Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Identifieur interne : 002603 ( PubMed/Corpus ); précédent : 002602; suivant : 002604Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Auteurs : Graham R. Foster ; Nezam Afdhal ; Stuart K. Roberts ; Norbert Br U ; Edward J. Gane ; Stephen Pianko ; Eric Lawitz ; Alex Thompson ; Mitchell L. Shiffman ; Curtis Cooper ; William J. Towner ; Brian Conway ; Peter Ruane ; Marc Bourlière ; Tarik Asselah ; Thomas Berg ; Stefan Zeuzem ; William Rosenberg ; Kosh Agarwal ; Catherine A M. Stedman ; Hongmei Mo ; Hadas Dvory-Sobol ; Lingling Han ; Jing Wang ; John Mcnally ; Anu Osinusi ; Diana M. Brainard ; John G. Mchutchison ; Francesco Mazzotta ; Tram T. Tran ; Stuart C. Gordon ; Keyur Patel ; Nancy Reau ; Alessandra Mangia ; Mark SulkowskiSource :
- The New England journal of medicine [ 1533-4406 ] ; 2015.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Carbamates (adverse effects), Carbamates (therapeutic use), Drug Combinations, Drug Resistance, Viral, Female, Genotype, Hepacivirus (genetics), Hepatitis C, Chronic (complications), Hepatitis C, Chronic (drug therapy), Hepatitis C, Chronic (virology), Heterocyclic Compounds, 4 or More Rings (adverse effects), Heterocyclic Compounds, 4 or More Rings (therapeutic use), Humans, Liver Cirrhosis (drug therapy), Liver Cirrhosis (etiology), Male, Middle Aged, Sofosbuvir (adverse effects), Sofosbuvir (therapeutic use), Treatment Outcome, Viral Nonstructural Proteins (antagonists & inhibitors), Young Adult.
- MESH :
- chemical , adverse effects : Antiviral Agents, Carbamates, Heterocyclic Compounds, 4 or More Rings, Sofosbuvir.
- chemical , antagonists & inhibitors : Viral Nonstructural Proteins.
- chemical , therapeutic use : Antiviral Agents, Carbamates, Heterocyclic Compounds, 4 or More Rings, Sofosbuvir.
- complications : Hepatitis C, Chronic.
- drug therapy : Hepatitis C, Chronic, Liver Cirrhosis.
- etiology : Liver Cirrhosis.
- genetics : Hepacivirus.
- virology : Hepatitis C, Chronic.
- Adult, Aged, Aged, 80 and over, Drug Combinations, Drug Resistance, Viral, Female, Genotype, Humans, Male, Middle Aged, Treatment Outcome, Young Adult.
Abstract
In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3.
DOI: 10.1056/NEJMoa1512612
PubMed: 26575258
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.</title><author><name sortKey="Foster, Graham R" sort="Foster, Graham R" uniqKey="Foster G" first="Graham R" last="Foster">Graham R. Foster</name><affiliation><nlm:affiliation>From Queen Mary University of London (G.R.F.), University College London (W.R.), King's College Hospital (W.R.), and Institute of Liver Studies (K.A.) - all in London; Beth Israel Deaconess Medical Center, Boston (N.A.); Alfred Health and Monash University (S.K.R.) and St. Vincent's Hospital (A.T.), Melbourne, VIC, and Monash Health and Monash University, Clayton, VIC (S.P.) - all in Australia; James J. Peters Veterans Affairs Medical Center, Bronx (N.B.), and Icahn School of Medicine at Mount Sinai, New York (N.B.) - both in New York; Auckland Clinical Studies, Auckland (E.J.G.), and Christchurch Clinical Studies Trust and University of Otago, Christchurch (C.A.M.S.) - both in New Zealand; Texas Liver Institute, University of Texas Health Science Center, San Antonio (E.L.); Liver Institute of Virginia, Richmond (M.L.S.); University of Ottawa, Ottawa (C.C.), and Vancouver Infectious Diseases Centre, Vancouver, BC (B.C.) - both in Canada; Kaiser Permanente (W.J.T.), Ruane Medical (P.R.), and Cedars-Sinai Medical Center (T.T.T.), Los Angeles, and Gilead Sciences, Foster City (H.M., H.D.