skip to main content
OSTI.GOV title logo U.S. Department of Energy
Office of Scientific and Technical Information

Title: Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study

Journal Article · · The Lancet Gastroenterology & Hepatology
 [1];  [2];  [3];  [4];  [3];  [3];  [3];  [3];  [3];  [5];  [5];  [6];  [7];  [7];  [7];  [8];  [8];  [7];  [9];  [9] more »;  [9];  [9];  [10];  [11];  [9] « less
  1. Humany and Helath Medical Centre, Hong Kong (China); Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing (China)
  2. Pitie-Salpetriere Hospital Univ. Hospital, Paris (France)
  3. Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing (China)
  4. Inst. of Infectious Disease, Beijing (China)
  5. Southern Medical Univ., Guangzhou (China). Dept. of Infectious Disease
  6. Humany and Helath Medical Centre, Hong Kong (China); Southern Medical Univ., Guangzhou (China). Dept. of Infectious Disease
  7. Humany and Helath Medical Centre, Hong Kong (China)
  8. Hong Kong Molecular Pathology Diagnostic Centre, Hong Kong (China)
  9. Emory Univ. School of Medicine, Atlanta, GA (United States). Center for AIDS Research
  10. Los Alamos National Lab. (LANL), Los Alamos, NM (United States). Theoretical Biology and Biophysics; North Carolina State Univ., Raleigh, NC (United States). Dept. of Mathematics
  11. Los Alamos National Lab. (LANL), Los Alamos, NM (United States). Theoretical Biology and Biophysics
+ Show Author Affiliations

Research Organization:
Los Alamos National Laboratory (LANL), Los Alamos, NM (United States)
Sponsoring Organization:
USDOE; National Institutes of Health (NIH)
Grant/Contract Number:
AC52-06NA25396; 5P30-AI-50409; R01-AI028433; R01-AI078881; R01-OD011095
OSTI ID:
1360712
Alternate ID(s):
OSTI ID: 1364534
Report Number(s):
LA-UR-17-20260; LA-UR-15-28932
Journal Information:
The Lancet Gastroenterology & Hepatology, Vol. 1, Issue 2; ISSN 2468-1253
Publisher:
ElsevierCopyright Statement
Country of Publication:
United States
Language:
English
Citation Metrics:
Cited by: 60 works
Citation information provided by
Web of Science

References (29)

Hepatitis C guidance: AASLD‐IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus journal August 2015
EASL Recommendations on Treatment of Hepatitis C 2015 journal July 2015
Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection journal April 2014
Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis journal May 2014
Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection journal January 2014
Treating Hepatitis C in Lower-Income Countries journal May 2014
Fake medicines are undermining global efforts to combat infectious disease, says US journal journal April 2015
Stopping Murder by Medicine: Introducing the Model Law on Medicine Crime journal June 2015
Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals journal May 2014
Minimum Costs for Producing Hepatitis C Direct-Acting Antivirals for Use in Large-Scale Treatment Access Programs in Developing Countries journal January 2014
Efficacy of Nucleotide Polymerase Inhibitor Sofosbuvir Plus the NS5A Inhibitor Ledipasvir or the NS5B Non-Nucleoside Inhibitor GS-9669 Against HCV Genotype 1 Infection journal March 2014
Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study journal March 2015
Modelling hepatitis C therapy—predicting effects of treatment journal June 2015
Hepatitis C viral kinetics with the nucleoside polymerase inhibitor mericitabine (RG7128) journal February 2012
Second-phase hepatitis C virus RNA decline during telaprevir-based therapy increases with drug effectiveness: Implications for treatment duration journal May 2011
Global distribution and prevalence of hepatitis C virus genotypes journal July 2014
Emergence of hepatitis C virus NS5A L31V plus Y93H variant upon treatment failure of daclatasvir and asunaprevir is relatively resistant to ledipasvir and NS5B polymerase nucleotide inhibitor GS-558093 in human hepatocyte chimeric mice journal July 2015
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial journal March 2015
Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life journal February 2013
Analysis of Hepatitis C Virus Decline during Treatment with the Protease Inhibitor Danoprevir Using a Multiscale Model journal March 2013
Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection: Hepatology, Vol. 00, No. X, 2014 Kumada et al. journal April 2014
O006 : C-swift: grazoprevir/elbasvir + sofosbuvir in cirrhotic and noncirrhotic, treatment-naive patients with hepatitis C virus genotype 1 infection, for durations of 4, 6 or 8 weeks and genotype 3 infection for durations of 8 or 12 weeks journal April 2015
P0875 : Predictors of sustained viral response to 4–6 week duration therapy with ledipasvir + sofosbuvir + GS-9451 +/− GS-9669 in early and advanced fibrosis (NIH/UMD synergy trial) journal April 2015
A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C journal July 2012
Infrequent Development of Resistance in Genotype 1–6 Hepatitis C Virus–Infected Subjects Treated With Sofosbuvir in Phase 2 and 3 Clinical Trials journal September 2014
Daclatasvir + asunaprevir versus sofosbuvir/ledipasvir for hepatitis C genotype 1 in Japanese patients: an indirect comparison journal May 2016
A Comprehensive Hepatitis C Viral Kinetic Model Explaining Cure journal May 2010
Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy journal October 2016
Systematic review: Asian patients with chronic hepatitis C infection journal April 2013

