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Cryoglobulinemia is an independent factor negatively associated with sustained virological response in chronic hepatitis C patients

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Chinese Medical Journal 2012年第22期125卷 4014-4017页

作者： FAN Xiao-hong WU Chi-hong WANG Li-fen ZHENG Ying-ying YAO Ying LU Hai-ying XU Xiao-yuan WEI Lai Peking Univ Hosp 1 Dept Infect Dis Beijing 100034 Peoples R China Peking Univ Hosp 1 Dept Nephrol Beijing 100034 Peoples R China Peking Univ Peoples Hosp Inst Hepatol Beijing 100044 Peoples R China

Background Mixed cryoglobulinemia （MC） is one of the most common and severe symptoms in chronic hepatitis C patients. The aim of this study was to investigate whether mixed cryoglobulinemia is a factor associated with sustained virological response in chronic hepatitis C patients treated with combination therapy of pegylated interferon alpha-2a and ribavirin. Methods This is a single-center study including 57 chronic hepatitis C patients who received combination treatments of pegylated interferon alfa-2a and ribavirin. Serum cryoglobulin was detected by cryoprecipitation prior to treatment. Serum hepatitis C virus （HCV） RNA levels were checked before treatment, during the fourth and 12th week of treatment, and during the 24th week after cessation of treatment. The genotype of HCV was determined at baseline. Logistic regression analysis was used to assess the factors associated with sustained virological response. Results Twenty-five patients were with MC （43.9%）. Twenty-four weeks after cessation of antiviral treatment, sustained virological response achievement in MC~ patients was significantly lower than that in MC- patients （32.0% vs. 75.0%, P=-0.001）. Univariate Logistic regression analysis and multivariate Logistic regression analysis found that only MC （odds ratio： 6.375; 95% Ch 1.998-20.343, P=0.002） was negatively associated with sustained virological response achievement. Conclusion MC is an independent factor negatively associated with sustained virological response in chronic hepatitis C patients treated with pegylated interferon alpha-2a and ribavirin.

关键词： hepatitis C cryoglobulinemia virological response

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Host genetic variations are associated with virological response to interferon therapy of chronic HCV in Han Chinese patients

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The Journal of Biomedical Research 2014年第6期28卷 476-483页

作者： Hongbo Chen Yuanyuan Zhang Peng Huang Yin Xu Jie Wang Jing Su Rongbin Yu Department of Infectious Diseases Jurong Peoples' Hospital Department of Epidemiology and Biostatistics School of Public HealthNanjing Medical University Department of General Practice Kangda CollegeNanjing Medical University

Previous studies have suggested that host genetic polymorphisms may affect virological response to pegylatedinterferon and ribavirin（PEG-IFN/ ribavirin） therapy in chronic HCV infection.IL28 B and MxA are the most intensively studied genes in Chinese Han population.The current research is to summarize published data and evaluate the overall association of meaningful SNPs in these two genes with virological response to interferon-based therapy.Literature search was performed in online database and a systematic review was conducted based on the search results.Meaningful single nucleotide polymorphisms（SNPs） were summarized and analyzed for odds ratio（OR） and 95%confidence intervals（95%CI）.Data manipulation and statistical analyses were performed by using STATA 12.0and Review Manager version 5.1.Eighteen papers were included for final data analysis.Three SNPs of IL28 B and two SNPs of MxA were found to be associated with higher sustained virological response（SVR） to interferon therapy.The ORs and 95%CIs of each variant were：IL28B rs8099917 TT（OR：4.35,95%CI：3.10-6.12）,IL28 B rs12979860CC（OR：5.37,95%CI：3.95-7.31）,IL28 B rs7248668 CC（OR：3.50,95%CI：2.30-5.35）,MxA rs2071430 GT（OR：2.03,95%CI：1.31-3.13）,and MxA rsl7000900 AC/AA（OR：1.82,95%CI：1.17-2.83）.The genotypes of IL28 B rs8099917,rsl2979860,rs7248668,MxA rs2071430,and MxA rs17000900 were strong SVR predictors for PEG-IFN/ribavirin-treated HCV patients in Han Chinese population.Our findings suggest that host genetic variations are associated with virological response to interferon therapy of chronic HCV in Han Chinese patients.

