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Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials.

Abstract Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by the S282T substitution in NS5B.
PMID
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Authors

Mayor MeshTerms
Keywords

GS-7977

HCV

NS5B polymerase

antiviral resistance

sofosbuvir

Journal Title clinical infectious diseases : an official publication of the infectious diseases society of america
Publication Year Start
%A Svarovskaia, Evguenia S.; Dvory-Sobol, Hadas; Parkin, Neil; Hebner, Christy; Gontcharova, Viktoria; Martin, Ross; Ouyang, Wen; Han, Bin; Xu, Simin; Ku, Karin; Chiu, Sophia; Gane, Edward; Jacobson, Ira M.; Nelson, David R.; Lawitz, Eric; Wyles, David L.; Bekele, Neby; Brainard, Diana; Symonds, William T.; McHutchison, John G.; Miller, Michael D.; Mo, Hongmei
%T Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials.
%J Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, vol. 59, no. 12, pp. 1666-1674
%D 12/2014
%V 59
%N 12
%M eng
%B Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by the S282T substitution in NS5B.
%K Antiviral Agents, Drug Resistance, Viral, Female, Hepacivirus, High-Throughput Nucleotide Sequencing, Humans, Male, Phenotype, Sofosbuvir, Treatment Outcome, Uridine Monophosphate
%P 1666
%L 1674
%Y 10.1093/cid/ciu697
%W PHY
%G AUTHOR
%R 2014.......59.1666S

@Article{Svarovskaia2014,
author="Svarovskaia, Evguenia S.
and Dvory-Sobol, Hadas
and Parkin, Neil
and Hebner, Christy
and Gontcharova, Viktoria
and Martin, Ross
and Ouyang, Wen
and Han, Bin
and Xu, Simin
and Ku, Karin
and Chiu, Sophia
and Gane, Edward
and Jacobson, Ira M.
and Nelson, David R.
and Lawitz, Eric
and Wyles, David L.
and Bekele, Neby
and Brainard, Diana
and Symonds, William T.
and McHutchison, John G.
and Miller, Michael D.
and Mo, Hongmei",
title="Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials.",
journal="Clinical infectious diseases : an official publication of the Infectious Diseases Society of America",
year="2014",
month="Dec",
day="15",
volume="59",
number="12",
pages="1666--1674",
keywords="Antiviral Agents",
keywords="Drug Resistance, Viral",
keywords="Female",
keywords="Hepacivirus",
keywords="High-Throughput Nucleotide Sequencing",
keywords="Humans",
keywords="Male",
keywords="Phenotype",
keywords="Sofosbuvir",
keywords="Treatment Outcome",
keywords="Uridine Monophosphate",
abstract="Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by the S282T substitution in NS5B.",
issn="1537-6591",
doi="10.1093/cid/ciu697",
url="http://www.ncbi.nlm.nih.gov/pubmed/25266287",
language="eng"
}

%0 Journal Article
%T Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials.
%A Svarovskaia, Evguenia S.
%A Dvory-Sobol, Hadas
%A Parkin, Neil
%A Hebner, Christy
%A Gontcharova, Viktoria
%A Martin, Ross
%A Ouyang, Wen
%A Han, Bin
%A Xu, Simin
%A Ku, Karin
%A Chiu, Sophia
%A Gane, Edward
%A Jacobson, Ira M.
%A Nelson, David R.
%A Lawitz, Eric
%A Wyles, David L.
%A Bekele, Neby
%A Brainard, Diana
%A Symonds, William T.
%A McHutchison, John G.
%A Miller, Michael D.
%A Mo, Hongmei
%J Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
%D 2014
%8 Dec 15
%V 59
%N 12
%@ 1537-6591
%G eng
%F Svarovskaia2014
%X Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by the S282T substitution in NS5B.
%K Antiviral Agents
%K Drug Resistance, Viral
%K Female
%K Hepacivirus
%K High-Throughput Nucleotide Sequencing
%K Humans
%K Male
%K Phenotype
%K Sofosbuvir
%K Treatment Outcome
%K Uridine Monophosphate
%U http://dx.doi.org/10.1093/cid/ciu697
%U http://www.ncbi.nlm.nih.gov/pubmed/25266287
%P 1666-1674

