Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection

Nezam Afdhal; Stefan Zeuzem; Paul Kwo; Mario Chojkier; Norman Gitlin; Massimo Puoti; Manuel Romero-Gomez; Jean-Pierre Zarski; Kosh Agarwal; Peter Buggisch; Graham Foster; Norbert Bräu; Maria Buti; Ira Jacobson; G. Mani Subramanian; Xiao Ding; Hongmei Mo; Jenny Yang; Phillip Pang; William Symonds; John G. Mchutchison; Andrew J. Muir; Alessandra Mangia; Patrick Marcellin; Marc Bourlière; Jean-Pierre Bronowicki; Christophe Hezode; Vlad Ratziu; Lawrence Serfaty; Thomas Berg; Peter Gallert; Guido Gerken; Tobias Goeser; Ansgar Lohse; Stefan Mauss; Robert Thimme; Hans Wedemeyer; Alfredo Alberti; Pietro Andreone; Mario Angelico; Massimo Colombo; Antonio Craxi; Mario Rizzetto; Maribel Rodriguez-Torres; Raúl Andrade; F. Javier Crespo; Xavier Forns; Javier García-Samaniego; Ashley Brown; Matthew Cramp; Geoffrey Dusheiko; David Mutimer; Andrew Ustianowski; Christopher Albers; Sanjeev Arora; Kimberly Beavers; Michael A. Bennett; David Bernstein; Robert Brown Jr.; Raymond Chung; James Cooper; Mitchell Davis; Adrian Di Bisceglie; Robin Dretler; Richard Elion; Gregory Everson; Steven Flamm; Bradley Freilich; Michael Fried; Joseph Galati; Reem Ghalib; Stuart Gordon; Steven-Huy Han; Trevor Hawkins; Robert Herring; Federico Hinestrosa; Lennox Jeffer; Kris V Kowdley; Marcelo Kugelmas; Eric Lawitz; William Lee; Timothy R Morgan; Ronald Nahass; David Nelson; Mindie Nguyen; Keyur Patel; Paul Pockros; Gary Poleynard; John Poterucha; John Poulos; David Pound; Ronald Pruitt; Natarajan Ravendhran; K. Rajender Reddy; Robert Reindollar; Lorenzo Rossaro; Peter Ruane; Vinod Rustgi; Michael Ryan; Michael S. Saag; Eugene Schiff; Aasim Sheikh; Mitchell L. Shiffman; Coleman Smith; Mark Sulkowski; Kimberly Workowski; Ziad Younes

doi:10.1056/NEJMoa1402454

Journal Articles New England Journal of Medicine Year : 2014

Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection

(1) , (2) , (3) , (4) , (5) , (6) , (7) , (8) , (9) , (10) , (11) , (12) , (13, 14) , (15) , (16) , (16) , (16) , (16) , (16) , (16) , (16) , (17) , (18) , (19) , , (20, 21) , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21

Nezam Afdhal

Function : Author

Beth Israel Medical Centre

Stefan Zeuzem

Function : Author

Johann Wolfgang Goethe University Medical Center

Paul Kwo

Function : Author

Indiana University School of Medicine

Mario Chojkier

Function : Author

University of California Medical Center [San Diego]

Norman Gitlin

Function : Author

Atlanta Gastroenterology Associates

Massimo Puoti

Function : Author
PersonId : 911129

Department of infectious Diseases

Manuel Romero-Gomez

Function : Author
PersonId : 914909

Unit for The Clinical Management of Digestive Diseases and CIBERehd

Jean-Pierre Zarski

Function : Author

Département de Gastroentérologie et hépatologie

Kosh Agarwal

Function : Author

Institute of Liver Studies

Peter Buggisch

Function : Author

Asklepios Klinik St. Georg Hamburg

Graham Foster

Function : Author

Queen Mary University of London

Norbert Bräu

Function : Author

James J. Peters VA Medical Center [New York]

Maria Buti

Function : Author
PersonId : 887014

Vall d'Hebron University Hospital [Barcelona]

Instituto de Salud Carlos III [Madrid]

Ira Jacobson

Function : Author

Weill Medical College of Cornell University [New York]

G. Mani Subramanian

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

Xiao Ding

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

Hongmei Mo

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

Jenny Yang

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

Phillip Pang

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

William Symonds

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

John G. Mchutchison

Function : Author

Gilead Sciences, Inc. [Foster City, CA, USA]

Andrew J. Muir

Function : Author
PersonId : 915178

Division of Gastroenterology

Alessandra Mangia

Function : Author
PersonId : 886918

Istituto di Ricovero e Cura a Carattere Scientifico, Ospedale Casa Sollievo della Sofferenza [San Giovanni Rotondo]

Patrick Marcellin

Function : Author

Service d'hépatologie

Marc Bourlière

Function : Author
PersonId : 900179

Jean-Pierre Bronowicki

Function : Author
PersonId : 900180

Nutrition-Génétique et Exposition aux Risques Environnementaux

Service d'Hépato-gastro-entérologie [CHRU Nancy]

