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Sustained virologic response to direct-acting antiviral agents predicts better outcomes in hepatitis C virus-infected patients: A retrospective study

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World Journal of Gastroenterology 2019年第40期25卷 6094-6106页

作者： Gian Luca Colussi Debora Donnini Rosario Francesco Brizzi Silvia Maier Luca Valenti Cristiana Catena Alessandro Cavarape Leonardo Alberto Sechi Giorgio Soardo Department of Medicine University of Udine

BACKGROUND Direct-acting antiviral agents(DAAs)are extremely effective in eradicating hepatitis C virus(HCV)in chronically infected ***,the protective role of the sustained virologic response(SVR)achieved by second-and thirdgeneration DAAs against the onset of hepatocellular carcinoma(HCC)and mortality is less well *** To examine the occurrence of HCC or death from any cause in a retrospectiveprospective study of patients treated with *** Patients were enrolled from a tertiary academic hospital center for liver disease management that collects subject data mainly from northeastern *** study was conducted in 380 patients(age:60±13 years,224 males,32%with cirrhosis)treated with DAAs with or without SVR(95/5%),with a median follow up of 58 wk(interquartile range:38-117).The baseline anthropometric features,HCV viral load,severity of liver disease,presence of extra-hepatic complications,coinfection with HIV and/or HBV,alcohol consumption,previous interferon use,alphafetoprotein levels,and renal function were considered to be *** The incidence rate of HCC in patients with and without SVR was 1.3 and 59 per 100 person-years,respectively(incidence rate ratio:44,95%CI:15-136,P<0.001).Considering the combined endpoint of HCC or death from any cause,the hazard ratio(HR)for the SVR patients was 0.070(95%CI:0.025-0.194,P<0.001).Other independent predictors of HCC or death were low HCV viremia(HR:0.808,P=0.030),low platelet count(HR:0.910,P=0.041),and presence of mixed cryoglobulinemia(HR:3.460,P=0.044).Considering SVR in a multi-state model,the independent predictors of SVR achievement were absence of cirrhosis(HR:0.521,P<0.001)and high platelet count(HR:1.019,P=0.026).Mixed cryoglobulinemia predicted the combined endpoint in patients with and without SVR(HR:5.982,P=0.028 and HR:5.633,P=0.047,respectively).CONCLUSION DAA treatment is effective in inducing SVR and protecting against HCC or death.A residual risk of HCC persi

关键词： Direct-acting antiviral agents Hepatitis C virus Mixed cryoglobulinemia Sustained virologic response Cirrhosis Survival analysis

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Hepatitis C virus-associated hepatocellular carcinoma after sustained virologic response

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World Journal of Hepatology 2018年第12期10卷 898-906页

作者： Reina Sasaki Tatsuo Kanda Naoya Kato Osamu Yokosuka Mitsuhiko Moriyama Department of Gastroenterology and Nephrology Chiba University Graduate School of Medicine Division of Gastroenterology and Hepatology Department of Medicine Nihon University School of Medicine

The introduction of a direct-acting antiviral(DAA) for patients with hepatitis C virus(HCV) infection, could lead to higher sustained virologic response(SVR)rates with fewer adverse events, and it could shorten the treatment duration relative to the interferon era. Although most recent clinical studies have demonstrated that the occurrence rates of hepatocellular carcinoma(HCC) are decreased by SVR with both interferon-based and interferon-free-regimens, there are several reports about the unexpected observation of high rates of early tumor occurrence and recurrence in patients with HCV-related HCC undergoing interferon-free therapy despite SVR. Several mechanisms of HCC occurrence and rapid immunological changes, including cytokines and chemokines during and after DAA treatment, have also been reported. We focused on the possibilities that HCC occurs or recurs during and after DAA treatment, based on the reported clinical and basic studies. Further studies and observations will be needed to determine the short-term and long-term effects on hepatocarcinogenesis caused by the eradication of HCV with DAAs. New serum biomarkers and a follow-up system for HCV-patients with SVR should be established.

