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Conference Paper: Sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in genotype 1, 2, 4, 5, 6 HCV patients: ASTRAL-1 study

TitleSofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in genotype 1, 2, 4, 5, 6 HCV patients: ASTRAL-1 study
Authors
Issue Date2016
PublisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0
Citation
The 25th Annual Conference of Asian Pacific Association for the Study of the Liver (APASL 2016), Tokyo, Japan, 20-24 February 2016. In Hepatology International, 2016, v. 10 n. 1 suppl., p. S12-S13, abstract no. O-018 How to Cite?
AbstractINTRODUCTION: Velpatasvir (VEL) is a pangenotypic HCV-NS5A inhibitor. This Phase 3 study evaluated treatment with a fixed dose combination of SOF/VEL for 12 weeks in patients with genotype 1, 2, 4, 5, or 6 HCV infection. METHODS: Patients with genotype 1, 2, 4, or 6 chronic HCV infection were randomized 5:1 to received SOF/VEL (400 mg /100 mg daily) or placebo for 12 weeks. Patients with genotype 5 infection were enrolled to the SOF/VEL treatment group and patients with genotype 3 were evaluated in a separate study. RESULTS: 740 patients were enrolled at 81 international sites: 60 % male, 79 % white, 32 % treatment-experienced (TE), and 19 % compensated-cirrhosis. Of the 624 patients treated with SOF/VEL, the genotype distribution was 53 % GT1, 17 % GT2, 19 % GT4, 6 % GT5 and 7 % GT6. Overall SVR12 for SOF/VEL-treated patients was 99.0 % and the study met its primary efficacy endpoint. SVR12 rates by HCV genotype are presented in the table. Two of 328 patients (0.6 %) with genotype-1 infection had virologic relapse. No patients with genotype 2, 4, 5, or 6, including 48 with cirrhosis, had virologic failure. Four patients did not achieve SVR12 for non-virologic reasons. AEs and laboratory abnormalities were similar in the SOF/VELS12 treated patients compared with the 116 placebo-treated patients. One patient discontinued SOF/VEL treatment due to adverse-events. CONCLUSIONS: Treatment with the once daily, all-oral, single tablet regimen of SOF/VEL for 12 weeks is well tolerated and results in high SVR12 rates in treatment-naı¨ve and treatment-experienced genotype 1,2,4,5,6 HCV-infected patients with and without cirrhosis.
DescriptionThis journal suppl. entitled: Conference Abstracts: 25th Annual Conference of APASL, February 20–24, 2016, Tokyo, Japan
Oral Presentation: O-018
Persistent Identifierhttp://hdl.handle.net/10722/235755
ISSN
2015 Impact Factor: 1.125
2015 SCImago Journal Rankings: 0.669

 

DC FieldValueLanguage
dc.contributor.authorChan, HLY-
dc.contributor.authorFeld, JJ-
dc.contributor.authorAgarwal, K-
dc.contributor.authorHezode, C-
dc.contributor.authorAsselah, T-
dc.contributor.authorRuane, PJ-
dc.contributor.authorGruener, N-
dc.contributor.authorAbergel, A-
dc.contributor.authorMangia, A-
dc.contributor.authorLai, CL-
dc.contributor.authorMazzotta, F-
dc.contributor.authorMoreno, C-
dc.contributor.authorYoshida, E-
dc.contributor.authorShafran, SD-
dc.contributor.authorTowner, WJ-
dc.contributor.authorTran, TT-
dc.contributor.authorMcNally, J-
dc.contributor.authorBrainard, DM-
dc.contributor.authorJacobson, IM-
dc.contributor.authorZeuzem, S-
dc.date.accessioned2016-10-17T03:35:33Z-
dc.date.available2016-10-17T03:35:33Z-
dc.date.issued2016-
dc.identifier.citationThe 25th Annual Conference of Asian Pacific Association for the Study of the Liver (APASL 2016), Tokyo, Japan, 20-24 February 2016. In Hepatology International, 2016, v. 10 n. 1 suppl., p. S12-S13, abstract no. O-018-
dc.identifier.issn1936-0533-
dc.identifier.urihttp://hdl.handle.net/10722/235755-
dc.descriptionThis journal suppl. entitled: Conference Abstracts: 25th Annual Conference of APASL, February 20–24, 2016, Tokyo, Japan-
dc.descriptionOral Presentation: O-018-
dc.description.abstractINTRODUCTION: Velpatasvir (VEL) is a pangenotypic HCV-NS5A inhibitor. This Phase 3 study evaluated treatment with a fixed dose combination of SOF/VEL for 12 weeks in patients with genotype 1, 2, 4, 5, or 6 HCV infection. METHODS: Patients with genotype 1, 2, 4, or 6 chronic HCV infection were randomized 5:1 to received SOF/VEL (400 mg /100 mg daily) or placebo for 12 weeks. Patients with genotype 5 infection were enrolled to the SOF/VEL treatment group and patients with genotype 3 were evaluated in a separate study. RESULTS: 740 patients were enrolled at 81 international sites: 60 % male, 79 % white, 32 % treatment-experienced (TE), and 19 % compensated-cirrhosis. Of the 624 patients treated with SOF/VEL, the genotype distribution was 53 % GT1, 17 % GT2, 19 % GT4, 6 % GT5 and 7 % GT6. Overall SVR12 for SOF/VEL-treated patients was 99.0 % and the study met its primary efficacy endpoint. SVR12 rates by HCV genotype are presented in the table. Two of 328 patients (0.6 %) with genotype-1 infection had virologic relapse. No patients with genotype 2, 4, 5, or 6, including 48 with cirrhosis, had virologic failure. Four patients did not achieve SVR12 for non-virologic reasons. AEs and laboratory abnormalities were similar in the SOF/VELS12 treated patients compared with the 116 placebo-treated patients. One patient discontinued SOF/VEL treatment due to adverse-events. CONCLUSIONS: Treatment with the once daily, all-oral, single tablet regimen of SOF/VEL for 12 weeks is well tolerated and results in high SVR12 rates in treatment-naı¨ve and treatment-experienced genotype 1,2,4,5,6 HCV-infected patients with and without cirrhosis.-
dc.languageeng-
dc.publisherSpringer New York LLC. The Journal's web site is located at http://www.springer.com/west/home/medicine?SGWID=4-10054-70-173733513-0-
dc.relation.ispartofHepatology International-
dc.titleSofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in genotype 1, 2, 4, 5, 6 HCV patients: ASTRAL-1 study-
dc.typeConference_Paper-
dc.identifier.emailLai, CL: hrmelcl@hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.identifier.doi10.1007/s12072-016-9707-8-
dc.identifier.hkuros267662-
dc.identifier.volume10-
dc.identifier.issue1 suppl.-
dc.identifier.spageS12, abstract no. O-018-
dc.identifier.epageS13-
dc.publisher.placeUnited States-

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