Christophe Hezode

Function : Author
PersonId : 881467

Vlad Ratziu

Function : Author
PersonId : 901286

Lawrence Serfaty

Function : Author
PersonId : 760409
ORCID : 0000-0003-3055-5579

Thomas Berg

Function : Author

Peter Gallert

Function : Author
PersonId : 1021192

Guido Gerken

Function : Author

Tobias Goeser

Function : Author

Ansgar Lohse

Function : Author
PersonId : 783656
ORCID : 0000-0002-8823-3129

Stefan Mauss

Function : Author

Robert Thimme

Function : Author

Hans Wedemeyer

Function : Author

Alfredo Alberti

Function : Author

Pietro Andreone

Function : Author

Mario Angelico

Function : Author

Massimo Colombo

Function : Author
PersonId : 915067

Antonio Craxi

Function : Author
PersonId : 912703

Mario Rizzetto

Function : Author

Maribel Rodriguez-Torres

Function : Author

Raúl Andrade

Function : Author

F. Javier Crespo

Function : Author

Xavier Forns

Function : Author
PersonId : 902771

Javier García-Samaniego

Function : Author

Ashley Brown

Function : Author

Matthew Cramp

Function : Author

Geoffrey Dusheiko

Function : Author

David Mutimer

Function : Author

Andrew Ustianowski

Function : Author

Christopher Albers

Function : Author

Sanjeev Arora

Function : Author

Kimberly Beavers

Function : Author

Michael A. Bennett

Function : Author
PersonId : 980173

David Bernstein

Function : Author

Robert Brown Jr.

Function : Author

Raymond Chung

Function : Author

James Cooper

Function : Author

Mitchell Davis

Function : Author

Adrian Di Bisceglie

Function : Author

Robin Dretler

Function : Author

Richard Elion

Function : Author

Gregory Everson

Function : Author

Steven Flamm

Function : Author

Bradley Freilich

Function : Author

Michael Fried

Function : Author

Joseph Galati

Function : Author

Reem Ghalib

Function : Author

Stuart Gordon

Function : Author

Steven-Huy Han

Function : Author

Trevor Hawkins

Function : Author

Robert Herring

Function : Author

Federico Hinestrosa

Function : Author

Lennox Jeffer

Function : Author

Kris V Kowdley

Function : Author

Marcelo Kugelmas

Function : Author

Eric Lawitz

Function : Author

William Lee

Function : Author

Timothy R Morgan

Function : Author

Ronald Nahass

Function : Author

David Nelson

Function : Author

Mindie Nguyen

Function : Author

Keyur Patel

Function : Author

Paul Pockros

Function : Author

Gary Poleynard

Function : Author

John Poterucha

Function : Author

John Poulos

Function : Author

David Pound

Function : Author

Ronald Pruitt

Function : Author

Natarajan Ravendhran

Function : Author

K. Rajender Reddy

Function : Author

Robert Reindollar

Function : Author

Lorenzo Rossaro

Function : Author

Peter Ruane

Function : Author

Vinod Rustgi

Function : Author

Michael Ryan

Function : Author

Michael S. Saag

Function : Author

Eugene Schiff

Function : Author

Aasim Sheikh

Function : Author

Mitchell L. Shiffman

Function : Author

Coleman Smith

Function : Author

Mark Sulkowski

Function : Author

Kimberly Workowski

Function : Author

Ziad Younes

Function : Author

Abstract

Background In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection. Methods We conducted a phase 3, open-label study involving previously untreated patients with chronic HCV genotype 1 infection. Patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir–sofosbuvir plus ribavirin for 12 weeks, ledipasvir–sofosbuvir for 24 weeks, or ledipasvir–sofosbuvir plus ribavirin for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. Results Of the 865 patients who underwent randomization and were treated, 16% had cirrhosis, 12% were black, and 67% had HCV genotype 1a infection. The rates of sustained virologic response were 99% (95% confidence interval [CI], 96 to 100) in the group that received 12 weeks of ledipasvir–sofosbuvir; 97% (95% CI, 94 to 99) in the group that received 12 weeks of ledipasvir–sofosbuvir plus ribavirin; 98% (95% CI, 95 to 99) in the group that received 24 weeks of ledipasvir–sofosbuvir; and 99% (95% CI, 97 to 100) in the group that received 24 weeks of ledipasvir–sofosbuvir plus ribavirin. No patient in either 12-week group discontinued ledipasvir–sofosbuvir owing to an adverse event. The most common adverse events were fatigue, headache, insomnia, and nausea. Conclusions Once-daily ledipasvir–sofosbuvir with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with HCV genotype 1 infection.

Domains

Life Sciences [q-bio]

NGERE UL : Connect in order to contact the contributor

https://hal.univ-lorraine.fr/hal-01690189

Submitted on : Monday, January 22, 2018-5:48:41 PM

Last modification on : Thursday, April 4, 2024-9:19:59 PM

Dates and versions

hal-01690189 , version 1 (22-01-2018)

Identifiers

HAL Id : hal-01690189 , version 1
DOI : 10.1056/NEJMoa1402454

Cite

Nezam Afdhal, Stefan Zeuzem, Paul Kwo, Mario Chojkier, Norman Gitlin, et al.. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. New England Journal of Medicine, 2014, 370 (20), pp.1889 - 1898. ⟨10.1056/NEJMoa1402454⟩. ⟨hal-01690189⟩

Export

BibTeX XML-TEI Dublin Core DC Terms EndNote DataCite

Collections

UNIV-PARIS7 UGA UBS IRISA_UBS UNIV-LORRAINE NGERE-UL BMS-UL

1261 View

0 Download

Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection

Abstract

Domains

Dates and versions

Identifiers

Cite

Export

Collections

Altmetric

Share