关键词： hepatitis C virus therapy virological response IL28B MxA meta-analysis

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Tenofovir amibufenamide vs tenofovir alafenamide for treating chronic hepatitis B:A real-world study

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World Journal of Gastroenterology 2023年第44期29卷 5907-5918页

作者： Wen-Ting Peng Chuan Jiang Fei-Lan Yang Nian-Qi Zhou Ke-Yu Chen Jin-Qing Liu Shi-Fang Peng Lei Fu Department of Infectious Diseases Xiangya Hospital Central South UniversityChangsha 410008Hunan ProvinceChina

BACKGROUND The efficacy and safety profile of tenofovir amibufenamide(TMF)in chronic hepatitis B(CHB)patients is not well-established.AIM To compare the efficacy and safety of TMF and tenofovir alafenamide(TAF)over a 48-wk period in patients with CHB.METHODS A total of 215 subjects meeting the inclusion criteria were enrolled and divided into two groups:TMF group(n=106)and the TAF group(n=109).The study included a comparison of virological response(VR):Undetectable hepatitis B virus DNA levels,alanine transaminase(ALT)normalization rates,renal function parameters,and blood lipid profiles.RESULTS At 24 and 48 wk,VR rates for the TMF group were 53.57%and 78.57%,respectively,compared with 48.31%and 78.65%for the TAF group(P>0.05).The VR rates were also similar in both groups among patients with low-level viremia,both hepatitis B e antigen(HBeAg)-positive and HBeAg-negative subgroups.The TMF cohort showed ALT normalization and renal safety profiles similar to the TAF group.There was a notable increase in total cholesterol levels in the TAF group(P=0.045),which was not observed in the TMF group(P>0.05).In patients with liver cirrhosis,both groups exhibited comparable VR and ALT normalization rates and renal safety profiles.However,the fibrosis 4 score at 48 wk showed a significant reduction in the TAF group as compared to the TMF group within the liver cirrhosis subgroup.CONCLUSION Our study found TMF is as effective as TAF in treating CHB and has a comparable safety profile.However,TAF may be associated with worsening lipid profiles.

关键词： Alanine transaminase normalization Chronic hepatitis B Renal safety virological response Blood lipid Tenofovir

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Efficacy of Real-world Entecavir Therapy in Treatment-naive Chronic Hepatitis B Patients

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Chinese Medical Journal 2017年第18期130卷 2190-2197页

作者： Yan-Di Xie Hui Ma Bo Feng Lai Wei Peking University Hepatology Institute Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases Peking University People's HospitalBeijing 100044 China

Background：Entecavir （ETV） has been shown to be effective in randomized controlled trials in highly selected patients with hepatitis B virus （HBV） infection.This study aimed to evaluate the efficacy of ETV in chronic hepatitis B （CHB） patients in the real-world setting.Methods：A total of 233 treatment-na（i）ve,CHB patients who received at least 12 months of ETV treatment were included in this retrospective study.Rates of virological response （VR）,hepatitis B s antigen （HBsAg） loss,hepatitis B e antigen （HBeAg） clearance/seroconversion,virological breakthrough,cirrhosis,and hepatocellular carcinoma were evaluated.Results：Of 233 patients,175 patients were male,with mean age of 43 years old,and 135 patients were HBeAg positive.The mean baseline levels of serum alanine aminotransferase and HBV DNA in all patients were 230 U/L and 6.6 log 10 IU/ml,respectively.The mean follow-up period was 28 months.The cumulative rates of achieving VR increased from 3.4% at 3 months to 94.4% at 60 months.Primary nonresponse occurred in 3 （1.3%） patients.Partial VR （PVR） occurred in 61 （26.2%） patients at 12 months.The baseline serum HBV DNA level （hazard ratio [HR],2.054;P 〈 0.001） was an independent risk factor for PVR.HBsAg loss did not occur.The cumulative rates of HBeAg clearance increased from 2.2% at 3 months to 28.2% at 60 months.PVR was the significant determinant of HBeAg clearance （HR,0.341;P =0.026）.Age （HR,1.072;P =0.013） and PVR （HR,5.131;P =0.017） were the significant determinants of cirrhosis.Conclusions：ETV treatment was effective for HBV DNA suppression in this study,but HBsAg loss and HBeAg clearance/seroconversion rates were lower compared with previous clinical trials.PVR was associated with HBeAg clearance and cirrhosis.