关键词： Hepatitis C virus Hepatocellular carcinoma Sustained virologic response Direct-acting antiviral agents

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Prevalence and Factors Associated with virologic Failure among People Living with HIV (PLHIV) Monitored in a Decentralized Health Care Facility

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Advances in Infectious Diseases 2019年第3期9卷 226-237页

作者： Selly Ba Ndeye Diama Ba Lamanatou Sembene Habibatou Dia Mohamed Coulibaly Jean Louis Ndiaye Ndeye Méry Dia Cheikh Tidiane Ndour Doctoral School of Thies University Thies Senegal Intrahealth International Dakar Senegal Roi Baudouin Hospital Dakar Senegal AIDS Monitoring Unit/Ministry of Health Dakar Senegal Department of Health Gaston Berger University Saint Louis Senegal

Introduction: In Senegal, the decentralization of Health Care Centers has contributed significantly to the intensification of antiretroviral treatment. However, Care providers are still facing the treatment optimizing challenge. Objectives: To determine the prevalence of virologic failures of PLHIV monitored in a decentralized Health care center and to determine associated factors. Patients and Methods: This is a cross-sectional descriptive and analytical study of PLHIV, aged 18 years and over, on first-line treatment, monitored onsite from February 1st to December 31st, 2018. A data collection form was completed from medical records (clinical, immuno-virologic and evolutionary). Any VL > 1000 cp/ml after 6 months of antiretroviral therapy (ART) was considered as virologic failure. Data were captured and analysed using the EPI INFO 2002software. Chi-square test and the Fisher test were used to compare the proportions;a value of p ≤ 0.05 was considered significant. Results: 331 patients were treated with HIV-1 profile in 89% of cases. A proportion of 55% was married and 97% came from rural areas. 80% were either not or poorly educated. The median of age was 44 ± 11 years with a F/M ratio of 3.4. At baseline, 56% were symptomatic at stage 3 or 4 of WHO. They had severe immunosuppression with a median CD4 count of 217 ± 187 cells/mm3, the viral load was detectable in half of the patients with a median VL of 97,000 cp/ml ± 70,569. The antiretroviral regimen combined 2 NRTIs with 1 NNRTI in 88% of cases. The median of follow-up was estimated at 60 ± 43 months. The prevalence of virologic failure was 19%. This prevalence was associated with age less than 25 years (p = 0.04), late diagnosis (CD4 at baseline less than 200 cel/mm3 (p = 0.002), stage 3 or 4 WHO (p = 0.04) High viral load greater than 10,000 (p = 0.04) at baseline. Conclusion: These results suggest making the new therapeutic classes accessible for first-line treatment.

关键词： ART virologic Failure Associated Factors

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Direct anti-HCV agents

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Acta Pharmaceutica Sinica B 2016年第1期6卷 26-31页

作者： Xingquan Zhang Division of Infectious Diseases University of CaliforniaSan Diego School of Medicine

Unlike human immunodeficiency virus(HIV)and hepatitis B virus(HBV),hepatitis C virus(HCV)infection is a curable *** direct antiviral agent(DAA)targets are focused on HCV NS3/4A protein(protease),NS5 B protein(polymerase)and NS5 A *** first generation of DAAs includes boceprevir and telaprevir,which are protease inhibitors and were approved for clinical use *** cure rate for genotype 1 patients increased from 45% to 70% when boceprevir or telaprevir was added to standard PEG-IFN/*** effective and less toxic second generation DAAs supplanted these drugs by *** second generation of DAAs includes sofosbuvir(Sovaldi),simeprevir(Olysio),and fixed combination medicines Harvoni and Viekira *** drugs increase cure rates to over 90%without the need for interferon and effectively treat all HCV *** these drugs the "cure HCV"goal has become a *** remain about drug resistance mutations and the high cost of these *** investigation of new HCV drugs is progressing rapidly;fixed dose combination medicines in phase III clinical trials include Viekirax,asunaprevirtdaclatasvirtbeclabuvir,grazoprevirtelbasvir and others.

关键词： Hepatitis C virus Cure HCV Sustained virologic response Direct antiviral agents NS3/4A protease inhibitor

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Consensus on management of hepatitis C virus infection in resource-limited Ukraine and Commonwealth of Independent States regions

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World Journal of Gastroenterology 2019年第29期25卷 3897-3919页

