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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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Establishment of a new quantitative detection approach to adefovir-resistant HBV and its clinical application

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World Journal of Gastroenterology 2010年第10期16卷 1267-1273页

作者： Zhao, Wei-Feng Shao, You-Lin Chen, Liang-Yun Wu, Jin-Hua Zhu, Yi-Ling Gan, Jian-He Xiong, Hui Chinese Natl Human Genome Ctr Shanghai Lab Dis & Hlth Genom Shanghai 201203 Peoples R China Soochow Univ Dept Infect Dis Affiliated Hosp 1 Suzhou 215006 Jiangsu Prov Peoples R China

AIM:To establish the more feasible and sensitive assessment approach to the detection of adefovir (ADV) resistance-associated hepatitis B virus (HBV) quasispecies.METHODS: Based on the characteristics of rtA181V/T and rtN236T mutations, a new approach based on real-time fluorescent quantitative polymerase chain reaction (RT-PCR) was established for the detection of ADV-resistant HBV quasispecies, total HBV DNA, rtA181 and rtN236 mutations in blood samples from 32 chronic hepatitis B (CHB) patients with unsatisfactory curative effect on ADV and compared with routine HBV DNA sequencing.RESULTS: Both the sensitivity and specificity of this new detection approach to ADV-resistant HBV quasispecies were 100%, which were much higher than those of direct HBV DNA sequencing. The approach was able to detect 0.1% of mutated strains in a total plasmid population. Among the 32 clinical patients, single rtA181 and rtN236T mutation and double rtA181T and rtN236T mutations were detected in 20 and 8, respectively, while ADV-resistant mutations in 6 (including, rtA181V/T mutation alone in 5 patients) and no associated mutations in 26.CONCLUSION: This new approach is more feasible and efficient to detect ADV-resistant mutants of HBV and ADV-resistant mutations before and during ADV treatment with a specificity of 100% and a sensitivity of 100%.

关键词： Chronic hepatitis B adefovir Drug resistance Quantitative detection Real-time fluorescent quantitative polymerase chain reaction

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Voltammetric quantification of anti-hepatitis drug adefovir in biological matrix and pharmaceutical formulation

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Journal of Pharmaceutical Analysis 2012年第2期2卷 98-104页

作者： Rajeev Jain Ramkishor Sharma School of Studies in Chemistry Jiwaji University

Electrochemical reduction behavior of adefovir was studied using Hanging Mercury Drop Electrode (HMDE) in Britton-Robinson (BR) buffer solution.Voltammetric study showed one well-defined reduction peak in the potential range -1.2 to -1.4 V (vs.Ag/AgCl) due to reduction of C=N bond of the imidazole ring.Solid-phase extraction and protein-precipitation techniques were employed for extraction of adefovir from human plasma.The proposed method allows quantification of adefovir in human plasma over the concentration range 0.50-5.00 μg/mL with the detection limit 0.17 μg/mL,whereas in pharmaceutical formulation 0.25-2.25 μg/mL with the detection limit 0.08 μg/mL.

关键词： Voltammetry adefovir Solid-phase extraction Protein-precipitation Human plasma Pharmaceutical formulation

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Synthesis and Crystal Structure of a Ca~Ⅱ Coordination Polymer of H_2adefovir (H_2adefovir={[2-(6-Amino-9H-purin-9-yl)ethoxy]methyl}phosphonic Acid)

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Chinese Journal of Structural Chemistry 2011年第7期30卷 1059-1063页

作者：娄本勇林棋 Department of Chemistry and Chemical Engineering Minjiang University State Key Laboratory of Structural Chemistry

A CaⅡ coordination polymer of H2adefovir （H2adefovir = {[2-（6-amino-9H- purin-9-yl）ethoxy]methyl}phosphonic acid）, [Ca（H2O）（adefovir）]n （1）, has been synthesized via the reaction of Ca（OH）2 and H2adefovir under hydrothermal conditions. Complex 1 crystallizes in the monoclinic system, space group P21/c with a = 22.344（5）, b = 6.8505（14）, c = 8.0101（17）/k, β = 90.356（4）°, V= 1226.0（4）A3, Mr = 329.28, Dc = 1.784 g/cm3,μ = 0.672 mm1, F（000） = 680, Z = 4, the final R = 0.0296 and wR = 0.0916 for 2295 observed reflections with I 〉 20（I）. In the structure, the Cau center is coordinated to the phosphate group of adefovir anion, forming a 2D coordination layer, and such layers are linked into a 3D framework by hydrogen-bonding interactions between the adenine groups of adefovir anion.

