),and 50(17.86%),respectively.There was a statistically significant difference between two groups on week 48(P<0.01).No additional AEs were found in EG.Subgroup analysis suggested different outcomes among treatment patterns.Conclusion:Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy.The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile(ChiCTR-TRC-11001263).

关键词： Adefovir dipivoxil Tiaogan Jianpi Hexue Tiaogan Jiedu Huashi Chinese medicine HBeAg combination therapy

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De novo combined lamivudine and adefovir dipivoxil therapy vs entecavir monotherapy for hepatitis B virus-related decompensated cirrhosis

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World Journal of Gastroenterology 2013年第37期19卷 6278-6283页

作者： Jiang-Shan Lian Lin-Yan Zeng Jian-Yang Chen Hong-Yu Jia Yi-Min Zhang Dai-Rong Xiang Liang Yu Jian-Hua Hu Ying-Feng Lu Ling Zheng Lan-Juan Li Yi-Da Yang State Key Laboratory for Diagnosis and Treatment of Infectious Diseases the FirstAffiliated HospitalZhejiang University School of Medicine

AIM:To compare efficacy of combined lamivudine(LAM)and adefovir dipivoxil(ADV)therapy with that of entecavir(ETV)monotherapy for hepatitis B virus(HBV)-related decompensated liver cirrhosis.METHODS:A total of 120 na ve patients with HBVrelated decompensated cirrhosis participated in this study.Sixty patients were treated with combined LAM and ADV therapy(LAM+ADV group),while the other60 were treated with ETV monotherapy(ETV group)for two years.Tests for liver and kidney function,alpha-fetoprotein,HBV serum markers,HBV DNA load,prothrombin time(PT),and ultrasonography or computed tomography scan of the liver were performed every1 to 3 mo.Repeated measure ANOVA and theχ2test were performed to compare the efficacy,side effects,and the cumulative survival rates at 48 and 96 wk.RESULTS:Forty-five patients in each group were observed for 96 wk.No significant differences in HBV DNA negative rates and alanine aminotransferase(ALT)normalization rates at weeks 48(χ2=2.12 and 2.88)and96(χ2=3.21 and 3.24)between the two groups were observed.Hepatitis B e antigen seroconversion rate in the LAM+ADV group at week 96 was significantly higher in the ETV group(43.5%vs 36.4%,χ2=4.09,P<0.05).Viral breakthrough occurred in 2 cases(4.4%)by week 48 and in 3 cases(6.7%)by week 96 in the LAM+ADV group,and no viral mutation was detected.In the ETV group,viral breakthrough occurred in 1 case(2.2%)at the end of week 96.An increase in albumin(F=18.9 and 17.3),decrease in total bilirubin and in ALT(F=16.5,17.1 and 23.7,24.8),reduced PT(F=22.7 and 24.5),and improved Child-Turcotte-Pugh and the model for end-stage liver disease scores(F=18.5,17.8,and 24.2,23.8)were observed in both groups.The cumulative rates of mortality and liver transplantation were 16.7%(10/60)and 18.3%(11/60)in the LAM+ADV and ETV groups,respectively.CONCLUSION:Both LAM+ADV combination therapy and ETV monotherapy can effectively inhibit HBV replication,improve liver function,and decrease mortality.

关键词： Chronic hepatitis B Decompensated liver cirrhosis Lamivudine Adefovir dipivoxil Combination therapy Entecavir

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Resistant mutants induced by adefovir dipivoxil in hepatitis B virus isolates

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World Journal of Gastroenterology 2014年第45期20卷 17100-17106页

作者： Su-Wen Jiang Li-Peng Yao Ai-Rong Hu Yao-Ren Hu Shi-Xiang Chen Tao Xiong Guo-Sheng Gao Xiao-Yue Liang Shi-Xiong Ding Peng-Jian Weng Institute of Liver Diseases Ningbo No.2 Hospital Department of Molecular Biology School of Medicine Ningbo University Department of Infectious Diseases No.113 Hospital of the PLA

