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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 ***: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 *** major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12,24,36,48,*** endpoints including liver functions(enzymes and bilirubin readings)were evaluated every 4 weeks at the beginning of week 24,36,and *** blood,urine,and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety *** events(AEs)were ***:The combination therapy demonstrated superior HBeAg loss at 48 weeks,without additional *** full analysis population was 560 and 280 in each *** 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%),*** was a statistically significant difference between two groups on week 48(P<0.01).No additional AEs were found in *** analysis suggested different outcomes among treatment ***:Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV *** 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) ***: 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 ***: 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 ***: 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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Clonal evolution of hepatitis B virus polymerase gene mutations during lamivudine-adefovir combination treatment

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World Journal of Gastroenterology 2012年第44期18卷 6437-6446页

作者： Soon Young Ko Byung Kook Kim So Young Kwon Kyun-Hwan Kim Jeong Han Kim Won Hyeok Choe Chang Hong Lee Department of Internal Medicine Konkuk University School of MedicineSeoul 143-729South Korea Department of Pharmacology Konkuk University School of MedicineSeoul 143-729South Korea

AIM:To identify hepatitis B virus polymerase gene mutations during antiviral therapy using lamivudineadefovir sequential monotherapy followed by lamivudine-adefovir combination ***:The patient cohort included four adult chronic hepatitis B patients who had undergone sequential monotherapy,first with lamivudine(LMV) and then,after developing viral breakthrough,with adefovir(ADV) *** of the patients had non-response or viral breakthrough after LMV-ADV sequential monotherapy,which resulted in the switching of their antiviral regimen to LMV-ADV combination *** serum samples from the four patients who showed non-response to rescue LMV-ADV combination therapy were collected sequentially at a time before the antiviral treatment and then during the LMV monotherapy,ADV monotherapy,and LMV-ADV combination *** the genotypic analysis,the whole 1310-bp polymerase gene region was amplified,cloned and ***:All patients had been previously treated with 100 mg of LMV once daily for a 15-to 26-mo *** emergence of resistance mutations to LMV,such as rtM204V/I and/or rtL180M,were found in all *** antiviral regimens were switched to ADV monotherapy as the second line *** patients had viral breakthrough or non-response after the LMV-ADV sequential ***-resistant mutations were detected after 13 to 19 mo of LMV-ADV sequential *** rtA181V/T mutations were predominantly identified during the ADV treatment in the LMV-resistant ***-seven of 38 clones were combined with an amino acid change at rt181;three clones had mutations in rt236 and one clone had a combined *** rtA181V/T mutations were not suppressed by the LMV-ADV combination ***-nine of 64 clones showed an rtA181V/T mutation and six clones showed combined mutations in rt181 and *** in rt204 re-emerged during the combination *** rt181 and rt204 mutations did not co-exist in one clon

关键词： Hepatitis B virus Lamivudine adefovir Mutation Drug resistance

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Antiviral efficacy of adefovir dipivoxil versus lamivudine in patients with chronic hepatitis B sequentially treated with lamivudine and adefovir due to lamivudine resistance

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World Journal of Gastroenterology 2007年第30期13卷 4072-4079页

作者： Yeon Seok Seo Ji Hoon Kim Jong Eun Yeon Jong-Jae Park Jae Seon Kim Kwan Soo Byun Young-Tae Bak Chang Hong Lee Division of Gastroenterology and Hepatology Department of Internal Medicine Korea University College of Medicine Seoul Korea Division of Gastroenterology and Hepatology Department of Internal Medicine Konkuk University College of Medicine Seoul Korea

AIM： To compare the antiviral efficacy of adefovir （ADV） in lamivudine （LMV）-resistant patients with LMV treatment in nucleoside-naive patients, using serum samples collected sequentially during the course of treatment progressing from LMV to ADV.METHODS： Forty-four patients with chronic hepatitis B （CHB） were included. The patients were initially treated with LMV and then switched to ADV when LMV resistance developed. Antiviral efficacy was assessed by measuring the following： reduction in serum HBV DNA from baseline, HBV DNA negative conversion （defined as HBV DNA being undectable by the hybridization assay）, and HBV DNA response （either HBV DNA level ≤ 10^s copies/mL or a ≥ 2 log10 reduction from baseline HBV DNA level）.RESULTS： After two and six months of treatment, HBV DNA reduction was greater with LMV compared to ADV treatment （P = 0.021）. HBV DNA negative conversion rates were 64% and 27% after one month of LMV and ADV treatment respectively （P = 0.001）. Similarly, HBV DNA response rates were 74% and 51% after two months of LMV and ADV treatment respectively （P = 0.026）. The time taken to HBV DNA negative conversion and to HBV DNA response were both delayed in ADV treatment compared with LMV.CONCLUSION： The antiviral efficacy of ADV in LMV-resistant patients is slower and less potent than that with LMV in nucleoside-naive patients during the early course of treatment.

