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Interferon-free regimens in patients with hepatitis c infection and renal dysfunction or kidney transplantation

World Journal of Hepatology 2017年第4期9卷 180-190页

作者： Evangelos cholongitas chrysoula Pipili George V Papatheodoridis 4th Department of Internal Medicine Medical School of Aristotle University Hippokration General Hospital of Thessaloniki Division of Nephrology Queen Elizabeth University Hospital Department of Gastroenterology Medical School of National and Kapodistrian University of Athens Laiko General Hospital

Treatment of patients with chronic kidney disease(cKD) and chronic hepatitis c(cHc) differs from that used in the general cHc population mostly when glomerular filtration rate(GFR) is below 30 m L/min, as sofosbuvir, the backbone of several current regimens, is officially contraindicated. Given that ribavirin free regimens are preferable in cKD, elbasvir/grazoprevir is offered in cHc patients with genotype 1 or 4 and ombitasvir/paritaprevir and dasabuvir in genotype 1b for 12 wk. Although regimens containing peginterferon with or without ribavirin are officially recommended for patients with cKD and genotype 2, 3, 5, 6, such regimens are rarely used because of their low efficacy and the poor safety and tolerance profile. In this setting, especially in the presence of advanced liver disease, sofosbuvirbased regimens are often used, despite sofosbuvir contraindication. It seems to have good overall safety with only 6% or 3.4% of cKD patients to discontinue therapy or develop serious adverse events without drug discontinuation. In addition, sustained virological response(SVR) rates with sofosbuvir based regimens in cKD patients appear to be comparable with SVR rates in patients with normal renal function. Treatment recommendations for kidney transplant recipients are the same with those for patients with cHc, taking into consideration potential drug-drug interactions and baseline GFR before treatment initiation. This review summarizes recent data on the current managementof cHc in cKD patients highlighting their strengths and weaknesses and determining their usefulness in clinical practice.

关键词： chronic hepatitis c virus infection Kidney Renal Kidney transplantation Direct acting antiviral agents Glomerular filtration rate hepatitis c

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Impact of all oral anti-hepatitis c virus therapy:A metaanalysis

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World Journal of Hepatology 2015年第5期7卷 806-813页

作者： Siddharth Bansal Ashwani K Singal Brendan M Mc Guire Bhupinder S Anand Department of Internal Medicine University of Alabama Birmingham Department of Gastroenterology and Hepatology University of Alabama Birmingham Department of Gastroenterology and Hepatology Michael E.DeB akey VA Medical Center and Baylor College of Medicine

AIM:To investigate the efficacy,safety,and cost of treatment of direct acting antivirals(DAAs) with and without peg interferon alfa2a(P),and/or ribavirin(R) in treating hepatitis c virus(HcV) genotype 1 ***:MEDLINE was searched for randomized controlled trials(RcT) using DAAs for HcV *** 1 trials and studies with investigational drugs on genotype 2 or 3,and on human immunodeficiency virus patients were *** were pooled for sustained virologic response(SVR),serious adverse effects,and drug discontinuation rate on various treatment arms in trials:P + R;1st generation DAA(telaprevir or boceprevir) + P + R;2nd generation DAA(sofosbuvir or simeprevir) + P + R;2nd generation DAA + R;two 2nd generation DAA + R;and two 2nd gen *** were analyzed separately for each arm for treatment naive and non-responders(NR) to previous *** cost of treatment with each regimen for achieving one SVR was also ***:Twenty three RcTs(n = 9354,62% male,11% cirrhosis) were *** oral(P free) regimens with combination of 2 DAA achieved SVR above 95%.The cost of treatment to achieve an SVR with DAA based regimens was lower for NR compared to P+R ***,the cost per SVR remained higher for treatment naive ***:Second generation and emerging DAAs are promising agents in HcV treatment,with a very high level of safety and *** important drawback is their high ***,the present meta-analysis shows that the cost per SVR for non responders(but not for naive patients) was lower compared to P + *** finding together with the superior safety profile and better compliance makes these drugs highly *** is possible that further reduction in treatment duration may make them even more cost effective.

