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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Daclatasvir <italic>vs</italic> telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1</title><author><name sortKey="Jacobson, Ira" sort="Jacobson, Ira" uniqKey="Jacobson I" first="Ira" last="Jacobson">Ira Jacobson</name></author><author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name></author><author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name></author><author><name sortKey="Knysz, Brygida" sort="Knysz, Brygida" uniqKey="Knysz B" first="Brygida" last="Knysz">Brygida Knysz</name></author><author><name sortKey="Lueth, Stefan" sort="Lueth, Stefan" uniqKey="Lueth S" first="Stefan" last="Lueth">Stefan Lueth</name></author><author><name sortKey="Zarebska Michaluk, Dorota" sort="Zarebska Michaluk, Dorota" uniqKey="Zarebska Michaluk D" first="Dorota" last="Zarebska-Michaluk">Dorota Zarebska-Michaluk</name></author><author><name sortKey="Janczewska, Ewa" sort="Janczewska, Ewa" uniqKey="Janczewska E" first="Ewa" last="Janczewska">Ewa Janczewska</name></author><author><name sortKey="Ferenci, Peter" sort="Ferenci, Peter" uniqKey="Ferenci P" first="Peter" last="Ferenci">Peter Ferenci</name></author><author><name sortKey="Diago, Moises" sort="Diago, Moises" uniqKey="Diago M" first="Moises" last="Diago">Moises Diago</name></author><author><name sortKey="Zignego, Anna Linda" sort="Zignego, Anna Linda" uniqKey="Zignego A" first="Anna Linda" last="Zignego">Anna Linda Zignego</name></author><author><name sortKey="Safadi, Rifaat" sort="Safadi, Rifaat" uniqKey="Safadi R" first="Rifaat" last="Safadi">Rifaat Safadi</name></author><author><name sortKey="Baruch, Yaacov" sort="Baruch, Yaacov" uniqKey="Baruch Y" first="Yaacov" last="Baruch">Yaacov Baruch</name></author><author><name sortKey="Abdurakhmanov, Dzhamal" sort="Abdurakhmanov, Dzhamal" uniqKey="Abdurakhmanov D" first="Dzhamal" last="Abdurakhmanov">Dzhamal Abdurakhmanov</name></author><author><name sortKey="Shafran, Stephen" sort="Shafran, Stephen" uniqKey="Shafran S" first="Stephen" last="Shafran">Stephen Shafran</name></author><author><name sortKey="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name></author><author><name sortKey="Bruck, Rafael" sort="Bruck, Rafael" uniqKey="Bruck R" first="Rafael" last="Bruck">Rafael Bruck</name></author><author><name sortKey="Gadano, Adrian" sort="Gadano, Adrian" uniqKey="Gadano A" first="Adrian" last="Gadano">Adrian Gadano</name></author><author><name sortKey="Thompson, Alexander James" sort="Thompson, Alexander James" uniqKey="Thompson A" first="Alexander James" last="Thompson">Alexander James Thompson</name></author><author><name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name></author><author><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name></author><author><name sortKey="Michener, Tracy" sort="Michener, Tracy" uniqKey="Michener T" first="Tracy" last="Michener">Tracy Michener</name></author><author><name sortKey="Hughes, Eric A" sort="Hughes, Eric A" uniqKey="Hughes E" first="Eric A" last="Hughes">Eric A. Hughes</name></author><author><name sortKey="Yin, Philip D" sort="Yin, Philip D" uniqKey="Yin P" first="Philip D" last="Yin">Philip D. Yin</name></author><author><name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27022224</idno><idno type="pmc">4806200</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4806200</idno><idno type="RBID">PMC:4806200</idno><idno type="doi">10.3748/wjg.v22.i12.3418</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000503</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000503</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Daclatasvir <italic>vs</italic> telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1</title><author><name sortKey="Jacobson, Ira" sort="Jacobson, Ira" uniqKey="Jacobson