PT Journal
AU Svarovskaia, ES
   Dvory-Sobol, H
   Parkin, N
   Hebner, C
   Gontcharova, V
   Martin, R
   Ouyang, W
   Han, B
   Xu, S
   Ku, K
   Chiu, S
   Gane, E
   Jacobson, IM
   Nelson, DR
   Lawitz, E
   Wyles, DL
   Bekele, N
   Brainard, D
   Symonds, WT
   McHutchison, JG
   Miller, MD
   Mo, H
TI Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials.
SO Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
JI Clin. Infect. Dis.
PD Dec
PY 2014
BP 1666
EP 1674
VL 59
IS 12
DI 10.1093/cid/ciu697
LA eng
DE Antiviral Agents; Drug Resistance, Viral; Female; Hepacivirus; High-Throughput Nucleotide Sequencing; Humans; Male; Phenotype; Sofosbuvir; Treatment Outcome; Uridine Monophosphate
AB Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by the S282T substitution in NS5B.
ER

PMID- 25266287
OWN - NLM
STAT- MEDLINE
DA  - 20141126
DCOM- 20150901
LR  - 20151119
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 59
IP  - 12
DP  - 2014 Dec 15
TI  - Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected
      subjects treated with sofosbuvir in phase 2 and 3 clinical trials.
PG  - 1666-74
LID - 10.1093/cid/ciu697 [doi]
AB  - BACKGROUND: Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of
      the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects
      with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by 
      the S282T substitution in NS5B. METHODS: NS5B sequencing and susceptibility
      testing of HCV from subjects infected with genotypes 1-6 who participated in
      phase 2 and 3 sofosbuvir clinical trials was performed. RESULTS: No NS5B variants
      present at baseline among 1645 sofosbuvir-treated subjects were associated with
      treatment failure; sofosbuvir susceptibility was within 2-fold of reference.
      Among 282 subjects who did not achieve sustained virologic response, no novel
      sofosbuvir resistance-associated variants were identified, and the NS5B changes
      observed did not confer significant reductions in sofosbuvir susceptibility. In 1
      subject with S282T observed at relapse 4 weeks after sofosbuvir monotherapy, the 
      resistant variant (13.5-fold reduced sofosbuvir susceptibility, replication
      capacity <2% of control) became undetectable by deep sequencing 12 weeks after
      treatment. L159F and V321A were identified as treatment-emergent variants but did
      not confer resistance to sofosbuvir in the replicon system. CONCLUSIONS: These
      data demonstrate a uniform susceptibility of subject-derived HCV to sofosbuvir,
      and also show that selection of sofosbuvir-resistant HCV is exceedingly rare and 
      is associated with a significant reduction in viral fitness.
CI  - (c) The Author 2014. Published by Oxford University Press on behalf of the
      Infectious Diseases Society of America. All rights reserved. For Permissions,
      please e-mail: [email protected]
FAU - Svarovskaia, Evguenia S
AU  - Svarovskaia ES
AD  - Gilead Sciences, Foster City.
FAU - Dvory-Sobol, Hadas
AU  - Dvory-Sobol H
AD  - Gilead Sciences, Foster City.
FAU - Parkin, Neil
AU  - Parkin N
AD  - Data First Consulting Inc, Belmont, California.
FAU - Hebner, Christy
AU  - Hebner C
AD  - Gilead Sciences, Foster City.
FAU - Gontcharova, Viktoria
AU  - Gontcharova V
AD  - Gilead Sciences, Foster City.
FAU - Martin, Ross
AU  - Martin R
AD  - Gilead Sciences, Foster City.
FAU - Ouyang, Wen
AU  - Ouyang W
AD  - Gilead Sciences, Foster City.
FAU - Han, Bin