-S., L.H., J.W., J.M., A.O., D.M.B., J.G.M.) - all in California; Hôpital Saint Joseph, Marseilles (M.B.), and Service d'Hépatologie, Hôpital Beaujon, INSERM UMR 1149, Université Paris Diderot, Clichy (T.A.) - both in France; University Hospital Leipzig, Leipzig (T.B.), and Johann Wolfgang Goethe University, Frankfurt (S.Z.) - both in Germany; Santa Maria Annunziata Hospital, Florence (F.M.), and Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (A.M.) - both in Italy; Henry Ford Health System, Detroit (S.C.G.); Duke University School of Medicine, Durham, NC (K.P.); Rush University Medical Center, Chicago (N.R.); and Johns Hopkins University, Baltimore (M.S.).</nlm:affiliation></affiliation></author><author><name sortKey="Afdhal, Nezam" sort="Afdhal, Nezam" uniqKey="Afdhal N" first="Nezam" last="Afdhal">Nezam Afdhal</name></author><author><name sortKey="Roberts, Stuart K" sort="Roberts, Stuart K" uniqKey="Roberts S" first="Stuart K" last="Roberts">Stuart K. 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Stedman</name></author><author><name sortKey="Mo, Hongmei" sort="Mo, Hongmei" uniqKey="Mo H" first="Hongmei" last="Mo">Hongmei Mo</name></author><author><name sortKey="Dvory Sobol, Hadas" sort="Dvory Sobol, Hadas" uniqKey="Dvory Sobol H" first="Hadas" last="Dvory-Sobol">Hadas Dvory-Sobol</name></author><author><name sortKey="Han, Lingling" sort="Han, Lingling" uniqKey="Han L" first="Lingling" last="Han">Lingling Han</name></author><author><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name></author><author><name sortKey="Mcnally, John" sort="Mcnally, John" uniqKey="Mcnally J" first="John" last="Mcnally">John Mcnally</name></author><author><name sortKey="Osinusi, Anu" sort="Osinusi, Anu" uniqKey="Osinusi A" first="Anu" last="Osinusi">Anu Osinusi</name></author><author><name sortKey="Brainard, Diana M" sort="Brainard, Diana M" uniqKey="Brainard D" first="Diana M" last="Brainard">Diana M. Brainard</name></author><author><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G" last="Mchutchison">John G. Mchutchison</name></author><author><name sortKey="Mazzotta, Francesco" sort="Mazzotta, Francesco" uniqKey="Mazzotta F" first="Francesco" last="Mazzotta">Francesco Mazzotta</name></author><author><name sortKey="Tran, Tram T" sort="Tran, Tram T" uniqKey="Tran T" first="Tram T" last="Tran">Tram T. Tran</name></author><author><name sortKey="Gordon, Stuart C" sort="Gordon, Stuart C" uniqKey="Gordon S" first="Stuart C" last="Gordon">Stuart C. Gordon</name></author><author><name sortKey="Patel, Keyur" sort="Patel, Keyur" uniqKey="Patel K" first="Keyur" last="Patel">Keyur Patel</name></author><author><name sortKey="Reau, Nancy" sort="Reau, Nancy" uniqKey="Reau N" first="Nancy" last="Reau">Nancy Reau</name></author><author><name sortKey="Mangia, Alessandra" sort="Mangia, Alessandra" uniqKey="Mangia A" first="Alessandra" last="Mangia">Alessandra Mangia</name></author><author><name sortKey="Sulkowski, Mark" sort="Sulkowski, Mark" uniqKey="Sulkowski M" first="Mark" last="Sulkowski">Mark Sulkowski</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26575258</idno><idno type="pmid">26575258</idno><idno type="doi">10.1056/NEJMoa1512612</idno><idno type="wicri:Area/PubMed/Corpus">002603</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002603</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.</title><author><name sortKey="Foster, Graham R" sort="Foster, Graham R" uniqKey="Foster G" first="Graham R" last="Foster">Graham R. Foster</name><affiliation><nlm:affiliation>From Queen Mary University of London (G.R.F.), University College London (W.R.), King's College Hospital (W.R.), and Institute of Liver Studies (K.A.) - all in London; Beth Israel Deaconess Medical Center, Boston (N.A.); Alfred Health and Monash University (S.K.R.) and St. Vincent's Hospital (A.T.), Melbourne, VIC, and Monash Health and Monash University, Clayton, VIC (S.P.) - all in Australia; James J. Peters Veterans Affairs Medical Center, Bronx (N.B.), and Icahn