AIM:To investigate the loci of adefovir dipivoxil(ADV)-induced resistance in hepatitis B virus(HBV)isolates and optimize the management of ADV-treated patients.METHODS:Between June 2008 and August 2010,a cross-sectional control study was conducted comprising 79 patients with chronic HBV infection-related liver disease who had been administered ADV monotherapy.Patients underwent liver imaging.Serum DNA extracts were analyzed for HBV DNA levels,genotypes,and serology markers,and deep sequencing of the HBV P gene was performed.RESULTS:ADV-resistant patients were found either with a single mutated locus,or with coexisting mutated loci.The most prevalent mutations were rt A181T,rt V214A,and rt N236T.Twenty-six patients had more than two mutated loci.The mutants were distributed among the patients without any significant affinity for gender,age,end-stage of liver disease,complications of non-alcoholic fatty liver disease,or HBV DNA levels.Patients with the rt A181T mutant were primarily infected with genotype C and e-antigen negative HBV,while patients with the rt N236T mutant were primarily infected by genotype B HBV(χ2=6.004,7.159;P=0.023,0.007).The duration of treatment with ADV was shorter in the single mutant group compared with the multi-mutant group(t=2.426,P=0.018).CONCLUSION:Drug-resistant HBV mutants are complex and diverse.Patients should receive the standard and first-line antiviral treatment,strictly comply with medication dosage,and avoid short-term withdrawal.

关键词： Hepatitis B virus Adefovir dipivoxil Drug-resistan

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Early kidney injury during long-term adefovir dipivoxil therapy for chronic hepatitis B

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World Journal of Gastroenterology 2015年第12期21卷 3657-3662页

作者： Hong-Yu Jia Feng Ding Jian-Yang Chen Jiang-Shan Lian Yi-Min Zhang Lin-Yan Zeng Dai-Rong Xiang Liang Yu Jian-Hua Hu Guo-Dong Yu Huan Cai Ying-Feng Lu Lin Zheng Lan-Juan Li Yi-Da Yang Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases State Key Laboratory for Diagnosis and Treatment of Infectious Disease First Affiliated Hospital of Zhejiang University School of Medicine

AIM: To evaluate urine β2-microglobulin(β2-M), retinol-binding protein(RBP) excretion, and renal impairment with adefovir dipivoxil(ADV) for chronic hepatitis B. METHODS: We enrolled 165 patients with chronic hepatitis B infection who were treated with ADV monotherapy(n = 90) or ADV plus lamivudine combination therapy(n = 75). An additional 165 chronic hepatitis B patients treated with entecavir were recruited as controls. We detected serum creatinine, urine β2-M, and RBP levels, and estimated the glomerular filtration rate(e GFR) at the initiation of antiviral therapy and every 6 mo for a period of five years. RESULTS: Urine β2-M abnormalities were observed in patients during the first(n = 3), second(n = 7), third(n = 11), fourth(n = 16), and fifth(n = 21) year of ADV treatment. Urinary RBP abnormalities were observed in patients during the first(n = 2), second(n = 8), third(n = 12), fourth(n = 15), and fifth(n = 22) year of ADV treatment. e GFR decreased 20%-30% from baseline in 20 patients, 30%-50% in 12 patients, and > 50% in 3 patients during the five years of treatment. Further analysis indicated that decreases in e GFR of ≥ 30% relative to the baseline level correlated significantly with urine RBP and β2-M abnormalities. In contrast, both serum creatinine and e GFR remained stable in patients treated with entecavir, and only one of these patients developed a urine β2-M abnormality, and two developed urine RBP abnormalities during the five years of treatment. CONCLUSION: Urine RBP and β2-M are biomarkers of renal injury during long-term ADV treatment for chronic hepatitis B, and indicate when treatment should be switched to entecavir.

关键词： Adefovir dipivoxil Entecavir Retinol binding prote

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Development of osteomalacia in a post-liver transplant patient receiving adefovir dipivoxil

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World Journal of Hepatology 2010年第12期2卷 442-446页

作者： Masami Minemura Yoshiharu Tokimitsu Kazuto Tajiri Yasuhiro Nakayama Kengo Kawai Hiroshi Kudo Katsuharu Hirano Yoshinari Atarashi Yutaka Yata Satoshi Yasumura Terumi Takahara Toshiro Sugiyama Third Department of Internal Medicine Faculty of MedicineUniversity of Toyama

We report the case of a patient treated with living donor-related liver transplantation who suffered from osteomalacia during adefovir dipivoxil (ADV)-containing antiviral therapy for lamivudine-resistant hepatitis B virus infection. The patient had generalized bone pain,with severe hypophosphatemia after 20 mo of ADV therapy. Radiographic studies demonstrated the presence of osteomalacia. The peak plasma ADV level was 38 ng/mL after administration of ADV at 10mg/day. It was also found that ADV affected the metabolism of tacrolimus,a calcineurin-inhibitor,and caused an increase in the plasma levels of tacrolimus. The disability was reversed with the withdrawal of ADV and with mineral supplementation. ADV can cause an elevation of plasma tacrolimus levels,which may be associated with renal dysfunction. High levels of ADV and tacrolimus can cause nephrotoxicity and osteomalacia. This case highlights the importance of considering a diagnosis of osteomalacia in liver transplantation recipients treated with both ADV and tacrolimus.

