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http://hdl.handle.net/2445/118704
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DC Field | Value | Language |
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dc.contributor.author | Afdhal, Nezam | - |
dc.contributor.author | Zeuzem, Stefan | - |
dc.contributor.author | Kwo, Paul Y. | - |
dc.contributor.author | Chojkier, Mario | - |
dc.contributor.author | Gitlin, Norman | - |
dc.contributor.author | Puoti, Massimo | - |
dc.contributor.author | Romero-Gómez, Manuel | - |
dc.contributor.author | Zarski, Jean Pierre | - |
dc.contributor.author | Agarwal, Kosh | - |
dc.contributor.author | Buggisch, Peter | - |
dc.contributor.author | Foster, Graham R. | - |
dc.contributor.author | Bräu, Norbert | - |
dc.contributor.author | Buti, Maria | - |
dc.contributor.author | Jacobson, Ira M. | - |
dc.contributor.author | Subramanian, G.Mani | - |
dc.contributor.author | Ding, Xiao | - |
dc.contributor.author | Mo, Hongmei | - |
dc.contributor.author | Yang, Jenny C. | - |
dc.contributor.author | Pang, Philip S. | - |
dc.contributor.author | Symonds, William T. | - |
dc.contributor.author | McHutchison, John G. | - |
dc.contributor.author | Muir, Andrew J. | - |
dc.contributor.author | Mangia, Alessandra | - |
dc.contributor.author | Marcellin, Patrick | - |
dc.contributor.author | Forns, Xavier | - |
dc.date.accessioned | 2017-12-13T14:49:41Z | - |
dc.date.available | 2017-12-13T14:49:41Z | - |
dc.date.issued | 2014-05-15 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/118704 | - |
dc.description.abstract | BACKGROUND: In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection. METHODS: We conducted a phase 3, open-label study involving previously untreated patients with chronic HCV genotype 1 infection. Patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosbuvir plus ribavirin for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 865 patients who underwent randomization and were treated, 16% had cirrhosis, 12% were black, and 67% had HCV genotype 1a infection. The rates of sustained virologic response were 99% (95% confidence interval [CI], 96 to 100) in the group that received 12 weeks of ledipasvir-sofosbuvir; 97% (95% CI, 94 to 99) in the group that received 12 weeks of ledipasvir-sofosbuvir plus ribavirin; 98% (95% CI, 95 to 99) in the group that received 24 weeks of ledipasvir-sofosbuvir; and 99% (95% CI, 97 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir plus ribavirin. No patient in either 12-week group discontinued ledipasvir-sofosbuvir owing to an adverse event. The most common adverse events were fatigue, headache, insomnia, and nausea. CONCLUSIONS: Once-daily ledipasvir-sofosbuvir with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with HCV genotype 1 infection. (Funded by Gilead Sciences; ION-1 ClinicalTrials.gov number NCT01701401.). | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1402454 | - |
dc.relation.ispartof | New England Journal of Medicine, 2014, vol. 370, num. 20, p. 1889-1898 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1402454 | - |
dc.rights | (c) Massachusetts Medical Society, 2014 | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Virus de l'hepatitis C | - |
dc.subject.classification | Medicaments antivírics | - |
dc.subject.other | Hepatitis C virus | - |
dc.subject.other | Antiviral agents | - |
dc.title | Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 661902 | - |
dc.date.updated | 2017-12-13T14:49:41Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 24725239 | - |
Appears in Collections: | Articles publicats en revistes (Medicina) |
Files in This Item:
File | Description | Size | Format | |
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661902.pdf | 383.08 kB | Adobe PDF | View/Open | |
nejmoa1402454_appendix.pdf | 607.76 kB | Adobe PDF | View/Open |
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