{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T16:04:57Z","timestamp":1791043497952,"version":"4.1.0"},"reference-count":23,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2013,10,1]],"date-time":"2013-10-01T00:00:00Z","timestamp":1380585600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2013,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Asunaprevir is a selective NS3 protease inhibitor with in vitro activity against HCV genotypes 1 and 4.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this Phase IIa double-blind study, treatment-naive HCV genotype-1-infected patients in the United States and France were randomly assigned 1:1:1:1 to placebo or asunaprevir 200 mg twice daily, 600 mg twice daily or 600 mg once daily in combination with pegylated interferon (PEG-IFN)-\u03b12a and ribavirin for 48 weeks. The primary efficacy end point was undetectable HCV RNA at weeks 4 and 12 (extended rapid virological response [eRVR]). Other end points included safety and undetectable HCV RNA at 24 weeks post-treatment (24-week sustained virological response [SVR\n                      <jats:sub>24<\/jats:sub>\n                      ]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 47 patients were randomized and treated. eRVR was achieved by 75% (9\/12), 75% (9\/12) and 92% (11\/12) of patients in the asunaprevir 200 mg twice-daily, 600 mg twice-daily and 600 mg once-daily groups, respectively, versus 0% (0\/11) in the placebo group. Corresponding SVR\n                      <jats:sub>24<\/jats:sub>\n                      rates were 83% (10\/12), 83% (10\/12) and 92% (11\/12) in the asunaprevir groups and 46% (5\/11) in the placebo group. There was no virological breakthrough in any asunaprevir group. Following the 12-week analysis, the 600 mg doses were reduced to 200 mg twice daily because of a greater frequency of transaminase elevations at the 600 mg dose. The most common grade 3\u20134 laboratory abnormalities were consistent with those reported for PEG-IFN and ribavirin.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Asunaprevir plus PEG-IFN and ribavirin achieved higher response rates than placebo plus PEG-IFN and ribavirin, with a tolerable adverse event profile at the 200 mg twice-daily dose. This dose is being evaluated in the Phase IIb and Phase III studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp2660","type":"journal-article","created":{"date-parts":[[2013,6,26]],"date-time":"2013-06-26T10:35:52Z","timestamp":1372242952000},"page":"885-893","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":38,"title":["Randomized Study of Asunaprevir plus Pegylated Interferon-\u03b1 and Ribavirin for Previously Untreated Genotype 1 Chronic Hepatitis C"],"prefix":"10.1177","volume":"18","author":[{"given":"Jean-Pierre","family":"Bronowicki","sequence":"first","affiliation":[{"name":"INSERM 954, Centre Hospitalier Universitaire de Nancy, Universit\u00e9 de Lorraine, Vandoeuvre les Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanislas","family":"Pol","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Descartes, INSERM U1610 and Liver Unit, H\u00f4pital Cochin, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul J","family":"Thuluvath","sequence":"additional","affiliation":[{"name":"Mercy Medical Center, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Larrey","sequence":"additional","affiliation":[{"name":"H\u00f4pital Saint Eloi, Service d'H\u00e9pato-Gastroent\u00e9rologie et Transplantation, INSERM 1040-IRB, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia T","family":"Martorell","sequence":"additional","affiliation":[{"name":"The Research Institute, Springfield, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinod K","family":"Rustgi","sequence":"additional","affiliation":[{"name":"Metropolitan Research, Fairfax, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David W","family":"Morris","sequence":"additional","affiliation":[{"name":"Healthcare Research Consultants, Tulsa, OK, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziad","family":"Younes","sequence":"additional","affiliation":[{"name":"Gastro One, Germantown, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael W","family":"Fried","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Bourli\u00e8re","sequence":"additional","affiliation":[{"name":"H\u00f4pital Saint Joseph, Service d'H\u00e9pato-Gastroent\u00e9rologie, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"H\u00e9zode","sequence":"additional","affiliation":[{"name":"CHU Henri Mondor, Service d'H\u00e9pato-Gastroent\u00e9rologie, Cr\u00e9teil, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Massoud","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, AL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary A","family":"Abrams","sequence":"additional","affiliation":[{"name":"Alabama Liver & Digestive Specialists, Montgomery, AL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vlad","family":"Ratziu","sequence":"additional","affiliation":[{"name":"Groupe Hospitalier Piti\u00e9 Salp\u00eatri\u00e8re, Service d'H\u00e9pato-Gastroent\u00e9rologie, Paris, 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