关键词： hepatitis c Meta-analysis Direct actingantivirals Oral agents Newer agents hepatitis c virus

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Efficacy and safety of sofosbuvir/velpatasvir with or without ribavirin in hepatitis c genotype 3 compensated cirrhosis:A meta-analysis

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World Journal of Hepatology 2022年第6期14卷 1248-1257页

作者： Jing Hong Loo Wen Xin Flora Xu Jun Teck Low Wei Xuan Tay Le Shaun Ang Yew chong Tam Prem Harichander Thurairajah Rahul Kumar Yu Jun Wong Yong Loo Lin School of Medicine National University of SingaporeSingapore 119077Singapore Education Resource center Medical BoardSingapore General HospitalSingapore 100059Singapore Department of Gastroenterology and Hepatology National University HospitalSingapore 119077Singapore Department of Gastroenterology and Hepatology Changi General HospitalSingapore 529889Singapore Duke-NUS Medicine Academic clinical Program Singapore 100059Singapore

BAcKGROUND hepatitis c virus(HcV)is a leading cause of liver cirrhosis and hepatocellular carcinoma ***/velpatasvir(SOF/VEL)is an effective pangenotypic direct-acting antiviral combination for treatment of chronic HcV *** the addition of ribavirin(RBV)to SOF/VEL improved sustained virological response(SVR12)in genotype 3(GT3)decompensated cirrhosis patients,the benefits of RBV in GT3 compensated cirrhosis patients receiving SOF/VEL remains *** To evaluate the efficacy and safety of SOF/VEL,with or without RBV in GT3 compensated cirrhosis *** We searched four electronic databases(PubMed/Medline,Embase,cochrane Library and Web of Science)from inception up to June 2021 using both free text and MeSH *** was no restriction on language,geography,publication dates and publication status(full text or abstracts).All GT3 compensated cirrhosis patients treated with 12 wk of SOF/VEL,with or without RBV,were included,regardless of age,gender or prior treatment *** primary outcome was sustained virological response 12-wk posttreatment(SVR12).The secondary outcome was treatment-related adverse events,as defined by symptomatic anemia requiring transfusion or a drop in hemoglobin beyond 2 g/*** pooled relative risk(RR),95%cI and heterogeneity(I^(2))were estimated using Review Manager version *** From 1752 citations,a total of seven studies(2 randomized controlled trials,5 cohort studies)with 1088 subjects were *** SVR12 was similar in GT3 compensated cirrhosis patients,regardless of the use of RBV,for both the intention-to-treat RR 1.03,95%cI:0.99-1.07;I^(2)=0%)and the per-protocol analysis(RR:1.03,95%cI:0.99-1.07;I^(2)=48%).The overall pooled rate of treatment-related adverse events was 7.2%.Addition of RBV increased the pooled risk of treatment-related adverse events in GT3 compensated cirrhosis patients receiving SOF/VEL(RR:4.20,95%cI:1.29-13.68;I^(2)=0%).Subgroup analysis showed that RBV wa

关键词： Direct-acting antiviral hepatitis c cirrhosis Sofosbuvir/velpatasvir

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Efficacy and Safety of Daclatasvir in hepatitis c: An Overview

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Journal of clinical and Translational Hepatology 2016年第4期4卷 336-344页

作者： Nesrine Gamal Stefano Gitto Pietro Andreone Department of Medical and Surgical Sciences University of Bologna Bologna Italy

hepatitis c virus (HcV) infection is a growing public health concern,with 184 million people infected *** the past decade,interferon has been the backbone of HcV treatment,even though it remains far from *** latest development of the new direct antivirals has drastically changed the treatment approach for chronic hepatitis c (cHc).Inhibitors of the HcV NS5A region have garnered remarkable interest among treating physicians,due to their high potency and favourable safety *** particular,treatment with daclatasvir (DcV) has yielded high rates of vriologic response in patients infected with genotype (Gt) 1 and Gt 3,when used in combination with other antivirals of a different class,such as *** few data are available for DcV treatment of the other Gts,the results in patients with Gt 2 and Gt 4 infection appear promising,as do those for unique patient ***5A-resistant viral variants can pre-exist or emerge after treatment failure for the HcV NS5A ***,DcV-resistant viral variants continue to be sensitive to interferon and other classes of antivirals such as NS3/4A and NS5B ***,we aimed to provide an overview of the current knowledge about DcV in the treatment of cHc.

