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Gilead announces update on ION-1 trial
Gilead has announced the latest update on a phase III clinical study on the safety and efficacy of a fixed-dose combination of Sofosbuvir and Ledipasvir for the treatment of hepatitis C.
The US-based biotechnology company confirmed research into the once-daily medication, which is administered either with or without ribavirin, should continue without modification.
Scientists based the decision on the observed sustained virologic response four weeks after completion of therapy exceeding the predefined threshold of 60 per cent, as well as the absence of significant safety issues.
The combined treatment is also currently being tested in a second phase III clinical study – entitled ION-2 – which is evaluating the medication with and without ribavirin for 12 weeks and 24 weeks among patients who have experience with treatment for genotype 1 hepatitis C.
As present, the safety and efficacy of the Sofosbuvir and ledipasvir have not been determined, as both products are currently in the early stages of investigation.
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