- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
FDA approves Technivie for GT4 chronic HCV
27 July 2015 • Author: Victoria White
The US Food and Drug Administration (FDA) has approved AbbVie’s Technivie (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis.
Technivie is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the US for adult patients with GT4 chronic HCV infection. The approval of Technivie marks an important advancement in providing this historically difficult-to-treat population of HCV patients an opportunity for a cure. Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient’s blood 12 weeks after treatment (SVR12).
Approval of Technivie based on data from the PEARL-I study
“Physicians have previously had limited options when it comes to treating people living with GT4 chronic hepatitis C,” said Tarek Hassanein, M.D., professor of medicine, University of California San Diego School of Medicine. “The approval of Technivie in combination with ribavirin is important for these patients who now have an approved all-oral, interferon-free treatment option that provides a high probability of a cure.”
The approval of Technivie is based on data from the PEARL-I study, which demonstrated 100% sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received Technivie and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that evaluated the efficacy and safety of Technivie in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy or who had failed previous treatment with pegylated interferon (pegIFN) and RBV. Additionally, 91% percent of patients who were new to therapy achieved SVR12 after taking Technivie without RBV. In the treatment-naive group without RBV, on-treatment virologic breakthrough was reported in one patient, and two patients experienced post-treatment relapse. There were no virologic failures in the other treatment arms.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics