PMID- 24201995
OWN - NLM
STAT- MEDLINE
DCOM- 20140728
LR  - 20211021
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Print)
IS  - 0017-5749 (Linking)
VI  - 63
IP  - 7
DP  - 2014 Jul
TI  - Safety and on-treatment efficacy of telaprevir: the early access programme for 
      patients with advanced hepatitis C.
PG  - 1150-8
LID - 10.1136/gutjnl-2013-305667 [doi]
AB  - BACKGROUND AND AIM: Severe adverse events (AEs) compromise the outcome of direct 
      antiviral agent-based treatment in patients with advanced liver fibrosis due to 
      HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety 
      and efficacy of telaprevir (TVR) plus pegylated-interferon-alpha (PEG-IFNalpha) and 
      ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 
      (HCV-1). METHODS: 1782 patients with HCV-1 and bridging fibrosis or compensated 
      cirrhosis were prospectively recruited from 16 countries worldwide, and treated 
      with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and 
      RBV (PR) alone dependent on virological response to treatment and previous 
      response type. RESULTS: 1587 patients completed 12 weeks of triple therapy and 
      4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was 
      undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 
      72% of null responders. Overall, 931 patients (59%) developed grade 1-4 anaemia 
      (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin 
      and 157 (10%) were transfused. Age and female gender were the strongest 
      predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. 
      Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven 
      patients died (0.4%, six had cirrhosis). CONCLUSIONS: In compensated patients 
      with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory 
      rates of safety, tolerability and on-treatment virological response with adequate 
      managements of AEs.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://group.bmj.com/group/rights-licensing/permissions.
FAU - Colombo, M
AU  - Colombo M
AD  - Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca; Granda 
      Ospedale Maggiore Policlinico, Universita; degli Studi di Milano, Milan, Italy.
FAU - Fernandez, I
AU  - Fernandez I
AD  - Hospital Universitario 12 de Octubre, Seccion de Aparato Digestivo, Madrid, 
      Spain.
FAU - Abdurakhmanov, D
AU  - Abdurakhmanov D
AD  - I.M. Sechenov First Moscow State Medical University, E. M. Tareev Clinic for 
      Nephrology, Internal and Occupational Medicine, Moscow, Russia.
FAU - Ferreira, P A
AU  - Ferreira PA
AD  - Viral Hepatitis Division of Infectious Disease, Outpatient Clinic to HIV, Federal 
      University of Sao Paulo, Sao Paulo, Brazil.
FAU - Strasser, S I
AU  - Strasser SI
AD  - AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, 
      University of Sydney, Sydney, Australia.
FAU - Urbanek, P
AU  - Urbanek P
AD  - Department of Internal Medicine, First Medical Faculty, Charles University, and 
      Central Military Hospital Prague, Prague, Czech Republic.
FAU - Moreno, C
AU  - Moreno C
AD  - Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive 
      Oncology, Erasme University Hospital, Universite Libre de Bruxelles, Brussels, 
      Belgium.
FAU - Streinu-Cercel, A
AU  - Streinu-Cercel A
AD  - Carol Davila University of Medicine and Pharmacy, National Institute for 
      Infectious Diseases, "Prof. Dr. Matei Bals", Bucharest, Romania.
FAU - Verheyen, A
AU  - Verheyen A
AD  - Janssen Pharmaceutica, Beerse, Belgium.
FAU - Iraqi, W
AU  - Iraqi W
AD  - Janssen Pharmaceuticals, Paris, France.
FAU - DeMasi, R
AU  - DeMasi R
AD  - Janssen Research and Development, Titusville, New Jersey, USA.
FAU - Hill, A
AU  - Hill A
AD  - Janssen Research and Development, High Wycombe, UK.
FAU - Lauffer, J M
AU  - Lauffer JM
AD  - Janssen-Cilag AG, Zug, Switzerland.
FAU - Lonjon-Domanec, I
AU  - Lonjon-Domanec I
AD  - Janssen Pharmaceuticals, Paris, France.
FAU - Wedemeyer, H
AU  - Wedemeyer H
AD  - Medizinische Hochschule Hannover, Hannover, Germany.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20131107
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
RN  - 0 (Antiviral Agents)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Oligopeptides)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 49717AWG6K (Ribavirin)
RN  - 655M5O3W0U (telaprevir)
RN  - G8RGG88B68 (peginterferon alfa-2b)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
CIN - Gut. 2014 Jul;63(7):1033-4. PMID: 24334256
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Genotype
MH  - Hepacivirus/genetics
MH  - Hepatitis C, Chronic/complications/*drug therapy
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/*therapeutic use
MH  - Linear Models
MH  - Liver Cirrhosis/*virology
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Oligopeptides/adverse effects/*therapeutic use
MH  - Polyethylene Glycols/*therapeutic use
MH  - Prospective Studies
MH  - Recombinant Proteins/therapeutic use
MH  - Ribavirin/*therapeutic use
MH  - Treatment Outcome
PMC - PMC4078754
OTO - NOTNLM
OT  - ANEMIA
OT  - HEPATITIS C
OT  - INTERFERON
EDAT- 2013/11/10 06:00
MHDA- 2014/07/30 06:00
CRDT- 2013/11/09 06:00
PHST- 2013/11/09 06:00 [entrez]
PHST- 2013/11/10 06:00 [pubmed]
PHST- 2014/07/30 06:00 [medline]
AID - gutjnl-2013-305667 [pii]
AID - 10.1136/gutjnl-2013-305667 [doi]
PST - ppublish
SO  - Gut. 2014 Jul;63(7):1150-8. doi: 10.1136/gutjnl-2013-305667. Epub 2013 Nov 7.