作者： Massimo Giuseppe Colombo Erkin Isakovich Musabaev Umed Yusupovich Ismailov Igor A Zaytsev Alexander V Nersesov Igor Anatoliyevich Anastasiy Igor Alexandrovich Karpov Olga A Golubovska Kulpash S Kaliaskarova Ravishankar AC Sanjay Hadigal Research and Clinical Center Department of Medicine Humanitas Hospital Rozzano 20089 MI Italy Research Institute of Virology Scientific Research Institute of Virology Tashkent 100194 Uzbekistan Hepatoсenter Research Institute of Virology Scientific Research Institute of Virology Tashkent 100194 Uzbekistan Department of Therapy Infectious Diseases and Dermatology Bogomolets National Medical University Kyiv 01601 Ukraine Department of Gastroenterology and Hepatology National Research Institute of Cardiology and Internal Diseases Almaty 050000 Kazakhstan Department Infectious Diseases Bogomolets National Medical University Kyiv 01601 Ukraine Department Infectious Diseases Belarus State Medical University Minsk 220116 Belarus Hepatology Ministry of Health Astana 010000 Kazakhstan Medical Affairs Mylan Pharmaceuticals Private Limited Kadubeesanahalli Bengaluru 560103 India

Globally, 69.6 million individuals were infected with hepatitis C virus (HCV) infection in 2016. Of the six major HCV genotypes (GT), the most predominant one is GT1, worldwide. The prevalence of HCV in Central Asia, which includes most of the Commonwealth of Independent States (CIS), has been estimated to be 5.8% of the total global burden. The predominant genotype in the CIS and Ukraine regions has been reported to be GT1, followed by GT3. Inadequate HCV epidemiological data, multiple socio-economic barriers, and the lack of regionspecific guidelines have impeded the optimal management of HCV infection in this region. In this regard, a panel of regional experts in the field of hepatology convened to discuss and provide recommendations on the diagnosis, treatment, and pre-, on-, and posttreatment assessment of chronic HCV infection and to ensure the optimal use of cost-effective antiviral regimens in the region. A comprehensive evaluation of the literature along with expert recommendations for the management of GT1-GT6 HCV infection with the antiviral agents available in the region has been provided in this review. This consensus document will help guide clinical decision-making during the management of HCV infection, further optimizing treatment outcomes in these regions.

关键词： Antiviral agents Commonwealth of Independent States Genotype Hepatitis C virus Sustained virologic response Ukraine

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Hepatitis C virus cure with direct acting antivirals: Clinical,economic, societal and patient value for China

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World Journal of Hepatology 2019年第5期11卷 421-441页

作者： Qing Xie Jian-Wei Xuan Hong Tang Xiao-Guang Ye Peng Xu I-Heng Lee Shan-Lian Hu Department of Infectious Diseases Ruijin HospitalShanghai Jiaotong University School of MedicineShanghai 200025China Health Economic Research Institute School of PharmacySun Yat-Sen UniversityGuangzhou 510006Guangdong ProvinceChina Center of Infectious Diseases West China Hospital of Sichuan UniversityChengdu 610041Sichuan ProvinceChina Second Affiliated Hospital of Guangzhou Medical University Guangzhou 510260Guangdong ProvinceChina Gilead Sciences Inc Shanghai 200122China Gilead Sciences Inc Foster CityCA 94404United States School of Public Health Fudan UniversityShanghai 200032China Shanghai Health Development Research Center Shanghai 200032China

About 10 million people in China are infected with hepatitis C virus(HCV),with the seroprevalence of anti-HCV in the general population estimated at 0.6%.Delaying effective treatment of chronic hepatitis C(CHC)is associated with liver disease progression,cirrhosis,hepatocellular carcinoma,and liver-related *** extrahepatic manifestations of CHC further add to the disease burden of *** CHC-related advanced liver diseases and systemic manifestations are costly for both the healthcare system and *** of work productivity due to reduced well-being and quality of life in CHC patients further compounds the economic burden of the ***,pegylatedinterferon plus ribavirin(PR)was the standard of ***,a substantial number of patients are ineligible for PR treatment,and only 40%–75%achieved sustained virologic ***,PR is associated with impairment of patient-reported outcomes(PROs),high rates of adverse events,and poor *** the advent of direct acting antivirals(DAAs),the treatment of CHC patients has been *** have broader eligible patient populations,higher efficacy,better PRO profiles,fewer adverse events,and better adherence rates,thereby making it possible to cure a large proportion of all CHC *** article aims to provide a comprehensive evaluation on the value of effective,curative hepatitis C treatment from the clinical,economic,societal,and patient experience perspectives,with a focus on recent data from China,supplemented with other Asian and international experiences where China data are not available.

