Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400mg for treatment of patients with chronic hepatitis C genotype 1 infection.

The NDA includes data supporting the use of LDV/SOF in patients with genotype 1 HCV infection, with treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis.

The NDA is supported by three Phase III studies, ION-1, ION-2 and ION-3, where 2,000 genotype 1 HCV patients were given the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks.

Participants in these studies included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, as well as patients with compensated cirrhosis.

"The LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks, without the need for interferon injections or ribavirin."

Gilead Sciences executive vice-president of research and development Norbert Bischofberger said: "Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin."

Previously, the FDA has granted LDV/SOF a breakthrough therapy designation, which is given to investigational medicines that may provide major advances in treatment compared to the existing options.

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By GlobalData

The company intends to submit LDV/SOF for regulatory approval in other geographies, including the European Union (EU), in the first quarter of 2014.

Gilead has also filed an application to the European Medicines Agency (EMA) for accelerated assessment of LDV/SOF.

If accepted, accelerated assessment could shorten EMA’s review time of LDV/SOF by two months, although it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or approval by the European Commission (EC).

Image: In the US, about 75% of people infected with HCV have the genotype 1 strain of the virus. Photo: courtesy of