Título:
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Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.
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Autor/a:
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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
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Otros autores:
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Universitat de Barcelona |
Abstract:
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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.). |
Materia(s):
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-Virus de l'hepatitis C -Medicaments antivírics -Hepatitis C virus -Antiviral agents |
Derechos:
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(c) Massachusetts Medical Society, 2014
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Tipo de documento:
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Artículo Artículo - Versión publicada |
Editor:
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Massachusetts Medical Society
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