PMID- 27327078
OWN - NLM
STAT- MEDLINE
DCOM- 20171103
LR  - 20211204
IS  - 1557-7465 (Electronic)
IS  - 1079-9907 (Linking)
VI  - 36
IP  - 11
DP  - 2016 Nov
TI  - Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon 
      Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b.
PG  - 635-643
AB  - The study objective was to compare the efficacy and safety of peginterferon 
      lambda-1a combined with ribavirin/daclatasvir (Lambda/RBV/DCV), versus 
      peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in 
      patients chronically infected with hepatitis C virus (HCV), genotype 1b. This was 
      a prospective, randomized, open-label, phase 3 study (NCT01718158) in adults 
      (aged >/=18 years) who were treatment naive or prior relapsers to peginterferon 
      alfa/ribavirin therapy. The primary endpoint was sustained virologic response at 
      post-treatment follow-up week 12 (SVR12). Patients were randomized in a 2:1 ratio 
      to receive 24 weeks of Lambda/RBV/DCV or response-guided 24 or 48 weeks of 
      Alfa/RBV/TVR. Overall, 440 patients were treated (294 with Lambda/RBV/DCV; 146 
      with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8% in the 
      Lambda/RBV/DCV arm and 70.5% in the Alfa/RBV/TVR arm (difference between arms: 
      18.3%; 95% confidence interval: 9.9-25.7; P < 0.0001). Patients in the 
      Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic 
      abnormalities, flu-like symptoms, serious AEs, and discontinuations due to AEs, 
      but more liver abnormalities than those in the Alfa/RBV/TVR group. In conclusion, 
      treatment with Lambda/RBV/DCV led to higher SVR12 rates and a more favorable 
      safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b 
      infection.
FAU - Flisiak, Robert
AU  - Flisiak R
AD  - 1 Department of Infectious Diseases and Hepatology, Medical University of 
      Bialystok , Bialystok, Poland .
FAU - Kawazoe, Seiji
AU  - Kawazoe S
AD  - 2 Department of Hepatobiliary and Pancreatology, Saga Prefectural Hospital 
      Koseikan , Saga, Japan .
FAU - Znoyko, Olga
AU  - Znoyko O
AD  - 3 Moscow State University of Medicine and Dentistry , Moscow, Russia .
FAU - Assy, Nimer
AU  - Assy N
AD  - 4 Department of Liver, Ziv Medical Center and Bar-Ilan University , Safed, Israel 
      .
FAU - Gadano, Adrian
AU  - Gadano A
AD  - 5 Liver Unit, Hospital Italiano de Buenos Aires , Buenos Aires, Argentina .
FAU - Kao, Jia-Horng
AU  - Kao JH
AD  - 6 Hepatitis Research Center, National Taiwan University , Taipei, Taiwan .
FAU - Lee, Kwan-Sik
AU  - Lee KS
AD  - 7 Gastroenterology, Yonsei University College of Medicine , Seoul, South Korea .
FAU - Zwirtes, Ricardo
AU  - Zwirtes R
AD  - 8 Research and Development, Bristol-Myers Squibb, Inc. , Wallingford, 
      Connecticut.
FAU - Portsmouth, Simon
AU  - Portsmouth S
AD  - 8 Research and Development, Bristol-Myers Squibb, Inc. , Wallingford, 
      Connecticut.
FAU - Dong, Yuping
AU  - Dong Y
AD  - 9 Research and Development, Bristol-Myers Squibb, Inc. , Princeton, New Jersey.
FAU - Xu, Dong
AU  - Xu D
AD  - 8 Research and Development, Bristol-Myers Squibb, Inc. , Wallingford, 
      Connecticut.
FAU - Kumada, Hiromitsu
AU  - Kumada H
AD  - 10 Department of Hepatology, Toranomon Hospital , Tokyo, Japan .
FAU - Srinivasan, Subasree
AU  - Srinivasan S
AD  - 8 Research and Development, Bristol-Myers Squibb, Inc. , Wallingford, 
      Connecticut.
LA  - eng
SI  - ClinicalTrials.gov/NCT01718158
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160621
PL  - United States
TA  - J Interferon Cytokine Res
JT  - Journal of interferon & cytokine research : the official journal of the 
      International Society for Interferon and Cytokine Research
JID - 9507088
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Interferon-alpha)
RN  - 0 (Oligopeptides)
RN  - 0 (Pyrrolidines)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 49717AWG6K (Ribavirin)
RN  - 655M5O3W0U (telaprevir)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/administration & dosage/*therapeutic use
MH  - Carbamates
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*genetics
MH  - Hepatitis C, Chronic/*drug therapy/*virology
MH  - Humans
MH  - Imidazoles/administration & dosage/*therapeutic use
MH  - Interferon-alpha/administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Oligopeptides/administration & dosage/*therapeutic use
MH  - Polyethylene Glycols/administration & dosage/*therapeutic use
MH  - Prospective Studies
MH  - Pyrrolidines
MH  - Recombinant Proteins/administration & dosage/therapeutic use
MH  - Ribavirin/administration & dosage/*therapeutic use
MH  - Valine/analogs & derivatives
MH  - Young Adult
OTO - NOTNLM
OT  - clinical trial
OT  - daclatasvir
OT  - hepatitis C
OT  - interferon lambda-1a
OT  - ribavirin
EDAT- 2016/11/02 06:00
MHDA- 2017/11/04 06:00
CRDT- 2016/06/22 06:00
PHST- 2016/11/02 06:00 [pubmed]
PHST- 2017/11/04 06:00 [medline]
PHST- 2016/06/22 06:00 [entrez]
AID - 10.1089/jir.2015.0173 [doi]
PST - ppublish
SO  - J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. 
      Epub 2016 Jun 21.