关键词： Entecavir Hepatitis B Virus Partial virological response Primary Nonresponse Real-world virological response

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Potential use of serum HBV RNA in antiviral therapy for chronic hepatitis B in the era of nucleos（t）ide analogs

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Frontiers of Medicine 2017年第4期11卷 502-508页

作者： Fengmin Lu Jie Wang Xiangmei Chen Dongping Xu Ningshao Xia State Key Laboratory of Natural and Biomimetic Drugs Department of Microbiology & Infectious Disease Center School of Basic Medical Sciences Peking University Health Science Center Beijing 100191 China Institute of Infectious Diseases Beijing 302 Hospital Beijing 100039 China State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics School of Public Health Xiamen UniversityXiamen 361102 China

Although the efficacy of nucleos（t）ide analogue （NA） has been confirmed for treatment of chronic hepatitis B, long-term therapy has been recommended due to the high frequency of off-therapy viral DNA rebound and disease relapse. In this review, the RNA virion-like particles of hepatitis B virus （HBV） are integrated into the Hfe cycle of HBV replication, and the potential significance of serum HBV RNA is systematically described. The production of HBV RNA virion-like particles should not be blocked by NA; in this regard, serum HBV RNA is found to be a suitable surrogate marker for the activity of intrahepatic covalently closed circular DNA （cccDNA）, particularly among patients receiving NA therapy. Therefore, the concept of virological response is redefined as persistent loss of serum HBV DNA and HBV RNA. In contrast to hepatitis B surface antigen （HBsAg） that can originate from either the cccDNA or the integrated HBV DNA fragment, serum HBV RNA, with pregenomic RNA origination, can only be transcribed from cccDNA. Therefore, the loss of serum HBV RNA would likely be a promising predicator for safe drug discontinuation. The clinical status of consistent loss of serum HBV RNA accompanied with low serum HBsAg levels might be implicated as a ＂para-functional cure,＂ a status nearly close to the functional cure of chronic hepatitis B, to distinguish the ＂functional cure＂ characterized as serum HBsAg loss with or without anti-HBs seroconversion.

关键词： chronic hepatitis B serum HBV RNA nucleos（t）ide analogs virological response para-functional cure

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Tenofovir Alafenamide Fumarate,Tenofovir Disoproxil Fumarate and Entecavir:Which is the Most Effective Drug for Chronic Hepatitis B?A Systematic Review and Meta-analysis

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Journal of Clinical and Translational Hepatology 2021年第3期9卷 335-344页

作者： Xuefeng Ma Shousheng Liu Mengke Wang Yifen Wang Shuixian Du Yongning Xin Shiying Xuan Department of Infectious Disease Qingdao Municipal HospitalQingdao UniversityQingdaoShandongChina Clinical Research Center Qingdao Municipal HospitalQingdao UniversityQingdaoShandongChina Digestive Disease Key Laboratory of Qingdao QingdaoShandongChina

Background and Aims:The therapeutic effect of tenofovir alafenamide fumarate(TAF),tenofovir disoproxil fumarate(TDF)and entecavir(ETV)on chronic hepatitis B(CHB)patients remains inconsistent.The aim of this study was to explore the differences in virological responses to TAF,TDF and ETV in patients with CHB.Methods:Literature searches were conducted of the PubMed,EMBASE,and the Cochrane Library databases to identify randomized controlled trials and observational studies published up to July 21,2020.Statistical comparisons of virological response between TDF,ETV,and TAF were carried out with pooled odds ratio(OR)values.Results:The virological response in TDF-treated CHB patients was notably superior to that of the ETV-treated CHB patients after 12-weeks[OR=1.12,95%confidence interval(CI):0.89–1.41],24-weeks(OR=1.33,95%CI:1.11–1.61),48-weeks(OR=1.62,95%CI:1.16–2.25),72-weeks(OR=1.43,95%CI:0.78–2.62),and 96-weeks(OR=1.56,95%CI:0.87–2.81)treatment.No significant difference was observed for the virological responses in CHB patients after 48-weeks treatment with TAF or TDF.The virological response in TDF+ETV-treated CHB patients was superior to that of TDF-treated CHB patients after 24-weeks,48-weeks(OR=1.54,95%CI:1.17–2.02),96-weeks,and 144-weeks.Conclusions:The virological response in TDF-treated CHB patients was superior to that in ETV-treated CHB patients,but there was no significant difference between TAF and TDF.In addition,the therapeutic effect of TDF+ETV was superior to TDF alone.

关键词： Tenofovir alafenamide Entecavir Tenofovir disoprox Chronic hepatitis B virological response

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