关键词： Hepatitis B virus Osteomalacia Adefovir dipivoxil Living donor-related liver transplantation Tacrolimus

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Surgical treatment of HCC in a patient with lamivudine-resistant hepatitis B cirrhosis with adefovir dipivoxil

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World Journal of Hepatology 2010年第8期2卷 318-321页

作者： Takashi Akima Masaya Tamano Hidetsugu Yamagishi Keiichi Kubota Takahiro Fujimori Hideyuki Hiraishi Department of Gastroenterology Dokkyo Medical University Department of Gastroenterology Dokkyo Medical University Koshigaya Hospital Department of Surgical and Molecular Pathology Dokkyo Medical University Second Department of Surgery Dokkyo Medical University

We describe a 77-year-old woman with chronic hepatitis B who became resistant to lamivudine.She was started on adefovir(10 mg daily)while still continuing lamivudine therapy.Four mo later her liver function improved and serum Hepatitis B virus(HBV)-DNA level became undetectable.Three years after the start of additional adefovir treatment,hepatocellular carcinoma (HCC)was detected and the patient underwent a successful hepa-tectomy.Our findings suggest tha-t the addition of adefovir to ongoing lamivudine therapy cannot completely suppress hepatocarcinogenesis,but is useful for improving liver function in patients with lamivudine-resistant HBV-related cirrhosis,allowing HCC surgery.

关键词： Hepatitis B virus Hepatocellular carcinoma Hepatocarcinogenesis Lamivudine Adefovir dipivoxil

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抗病毒药Adefovir dipivoxil治疗慢性乙型肝炎的研究进展

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世界感染杂志 2002年第1期2卷 84-86页

作者：陈伟华林万隆上海市市北医院上海200435 上海第二医科大学附属新华医院消化内科上海200092

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Efficacy of combined therapy in patients with hepatitis B virus-related decompensated cirrhosis

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World Journal of Gastroenterology 2013年第22期19卷 3481-3486页

作者： Guo-Cai Lv Jin-Mei Yao Yi-Da Yang Lin Zheng Ji-Fang Sheng Yu Chen Lan-Juan Li Clinical Laboratory First Affiliated Hospital of Zhejiang University School of Medicine State Key Laboratory for Diagnosis and Treatment of Infectious Diseases First Affiliated Hospital of Zhejiang University School of Medicine

AIM: To investigate the efficacy and safety of combined de novo lamivudine (LAM) and adefovir dipivoxil (ADV) therapy in hepatitis B virus (HBV)-related decompensated liver cirrhosis patients. METHODS: One hundred and forty patients with HBVrelated decompensated cirrhosis were recruited, 70 patients were treated with combined LAM and ADV de novo therapy, and the other 70 patients were treated with LAM alone as controls. The follow-up period was 144 wk. All patients with LAM resistance were shifted to ADV. RESULTS: The percentage of HBV-related decompensated cirrhosis patients with undetectable HBV DNA inde novo combination group was 51.6% (33/64), 84.2% (48/57), and 92.3% (49/53) by weeks 48, 96, and 144, respectively. In monotherapy group, HBV DNA negativity rate was 46.1% (30/65), 56.1% (32/57), and 39.2% (20/51) by weeks 48, 96 and 144, respectively. There was a significant difference between the two groups by weeks 96 and 144 (P = 0.012 and 0.001). The hepatitis B e antigen seroconversion rate was 28.1% (9/32), 40.0% (12/30), and 53.6% (15/28) in the combination group by weeks 48, 96 and 144, respectively, and 24.2% (8/33), 31.0% (9/29), and 37.0% (10/27) by weeks 48, 96 and 144, respectively, in monotherapy group. A total of 68.6% (44/64), 84.2% (48/57), and 92.5% (49/53) patients achieved alanine aminotransferase (ALT) normalization by weeks 48, 96 and 144, respectively in the combination group. In monotherpy group, the ALT normalization rate was 64.6% (42/65) by week 48, 73.7% (42/57) by week 96, and 80.4% (41/51) by week 144. No patients in the combination group exhibited detectable resistance for at least 144 wk. The cumulative resistance rate in monotherapy group at weeks 48, 96, and 144 was 20.0%, 36.8%, and 56.9%. Both combination group and monotherapy group demonstrated an improvement in Child-Turcotte Pugh and Model for End-Stage Liver Disease scores at weeks 48, 96, and 144. All patients tolerated both combination and monotherapy. The ceratinine levels and glomerular filtration rate remained normal

