|View printer-friendly version|
|Enanta Pharmaceuticals Announces CHMP Positive Opinion for AbbVie’s VIEKIRAX® + EXVIERA® Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis|
Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the direct-acting antivirals in AbbVie’s VIEKIRAX + EXVIERA treatment regimen for chronic hepatitis C virus (HCV).
Approximately 160 million people worldwide are infected with HCV.1
Genotype 1 is the most common type of HCV genotype, accounting for 60
percent of cases worldwide.2 In the
The CHMP opinion regarding the pending application for expansion of the label for VIEKIRAX + EXVIERA is supported by data from AbbVie’s Phase 3b TURQUOISE-III study, which is part of AbbVie’s larger clinical program investigating efficacy and safety in a broad range of GT1 patients. The Phase 3b TURQUOISE‐III study is a dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks. No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).5
About VIEKIRAX® + EXVIERA® in
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.
Important EU Safety Information
Special warnings and precautions for use:
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
Viekirax and Exviera are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
Pregnancy and concomitant use with ribavirin
Use with concomitant medicinal products
Full summary of product characteristics is available at www.ema.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About VIEKIRA PAK
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).
VIEKIRA is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information to know about VIEKIRA PAK?
VIEKIRA PAK must not be taken if people:
What should people tell a doctor before taking VIEKIRA PAK?
What are the common side effects of VIEKIRA PAK?
These are not all of the possible side effects of VIEKIRA PAK. A doctor should be notified if there is any side effect that is bothersome or that does not go away.
This is the most important information to know about VIEKIRA PAK. For more information, talk with a doctor.
People are encouraged to report negative side effects of prescription
drugs to the
Click here for full Prescribing Information, including the Medication Guide.
Enanta has developed novel protease inhibitors and NS5A inhibitors that
are members of the direct-acting-antiviral (DAA) inhibitor classes
designed for use against the hepatitis C virus (HCV). Enanta’s protease
inhibitors, developed through its collaboration with
Forward Looking Statements Disclaimer
1 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15
2 Global Alert and Response (GAR):
3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman
LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver
Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
4 Hatzakis, A. et. al. The state of hepatitis B and C in
5 Feld JJ, Moreno C, Trinh R, et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks. J Hepatol. 2016 Feb;64(2):301-7