I" first="Ira" last="Jacobson">Ira Jacobson</name></author><author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name></author><author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name></author><author><name sortKey="Knysz, Brygida" sort="Knysz, Brygida" uniqKey="Knysz B" first="Brygida" last="Knysz">Brygida Knysz</name></author><author><name sortKey="Lueth, Stefan" sort="Lueth, Stefan" uniqKey="Lueth S" first="Stefan" last="Lueth">Stefan Lueth</name></author><author><name sortKey="Zarebska Michaluk, Dorota" sort="Zarebska Michaluk, Dorota" uniqKey="Zarebska Michaluk D" first="Dorota" last="Zarebska-Michaluk">Dorota Zarebska-Michaluk</name></author><author><name sortKey="Janczewska, Ewa" sort="Janczewska, Ewa" uniqKey="Janczewska E" first="Ewa" last="Janczewska">Ewa Janczewska</name></author><author><name sortKey="Ferenci, Peter" sort="Ferenci, Peter" uniqKey="Ferenci P" first="Peter" last="Ferenci">Peter Ferenci</name></author><author><name sortKey="Diago, Moises" sort="Diago, Moises" uniqKey="Diago M" first="Moises" last="Diago">Moises Diago</name></author><author><name sortKey="Zignego, Anna Linda" sort="Zignego, Anna Linda" uniqKey="Zignego A" first="Anna Linda" last="Zignego">Anna Linda Zignego</name></author><author><name sortKey="Safadi, Rifaat" sort="Safadi, Rifaat" uniqKey="Safadi R" first="Rifaat" last="Safadi">Rifaat Safadi</name></author><author><name sortKey="Baruch, Yaacov" sort="Baruch, Yaacov" uniqKey="Baruch Y" first="Yaacov" last="Baruch">Yaacov Baruch</name></author><author><name sortKey="Abdurakhmanov, Dzhamal" sort="Abdurakhmanov, Dzhamal" uniqKey="Abdurakhmanov D" first="Dzhamal" last="Abdurakhmanov">Dzhamal Abdurakhmanov</name></author><author><name sortKey="Shafran, Stephen" sort="Shafran, Stephen" uniqKey="Shafran S" first="Stephen" last="Shafran">Stephen Shafran</name></author><author><name sortKey="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name></author><author><name sortKey="Bruck, Rafael" sort="Bruck, Rafael" uniqKey="Bruck R" first="Rafael" last="Bruck">Rafael Bruck</name></author><author><name sortKey="Gadano, Adrian" sort="Gadano, Adrian" uniqKey="Gadano A" first="Adrian" last="Gadano">Adrian Gadano</name></author><author><name sortKey="Thompson, Alexander James" sort="Thompson, Alexander James" uniqKey="Thompson A" first="Alexander James" last="Thompson">Alexander James Thompson</name></author><author><name sortKey="Kopit, Justin" sort="Kopit, Justin" uniqKey="Kopit J" first="Justin" last="Kopit">Justin Kopit</name></author><author><name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name></author><author><name sortKey="Michener, Tracy" sort="Michener, Tracy" uniqKey="Michener T" first="Tracy" last="Michener">Tracy Michener</name></author><author><name sortKey="Hughes, Eric A" sort="Hughes, Eric A" uniqKey="Hughes E" first="Eric A" last="Hughes">Eric A. Hughes</name></author><author><name sortKey="Yin, Philip D" sort="Yin, Philip D" uniqKey="Yin P" first="Philip D" last="Yin">Philip D. Yin</name></author><author><name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name></author></analytic><series><title level="j">World Journal of Gastroenterology</title><idno type="ISSN">1007-9327</idno><idno type="eISSN">2219-2840</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>AIM: To evaluate daclatasvir <italic>vs</italic> telaprevir, each combined with peginterferon alfa-2a/ribavirin (pegIFN/RBV), in treatment-naive hepatitis C virus (HCV) genotype (GT) 1-infected patients.