关键词： Hepatitis C Value of cure Sustained virologic response End stage liver disease Prevention of transmission Cost-effectiveness Productivity Societal value Patient-reported outcomes

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Treatment strategies for chronic hepatitis C prior to andfollowing liver transplantation

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World Journal of Hepatology 2016年第1期8卷 69-73页

作者： Ryan B Perumpail Thomas A Hahambis Avin Aggarwal Zobair M Younossi Aijaz Ahmed Division of Gastroenterology and Hepatology Stanford University School of MedicinePalo AltoCA 94304United States Gilead Sciences Foster CityCA 94404United States Center for Liver Diseases Department of MedicineInova Fairfax HospitalFalls ChurchVA 22042United States Betty and Guy Beatty Center for Integrated Research Inova Health SystemFalls ChurchVA 22042United States

Hepatitis C virus(HCV)-related liver disease is the leading indication for liver transplantation(LT) worldwide. However, HCV is an independent predictor of lower survival following LT, and recurrence of HCV postLT is virtually universal. The historic standard of care during the interferon era of HCV therapy was expectant management-initiation of antiviral therapy in the setting of documented disease progression following LT. With the advent of new direct acting antiviral(DAA) therapies for HCV, the paradigm of expectant treatment for recurrent HCV infection post-LT is shifting. The safety, tolerability, and efficacy of DAAs, even among the sickest patients with advanced liver disease, enables treatment of HCV in the pre-transplant setting among LT waitlist registrants. Finally, emerging data are supportive of preemptive therapy with DAAs in liver transplant recipients as the preferred approach. Expectant management of HCV following LT can rarely be justified in the modern era of HCV therapy.

关键词： Hepatitis C virus Liver transplantation Direct acting antivirals Sustained virologic response

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A New Era in the Management of the Hepatitis C

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International Journal of Clinical Medicine 2014年第12期5卷 660-666页

作者： Alfredo Arredondo Bruce Osmani Risco Morales “Amalia Simoni” Teaching Hospital Camaguey Cuba

Hepatitis C is an infection caused by the hepatitis C virus that attacks the liver and leads to inflammation. The current standard-of-care regimens include a protease inhibitor—telaprevir or boceprevir—in combination with pegylated interferon and ribavirin. Hepatitis?C treatment options on the horizon hold promise for better viral clearance with less toxicity than current regimens. There are new data about new drugs, both direct-acting antivirals while minimizing intolerable side effects or adverse events. Developed new data from 4 phase 3 trials with the hepatitis C drug sofosbuvir and ribavirin show that a 12-week regimen is effective in treating HCV genotypes 1 through 6. In the Annual Scientific Meeting and Postgraduate Course of the American College of Gastroenterology, different research was presented that was drawn from 4 phase 3 studies: NEUTRINO, FISSION, POSITRON and FUSION which enrolled different types of patients, who received Sofosbuvir with Peginterferon Alfa 2a and Ribavirin for 12 or 24 weeks in treatment;for all studies, the primary end point was sustained virologic response at 12 and 24 weeks posttreatment. In all studies, sofosbuvir was well tolerated, with a low incidence of adverse events. In conjunction with the suggested brief duration of this regimen, this indicates that drug combinations should improve treatment adherence compared with IFN-based treatment. In conclusion, 2 novel direct-acting antiviral agents—sofosbuvir and simeprevir—target various components of the HCV genome. Advantages of these drugs include a high barrier to viral resistance, a shorter duration of treatment, once-daily dosing, absence of food restrictions, few clinically significant drug interactions, and similar efficacy in all genotypes.

关键词： Hepatitis C Sustained virologic Response Intolerable Side Effects or Adverse Events Sofosbuvir and Simeprevir

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Covalently closed-circular hepatitis B virus DNA reduction with entecavir or lamivudine

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World Journal of Gastroenterology 2015年第15期21卷 4644-4651页

作者： Scott Bowden Stephen Locarnini Ting-Tsung Chang You-Chen Chao Kwang-Hyub Han Robert G Gish Robert A de Man Miao Yu Cyril Llamoso Hong Tang Victorian Infectious Diseases Reference Laboratory Division of Gastroenterology Department of Internal Medicine National Cheng Kung University Hospital Division of Gastroenterology Department of Internal Medicine Tri-Service General Hospital National Defense Medical Center Division of Gastroenterology Department of Internal Medicine Severance Hospital of Yonsei University Consultants LLC San Diego St Joseph’s Hospital and Medical Center Phoenix Hepatitis B Foundation Doylestown Department of Gastroenterology and Hepatology Room H375 Erasmus Medical Center Bristol-Myers Squibb Research and Development 5 Research Pkwy Wallingford Center Bristol-Myers Squibb Research and Development Princeton

