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New Drug Application Filed for Ledipasvir/Sofosbuvir Combo Tablet for Hepatitis C

Treatment targets gentotype-1 HCV (February 10)

A new drug application (NDA) has been submitted to the FDA for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic genotype-1 hepatitis C virus (HCV) infection in adults.

According to the drug’s developer (Gilead Sciences, Inc.), the data submitted in the NDA support the use of LDV/SOF in this patient population, with a treatment duration of 8 or 12 weeks depending on the patients’ prior treatment history and whether they have cirrhosis.

Approximately 75% of people infected with HCV in the U.S. have the genotype 1 strain of the virus.

The NDA for LDV/SOF is supported by three phase III studies, in which nearly 2,000 patients with genotype-1 HCV were randomly assigned to receive the fixed-dose combination, with or without RBV, for treatment durations of 8, 12, or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, as well as patients with compensated cirrhosis.

SOF as a single agent was approved by the FDA under the trade name Sovaldi in December 2013.

Source: Gilead; February 10, 2014.

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