关键词： Chronic hepatitis B Lamivudine adefovir Treatment efficacy

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Low-dose tenofovir is more potent than adefovir and is effective in controlling HBV viremia in chronic HBeAg-negative hepatitis B

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World Journal of Gastroenterology 2007年第30期13卷 4096-4099页

作者： Paolo Del Poggio Maurizio Zaccanelli Maria Oggionni Silvia Colombo Carlo Jamoletti Vesna Puhalo Hepatology Unit Treviglio Hospital (Bg) Italy Blood Bank (Molecular Biology Section) Treviglio Hospital (Bg) Italy

AIM: To study the efficacy of tenofovir disoproxil fumarate (TDF) at low dose in a small open trial of chronic hepatitis B patients with advanced stage disease. METHODS: Eleven patients were treated with TDF 75 mg for a median period of 80 (range, 24-576) wk and then 7 cases were shifted to an adefovir 10 mg treatment group. All patients had been pre-treated with lamivudine: 5 had YMDD resistant mutants and 6 wild- type virus. When TDF was started, 4 patients had low- level viremia and 6 were PCR-negative. RESULTS: During TDF treatment, PCR remained negative in 10 patients, transaminase levels were normal and no significant viral breakthrough was observed. The drug was well tolerated in all cases. When TDF 75 mg was substituted with adefovir 10 mg, 3 out of 7 patients had a persistent viral rebound (2700-130 000 copies/mL), in whom lamivudine had to be reintroduced. CONCLUSION: Low-dose TDF monotherapy can control HBV viremia for an extended period of time without the emergence of resistance and is more potent than adefovir at the standard dosage. The use of a reduced dose of TDF could diminish the cost of therapy in low-income countries, but further studies in a larger population and in HBeAg-positive subjects are needed.

关键词： Tenofovir Chronic Hepatitis B adefovir Nucleotide analogues Low-income countries

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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 ***: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 *** was defined by the presence of at least two of the following five abnormalities:phosphate diabetes,nondiabetic glucosuria,metabolic acidosis,β2-microglobulinuria,or renal *** 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 ***: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 *** 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 *** incidence of PKTD dramatically increased after 96 mo from the start of ADV *** contrast,the SNPs were not correlated with *** 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 ***: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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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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Virological response to adefovir monotherapy and the risk of adefovir resistance

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World Journal of Gastroenterology 2011年第30期17卷 3526-3530页

作者： Dong Hyun Sinn Geum-Youn Gwak Moon Seok Choi Kwang Cheol Koh Seung Woon Paik Byung Chul Yoo Joon Hyeok Lee Hyang Ie Lee Department of Medicine Samsung Medical CenterSungkyunkwan University School of Medicine135-710 SeoulSouth Korea Department of Internal Medicine Eulji University Hospital302-799 DaejeonSouth Korea

AIM:To evaluate virological response to adefovir(ADV) monotherapy and emergence of ADV-resistant mutations in lamivudine(LAM)-resistant chronic hepatitis B ***:Seventy-seven patients with documented LAM resistance who were treated with 10 mg/d ADV for>96 wk were analyzed for ADV ***:At week 48 and 96,eight(10%)and 14(18%)of 77 LAM-resistant patients developed the ADV-resistant strain(rtA181V/T and/or rtN236T mutations),*** B virus(HBV)DNA levels during therapy were significantly higher in patients who developed ADV resistance than in those who did *** of ADV resistance at week 96 was 11%,8%and 6%among patients with complete virological response(HBV DNA level2000 IU/mL)at week 12,week 24 and week 48,*** DNA levels >2000 IU/mL at week 24 showed best performance characteristics in predicting ADV ***:Development of ADV resistance mutations was associated with HBV DNA levels,which could identify patients with LAM resistance who are likely to respond to ADV monotherapy.

关键词： Hepatitis B virus Viral DNA adefovir Lamivudine Drug resistance

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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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Treatment strategies using adefovir dipivoxil for individuals with lamivudine-resistant chronic hepatitis B

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World Journal of Gastroenterology 2012年第47期18卷 6987-6995页

作者： Tae Jung Yun Jin Yong Jung Chang Ha Kim Soon Ho Um Hyonggin An Yeon Seok Seo Jin Dong Kim Hyung Joon Yim Bora Keum Yong Sik Kim Yoon Tae Jeen Hong Sik Lee Hoon Jai Chun Chang Duck Kim Ho Sang Ryu Department of Internal Medicine Korea University College of MedicineSeoul 136-705South Korea Department of Biostatistics Korea University College of MedicineSeoul 136-705South Korea

AIM:To investigate retrospectively the long-term efficacy of various treatment strategies using adefovir dipivoxil(adefovir) in patients with lamivudine-resistant chronic hepatitis ***:We included 154 consecutive patients in two treatment groups:the "add-on" group(n = 79),in which adefovir was added to ongoing lamivudine treatment due to lamivudine resistance,and the "switch/combination" group(n = 75),in which lamivudine was first switched to adefovir and then re-added later as *** "switch/combination" group was then divided into two subgroups depending on whether participants followed(group A,n = 30) or violated(group B,n = 45) a proposed treatment strategy that determined whether to add lamivudine based on the serum hepatitis B virus(HBV) DNA levels(adefovir with lamivudine based upon early treatment responses increased the odds of virologic breakthrough relative to the use of uniform combination therapy from the beginning of treatment.

关键词： Chronic hepatitis B Lamivudine-resistant adefovir Combination therapy Roadmap concept

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