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Gilead two-drug hep C combination cures 94% of genotype 1 patients in 8 weeks
Keith Alcorn, 2013-12-18 17:20:00
A two-drug combination of sofosbuvir and ledipasvir cured 94% of previously untreated patients with genotype 1 hepatitis C infection after 8 weeks, without the need for ribavirin, Gilead Sciences announced on Wednesday.
The results released on 18 December come from one of three trials of the combination, ION-3. Two other studies tested the combination for longer periods and previously untreated and treatment-experienced patients, and showed similarly high cure rates after 12 or 24 weeks of treatment, with or without ribavirin.
Gilead Sciences said that the very high cure rates observed in the studies mean that it will be possible to speed up registration plans for the combination. The company now plans to submit a licensing application in the first quarter of 2014, which means that the combination could receive marketing approval in the United States in the final quarter of 2014.
Sofosbuvir, a nucleotide polymerase inhibitor recently approved in the United States and European Union, was paired with ledipasvir, a NS5a inhibitor, in three studies testing different durations of treatment in various populations.
The ION-1 study compared 12 and 24 weeks of treatment with sofosbuvir and ledipasvir, with and without ribavirin, in previously untreated patients with genotype 1 infection. Approximately 15% had cirrhosis.
The ION-2 study compared 8, 12 and 24 weeks of treatment with sofosbuvir and ledipasvir, with and without ribavirin, in treatment-experienced patients with genotype 1 infection who had experienced failure of previous triple therapy with pegylated interferon, ribavirin and a protease inihbitor. Approximately 20% had cirrhosis.
The ION-3 study compared 8 and 12 weeks of treatment with sofosbuvir and ledipasvir without ribavirin, with 12 weeks of treatment with sofosbuvir and ledipasvir with ribavirin. All patients in this study were previously untreated and had genotype 1 infection. None had cirrhosis.
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