Category: HCV

EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy

The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.

Sofosbuvir/velpatasvir improved patient-reported outcomes, knocked out HCV genotypes 1-6

AT THE LIVER MEETING 2016 BOSTON (FRONTLINE MEDICAL NEWS) – When given with ribavirin, a fixed-dose combination of sofosbuvir/velpatasvir (Epclusa) achieved a sustained viral response at 12 weeks (SVR-12) in 94% of decompensated cirrhotic patients with hepatitis C virus (HCV) genotypes 1-6 infection, according to Zobair M. Younossi, MD. Patients with and without cirrhosis also […]

Provisional NICE recommendation for Gilead’s Hepatitis C treatment

NICE has issued provisional guidance recommending the use of Gilead Sciences’ Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adult chronic hepatitis C genotype 1-6 patients in England and Wales.
This is the third sofosbuvir-based treatment to be recommended by NICE for treatment of the disease. Hepatitis C, if untreated, can cause serious liver damage and potentially life-threatening complications such as liver cancer.
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