关键词： Daclatasvir NS5A inhibitor hepatitis c Direct antivirals New antiviral therapy

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Impact of sustained virologic response on chronic kidney disease progression in hepatitis c

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World Journal of Hepatology 2017年第36期9卷 1352-1360页

作者： Elizabeth S Aby Tien S Dong Jenna Kawamoto Joseph R Pisegna Jihane N Benhammou Division of Gastroenterology Hepatology and Parenteral Nutrition Department of Medicine VA Greater Los Angeles Healthcare System the Vatche and Tamar Manoukian Division of Digestive Diseases UCLA Los Angeles Department of Medicine University of California David Geffen School of Medicine

AIM To determine how sustained virological response at 12 wk(SVR12) with direct acting antivirals(DAAs) for the treatment of hepatitis c virus(HcV) infection affects chronic kidney disease(cKD) progression. METHODS A retrospective analysis was performed in patients aged ≥ 18 years treated for HcV with DAAs at the VA Greater Los Angeles Healthcare System from 2014-2016. The treatment group was compared to patients with HcV from 2011-2013 who did not undergo HcV treatment, prior to the introduction of DAAs; the control group was matched to the study group in terms of age, gender, and ethnicity. Analysis of variance and co-variance was performed to compare means between SVR12 subgroups adjusting for *** Five hundred and twenty-three patients were evaluated. When comparing the rate of change in estimated glomerular filtration rate(e GFR) one-year after HcV treatment to one-year before treatment, patients who achieved SVR12 had a decline in GFR of 3.1 m L/min ± 0.75 m L/min per 1.73 m^2 compared to a decline in e GFR of 11.0 m L/min ± 2.81 m L/min per 1.73 m^2 in patients who did not achieve SVR12(P = 0.002). There were no significant clinical differences between patients who achieved SVR12 compared to those who did not in terms of cirrhosis, treatment course, treatment experience, cKD stage prior to treatment, diuretic use or other co-morbidities. The decline in e GFR in those with untreated HcV over 2 years was 2.8 m L/min ± 1.0 m L/min per 1.73 m^2, which was not significantly different from the e GFR decline noted in HcV-treated patients who achieved SVR12(P = 0.43).cONcLUSION Patients who achieve SVR12 have a lesser decline in renal function, but viral eradication in itself may not be associated improvement in renal disease progression.

关键词： hepatitis c Direct-acting antivirals chronic kidney disease End stage renal disease Sustained virological response

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Management of hepatitis c Before and After Liver Transplantation in the Era of Rapidly Evolving Therapeutic Advances

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Journal of clinical and Translational Hepatology 2014年第2期2卷 124-133页

作者： chalermrat Bunchorntavakul K. Rajender Reddy Division of Gastroenterology and Hepatology Department of Medicine Rajavithi Hospital College of Medicine Rangsit University Bangkok Thailand Hospital of the University of Pennsylvania University of Pennsylvania Philadelphia PA USA

Management of hepatitis c (HcV) in liver transplantation (LT) population presents unique challenges. Suboptimal graft survival in HcV+ LT recipients is attributable to universal HcV recurrence following LT. Although eradication of HcV prior to LT is ideal for the prevention of HcV recurrence it is often limited by adverse events, particularly in patients with advanced cirrhosis. Antiviral therapy in LT candidates needs careful monitoring, and prophylaxis with HcV antibodies is ineffective. Early antiviral therapy after LT has been investi-gated, but no clear benefit has been demonstrated. Protocol liver biopsy is generally recommended in HcV+LT recipients, and antiviral therapy can be considered in those with severe/progressive HcV recurrence. Sustained virological response (SVR) can be achieved in approximately 30%of LT recipients with pegylated interferon/ribavirin (PEG-IFN/RBV) with sur-vival benefit, but adverse effects are common. Favorable patient characteristics for response to therapy include non-1 genotype, previously untreated, low baseline HcV-RNA, and donor IL28B genotype cc. Direct acting antiviral (DAA)-based triple therapy is associated with higher rates of SVR, but with similar or slightly higher rates of side effects, and immunosuppressive regimens need to be closely monitored and adjusted during the treatment period. Notably, the safety and efficacy of HcV treatment are very likely to improve with newer generation DAA. The benefit of immunosuppressive strategy on the natural history HcV recurrence has not been well elucidated. Based upon available evidence, cyclosporine A (cSA), mycophenolate mofetil (MMF), and sirolimus appear to have a neutral or small beneficial impact on HcV recurrence. Donor interleukin 28 B (IL28B) polymorphisms appear to impact the course and treatment outcomes in recurrent HcV. Retransplantation should be considered for patients with reasonable survival probability.

