Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis.

Abstract:

:A simple, pangenotypic and effective treatment regimen for patients with a broad range of chronic hepatitis C virus (HCV) infections remains an unmet medical need. We conducted a phase 2, randomized, open study involving untreated patients with chronic HCV genotypes 1, 2, 3, or 6 infections. Patients without cirrhosis were randomly assigned in a 1:2 ratio to receive capsules of the NS5A inhibitor coblopasvir at a dose of 30 or 60 mg plus tablets of the nucleotide polymerase inhibitor sofosbuvir (400 mg) once daily for 12 weeks. Patients with cirrhosis received 60 mg coblopasvir plus sofosbuvir for 12 weeks. The primary endpoint was the sustained virologic response at 12 weeks after the end of therapy (SVR12). Of the 110 patients who were enrolled in the study, 59 were male, 62.7% had HCV genotype 1, 24.5% had genotype 2, 6.4% had genotype 3, and 6.4% had genotype 6. The average age was 45.5 years. A total of 10.9% of patients had compensated cirrhosis. The rate of SVR12 was 98.2% in the intention-to-treat (ITT). One genotype 6 patient with cirrhosis experienced virologic relapse. One genotype 2 patient without cirrhosis failed to complete the follow-up and quit the study. Serious adverse events (SAEs) were reported in 2 patients and were not related to coblopasvir and sofosbuvir. Most adverse events (AEs) did not require treatment. Coblopasvir plus sofosbuvir taken once daily for 12 weeks provided high rates of sustained virologic response (SVR) and had a good safety profile among patients with HCV genotypes 1, 2, 3, or 6 infections, including those with compensated cirrhosis.

journal_name

J Viral Hepat

authors

Rao H,Song G,Li G,Yang Y,Wu X,Guan Y,Mao Q,Jiang X,Wang C,Zhang Y,Jia J,Guo X,Li C,Ning J,Qin H,Pan H,Wei L

doi

10.1111/jvh.13208

subject

Has Abstract

pub_date

2020-01-01 00:00:00

pages

45-51

issue

1

eissn

1352-0504

issn

1365-2893

journal_volume

27

pub_type

杂志文章
  • Serum peptide profiles during progression of chronic hepatitis B virus infection to liver failure.

    abstract::Chronic hepatitis B virus (HBV)-infected patients with liver failure have a poor prognosis, and no satisfactory biomarkers are available for diagnosis before the end-stage. We explored serum peptide profiling for diagnosis and prediction of progression to liver failure in HBV-infected patients. Serum samples (164) fro...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/j.1365-2893.2010.01267.x

    authors: Han T,Liu H,Yu ZL,Li J,Wang L,Xiao SX,Li Y,Yu ML

    更新日期:2010-03-01 00:00:00

  • Dietary alterations due to perceptions in acute viral hepatitis lead to sub-optimal calorie intake and increased length of hospitalization.

    abstract::Although there are no dietary restrictions recommended in acute viral hepatitis (AVH), there is an altered food intake, probably because of perceptions and traditional nutritional practices, leading to sub-optimal intake and poorer clinical outcome. Therefore, we aimed to determine nutritional intake of AVH patients b...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/j.1365-2893.2009.01184.x

    authors: Sathiaraj E,Chutke M,Mahurkar S,Nagaraja Rao P,Nageshwar Reddy D

    更新日期:2010-05-01 00:00:00

  • Point of care and oral fluid hepatitis B testing in remote Indigenous communities of northern Australia.

    abstract::Many Indigenous Australians in northern Australia living with chronic hepatitis B are unaware of their diagnosis due to low screening rates. A venous blood point of care test (POCT) or oral fluid laboratory test could improve testing uptake in this region. The purpose of this study was to assess the field performance ...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.13243

    authors: Sullivan RP,Davies J,Binks P,Dhurrkay RG,Gurruwiwi GG,Bukulatjpi SM,McKinnon M,Hosking K,Littlejohn M,Jackson K,Locarnini S,Davis JS,Tong SYC

    更新日期:2020-04-01 00:00:00

  • Analysis of resistance-associated substitutions in acute hepatitis C virus infection by deep sequencing across six genotypes and three continents.

    abstract::Several direct-acting antivirals (DAAs) have been approved for the treatment of chronic hepatitis C virus (HCV) infections, opening the door to highly effective interferon-free treatment regimens. Resistance-associated substitutions (RASs) have been reported both in treatment-naïve patients and following treatment wit...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12615

    authors: Eltahla AA,Rodrigo C,Betz-Stablein B,Grebely J,Applegate T,Luciani F,Schinkel J,Dore GJ,Page K,Bruneau J,Morris MD,Cox AL,Kim AY,Shoukry NH,Lauer GM,Maher L,Hellard M,Prins M,Lloyd AR,Bull RA,InC3 Study Group.