Cited By (21)

Required concentration index quantifies effective drug combinations against hepatitis C virus infection posted_content January 2020
Management of acute HCV infection in the era of direct-acting antiviral therapy journal May 2018
Superinfection and cure of infected cells as mechanisms for hepatitis C virus adaptation and persistence journal July 2018
The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam journal May 2020
The preoperative management of Hepatitis C may improve the outcome after total knee arthroplasty journal June 2019
Editorial: are additional tests needed to predict sustained virologic response in hepatitis C treated with interferon-free direct-acting antiviral combinations? journal February 2018
Disentangling the lifespans of hepatitis C virus‐infected cells and intracellular vRNA replication‐complexes during direct‐acting anti‐viral therapy journal November 2019
Treatment optimisation for hepatitis C in the era of combination direct-acting antiviral therapy: a systematic review and meta-analysis journal January 2019
Rapid hepatitis C virus clearance by antivirals correlates with immune status of infected patients: SASAKI et al. journal October 2018
Early HCV viral kinetics under DAAs may optimize duration of therapy in patients with compensated cirrhosis journal December 2018
Utility of viral kinetics in HCV therapy – It is not over until it is over? journal February 2019
Hepatitis C virus infection journal March 2017
Interferon at the cellular, individual, and population level in hepatitis C virus infection: Its role in the interferon-free treatment era journal August 2018
Sustained virologic response with 6 weeks or less of direct‐acting antiviral therapy for chronic hepatitis C: Experience at a veterans affairs healthcare system journal June 2019
Modelling how responsiveness to interferon improves interferon-free treatment of hepatitis C virus infection journal July 2018
Mutational pathway maps and founder effects define the within-host spectrum of hepatitis C virus mutants resistant to drugs journal April 2019
Hepatitis C Virus Infection book November 2008
Hepatitis C virus infection journal February 2005
Required concentration index quantifies effective drug combinations against hepatitis C virus infection journal January 2021
Required concentration index quantifies effective drug combinations against hepatitis C virus infection posted_content June 2020
Hepatitis C virus infection journal June 1994

Similar Records

Intracellular hepatitis C virus modeling predicts infection dynamics and viral protein mechanisms
Journal Article · Wed Mar 21 00:00:00 EDT 2018 · Journal of Virology · OSTI ID:1360712
+3 more
Superinfection and cure of infected cells as mechanisms for hepatitis C virus adaptation and persistence
Journal Article · Mon Jul 09 00:00:00 EDT 2018 · Proceedings of the National Academy of Sciences of the United States of America · OSTI ID:1360712
+8 more
A Hepatitis C Virus Infection Model with Time-Varying Drug Effectiveness: Solution and Analysis
Journal Article · Thu Aug 07 00:00:00 EDT 2014 · PLoS Computational Biology (Online) · OSTI ID:1360712

Related Subjects

59 BASIC BIOLOGICAL SCIENCES
60 APPLIED LIFE SCIENCES
Biological Science