作者
Kris V Kowdley, Stuart C Gordon, K Rajender Reddy, Lorenzo Rossaro, David E Bernstein, Eric Lawitz, Mitchell L Shiffman, Eugene Schiff, Reem Ghalib, Michael Ryan, Vinod Rustgi, Mario Chojkier, Robert Herring, Adrian M Di Bisceglie, Paul J Pockros, G Mani Subramanian, Di An, Evguenia Svarovskaia, Robert H Hyland, Phillip S Pang, William T Symonds, John G McHutchison, Andrew J Muir, David Pound, Michael W Fried
发表日期
2014/5/15
期刊
New England Journal of Medicine
卷号
370
期号
20
页码范围
1879-1888
出版商
Massachusetts Medical Society
简介
Background
High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen.
Methods
In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir–sofosbuvir) for 8 weeks, ledipasvir–sofosbuvir plus ribavirin for 8 weeks, or ledipasvir–sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy.
Results
The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir–sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir–sofosbuvir …
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KV Kowdley, SC Gordon, KR Reddy, L Rossaro… - New England Journal of Medicine, 2014