    更新日期:2017-01-01 00:00:00

  • Hepatitis C is more severe in drug users with human immunodeficiency virus infection.

    abstract::Drug users with chronic hepatitis C virus (HCV) infection are frequently co-infected with human immunodeficiency virus-1 (HIV-1), but it is still not clear whether HIV-1 worsens the natural history of hepatitis C. To investigate this, we conducted a multicentre observational study in 163 drug addicts with histological...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1046/j.1365-2893.2000.00230.x

    authors: Romeo R,Rumi MG,Donato MF,Cargnel MA,Viganò P,Mondelli M,Cesana B,Colombo M

    更新日期:2000-07-01 00:00:00

  • In vivo immunization in combination with peg-interferon for chronic hepatitis B virus infection.

    abstract::Only in a minority of patients with chronic hepatitis B (CHB) will treatment with interferon (IFN)-alpha or nucleoside analogues lead to sustained virological response. In vivo immunization (IVI) following virus suppression aims to optimize conditions for an effective immune response: following rapid and profound viru...

    journal_title:Journal of viral hepatitis

    pub_type: 临床试验,杂志文章

    doi:10.1111/j.1365-2893.2007.00841.x

    authors: Sprengers D,van der Molen RG,Binda R,Kusters JG,de Man RA,Niesters HG,Schalm SW,Janssen HL

    更新日期:2007-10-01 00:00:00

  • Clinical characteristics and long-term outcome of acute kidney injury in patients with HBV-related acute-on-chronic liver failure.

    abstract::Acute kidney injury (AKI) is a common complication in patients with decompensated cirrhosis and is also an important cause for poor outcome. This study aimed at investigating the clinical characteristics and long-term prognosis of AKI in patients with hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACL...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12566

    authors: Shi X,Zhu P,Yan G,Liu C,Zhang C,Huang G,Zhang Y,Yan Z,Wang Y

    更新日期:2016-11-01 00:00:00

  • Determination of hepatitis B phenotype using biochemical and serological markers.

    abstract::The aim of this study was to assess the validity of categorization of chronic hepatitis B viral infection into stages or phases based upon measures of disease activity and viral load, assuming these phenotypes will be useful for prognostication and determining the need for antiviral therapy. We assessed the phenotype ...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12643

    authors: Di Bisceglie AM,Lombardero M,Teckman J,Roberts L,Janssen HL,Belle SH,Hoofnagle JH,Hepatitis B Research Network (HBRN).

    更新日期:2017-04-01 00:00:00

  • A possible role of hypervariable region 1 quasispecies in escape of hepatitis C virus particles from neutralization.

    abstract::We examined serial changes in the hypervariable region 1(HVR1) quasispecies both in immune and nonimmune complexed hepatitis C virus (HCV) particles from 12 patients with chronic hepatitis C to elucidate the mechanism by which genetic diversification of HCV during the course of infection allows escape of virus from th...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1046/j.1365-2893.2001.00305.x

    authors: Korenaga M,Hino K,Katoh Y,Yamaguchi Y,Okuda M,Yoshioka K,Okita K

    更新日期:2001-09-01 00:00:00

  • The role of the hepatitis viruses in cholangiocarcinoma.

    abstract::Cholangiocarcinoma is the second most common liver cancer in the world. The aetiology of the disease is diverse incorporating a variety of conditions leading to biliary stasis, biliary and liver inflammation, but a large number of cases still occur in the absence of established risk factors. Its incidence and mortalit...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章,评审

    doi:10.1111/jvh.12093

    authors: Ralphs S,Khan SA

    更新日期:2013-05-01 00:00:00

  • Hepatitis B virus genotype and basal core promoter/precore mutations are associated with hepatitis B-related acute-on-chronic liver failure without pre-existing liver cirrhosis.