</p><p>METHODS: In this phase 3, randomized, open-label, noninferiority study, 602 patients were randomly assigned (2:1) to daclatasvir <italic>vs</italic> telaprevir, stratified by <italic>IL28B</italic> rs12979860 host genotype (CC <italic>vs</italic> non-CC), cirrhosis status (compensated cirrhosis <italic>vs</italic> no cirrhosis), and HCV GT1 subtype (GT1a <italic>vs</italic> GT1b). Patients were selected by study inclusion criteria from a total of 793 enrolled patients. Patients received daclatasvir 60 mg once daily or telaprevir 750 mg 3 times daily plus pegIFN/RBV. Daclatasvir recipients received 24 wk of daclatasvir plus pegIFN/RBV; those without an extended rapid virologic response (eRVR; undetectable HCV-RNA at weeks 4 and 12) received an additional 24 wk of pegIFN/RBV. Telaprevir-treated patients received 12 wk of telaprevir plus pegIFN/RBV followed by 12 (with eRVR) or 36 (no eRVR) wk of pegIFN/RBV. The primary objective was to compare for noninferiority of sustained virologic response rates at posttreatment week 12 (SVR12) in GT1b-infected patients. Key secondary objectives were to demonstrate that the rates of anemia (hemoglobin < 10 g/dL) and rash-related events, through week 12, were lower with daclatasvir + pegIFN/RBV than with telaprevir + pegIFN/RBV among GT1b-infected patients. Resistance testing was performed using population-based sequencing of the NS5A region for all patients at baseline, and for patients with virologic failure or relapse and HCV-RNA ≥ 1000 IU/mL, to investigate any link between NS5A polymorphisms associated with daclatasvir resistance and virologic outcome.</p><p>RESULTS: Patient demographics and disease characteristics were generally balanced across treatment arms; however, there was a higher proportion of black/African Americans in the daclatasvir groups (6.0% and 8.2% in the GT1b and GT1a groups, respectively) than in the telaprevir groups (2.2% and 3.0%). Among GT1b-infected patients, daclatasvir plus pegIFN/RBV was noninferior to telaprevir plus pegIFN/RBV for SVR12 [85% (228/268) <italic>vs</italic> 81% (109/134); difference, 4.3% (95%CI: -3.3% to 11.9%)]. Anemia (hemoglobin < 10 g/dL) was significantly less frequent with daclatasvir than with telaprevir [difference, -29.1% (95%CI: -38.8% to -19.4%)]. Rash-related events were also less common with daclatasvir than with telaprevir, but the difference was not statistically significant. In GT1a-infected patients, SVR12 was 64.9% with daclatasvir and 69.7% with telaprevir. Among both daclatasvir and telaprevir treatment groups, across GT1b- or GT1a-infected patients, lower response rates were observed in patients with <italic>IL28B</italic> non-CC and cirrhosis - factors known to affect response to pegIFN/RBV. Consistent with these observations, a multivariate logistic regression analysis in GT1b-infected patients demonstrated that SVR12 was associated with <italic>IL28B</italic> host genotype (CC <italic>vs</italic> non-CC, <italic>P</italic> = 0.011) and cirrhosis status (absent <italic>vs</italic> present, <italic>P</italic> = 0.031). NS5A polymorphisms associated with daclatasvir resistance (at L28, R30, L31, or Y93) were observed in 17.3% of GT1b-infected patients at baseline; such variants did not appear to be absolute predictors of failure since 72.1% of these patients achieved SVR12 compared with 86.9% without these polymorphisms. Among GT1b-infected patients, treatment was completed by 85.4% (229/268) in the daclatasvir group, and by 85.1% (114/134) in the telaprevir group, and among GT1a-infected patients, by 67.2% (90/134) and 69.7% (46/66), respectively. Discontinuations (of all 3 agents) due to an AE were more frequent with telaprevir than with daclatasvir, whereas discontinuations due to lack of efficacy were more frequent with daclatasvir, due, in part, to differences in futility criteria.</p><p>CONCLUSION: Daclatasvir plus pegIFN/RBV demonstrated noninferiority to telaprevir plus pegIFN/RBV for SVR12 and was well-tolerated in treatment-naive GT1b-infected patients, supporting the use of daclatasvir with other direct-acting antivirals.