School of Medicine at Mount Sinai, New York (N.B.) - both in New York; Auckland Clinical Studies, Auckland (E.J.G.), and Christchurch Clinical Studies Trust and University of Otago, Christchurch (C.A.M.S.) - both in New Zealand; Texas Liver Institute, University of Texas Health Science Center, San Antonio (E.L.); Liver Institute of Virginia, Richmond (M.L.S.); University of Ottawa, Ottawa (C.C.), and Vancouver Infectious Diseases Centre, Vancouver, BC (B.C.) - both in Canada; Kaiser Permanente (W.J.T.), Ruane Medical (P.R.), and Cedars-Sinai Medical Center (T.T.T.), Los Angeles, and Gilead Sciences, Foster City (H.M., H.D.-S., L.H., J.W., J.M., A.O., D.M.B., J.G.M.) - all in California; Hôpital Saint Joseph, Marseilles (M.B.), and Service d'Hépatologie, Hôpital Beaujon, INSERM UMR 1149, Université Paris Diderot, Clichy (T.A.) - both in France; University Hospital Leipzig, Leipzig (T.B.), and Johann Wolfgang Goethe University, Frankfurt (S.Z.) - both in Germany; Santa Maria Annunziata Hospital, Florence (F.M.), and Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (A.M.) - both in Italy; Henry Ford Health System, Detroit (S.C.G.); Duke University School of Medicine, Durham, NC (K.P.); Rush University Medical Center, Chicago (N.R.); and Johns Hopkins University, Baltimore (M.S.).</nlm:affiliation></affiliation></author><author><name sortKey="Afdhal, Nezam" sort="Afdhal, Nezam" uniqKey="Afdhal N" first="Nezam" last="Afdhal">Nezam Afdhal</name></author><author><name sortKey="Roberts, Stuart K" sort="Roberts, Stuart K" uniqKey="Roberts S" first="Stuart K" last="Roberts">Stuart K. Roberts</name></author><author><name sortKey="Br U, Norbert" sort="Br U, Norbert" uniqKey="Br U N" first="Norbert" last="Br U">Norbert Br U</name></author><author><name sortKey="Gane, Edward J" sort="Gane, Edward J" uniqKey="Gane E" first="Edward J" last="Gane">Edward J. Gane</name></author><author><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name></author><author><name sortKey="Lawitz, Eric" sort="Lawitz, Eric" uniqKey="Lawitz E" first="Eric" last="Lawitz">Eric Lawitz</name></author><author><name sortKey="Thompson, Alex" sort="Thompson, Alex" uniqKey="Thompson A" first="Alex" last="Thompson">Alex Thompson</name></author><author><name sortKey="Shiffman, Mitchell L" sort="Shiffman, Mitchell L" uniqKey="Shiffman M" first="Mitchell L" last="Shiffman">Mitchell L. Shiffman</name></author><author><name sortKey="Cooper, Curtis" sort="Cooper, Curtis" uniqKey="Cooper C" first="Curtis" last="Cooper">Curtis Cooper</name></author><author><name sortKey="Towner, William J" sort="Towner, William J" uniqKey="Towner W" first="William J" last="Towner">William J. Towner</name></author><author><name sortKey="Conway, Brian" sort="Conway, Brian" uniqKey="Conway B" first="Brian" last="Conway">Brian Conway</name></author><author><name sortKey="Ruane, Peter" sort="Ruane, Peter" uniqKey="Ruane P" first="Peter" last="Ruane">Peter Ruane</name></author><author><name sortKey="Bourliere, Marc" sort="Bourliere, Marc" uniqKey="Bourliere M" first="Marc" last="Bourlière">Marc Bourlière</name></author><author><name sortKey="Asselah, Tarik" sort="Asselah, Tarik" uniqKey="Asselah T" first="Tarik" last="Asselah">Tarik Asselah</name></author><author><name sortKey="Berg, Thomas" sort="Berg, Thomas" uniqKey="Berg T" first="Thomas" last="Berg">Thomas Berg</name></author><author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name></author><author><name sortKey="Rosenberg, William" sort="Rosenberg, William" uniqKey="Rosenberg W" first="William" last="Rosenberg">William Rosenberg</name></author><author><name sortKey="Agarwal, Kosh" sort="Agarwal, Kosh" uniqKey="Agarwal K" first="Kosh" last="Agarwal">Kosh Agarwal</name></author><author><name sortKey="Stedman, Catherine A M" sort="Stedman, Catherine