    abstract::The study was undertaken to investigate the features and clinical implications of hepatitis B virus (HBV) genotypes, basal core promoter (BCP) and precore (PC) mutations in hepatitis B-related acute-on-chronic liver failure (HB-ACLF). Samples from 75 patients with HB-ACLF and without pre-existing liver cirrhosis and 3...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/j.1365-2893.2009.01254.x

    authors: Ren X,Xu Z,Liu Y,Li X,Bai S,Ding N,Zhong Y,Wang L,Mao P,Zoulim F,Xu D

    更新日期:2010-12-01 00:00:00

  • Hypervariable region 1 quasispecies in hepatitis C virus genotypes 1b and 3 infected patients with normal and abnormal alanine aminotransferase levels.

    abstract::The role of hepatitis C virus (HCV) heterogeneity in the severity of chronic hepatitis C infection remains unclear. Our aim was to study the hypervariable region 1 (HVR1) heterogeneity in patients with chronic hepatitis C infected with genotype 1b or 3 and with normal or abnormal alanine aminotransferase (ALT). HVR1 q...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1046/j.1365-2893.2002.00327.x

    authors: Asselah T,Martinot M,Cazals-Hatem D,Boyer N,Auperin A,Le Breton V,Erlinger S,Degott C,Valla D,Marcellin P

    更新日期:2002-01-01 00:00:00

  • Cirrhosis, high age and high body mass index are risk factors for persisting advanced fibrosis after sustained virological response in chronic hepatitis C.

    abstract::We aimed to assess fibrosis with liver stiffness measurement long-term after sustained virological response of chronic hepatitis C and to identify risk factors associated with persisting fibrosis. In this cross-sectional study, patients with chronic hepatitis C and pretreatment advanced fibrosis or cirrhosis treated s...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12879

    authors: Hedenstierna M,Nangarhari A,El-Sabini A,Weiland O,Aleman S

    更新日期:2018-07-01 00:00:00

  • Consistent high prevalence of undiagnosed blood-borne virus infection in patients attending large urban emergency departments in England.

    abstract::Understanding local viral hepatitis and HIV epidemiology is essential if WHO elimination targets are to be achieved. We demonstrate a consistently high prevalence of undiagnosed active infection in urban emergency department attendees in England, with variations in local risk groups crucial to informing targeted testi...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.13197

    authors: Hopkins MJ,Todd S,Beadsworth M,Anderson C,Mohamed Z,Muir D,Vivancos R,Brown AS,Ruf M,Chawla A

    更新日期:2020-01-01 00:00:00

  • Early viral kinetics on treatment with pegylated interferon-alpha-2a in chronic hepatitis C virus genotype 1 infection.

    abstract::Even with pegylated (PEG) interferons (IFN), therapy of chronic hepatitis C (genotype 1) remains unsatisfactory. The initial viral response to IFN identifies patients infected with IFN resistant viruses not responding to standard IFN/ribavirin therapy. The impact of primary IFN unresponsiveness for PEG-IFN-alpha-2a/ri...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1046/j.1365-2893.2003.00396.x

    authors: Jessner W,Stauber R,Hackl F,Datz C,Watkins-Riedel T,Hofer H,Gangl A,Kessler H,Ferenci P

    更新日期:2003-01-01 00:00:00

  • How far is noninvasive assessment of liver fibrosis from replacing liver biopsy in hepatitis C?

    abstract::Chronic hepatitis C represents a major cause of progressive liver disease that can eventually evolve into cirrhosis and its end-stage complications. Formation and accumulation of fibrosis in the liver is the common pathway that leads to evolutive liver disease. Precise staging of liver fibrosis is essential for patien...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/j.1365-2893.2011.01518.x

    authors: Sebastiani G,Alberti A

    更新日期:2012-01-01 00:00:00

  • Pharmacokinetics and enhanced PKR response in patients with chronic hepatitis C treated with pegylated interferon alpha-2b and ribavirin.

    abstract::This study investigated the molecular and pharmacokinetic mechanisms of the enhanced antiviral efficacy associated with pegylated interferon (PEG-IFN) alpha-2b and ribavirin. The study involved comparing the expression of serial double-stranded RNA-activated protein kinase (PKR) before and during treatment in 26 PEG-I...

    journal_title:Journal of viral hepatitis

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1111/j.1365-2893.2006.00803.x

    authors: Asahina Y,Izumi N,Umeda N,Hosokawa T,Ueda K,Doi F,Tsuchiya K,Nakanishi H,Matsunaga K,Kitamura T,Kurosaki M,Uchihara M,Higaki M,Miyake S

