AbbVie’s experimental Hepatitis C oral treatment consisting of the combination of VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) with EXVIERA™ (dasabuvir) with or without ribavirin (RBV), interferon-free, for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus (HCV) infection received positive opinions from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
“The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie, in the press release. “Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse.”
In Europe, around 9 million people are infected with chronic hepatitis C virus, among which 10 to 20% may develop cirrhosis and liver failure. In Europe, the dominant genotype is 1b, accounting for 47% of the cases. Genotype 1 HCV is the most frequent type of HCV genotype contributing for 60% of cases in the world. The genotype 4 is most frequent in the Middle East, sub-Saharan Africa and Egypt but is wide spreading into various European countries like Italy, France, Greece and Spain.
Various clinical studies performed by AbbVie contributed to the positive CHMP report for HCV treatment. This includes the clinical development program, which contributed to the positive CHMP report 6 important Phase 3 studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II). The clinical program included over 2,300 patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) recruited from 25 countries. In addition, the Phase 2 study, PEARL-I, with GT4 patients with no cirrhosis, and preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection that experienced first-time treatment after transplantation.
AbbVie is a worldwide biopharmaceutical company focused on research, formed after the partition of Abbott Laboratories. The chronic HCV treatment from AbbVie combines 3 anti-virals with different mechanisms of action affecting and inhibiting specific proteins from HCV involved in the process of viral replication.
Last June, the AbbVie’s treatment for patients with GT1 chronic HCV infection was granted priority review and Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). This last designation is normally given to experimental treatments that demonstrated improvement in a clinically significant endpoint when compared to the standard therapy for severe or life-threatening diseases.
In the beginning of 2015 the European Commission will give the final decision concerning the AbbVie’s HCV treatment that if approved will enable its commercialization in all the countries of the European Union, including Iceland, Liechtenstein and Norway.
The AbbVie’s development program for HCV can be found on www.clinicaltrials.gov.