A M" uniqKey="Stedman C" first="Catherine A M" last="Stedman">Catherine A M. Stedman</name></author><author><name sortKey="Mo, Hongmei" sort="Mo, Hongmei" uniqKey="Mo H" first="Hongmei" last="Mo">Hongmei Mo</name></author><author><name sortKey="Dvory Sobol, Hadas" sort="Dvory Sobol, Hadas" uniqKey="Dvory Sobol H" first="Hadas" last="Dvory-Sobol">Hadas Dvory-Sobol</name></author><author><name sortKey="Han, Lingling" sort="Han, Lingling" uniqKey="Han L" first="Lingling" last="Han">Lingling Han</name></author><author><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name></author><author><name sortKey="Mcnally, John" sort="Mcnally, John" uniqKey="Mcnally J" first="John" last="Mcnally">John Mcnally</name></author><author><name sortKey="Osinusi, Anu" sort="Osinusi, Anu" uniqKey="Osinusi A" first="Anu" last="Osinusi">Anu Osinusi</name></author><author><name sortKey="Brainard, Diana M" sort="Brainard, Diana M" uniqKey="Brainard D" first="Diana M" last="Brainard">Diana M. Brainard</name></author><author><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G" last="Mchutchison">John G. Mchutchison</name></author><author><name sortKey="Mazzotta, Francesco" sort="Mazzotta, Francesco" uniqKey="Mazzotta F" first="Francesco" last="Mazzotta">Francesco Mazzotta</name></author><author><name sortKey="Tran, Tram T" sort="Tran, Tram T" uniqKey="Tran T" first="Tram T" last="Tran">Tram T. Tran</name></author><author><name sortKey="Gordon, Stuart C" sort="Gordon, Stuart C" uniqKey="Gordon S" first="Stuart C" last="Gordon">Stuart C. Gordon</name></author><author><name sortKey="Patel, Keyur" sort="Patel, Keyur" uniqKey="Patel K" first="Keyur" last="Patel">Keyur Patel</name></author><author><name sortKey="Reau, Nancy" sort="Reau, Nancy" uniqKey="Reau N" first="Nancy" last="Reau">Nancy Reau</name></author><author><name sortKey="Mangia, Alessandra" sort="Mangia, Alessandra" uniqKey="Mangia A" first="Alessandra" last="Mangia">Alessandra Mangia</name></author><author><name sortKey="Sulkowski, Mark" sort="Sulkowski, Mark" uniqKey="Sulkowski M" first="Mark" last="Sulkowski">Mark Sulkowski</name></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="eISSN">1533-4406</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (therapeutic use)</term><term>Carbamates (adverse effects)</term><term>Carbamates (therapeutic use)</term><term>Drug Combinations</term><term>Drug Resistance, Viral</term><term>Female</term><term>Genotype</term><term>Hepacivirus (genetics)</term><term>Hepatitis C, Chronic (complications)</term><term>Hepatitis C, Chronic (drug therapy)</term><term>Hepatitis C, Chronic (virology)</term><term>Heterocyclic Compounds, 4 or More Rings (adverse effects)</term><term>Heterocyclic Compounds, 4 or More Rings (therapeutic use)</term><term>Humans</term><term>Liver Cirrhosis (drug therapy)</term><term>Liver Cirrhosis (etiology)</term><term>Male</term><term>Middle Aged</term><term>Sofosbuvir (adverse effects)</term><term>Sofosbuvir (therapeutic use)</term><term>Treatment Outcome</term><term>Viral Nonstructural Proteins (antagonists & inhibitors)</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Carbamates</term><term>Heterocyclic Compounds, 4 or More Rings</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Viral Nonstructural Proteins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Carbamates</term><term>Heterocyclic Compounds, 4 or More Rings</term><term>Sofosbuvir</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C, Chronic</term><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Liver Cirrhosis</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Hepatitis C, Chronic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Drug Combinations</term><term>Drug Resistance, Viral</term><term>Female</term><term>Genotype</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26575258</PMID><DateCreated><Year>2015</Year><Month>12</Month><Day>31</Day></DateCreated><DateCompleted><Year>2016</Year><Month>01</Month><Day>15</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1533-4406</ISSN><JournalIssue CitedMedium="Internet"><Volume>373</Volume><Issue>27</Issue><PubDate><Year>2015</Year><Month>Dec</Month><Day>31</Day></PubDate></JournalIssue><Title>The New England journal of medicine</Title><ISOAbbreviation>N. Engl. J. Med.