    更新日期:2007-06-01 00:00:00

  • Improvement in cognitive impairment following a 12-week aerobic exercise intervention in individuals with non-cirrhotic chronic hepatitis C.

    abstract::Cognitive impairment occurs in 30%-50% of patients with non-cirrhotic chronic hepatitis C virus (HCV) infection. Exercise is beneficial in preventing and treating cognitive impairment and cardiometabolic abnormalities in many chronic inflammatory diseases, but there are few studies investigating the impact of exercise...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.13460

    authors: O'Gorman P,Strahan O,Ferguson D,Monaghan A,Kennedy M,Forde C,Melo AM,Doherty DG,O'Brien KK,McKiernan S,Kenny RA,Coen R,Doherty C,Bergin C,Gormley J,Norris S

    更新日期:2020-12-28 00:00:00

  • Approaches to the development of novel inhibitors of hepatitis C virus replication.

    abstract::Chronic infection with the hepatitis C virus is a major health problem. Conventional therapy, with interferon-alpha is effective in only a minority of patients. The failure of current treatments has led to a major initiative to identify new antiviral agents. In the absence of a tissue culture model for hepatitis C inf...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章,评审

    doi:10.1111/j.1365-2893.1995.tb00066.x

    authors: Clarke BE

    更新日期:1995-01-01 00:00:00

  • Inverse relationship between hepatic steatosis and hepatitis B viremia: Results of a large case-control study.

    abstract::The potential interaction between chronic hepatitis B (CHB) and nonalcoholic fatty liver disease (NAFLD), two of the most prevalent liver diseases worldwide, has not been well defined. We performed liver stiffness (LS) and controlled attenuation parameter (CAP) measurements using transient elastography in 1202 CHB pat...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12766

    authors: Hui RWH,Seto WK,Cheung KS,Mak LY,Liu KSH,Fung J,Wong DK,Lai CL,Yuen MF

    更新日期:2018-01-01 00:00:00

  • Morbidity and mortality of recurrent hepatitis C infection after orthotopic liver transplantation.

    abstract::Through molecular virological testing it is now clear that HCV reinfection of the allograft is virtually universal in liver transplant recipients. Although histopathological recurrence of hepatitis C occurs in the majority of patients, it is absent in a substantial minority. To date, no prognostic factors, other than ...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章,评审

    doi:10.1111/j.1365-2893.1997.tb00172.x

    authors: Vierling JM,Villamil FG,Rojter SE,Camacho KB,Goldman DE

    更新日期:1997-01-01 00:00:00

  • Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a ‘real-world’ clinical practice setting in China.

    abstract::Chronic hepatitis B infection is an important cause of liver-related mortality in China. This study assessed the efficacy and safety of entecavir in a heterogeneous patient population from a ‘real-world’ clinical practice setting in China. This prospective, observational cohort provides 48-week data on 2600 patients f...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12115

    authors: Hou JL,Jia JD,Wei L,Zhao W,Wang YM,Cheng M,Tang X,Tan DM,Ren H,Tang H,Cohen D,Llamoso C

    更新日期:2013-11-01 00:00:00

  • Applicability and accuracy improvement of transient elastography using the M and XL probes by experienced operators.

    abstract::Transient elastography (TE) is the reference method to obtain liver stiffness measurements (LSM), but no results are obtained in 3.1% and unreliable in 15.8%. We assessed the applicability and diagnostic accuracy of TE re-evaluation using M and XL probes. From March 2011 to April 2012 868 LSM were performed with the M...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12296

    authors: Carrión JA,Puigvehí M,Coll S,Garcia-Retortillo M,Cañete N,Fernández R,Márquez C,Giménez MD,Garcia M,Bory F,Solà R

    更新日期:2015-03-01 00:00:00

  • Estimating the future health burden of chronic hepatitis C and human immunodeficiency virus infections in the United States.

    abstract::The aim of this work was to estimate the future disease burden of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infections in the United States until the year 2030. Two back-calculation models of the HIV and the HCV epidemic were developed. They were based on US epidemiological data regarding prevalen...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/j.1365-2893.2006.00785.x

    authors: Deuffic-Burban S,Poynard T,Sulkowski MS,Wong JB

    更新日期:2007-02-01 00:00:00

  • Clinical relevance of total HCV core antigen testing for hepatitis C monitoring and for predicting patients' response to therapy.

