Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 370, Issue 16, Pages 1483-1493Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1316366
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Categories
Funding
- Gilead Sciences
- Medgenics
- Boehringer Ingelheim
- Merck
- Abbott Laboratories
- Vertex Pharmaceuticals
- Bristol-Myers Squibb
- AbbVie
- Janssen Pharmaceuticals
- Genentech-Roche
- Idenix Pharmaceuticals
- Genfit
- Ikaria
- Hyperion Therapeutics
- Clinical Care Options
- Projects in Knowledge
- Practice Point Communications
- Genentech
- Kadmon Pharmaceuticals
- Achillion Pharmaceuticals
- Novartis
- BioCryst Pharmaceuticals
- Biotica
- Enanta Pharmaceuticals
- Santaris Pharma
- Theravance
- GlaxoSmithKline
- Intercept Pharmaceuticals
- Medtronic
- Presidio Therapeutics
- Roche
- Janssen-Cilag
- Amgen
- CVS Caremark
- Pharmasset
- Idera Pharmaceuticals
- Salix Pharmaceuticals
- Takeda Pharmaceuticals
- ViroChem Pharma
- Inhibitex
- ZymoGenetics
- Biolex Therapeutics
- Anadys Pharmaceuticals
- Beckman Coulter
- Profectus BioSciences
- Scy-nexis
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Background: Effective treatment for hepatitis C virus (HCV) genotype 1 infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need. Methods: We conducted a phase 3, randomized, open-label study involving patients infected with HCV genotype 1 who had not had a sustained virologic response after treatment with peginterferon and ribavirin, with or without a protease inhibitor. Patients were randomly assigned to receive the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily, fixed-dose combination tablet 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: Among the 440 patients who underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection. The rates of sustained virologic response were high in all treatment groups: 94% (95% confidence interval [CI], 87 to 97) in the group that received 12 weeks of ledipasvir-sofosbuvir; 96% (95% CI, 91 to 99) in the group that received 12 weeks of ledipasvir-sofosbuvir and ribavirin; 99% (95% CI, 95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir; and 99% (95% CI, 95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and ribavirin. No patient discontinued treatment owing to an adverse event. The most common adverse events were fatigue, headache, and nausea. Conclusions: Treatment with a once-daily, single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sustained virologic response among patients with HCV genotype 1 infection who had not had a sustained virologic response to prior interferon-based treatment. (Funded by Gilead Sciences; ION-2 ClinicalTrials.gov number, NCT01768286.)
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