European Commission Also Extends Marketing Authorization for Harvoni ® (sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral Regimen for Adolescent Hepatitis C Patients
The studies demonstrated HCV cure rates of 99 percent in children aged 6 to 11 years (#PS-101), and 100 percent in adult patients co-infected with HCV and hepatitis B virus (HBV) (#PS-098).
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved additional indications for Harvoni ® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease.
In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval
Among patients receiving 12 weeks of LDV/SOF without RBV, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12).
Every value below carries the sentence it was read from.
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Field
Value
Cited text
Known as
LDV/SOF
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT01768286 ↗
Known as
ledipasvir/sofosbuvir
“The phase 3 ION studies evaluated a fixed-dose combination of ledipasvir/sofosbuvir ± ribavirin administered for 8, 12, or 24 weeks in patients with chronic HCV genotype 1.” PMID 27553375 ↗Aug 2016
Action
Inhibit
“the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir” PMID 24725238 ↗Apr 2014