Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/118704
Title: Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.
Author: Afdhal, Nezam
Zeuzem, Stefan
Kwo, Paul Y.
Chojkier, Mario
Gitlin, Norman
Puoti, Massimo
Romero Gomez, Manuel
Zarski, Jean Pierre
Agarwal, Kosh
Buggisch, Peter
Foster, Graham R.
Bräu, Norbert
Buti, Maria
Jacobson, Ira M.
Subramanian, G.Mani
Ding, Xiao
Mo, Hongmei
Yang, Jenny C.
Pang, Philip S.
Symonds, William T.
McHutchison, John G.
Muir, Andrew J.
Mangia, Alessandra
Marcellin, Patrick
Forns, Xavier
Keywords: Virus de l'hepatitis C
Medicaments antivírics
Hepatitis C virus
Antiviral agents
Issue Date: 15-May-2014
Publisher: Massachusetts Medical Society
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.).
Note: Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1402454
It is part of: New England Journal of Medicine, 2014, vol. 370, num. 20, p. 1889-1898
Related resource: https://doi.org/10.1056/NEJMoa1402454
URI: http://hdl.handle.net/2445/118704
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Medicina)

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