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Article: Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection

TitleSofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
Authors
Issue Date2015
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2015, v. 373 n. 27, p. 2599-2607 How to Cite?
AbstractBACKGROUND: A simple treatment regimen that is effective in a broad range of patients who are chronically infected with the hepatitis C virus (HCV) remains an unmet medical need. METHODS: We conducted a phase 3, double-blind, placebo-controlled study involving untreated and previously treated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection, including those with compensated cirrhosis. Patients with HCV genotype 1, 2, 4, or 6 were randomly assigned in a 5:1 ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir in a once-daily, fixed-dose combination tablet or matching placebo for 12 weeks. Because of the low prevalence of genotype 5 in the study regions, patients with genotype 5 did not undergo randomization but were assigned to the sofosbuvir–velpatasvir group. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 624 patients who received treatment with sofosbuvir–velpatasvir, 34% had HCV genotype 1a, 19% genotype 1b, 17% genotype 2, 19% genotype 4, 6% genotype 5, and 7% genotype 6. A total of 8% of patients were black, 19% had cirrhosis, and 32% had been previously treated for HCV. The rate of sustained virologic response among patients receiving sofosbuvir–velpatasvir was 99% (95% confidence interval, 98 to >99). Two patients receiving sofosbuvir–velpatasvir, both with HCV genotype 1, had a virologic relapse. None of the 116 patients receiving placebo had a sustained virologic response. Serious adverse events were reported in 15 patients (2%) in the sofosbuvir–velpatasvir group and none in the placebo group. CONCLUSIONS: Once-daily sofosbuvir–velpatasvir for 12 weeks provided high rates of sustained virologic response among both previously treated and untreated patients infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis. (Funded by Gilead Sciences; ClinicalTrials.gov number, NCT02201940. opens in new tab.)
Persistent Identifierhttp://hdl.handle.net/10722/226358
ISSN
2019 Impact Factor: 74.699
2015 SCImago Journal Rankings: 14.619
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorFeld, JJ-
dc.contributor.authorJacobson, IM-
dc.contributor.authorHézode, 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.authorChan, HLY-
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.authorOsinusi, A-
dc.contributor.authorSvarovskaia, E-
dc.contributor.authorZhu, Y-
dc.contributor.authorBrainard, DM-
dc.contributor.authorMcHutchison, JG-
dc.contributor.authorAgarwal, K-
dc.contributor.authorZeuzem, S-
dc.date.accessioned2016-06-17T07:43:36Z-
dc.date.available2016-06-17T07:43:36Z-
dc.date.issued2015-
dc.identifier.citationNew England Journal of Medicine, 2015, v. 373 n. 27, p. 2599-2607-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/226358-
dc.description.abstractBACKGROUND: A simple treatment regimen that is effective in a broad range of patients who are chronically infected with the hepatitis C virus (HCV) remains an unmet medical need. METHODS: We conducted a phase 3, double-blind, placebo-controlled study involving untreated and previously treated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection, including those with compensated cirrhosis. Patients with HCV genotype 1, 2, 4, or 6 were randomly assigned in a 5:1 ratio to receive the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir in a once-daily, fixed-dose combination tablet or matching placebo for 12 weeks. Because of the low prevalence of genotype 5 in the study regions, patients with genotype 5 did not undergo randomization but were assigned to the sofosbuvir–velpatasvir group. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 624 patients who received treatment with sofosbuvir–velpatasvir, 34% had HCV genotype 1a, 19% genotype 1b, 17% genotype 2, 19% genotype 4, 6% genotype 5, and 7% genotype 6. A total of 8% of patients were black, 19% had cirrhosis, and 32% had been previously treated for HCV. The rate of sustained virologic response among patients receiving sofosbuvir–velpatasvir was 99% (95% confidence interval, 98 to >99). Two patients receiving sofosbuvir–velpatasvir, both with HCV genotype 1, had a virologic relapse. None of the 116 patients receiving placebo had a sustained virologic response. Serious adverse events were reported in 15 patients (2%) in the sofosbuvir–velpatasvir group and none in the placebo group. CONCLUSIONS: Once-daily sofosbuvir–velpatasvir for 12 weeks provided high rates of sustained virologic response among both previously treated and untreated patients infected with HCV genotype 1, 2, 4, 5, or 6, including those with compensated cirrhosis. (Funded by Gilead Sciences; ClinicalTrials.gov number, NCT02201940. opens in new tab.)-
dc.languageeng-
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/-
dc.relation.ispartofNew England Journal of Medicine-
dc.rightsFrom New England Journal of Medicine, Jordan J. Feld, Ira M. Jacobson, Christophe Hézode, et al., Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection, vol. 373, p. 2599-2607. Copyright © 2015 Massachusetts Medical Society. Reprinted with permission.-
dc.titleSofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection-
dc.typeArticle-
dc.identifier.emailLai, CL: hrmelcl@hkucc.hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1056/NEJMoa1512610-
dc.identifier.pmid26571066-
dc.identifier.scopuseid_2-s2.0-84952883325-
dc.identifier.hkuros258635-
dc.identifier.volume373-
dc.identifier.issue27-
dc.identifier.spage2599-
dc.identifier.epage2607-
dc.identifier.isiWOS:000367374100005-
dc.publisher.placeUnited States-
dc.identifier.f1000725938972-
dc.identifier.issnl0028-4793-

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