AU  - Han B
AD  - Gilead Sciences, Foster City.
FAU - Xu, Simin
AU  - Xu S
AD  - Gilead Sciences, Foster City.
FAU - Ku, Karin
AU  - Ku K
AD  - Gilead Sciences, Foster City.
FAU - Chiu, Sophia
AU  - Chiu S
AD  - Gilead Sciences, Foster City.
FAU - Gane, Edward
AU  - Gane E
AD  - University of Auckland, Auckland City Hospital, New Zealand.
FAU - Jacobson, Ira M
AU  - Jacobson IM
AD  - Weill Cornell Medical College, New York, New York.
FAU - Nelson, David R
AU  - Nelson DR
AD  - University of Florida, Gainesville.
FAU - Lawitz, Eric
AU  - Lawitz E
AD  - Texas Liver Institute, San Antonio.
FAU - Wyles, David L
AU  - Wyles DL
AD  - Division of Infectious Diseases, University of California, San Diego.
FAU - Bekele, Neby
AU  - Bekele N
AD  - Gilead Sciences, Foster City.
FAU - Brainard, Diana
AU  - Brainard D
AD  - Gilead Sciences, Foster City.
FAU - Symonds, William T
AU  - Symonds WT
AD  - Gilead Sciences, Foster City.
FAU - McHutchison, John G
AU  - McHutchison JG
AD  - Gilead Sciences, Foster City.
FAU - Miller, Michael D
AU  - Miller MD
AD  - Gilead Sciences, Foster City.
FAU - Mo, Hongmei
AU  - Mo H
AD  - Gilead Sciences, Foster City.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140928
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases
      Society of America
JID - 9203213
RN  - 0 (Antiviral Agents)
RN  - E2OU15WN0N (Uridine Monophosphate)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/*therapeutic use
MH  - Drug Resistance, Viral
MH  - Female
MH  - Hepacivirus/*pathogenicity
MH  - High-Throughput Nucleotide Sequencing
MH  - Humans
MH  - Male
MH  - Phenotype
MH  - Sofosbuvir
MH  - Treatment Outcome
MH  - Uridine Monophosphate/*analogs & derivatives/therapeutic use
OTO - NOTNLM
OT  - GS-7977
OT  - HCV
OT  - NS5B polymerase
OT  - antiviral resistance
OT  - sofosbuvir
EDAT- 2014/10/01 06:00
MHDA- 2015/09/02 06:00
CRDT- 2014/10/01 06:00
PHST- 2014/09/28 [aheadofprint]
AID - ciu697 [pii]
AID - 10.1093/cid/ciu697 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2014 Dec 15;59(12):1666-74. doi: 10.1093/cid/ciu697. Epub 2014
      Sep 28.
TY  - JOUR
AU  - Svarovskaia, Evguenia S.
AU  - Dvory-Sobol, Hadas
AU  - Parkin, Neil
AU  - Hebner, Christy
AU  - Gontcharova, Viktoria
AU  - Martin, Ross
AU  - Ouyang, Wen
AU  - Han, Bin
AU  - Xu, Simin
AU  - Ku, Karin
AU  - Chiu, Sophia
AU  - Gane, Edward
AU  - Jacobson, Ira M.
AU  - Nelson, David R.
AU  - Lawitz, Eric
AU  - Wyles, David L.
AU  - Bekele, Neby
AU  - Brainard, Diana
AU  - Symonds, William T.
AU  - McHutchison, John G.
AU  - Miller, Michael D.
AU  - Mo, Hongmei
PY  - 2014/Dec/15
TI  - Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials.
T2  - Clin. Infect. Dis.
JO  - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
SP  - 1666
EP  - 1674
VL  - 59
IS  - 12
KW  - Antiviral Agents
KW  - Drug Resistance, Viral
KW  - Female
KW  - Hepacivirus
KW  - High-Throughput Nucleotide Sequencing
KW  - Humans
KW  - Male
KW  - Phenotype
KW  - Sofosbuvir
KW  - Treatment Outcome
KW  - Uridine Monophosphate
N2  - Sofosbuvir is a chain-terminating nucleotide analogue inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase that is efficacious in subjects with HCV genotype 1-6 infection. Sofosbuvir resistance is primarily conferred by the S282T substitution in NS5B.
SN  - 1537-6591
UR  - http://dx.doi.org/10.1093/cid/ciu697
UR  - http://www.ncbi.nlm.nih.gov/pubmed/25266287
ID  - Svarovskaia2014
ER  - 
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