</ISOAbbreviation></Journal><ArticleTitle>Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.</ArticleTitle><Pagination><MedlinePgn>2608-17</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1056/NEJMoa1512612</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients). The primary end point for the two trials was a sustained virologic response at 12 weeks after the end of therapy.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Among patients with HCV genotype 2, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence interval [CI], 96 to 100), which was superior to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P=0.02). Among patients with HCV genotype 3, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 95% (95% CI, 92 to 98), which was superior to the rate of 80% (95% CI, 75 to 85) in the sofosbuvir-ribavirin group (P<0.001). The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Among patients with HCV genotype 2 or 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. (Funded by Gilead Sciences; ASTRAL-2 ClinicalTrials.gov number, NCT02220998; and ASTRAL-3, NCT02201953.).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Foster</LastName><ForeName>Graham R</ForeName><Initials>GR</Initials><AffiliationInfo><Affiliation>From Queen Mary University of London (G.R.F.), University College London (W.R.), King's College Hospital (W.R.), and Institute of Liver Studies (K.A.) - all in London; Beth Israel Deaconess Medical Center, Boston (N.A.); Alfred Health and Monash University (S.K.R.) and St. Vincent's Hospital (A.T.), Melbourne, VIC, and Monash Health and Monash University, Clayton, VIC (S.P.) - all in Australia; James J. Peters Veterans Affairs Medical Center, Bronx (N.B.), and Icahn School of Medicine at Mount Sinai, New York (N.B.) - both in New York; Auckland Clinical Studies, Auckland (E.J.G.), and Christchurch Clinical Studies Trust and University of Otago, Christchurch (C.A.M.S.) - both in New Zealand; Texas Liver Institute, University of Texas Health Science Center, San Antonio (E.L.); Liver Institute of Virginia, Richmond (M.L.S.); University of Ottawa, Ottawa (C.C.), and Vancouver Infectious Diseases Centre, Vancouver, BC (B.C.) - both in Canada; Kaiser Permanente (W.J.T.), Ruane Medical (P.R.), and Cedars-Sinai Medical Center (T.T.T.), Los Angeles, and Gilead Sciences, Foster City (H.M., H.D.-S., L.H., J.W., J.M., A.O., D.M.B., J.G.M.) - all in California; Hôpital Saint Joseph, Marseilles (M.B.), and Service d'Hépatologie, Hôpital Beaujon, INSERM UMR 1149, Université Paris Diderot, Clichy (T.A.) - both in France; University Hospital Leipzig, Leipzig (T.B.), and Johann Wolfgang Goethe University, Frankfurt (S.Z.) - both in Germany; Santa Maria Annunziata Hospital, Florence (F.M.), and Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (A.M.) - both in Italy; Henry Ford Health System, Detroit (S.C.G.); Duke University School of Medicine, Durham, NC (K.P.); Rush University Medical Center, Chicago (N.R.); and Johns Hopkins University, Baltimore (M.S.).