关键词： hepatitis c Liver transplantation Prevention Treatment Interferon Protease inhibitors Immunosuppression

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Update on hepatitis c Virus and HIV coinfection

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Journal of clinical and Translational Hepatology 2013年第2期1卷 109-115页

作者： Tilahun Amdissa Gemtessa Lisa M.chirch Division of Infectious Diseases University of Connecticut Health Center Farmington CT USA

chronic hepatitis c virus (HcV) infection has historically been difficult to treat in the HIV-infected population,owing to generally poor responses to interferon-based *** recent rapid development of directly acting antiviral agents (DAAs) against HcV has the potential to revolutionize treatment of this infection in the HIV population by improving tolerability and outcome,and,ultimately,reducing the significant burden of liver-related morbidity and mortality in this *** trials to address the safety and efficacy of novel DAAs in the HcV/HIV coinfected population are ongoing,and show much *** rapidity of current drug discovery in the field of HcV is both impressive and daunting for clinicians who will have to master these *** forward,the inclusion of individuals from this large and growing patient population in clinical trials will be of paramount importance.

关键词： hepatitis c HcV HIV coinfection Antiretroviral therapy ART Drug interaction

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chronic hepatitis c Infection in children: current Treatment and New Therapies

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Journal of clinical and Translational Hepatology 2015年第1期3卷 36-41页

作者： Andrew Lee Jeremy Rajanayagam Mona Abdel-Hady Birmingham children's Hospital Liver Unit Birmingham United Kingdom The University of Queensland School of MedicineBrisbane Australia Birmingham children's Hospital Liver Unit Birmingham United Kingdom University of Birmingham School of Infection and Immunity Birmingham United Kingdom Birmingham children's Hospital Liver Unit Birmingham United Kingdom

Viral hepatitis c is responsible for a large burden of disease *** of hepatitis c infection is currently undergoing a revolution with the development of new direct acting antivirals that offer higher cure rates and fewer side effects than other medications currently *** options for children,although well-defined and evidencebased,are limited relative to adults as there are few trials regarding the use of these newly developed agents in *** so much optimism in the development of novel therapeutic options for hepatitis c,it is timely to review and summarize the current standard of care treatment and indications for treatment of chronic hepatitis c in *** provide here an overview of recent drug developments and their potential for use in children.

关键词： hepatitis c children Treatment Direct acting antivirals Host targeting agents

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Miliary tuberculosis infection during hepatitis c treatment with sofosbuvir and ledipasvir plus ribavirin

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World Journal of Hepatology 2017年第3期9卷 161-166页

作者： Maria Pilar Ballester-Ferré Fernando Martínez Natalia Garcia-Gimeno Francisco Mora Miguel A Serra Gastroenterology and Hepatology Department University Clinic Hospital of Valencia University of Valencia Digestive Medicine Department University Clinic Hospital of Valencia University of Valencia Internal Medicine Department University Clinic Hospital of Valencia University of Valencia

