PMID- 27418632
OWN - NLM
STAT- MEDLINE
DCOM- 20170925
LR  - 20220408
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Print)
IS  - 0017-5749 (Linking)
VI  - 66
IP  - 10
DP  - 2017 Oct
TI  - Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV 
      genotype 2 infection: results of the real-world, clinical practice HCV-TARGET 
      study.
PG  - 1844-1852
LID - 10.1136/gutjnl-2016-311609 [doi]
AB  - OBJECTIVE: Due to a high efficacy in clinical trials, sofosbuvir (SOF) and 
      ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with 
      HCV genotype (GT) 2 infection. We investigated safety and effectiveness of these 
      regimens for GT2 in HCV-TARGET participants. DESIGN: HCV-TARGET, an 
      international, prospective observational study evaluates clinical practice data 
      on novel antiviral therapies at 44 academic and 17 community medical centres in 
      North America and Europe. Clinical data were centrally abstracted from medical 
      records. Selection of treatment regimen and duration was the investigator's 
      choice. The primary efficacy outcome was sustained virological response 12 weeks 
      after therapy (SVR12). RESULTS: Between December 2013 and April 2015, 321 
      patients completed 12 weeks (n=283) or 16 weeks (n=38) of treatment with SOF and 
      RBV. Prior treatment experience and cirrhosis was more frequent among patients in 
      the 16-week regimen compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, 
      respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without cirrhosis 
      was 91.0% and 92.9% for 12 or 16 weeks of therapy, respectively. In patients with 
      cirrhosis treated for 12 or 16 weeks, SVR12 was 79.0% and 83%. In the 
      multivariate analysis, liver cirrhosis, lower serum albumin and RBV dose at 
      baseline were significantly associated with SVR12. Common adverse events (AEs) 
      included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like 
      symptoms. Discontinuation due to AEs occurred in 2.8%. CONCLUSIONS: In this 
      clinical practice setting, SOF and RBV was safe and effective for treatment of 
      patients with HCV GT2 infection. TRIAL REGISTRATION NUMBER: NCT01474811.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://www.bmj.com/company/products-services/rights-and-licensing/.
FAU - Welzel, Tania M
AU  - Welzel TM
AD  - JW Goethe University Hospital, Frankfurt am Main, Germany.
FAU - Nelson, David R
AU  - Nelson DR
AD  - University of Florida, Gainesville, Florida, USA.
FAU - Morelli, Giuseppe
AU  - Morelli G
AD  - University of Florida, Gainesville, Florida, USA.
FAU - Di Bisceglie, Adrian
AU  - Di Bisceglie A
AD  - Saint Louis University School of Medicine, St. Louis, Missouri, USA.
FAU - Reddy, Rajender K
AU  - Reddy RK
AD  - University of Pennsylvania, Philadelphia, Pennsylvania, USA.
FAU - Kuo, Alexander
AU  - Kuo A
AD  - University of California, San Diego, San Diego, California, USA.
FAU - Lim, Joseph K
AU  - Lim JK
AD  - Yale University of School of Medicine, New Haven, Connecticut, USA.
FAU - Darling, Jama
AU  - Darling J
AD  - University of North Carolina, Chapel Hill, North Carolina, USA.
FAU - Pockros, Paul
AU  - Pockros P
AD  - Scripps Clinic, La Jolla, California, USA.
FAU - Galati, Joseph S
AU  - Galati JS
AD  - Research Specialists of Texas, Houston, Texas, USA.
FAU - Frazier, Lynn M
AU  - Frazier LM
AD  - Liver Wellness Clinic, Little Rock, Arkansas, USA.
FAU - Alqahtani, Saleh
AU  - Alqahtani S
AD  - Johns Hopkins University, Baltimore, Maryland, USA.
FAU - Sulkowski, Mark S
AU  - Sulkowski MS
AD  - Johns Hopkins University, Baltimore, Maryland, USA.
FAU - Vainorius, Monika
AU  - Vainorius M
AD  - University of North Carolina, Chapel Hill, North Carolina, USA.
FAU - Akushevich, Lucy
AU  - Akushevich L
AD  - University of North Carolina, Chapel Hill, North Carolina, USA.
FAU - Fried, Michael W
AU  - Fried MW
AD  - University of North Carolina, Chapel Hill, North Carolina, USA.
FAU - Zeuzem, Stefan
AU  - Zeuzem S
AD  - JW Goethe University Hospital, Frankfurt am Main, Germany.