</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Afdhal</LastName><ForeName>Nezam</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Roberts</LastName><ForeName>Stuart K</ForeName><Initials>SK</Initials></Author><Author ValidYN="Y"><LastName>Bräu</LastName><ForeName>Norbert</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Gane</LastName><ForeName>Edward J</ForeName><Initials>EJ</Initials></Author><Author ValidYN="Y"><LastName>Pianko</LastName><ForeName>Stephen</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Lawitz</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Thompson</LastName><ForeName>Alex</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Shiffman</LastName><ForeName>Mitchell L</ForeName><Initials>ML</Initials></Author><Author ValidYN="Y"><LastName>Cooper</LastName><ForeName>Curtis</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Towner</LastName><ForeName>William J</ForeName><Initials>WJ</Initials></Author><Author ValidYN="Y"><LastName>Conway</LastName><ForeName>Brian</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Ruane</LastName><ForeName>Peter</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Bourlière</LastName><ForeName>Marc</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Asselah</LastName><ForeName>Tarik</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Berg</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Zeuzem</LastName><ForeName>Stefan</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Rosenberg</LastName><ForeName>William</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Agarwal</LastName><ForeName>Kosh</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Stedman</LastName><ForeName>Catherine A M</ForeName><Initials>CA</Initials></Author><Author ValidYN="Y"><LastName>Mo</LastName><ForeName>Hongmei</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Dvory-Sobol</LastName><ForeName>Hadas</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Han</LastName><ForeName>Lingling</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Jing</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>McNally</LastName><ForeName>John</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Osinusi</LastName><ForeName>Anu</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Brainard</LastName><ForeName>Diana M</ForeName><Initials>DM</Initials></Author><Author ValidYN="Y"><LastName>McHutchison</LastName><ForeName>John G</ForeName><Initials>JG</Initials></Author><Author ValidYN="Y"><LastName>Mazzotta</LastName><ForeName>Francesco</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Tran</LastName><ForeName>Tram T</ForeName><Initials>TT</Initials></Author><Author ValidYN="Y"><LastName>Gordon</LastName><ForeName>Stuart C</ForeName><Initials>SC</Initials></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Keyur</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Reau</LastName><ForeName>Nancy</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Mangia</LastName><ForeName>Alessandra</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Sulkowski</LastName><ForeName>Mark</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><CollectiveName>ASTRAL-2 Investigators</CollectiveName></Author><Author ValidYN="Y"><CollectiveName>ASTRAL-3 Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02201953</AccessionNumber><AccessionNumber>NCT02220998</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>11</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>N Engl J Med</MedlineTA><NlmUniqueID>0255562</NlmUniqueID><ISSNLinking>0028-4793</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D002219">Carbamates</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D006576">Heterocyclic Compounds, 4 or More Rings</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C087036">NS-5 protein, hepatitis C 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Version="1">27119242</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002219" MajorTopicYN="N">Carbamates</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug 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