</p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">World J Gastroenterol</journal-id><journal-id journal-id-type="iso-abbrev">World J. Gastroenterol</journal-id><journal-id journal-id-type="publisher-id">WJG</journal-id><journal-title-group><journal-title>World Journal of Gastroenterology</journal-title></journal-title-group><issn pub-type="ppub">1007-9327</issn><issn pub-type="epub">2219-2840</issn><publisher><publisher-name>Baishideng Publishing Group Inc</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27022224</article-id><article-id pub-id-type="pmc">4806200</article-id><article-id pub-id-type="other">jWJG.v22.i12.pg3418</article-id><article-id pub-id-type="doi">10.3748/wjg.v22.i12.3418</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical Trials Study</subject></subj-group></article-categories><title-group><article-title>Daclatasvir <italic>vs</italic> telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Jacobson</surname><given-names>Ira</given-names></name></contrib><contrib contrib-type="author"><name><surname>Zeuzem</surname><given-names>Stefan</given-names></name></contrib><contrib contrib-type="author"><name><surname>Flisiak</surname><given-names>Robert</given-names></name></contrib><contrib contrib-type="author"><name><surname>Knysz</surname><given-names>Brygida</given-names></name></contrib><contrib contrib-type="author"><name><surname>Lueth</surname><given-names>Stefan</given-names></name></contrib><contrib contrib-type="author"><name><surname>Zarebska-Michaluk</surname><given-names>Dorota</given-names></name></contrib><contrib contrib-type="author"><name><surname>Janczewska</surname><given-names>Ewa</given-names></name></contrib><contrib contrib-type="author"><name><surname>Ferenci</surname><given-names>Peter</given-names></name></contrib><contrib contrib-type="author"><name><surname>Diago</surname><given-names>Moises</given-names></name></contrib><contrib contrib-type="author"><name><surname>Zignego</surname><given-names>Anna Linda</given-names></name></contrib><contrib contrib-type="author"><name><surname>Safadi</surname><given-names>Rifaat</given-names></name></contrib><contrib contrib-type="author"><name><surname>Baruch</surname><given-names>Yaacov</given-names></name></contrib><contrib contrib-type="author"><name><surname>Abdurakhmanov</surname><given-names>Dzhamal</given-names></name></contrib><contrib contrib-type="author"><name><surname>Shafran</surname><given-names>Stephen</given-names></name></contrib><contrib contrib-type="author"><name><surname>Thabut</surname><given-names>Dominique</given-names></name></contrib><contrib contrib-type="author"><name><surname>Bruck</surname><given-names>Rafael</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gadano</surname><given-names>Adrian</given-names></name></contrib><contrib contrib-type="author"><name><surname>Thompson</surname><given-names>Alexander James</given-names></name></contrib><contrib contrib-type="author"><name><surname>Kopit</surname><given-names>Justin</given-names></name></contrib><contrib contrib-type="author"><name><surname>McPhee</surname><given-names>Fiona</given-names></name></contrib><contrib contrib-type="author"><name><surname>Michener</surname><given-names>Tracy</given-names></name></contrib><contrib contrib-type="author"><name><surname>Hughes</surname><given-names>Eric A</given-names></name></contrib><contrib contrib-type="author"><name><surname>Yin</surname><given-names>Philip D</given-names></name></contrib><contrib contrib-type="author"><name><surname>Noviello</surname><given-names>Stephanie</given-names></name></contrib><aff>Ira Jacobson, Weill Cornell Medical College, New York, NY 10029, United States</aff><aff>Ira Jacobson, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States</aff><aff>Stefan Zeuzem, JW Goethe University Hospital, 60323 Frankfurt, Germany</aff><aff>Robert Flisiak, Uniwersytet Medyczny w Białymstoku, 