AIM: To investigate the reduction in hepatitis B virus(HBV) covalently closed-circular DNA(ccc DNA) with entecavir(ETV) or lamivudine(LAM). METHODS: This analysis included patients who had participated in the randomized Phase Ⅲ study ETV-022 comparing ETV vs LAM in nucleos(t)ide-naive, HBe Agpositive patients. Patients received ETV(0.5 mg daily) or LAM(100 mg daily) for a minimum of 52 wk. Patients were eligible to participate in this sub-study if they had paired biopsies at baseline and week 48 with evaluable measurements for hepatic HBV ccc DNA and total hepatic HBV DNA. The main objective was to compare changes in hepatic HBV ccc DNA and total hepatic HBV DNA at week 48 of ETV or LAM treatment, which was a secondary endpoint of study ETV-022. Additional post hoc analyses included linear regression analyses to assess associations of baseline levels and on-treatment changes of ccc DNA with other baseline factors [sex,age, serum HBV DNA, alanine aminotransferase(ALT), Knodell necroinflammatory score, Ishak fibrosis score, total hepatic HBV DNA, and HBV genotype], or ontreatment factors(changes from baseline at week 48 in serum HBV DNA, ALT, Knodell necroinflammatory score, Ishak fibrosis score, total hepatic HBV DNA, and HBe Ag loss at week 48).RESULTS: Overall, 305 patients(ETV = 159; LAM = 146) of ETV-022 had paired baseline and week 48 liver biopsies with evaluable measurements for hepatic HBV ccc DNA and total hepatic HBV DNA, and were included in this analysis. Baseline demographics and disease characteristics were comparable between the two arms. After 48 wk, ETV resulted in significantly greater reductions in hepatic HBV ccc DNA [-0.9 log10 copies/human genome equivalent(HGEq) vs-0.7 log10 copies/HGEq; P = 0.0033] and total hepatic DNA levels(-2.1 log10 copies/HGEq vs-1.6 log10 copies/HGEq; P virologic, biochemical, and histologic response rates at week 48 were also greater with ETV than with LAM. Baseline HBV ccc DNA levels were positivel

关键词： Hepatitis B virus Nucleos(t)ide analogtherapy Intrahepatic hepatitis B virus DNA Antiviralsuppression virologic cure

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Sofosbuvir and ABT-450: Terminator of hepatitis C virus?

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World Journal of Gastroenterology 2013年第21期19卷 3199-3206页

作者： Qing-Lei Zeng Ji-Yuan Zhang Zheng Zhang Li-Feng Wang Fu-Sheng The Institute of Translational Hepatology Beijing 302 HospitalPeking University Research Center for Biological Therapy Beijing 302 Hospital

Combination therapy with peginterferon (pegIFN)-α and ribavirin (RBV) has been the standard of care (SOC) for chronic hepatitis C. Unfortunately, not all patients can achieve a sustained virologic response (SVR) with this regimen. SVR rates are approximately 80% in patients with hepatitis C virus (HCV) genotype 2, 3, 5 and 6 and 40%-50% in patients with genotype 1 and 4. Therefore, strategies to improve SVR rates have been an important issue for clinical physicians. Several direct acting antiviral agents (DAAs) have significantly higher SVR rates when combined with pegIFN-α and RBV than pegIFN-α and RBV alone. Treatments containing DAAs have several advantages over the previous SOC, including higher specificity and efficacy, shorter treatment durations, fewer side effects, and oral administration. Based on these advantages, treatment with pegIFN-α and RBV plus telaprevir or boceprevir has become the current SOC for patients with genotype 1 HCV infection. However, many patients are either not eligible for therapy or decline treatment due to coexisting relative or absolute contraindications as well as an inability to tolerate the hematological side effects and adverse events caused by the new SOC. These factors have contributed to the advent of pegIFN-α-free regimens. The newest therapeutic regimens containing sofosbuvir and ABT-450 have shown promising results. In this review, we summarize the development of anti-HCV agents and the clinical efficacy of sofosbuvir and ABT-450-based therapies as well as the potential for future HCV studies.

关键词： Sofosbuvir ABT-450 Hepatitis C virus Antiviral therapy Sustained virologic response

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