关键词： adefovir coordination polymer phosphate

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Tenofovir disoproxil fumarate is superior to lamivudine plus adefovir in lamivudine-resistant chronic hepatitis B patients

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World Journal of Gastroenterology 2015年第9期21卷 2746-2753页

作者： Dan-Hong Yang Yuan-Jun Xie Nian-Feng Zhao Hong-Ying Pan Ming-Wei Li Hai-Jun Huang Department of Infectious Diseases Zhejiang Provincial People’s Hospital The Third Affiliated Hospital of Zhejiang Chinese Medical University Department of Infectious Diseases The First Affiliated HospitalCollege of MedicineZhejiang University

AIM:To assess the efficacy of tenofovir disoproxil fumarate(TDF) in lamivudine(LAM)-resistant patients with a suboptimal response to LAM plus adefovir(ADV).METHODS:We retrospectively analyzed the efficacy of switching to tenofovir disoproxil fumarate in suboptimal responders to lamivudine plus adefovir.Charts were reviewed for LAM-resistant chronic hepatitis B(CHB) patients who visited the Zhejiang Province People's Hospital and The First Affiliated Hospital,College of Medicine,Zhejiang University,from June 2009 to May 2013.Patients whose serum hepatitis B virus(HBV) DNA remained detectable despite at least 6 mo of LAM plus ADV combination therapy were included.Patients with a suboptimal response to LAM plus ADV were randomized to switch to TDF monotherapy(300 mg/d orally; TDF group) or to continuation with LAM(100 mg/d orally) plus ADV(10 mg/d orally; LAM plus ADV group) and were followed for 48 wk.Serum HBV DNA was determined at baseline and weeks 4,12,24,36,and 48.HBV serological markers and biochemistry were assessed at baseline and weeks 12,24,and 48.Resistance surveillance and side effects were monitored during therapy.RESULTS:Fifty-nine patient were randomized to switch to TDF(n =28) or continuation with LAM plus ADV(n =31).No significant differences were found between the groups at baseline.Prior to TDF therapy,all patients had been exposed to LAM plus ADV for a median of 11 mo(range:6-24 mo).No difference was seen in baseline serum HBV DNA between the two groups [5.13 ± 1.08 log10 copies/m L(TDF) vs 5.04 ± 31.16 log10 copies/m L(LAM +ADV),P =0.639].There was no significant difference in the rates of achieving complete virological response(CVR) at week 4 between the TDF and LAM +ADV groups(17.86% vs 6.45%,P =0.24).The rate of achieving CVR in the TDF and LAM plus ADV groups was 75% vs 16.13% at week 12,82.14% vs 22.58% at week 24,89.29% vs 25.81% at week 36,and 96.43% vs 29.03% at week 48,respectively(P < 0.001).The rate of alanine aminotransferase normalization was significantly higher in the TDF than in

关键词： Hepatitis B virus adefovir Lamivudine Tenofovir di

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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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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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Predictors of kidney tubular dysfunction induced by adefovir treatment for chronic hepatitis B

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World Journal of Gastroenterology 2015年第7期21卷 2116-2123页

作者： Motohiro Shimizu Norihiro Furusyo Hiroaki Ikezaki Eiichi Ogawa Takeo Hayashi Takeshi Ihara Yuji Harada Kazuhiro Toyoda Masayuki Murata Jun Hayashi Department of General Internal Medicine Kyushu University Hospital Kyushu General Internal Medicine Center Haradoi Hospital

AIM:To investigate the predictors of proximal kidney tubular dysfunction(PKTD)induced by adefovir dipivoxil(ADV)treatment for chronic hepatitis B.METHODS:Seventy-nine patients(age at the evaluation of PKTD:56.9±10.7 years)with chronic hepatitis B undergoing long-term oral antiviral nucleos(t)ide analogue treatment were consecutively recruited.PKTD was defined by the presence of at least two of the following five abnormalities:phosphate diabetes,nondiabetic glucosuria,metabolic acidosis,β2-microglobulinuria,or renal hypouricemia.The single-nucleotide polymorphisms(SNPs)in the SLC22A6 gene encoding human organic anion transporter 1(h OAT1)and ABCC2 encoding multidrug resistance protein 2(MRP2)were analyzed using the Taq Man Allelic Discrimination Demonstration Kit.RESULTS:Nine(30.0%)of the 30 ADV-treated patients were diagnosed with PKTD,while no patients without ADV developed PKTD(P<0.001).Three patients with ADV were diagnosed with symptomatic osteomalacia.Among the patients who took ADV,those with PKTD were of higher age at initiation,had significantly longer treatment duration,and had a significantly lower body mass index than those without PKTD.The incidence of PKTD dramatically increased after 96 mo from the start of ADV administration.In contrast,the SNPs were not correlated with PKTD.Logistic regression analysis extracted older age at initiation(OR=5.0,95%CI:1.1-23.4;P=0.040)and longer treatment duration(OR=3.2,95%CI:1.2-8.6;P=0.020)as significant factors associated with PKTD.CONCLUSION:Our results suggest that the tubular function of the kidney of older patients undergoing longterm ADV treatment should be carefully evaluated.

关键词： adefovir dipivoxil Proximal kidney tubular dysfunc

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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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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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