CN  - HCV-TARGET Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01474811
GR  - K24 DA034621/DA/NIDA NIH HHS/United States
GR  - UL1 TR000064/TR/NCATS NIH HHS/United States
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
GR  - K24 DK066144/DK/NIDDK NIH HHS/United States
GR  - P30 AG028740/AG/NIA NIH HHS/United States
GR  - UL1 TR001427/TR/NCATS NIH HHS/United States
GR  - K24 DK070528/DK/NIDDK NIH HHS/United States
GR  - P30 DK034989/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20160713
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
RN  - 0 (Antiviral Agents)
RN  - 0 (Serum Albumin)
RN  - 49717AWG6K (Ribavirin)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*genetics
MH  - Hepatitis C, Chronic/complications/*drug therapy/*virology
MH  - Humans
MH  - Liver Cirrhosis/virology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Ribavirin/administration & dosage/adverse effects/*therapeutic use
MH  - Serum Albumin/metabolism
MH  - Sofosbuvir/administration & dosage/adverse effects/*therapeutic use
MH  - Sustained Virologic Response
MH  - Young Adult
PMC - PMC5595101
OTO - NOTNLM
OT  - CLINICAL TRIALS
OT  - GENOTYPE
OT  - HEPATITIS C
COIS- Competing interests: TMW: Consultancies/speaker for Abbvie, Bristol-Myers Squibb, 
      Gilead, Janssen. DRN: Grant funding from AbbVie, Gilead, BMS, Janssen, Merck, 
      GSK. GM: Grant funding from AbbVie, BMs, Gilead, Merck, Janssen, Vertex, Idenix, 
      Conatus and Salix. ADB: Grant funding from Gilead, AbbVie and BMS. Consultant for 
      Gilead, AbbVie and BMS. Expert testimony/advisory board from Gilead, AbbVie and 
      BMS. RKR: Grant funding from AbbVie, Merck, Gilead, Janssen, Vertex (Money paid 
      to Pennsylvania). Expert testimony/advisory board from AbbVie Merck, Gilead, BMS, 
      Janssen. AK: Grant funding from Gilead. JKL: Grant funding from BMS, Gilead, 
      Janssen, Hologic (All to institution). Consultant to BMS, Gilead, Janssen. JD: 
      Grant funding and consulting from BMS. PP: Grant funding from Gilead, BMS, 
      AbbVie, Merck, Janssen. Consultant for Gilead, BMS, AbbVie, Merck and Janssen. 
      Sponsored lectures/Honoraria from Gilead, BMS, AbbVie, Janssen. JSG: Grant 
      funding from Merck and Gilead. Sponsored lectures/Honoraria from Gilead Speakers 
      Bureau. LMF: Grant funding and consulting from Gilead, AbbVie, Janssen and Merck. 
      SA: Grant funding from Gilead, AbbVie and Merck. Consultant for Gilead, AbbVie, 
      Merck and Janssen. Sponsored Lectures/Honoraria from Gilead and AbbVie. MSS: 
      Grant funding from AbbVie, BMS, Gilead, Janssen and Merck. (Paid to Johns Hopkins 
      University, NIH/NDA K24DA034621). Consultant for AbbVie, CoCrystal Pharma, 
      Gilead, Janssen, Merck and Trek. MV: No Disclosures. LA: No Disclosures. MWF: 
      Grant funding from Merck, Janssen, Gilead, BMS, AbbVie and research grants from 
      NIH. Consultant for Merck, AbbVie, Gilead and BMS. SZ: Consultant for AbbVie, 
      BMS, Gilead, Janssen and Merck. Sponsored Lectures/Honoraria from AbbVie, BMS, 
      Gilead, Janssen and Merck.
EDAT- 2016/07/16 06:00
MHDA- 2017/09/26 06:00
PMCR- 2017/09/12
CRDT- 2016/07/16 06:00
PHST- 2016/02/06 00:00 [received]
PHST- 2016/06/01 00:00 [revised]
PHST- 2016/06/04 00:00 [accepted]
PHST- 2016/07/16 06:00 [pubmed]
PHST- 2017/09/26 06:00 [medline]
PHST- 2016/07/16 06:00 [entrez]
PHST- 2017/09/12 00:00 [pmc-release]
AID - gutjnl-2016-311609 [pii]
AID - 10.1136/gutjnl-2016-311609 [doi]
PST - ppublish
SO  - Gut. 2017 Oct;66(10):1844-1852. doi: 10.1136/gutjnl-2016-311609. Epub 2016 Jul 
      13.