15-089 Białystok, Poland</aff><aff>Brygida Knysz, EMC and Medical University, 50-220 Wrocław, Poland</aff><aff>Stefan Lueth, Universitatsklinikum Hamburg-Eppendorf, 20246 Hamburg, Germany</aff><aff>Dorota Zarebska-Michaluk, Wojewodzki Szpital Zespolony w Kielcach, 25-736 Kielce, Poland</aff><aff>Ewa Janczewska, ID Clinic, 41-400 Mysłowice, Poland</aff><aff>Peter Ferenci, Medizinische Universität Wien, 1090 Vienna, Austria</aff><aff>Moises Diago, Clinica Quiron, 46010 Valencia, Spain</aff><aff>Anna Linda Zignego, Università degli Studi di Firenze, 50121 Florence, Italy</aff><aff>Rifaat Safadi, Holy Family Hospital, Nazareth 6004, Israel</aff><aff>Yaacov Baruch, Rambam Medical Center, Haifa 31096, Israel</aff><aff>Dzhamal Abdurakhmanov, 1st Moscow State Medical University N.A.I.M. Sechenov, 119991 Moscow, Russia</aff><aff>Stephen Shafran, University of Alberta Hospital, Edmonton, Alberta T6G 2B7, Canada</aff><aff>Dominique Thabut, Groupe Hospitalier Pitié-Salpêtrière, 75013 Paris, France</aff><aff>Rafael Bruck, Tel Aviv Sourasky Medical Center and Tel Aviv University, Tel Aviv 64239, Israel</aff><aff>Adrian Gadano, Hospital Italiano de Buenos Aires, Buenos Aires C1181ACH, Argentina</aff><aff>Alexander James Thompson, St. Vincents Hospital and the University of Melbourne, Melbourne 3065, Australia</aff><aff>Justin Kopit, Fiona McPhee, Philip D Yin, Bristol-Myers Squibb Research and Development, Wallingford, CT 06492, United States</aff><aff>Tracy Michener, Eric A Hughes, Stephanie Noviello, Bristol-Myers Squibb Research and Development, Princeton, NJ 08450, United States</aff></contrib-group><author-notes><fn><p>Author contributions: Hughes EA, Yin PD, Noviello S, McPhee F, Kopit J, and Jacobson I designed the research; Jacobson I, Zeuzem S, Flisiak R, Knysz B, Lueth S, Zarebska-Michaluk D, Janczewska E, Ferenci P, Diago M, Zignego AL, Safadi R, Baruch Y, Abdurakhmanov D, Shafran S, Thabut D, Bruck R, Gadano A, Thompson AJ, and McPhee F performed the research; Kopit J analyzed the data; Michener T, Hughes EA, Yin PD, and Noviello S monitored the study conduct; all authors wrote the paper; all authors had access to the study data and have reviewed and approved the final manuscript.</p><p>Correspondence to: Dr. Ira Jacobson, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States. <email>ijacobson@chpnet.org</email></p><p>Telephone: +1-917-7978812</p></fn></author-notes><pub-date pub-type="ppub"><day>28</day><month>3</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>28</day><month>3</month><year>2016</year></pub-date><volume>22</volume><issue>12</issue><fpage>3418</fpage><lpage>3431</lpage><history><date date-type="received"><day>22</day><month>8</month><year>2015</year></date><date date-type="rev-recd"><day>17</day><month>10</month><year>2015</year></date><date date-type="accepted"><day>30</day><month>11</month><year>2015</year></date></history><permissions><copyright-statement>©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.</copyright-statement><copyright-year>2016</copyright-year></permissions><abstract><p>AIM: To evaluate daclatasvir <italic>vs</italic> telaprevir, each combined with peginterferon alfa-2a/ribavirin (pegIFN/RBV), in treatment-naive hepatitis C virus (HCV) genotype (GT) 1-infected patients.