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: 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.).
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Authors | Nezam Afdhal, Stefan Zeuzem, Paul Kwo, Mario Chojkier, Norman Gitlin, Massimo Puoti, Manuel Romero-Gomez, Jean-Pierre Zarski, Kosh Agarwal, Peter Buggisch, Graham R Foster, Norbert Bräu, Maria Buti, Ira M Jacobson, G Mani Subramanian, Xiao Ding, Hongmei Mo, Jenny C Yang, Phillip S Pang, William T Symonds, John G McHutchison, Andrew J Muir, Alessandra Mangia, Patrick Marcellin, ION-1 Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 370
Issue 20
Pg. 1889-98
(May 15 2014)
ISSN: 1533-4406 [Electronic] United States |
PMID | 24725239
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- Benzimidazoles
- Fluorenes
- RNA, Viral
- ledipasvir
- Ribavirin
- Uridine Monophosphate
- Sofosbuvir
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Antiviral Agents
(adverse effects, therapeutic use)
- Benzimidazoles
(adverse effects, therapeutic use)
- Drug Administration Schedule
- Drug Resistance, Viral
- Drug Therapy, Combination
- Female
- Fluorenes
(adverse effects, therapeutic use)
- Genotype
- Hepacivirus
(genetics)
- Hepatitis C, Chronic
(drug therapy, virology)
- Humans
- Male
- Middle Aged
- RNA, Viral
(blood)
- Ribavirin
(adverse effects, therapeutic use)
- Sofosbuvir
- Uridine Monophosphate
(adverse effects, analogs & derivatives, therapeutic use)
- Viral Load
- Young Adult
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