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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
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
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
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.