关键词： Liver cirrhosis Lamivudine Adefovir dipivoxil Efficacy Alanine transaminase

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Choice of drugs in the treatment of chronic hepatitis B in pregnancy

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World Journal of Gastroenterology 2013年第10期19卷 1671-1672页

作者： Ertugrul Guclu Oguz Karabay Department of Infectious Diseases and Clinical Microbiology Sakarya University Faculty of Medicine54200 SakaryaTurkey

The selection of antiviral drugs for chronic hepatitis B(CHB) treatment in pregnancy is very difficult since none of the drugs have been approved for use in pregnancy.Transmission from mother to newborn remains the most frequent route of infection in mothers with high viral load and positive hepatitis B e antigen status,even with the use of appropriate prophylaxis with hepatitis B virus(HBV) immunoglobulin and HBV vaccination.We read from the article written by Yi et al that lamivudine treatment in early pregnancy was safe and effective.However,we could not understand why adefovir dipivoxil(ADV) was used in three pregnancy cases,since ADV has been classified as pregnancy category C.In pregnancy,telbivudine or tenofovir should be selected when the treatment of CHB is necessary,since these drugs have been classified as Food and Drug Administration pregnancy risk category B.

关键词： Pregnancy Adefovir dipivoxil Lamivudine Tenofovir Entecavir Chronic hepatitis B Treatment

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Response-guided treatment of cirrhotic chronic hepatitis B patients: Multicenter prospective study

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World Journal of Gastroenterology 2015年第2期21卷 653-660页

作者： Er-Li Gu Yi-Qi Yu Jia-Li Wang Yan-Yan Ji Xiu-Yun Ma Qing Xie Hong-Ying Pan Shan-Min Wu Jun Li Cheng-Wei Chen Xiao-Wei Xu Yue-Er Wang Guang-Bi Yao Hong Wang Wen-Hong Zhang Department of Gastroenterology and Hepatology Jing’an District Central Hospital Jing’an Branch of Huashan Hospital Fudan University Department of Infectious Diseases Huashan HospitalFudan University Department of Infectious Diseases Ditan Hospital Department of Hepatology Department of Infectious DiseasesRuijin HospitalSchool of MedicineShanghai Jiaotong University Department of Infectious Diseases The 6th People’s Hospital of Hangzhou Shanghai Public Health Clincal Center Department of Infectious Diseases Jiangsu Provincial Hospital Department of Hepatology Shanghai Liver Disease Research Center of Nanjing Military Area Department of Infectious Diseases The 1st Affiliated Hospital of Zhejiang University MOH and MOE Key Laboratory of Medical Molecular Virology Shanghai Medical CollegeFudan University Institutes of Biomedical Sciences Fudan University

AIM: To observe the effect of response-guided add-on therapy with adefovir(ADV) and lamivudine(LAM) in cirrhotic hepatitis B(CHB) patients.METHODS: A total of 100 patients with CHB and cirrhosis were divided into three arms according to hepatitis B virus(HBV) DNA level after 24 wk LAM monotherapy: Arm A(complete response, HBV DNA ≤ 60 IU/m L, n = 49), Arm B(partial response, HBV DNA: 60-2000 IU/m L, n = 31) and Arm C(inadequate response, HBV DNA > 2000 IU/m L, n = 20). ADV was added to LAM at week 48 in Arms A and B, but at week 24 in Arm C. Virological response, YMDD mutations, biochemical response, and liver function were evaluated.RESULTS: Comparison of the three arms demonstrated that early complete virologic response at week 24was associated with maintained viral suppression(undetectable rate of HBV DNA at week 144 was 95.96%, 66.67% and 35.29%, respectively, P = 0.000) and reduced YMDD mutations(mutation rate at week 144 was 0%, 3.23% and 15%, respectively, P = 0.015) after 144 wk treatment. For patients who failed to achieve complete virological response at week 24, switching to combination therapy further decreased HBV DNA level by 1 log10 IU/m L. All three arms obtained biochemical benefits including decline of alanine aminotransferase and elevation of albumin. In patients who developed HBV DNA breakthrough for YMDD mutations, ADV add-on therapy did not induce further multiple drug resistance to LAM or ADV.CONCLUSION: Optimized response-guided add-on therapy of ADV and LAM maintains long-term suppression of HBV DNA and improves liver function in CHB patients with compensated liver cirrhosis.

关键词： Hepatitis B Cirrhosis Adefovir dipivoxil Lamivudin

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