chronic hepatitis c virus(HcV) infection is one of the main causes of chronic liver disease worldwide. In the last 5 years, treatment for HcV infection has experienced a marked development. In 2014, the use of ledipasvir/sofosbuvir with or without concomitant weight-based ribavirin was approved with a very significant increase in the sustained virological response. However, new side effects have been associated. We report the first case of an HcV infected patient treated for 12 wk with the combination of sofosbuvir/ledipasvir plus ribavirin who developed a miliary tuberculosis(TB) infection while on therapy. The patient was a 65-year-old woman, who referred malaise, asthenia, hyporexia, 7 kg weight loss, productive cough, evening fever and night sweats, right after finishing the treatment. The chest computed tomography-scan revealed a superior mediastinal widening secondary to numerous lymphadenopathies with extensive necrosis and bilateral diffuse lung miliary pattern with little subsequent bilateral pleural effusion, highly suggestive of lymph node tuberculosis with lung miliary spread. A bronchoscopy was performed and bronchial suction showed more than 50 acid-alcohol resistant bacillus per line. A Mycobacterium tuberculosis DNA was detected in blood by polymerase chain reaction, which confirmed the diagnosis of miliary tuberculosis. Some cases of TB infection have been identified with α-interferon-based therapy and with the triple therapy of pegylated interferon, ribavirin and boceprevir or telaprevir. However, significant infection has not been reported with sofosbuvir/ledipasvir plus *** believe that the case is relevant to increase awareness of opportunistic infections and particularly TB infection. Although the international guidelines offer no recommendation regarding TB screening, we wonder whether it would be advisable to screen for opportunistic infections prior to the introduction of HcV therapy.

关键词： Tuberculosis Ledipasvir Ribavirin Sofosbuvir hepatitis c

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Impact of utilization of hepatitis c positive organs in liver transplant:Analysis of united network for organ sharing database

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World Journal of Hepatology 2022年第5期14卷 984-991页

作者： Amaninder Dhaliwal Banreet Dhindsa Daryl Ramai Harlan Sayles Saurabh chandan Rajani Rangray Department of Gastroenterology and Hepatology Moffitt Cancer CenterTampaFL 33612United States Department of Gastroenterology and Hepatology University of Nebraska Medical CenterOmahaNE 68198United States Department of Internal Medicine The Brooklyn Hospital CenterBrooklynNY 11201United States Department of Biostatistics University of Nebraska Medical CenterOmahaNE 68198United States Department of Gastroenterology and Hepatology Creighton University Medical CenterOmahaNE 68124United States

BAcKGROUND The utility of hepatitis c virus(HcV)organs has increased after the Food and Drug Administration approval of direct acting anti-viral(DAA)medications for the HcV *** efficacy of DAA in treating HcV is nearly 100%.AIM To analyze the United Network for Organ Sharing(UNOS)database to compare the survival rates between the hepatitis c positive donors and negative recipients and hepatitis c negative donors and *** We analyzed the adult patients in UNOS database who underwent deceased donor liver transplant from January 2014 to December *** primary endpoint was to compare the survival rates among the four groups with different hepatitis c donor and recipient status:(Group 1)Both donor and recipient negative for HcV(Group 2)Negative donor and positive recipient for HcV(Group 3)Positive donor and negative recipient for HcV(Group 4)Both positive donor and recipient for *** 9.4 software was used for the data *** Meier log rank test was used to analyze the estimated survival rates among the four *** A total of 24512 patients were included:Group 1:16436,Group 2:6174,Group 3:253 and Group 4:*** 1-year(Group 1:91.8%,Group 2:92.12%,Group 3:87%,Group 4:92.8%),2-year(Group 1:88.4%,Group 2:88.1%,Group 3:84.3%,Group 4:87.5%),3-year(Group 1:84.9%,Group 2:84.3%,Group 3:75.9%,Group 4:83.2%)survival rates showed no statistical significance among the four *** Meier log rank test did not show any statistical significance difference in the estimated survival rates between Group 3 vs all the other *** The survival rates in hepatitis c positive donors and negative recipients are similar as compared to both hepatitis c negative donors and *** could be due to the use of DAA therapy with cure rates of nearly 100%.This study supports the use of hepatitis c positive organs in the selected group of recipients with and without HcV *** long-term studies are needed to further valid

关键词： hepatitis c Liver transplant Survival United Network for Organ Sharing Direct acting antiviral

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