    abstract::To study the correlation between total Hepatitis C virus (HCV) Core antigen (Ag) and HCV-RNA, and to assess the proficiency of HCV Core Ag testing in monitoring and predicting virologic response during and after pegylated interferon (PEG-IFN) and ribavirin combination therapy. A total of 307 samples from treated and u...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1046/j.1365-2893.2003.00430.x

    authors: Maynard M,Pradat P,Berthillon P,Picchio G,Voirin N,Martinot M,Marcellin P,Trepo C

    更新日期:2003-07-01 00:00:00

  • Elimination of hepatitis B virus surface antigen and appearance of neutralizing antibodies in chronically infected patients without viral clearance.

    abstract::Seroconversion from hepatitis B surface antigen (HBsAg) to antibodies against HBsAg (anti-HBs) usually indicates resolution of hepatitis B virus (HBV) infection. Here, two HBV-infected patients with seroconversion to anti-HBs were found to be persistently positive for HBeAg and HBV DNA. Immunohistology of liver biopsi...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/j.1365-2893.2010.01322.x

    authors: Zhang ZH,Li L,Zhao XP,Glebe D,Bremer CM,Zhang ZM,Tian YJ,Wang BJ,Yang Y,Gerlich W,Roggendorf M,Li X,Lu M,Yang DL

    更新日期:2011-06-01 00:00:00

  • The impact of SVR from direct-acting antiviral- and interferon-based treatments for HCV on hepatocellular carcinoma risk.

    abstract::We evaluated the effect of sustained virologic response (SVR) from direct-acting antiviral (DAA)- and interferon-based treatments on hepatocellular carcinoma (HCC) risk in a large population-based cohort in Canada. We used data from the BC Hepatitis Testers Cohort, which includes ~1.3 million individuals tested for HC...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.13295

    authors: Janjua NZ,Wong S,Darvishian M,Butt ZA,Yu A,Binka M,Alvarez M,Woods R,Yoshida EM,Ramji A,Feld J,Krajden M

    更新日期:2020-08-01 00:00:00

  • Metformin inhibits hepatitis B virus protein production and replication in human hepatoma cells.

    abstract::Hepatitis B virus surface antigen (HBsAg) plays an important role in maintaining the tolerance and may interfere with host innate and adaptive immune responses; therefore, novel therapeutic strategies to reduce HBsAg loads in patients infected with hepatitis B virus (HBV) are emerging as an attractive but challenging ...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.12187

    authors: Xun YH,Zhang YJ,Pan QC,Mao RC,Qin YL,Liu HY,Zhang YM,Yu YS,Tang ZH,Lu MJ,Zang GQ,Zhang JM

    更新日期:2014-08-01 00:00:00

  • Pharmacokinetics, efficacy and safety of daclatasvir plus asunaprevir in dialysis patients with chronic hepatitis C: pilot study.

    abstract::The aim of this study was to evaluate the pharmacokinetic profile of daclatasvir (DCV) and asunaprevir (ASV) dual therapy in haemodialysis patients infected with hepatitis C virus (HCV). Eighteen haemodialysis patients and 54 patients with normal renal function were treated with DCV and ASV dual therapy for 24 weeks. ...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章,多中心研究

    doi:10.1111/jvh.12553

    authors: Kawakami Y,Imamura M,Ikeda H,Suzuki M,Arataki K,Moriishi M,Mori N,Kokoroishi K,Katamura Y,Ezaki T,Ueno T,Ide K,Masaki T,Ohdan H,Chayama K

    更新日期:2016-11-01 00:00:00

  • Comparison of liver disease state progression in patients with eradication of versus persistent infection with hepatitis C virus: Markov chain analysis.

    abstract::To investigate the long-term prognosis of liver disease in patients with hepatitis C virus (HCV) eradication after antiviral therapy versus those with persistent HCV infection. Four hundred and eighty patients (5259 person-years [PYs]) who received interferon-based therapy and achieved sustained virologic response and...

    journal_title:Journal of viral hepatitis

    pub_type: 杂志文章

    doi:10.1111/jvh.13444

    authors: Tada T,Toyoda H,Kumada T,Kurisu A,Sugiyama A,Akita T,Ohisa M,Aikata H,Miki D,Chayama K,Tanaka J

    更新日期:2020-11-20 00:00:00