</p><p>METHODS: In this phase 3, randomized, open-label, noninferiority study, 602 patients were randomly assigned (2:1) to daclatasvir <italic>vs</italic> telaprevir, stratified by <italic>IL28B</italic> rs12979860 host genotype (CC <italic>vs</italic> non-CC), cirrhosis status (compensated cirrhosis <italic>vs</italic> no cirrhosis), and HCV GT1 subtype (GT1a <italic>vs</italic> GT1b). Patients were selected by study inclusion criteria from a total of 793 enrolled patients. Patients received daclatasvir 60 mg once daily or telaprevir 750 mg 3 times daily plus pegIFN/RBV. Daclatasvir recipients received 24 wk of daclatasvir plus pegIFN/RBV; those without an extended rapid virologic response (eRVR; undetectable HCV-RNA at weeks 4 and 12) received an additional 24 wk of pegIFN/RBV. Telaprevir-treated patients received 12 wk of telaprevir plus pegIFN/RBV followed by 12 (with eRVR) or 36 (no eRVR) wk of pegIFN/RBV. The primary objective was to compare for noninferiority of sustained virologic response rates at posttreatment week 12 (SVR12) in GT1b-infected patients. Key secondary objectives were to demonstrate that the rates of anemia (hemoglobin < 10 g/dL) and rash-related events, through week 12, were lower with daclatasvir + pegIFN/RBV than with telaprevir + pegIFN/RBV among GT1b-infected patients. Resistance testing was performed using population-based sequencing of the NS5A region for all patients at baseline, and for patients with virologic failure or relapse and HCV-RNA ≥ 1000 IU/mL, to investigate any link between NS5A polymorphisms associated with daclatasvir resistance and virologic outcome.</p><p>RESULTS: Patient demographics and disease characteristics were generally balanced across treatment arms; however, there was a higher proportion of black/African Americans in the daclatasvir groups (6.0% and 8.2% in the GT1b and GT1a groups, respectively) than in the telaprevir groups (2.2% and 3.0%). Among GT1b-infected patients, daclatasvir plus pegIFN/RBV was noninferior to telaprevir plus pegIFN/RBV for SVR12 [85% (228/268) <italic>vs</italic> 81% (109/134); difference, 4.3% (95%CI: -3.3% to 11.9%)]. Anemia (hemoglobin < 10 g/dL) was significantly less frequent with daclatasvir than with telaprevir [difference, -29.1% (95%CI: -38.8% to -19.4%)]. Rash-related events were also less common with daclatasvir than with telaprevir, but the difference was not statistically significant. In GT1a-infected patients, SVR12 was 64.9% with daclatasvir and 69.7% with telaprevir. Among both daclatasvir and telaprevir treatment groups, across GT1b- or GT1a-infected patients, lower response rates were observed in patients with <italic>IL28B</italic> non-CC and cirrhosis - factors known to affect response to pegIFN/RBV. Consistent with these observations, a multivariate logistic regression analysis in GT1b-infected patients demonstrated that SVR12 was associated with <italic>IL28B</italic> host genotype (CC <italic>vs</italic> non-CC, <italic>P</italic> = 0.011) and cirrhosis status (absent <italic>vs</italic> present, <italic>P</italic> = 0.031). NS5A polymorphisms associated with daclatasvir resistance (at L28, R30, L31, or Y93) were observed in 17.3% of GT1b-infected patients at baseline; such variants did not appear to be absolute predictors of failure since 72.1% of these patients achieved SVR12 compared with 86.9% without these polymorphisms. Among GT1b-infected patients, treatment was completed by 85.4% (229/268) in the daclatasvir group, and by 85.1% (114/134) in the telaprevir group, and among GT1a-infected patients, by 67.2% (90/134) and 69.7% (46/66), respectively. Discontinuations (of all 3 agents) due to an AE were more frequent with telaprevir than with daclatasvir, whereas discontinuations due to lack of efficacy were more frequent with daclatasvir, due, in part, to differences in futility criteria.</p><p>CONCLUSION: Daclatasvir plus pegIFN/RBV demonstrated noninferiority to telaprevir plus pegIFN/RBV for SVR12 and was well-tolerated in treatment-naive GT1b-infected patients, supporting the use of daclatasvir with other direct-acting antivirals.</p></abstract><kwd-group><kwd>Direct-acting antiviral</kwd><kwd>Chronic hepatitis C</kwd><kwd>Daclatasvir</kwd><kwd>Genotype 1b</kwd><kwd>NS5A inhibitor</kwd><kwd>Liver disease</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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