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More Phase III Results Confirm Response to Investigational Hepatitis C Regimen
All-oral, interferon-free therapy studied with and without ribavirin in 2,300 patients (January 31)
Results from four more phase III studies of AbbVie’s investigational therapy for chronic genotype 1 hepatitis C virus (HCV) infection confirm its tolerability and high sustained virologic response rates 12 weeks after treatment, the company said. AbbVie has now completed the phase III clinical program for its all-oral, interferon-free therapy, studied with and without ribavirin in 2,300 patients across 25 countries.
Sustained virology response rates 12 weeks after treatment (SVR12) ranged from 90% to 100% with and without ribavirin in the PEARL-II, PEARL-III, and PEARL-IV studies of 903 patients. In the Turquoise II trial, 380 genotype 1 HCV patients with compensated liver cirrhosis achieved SVR12 rates of 92% (after 12 weeks of therapy) to 96% (after 24 weeks of therapy) using the AbbVie regimen and ribavirin.
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100 mg) coformulated with ABT-267 (25 mg), dosed once daily, and ABT-333 (250 mg) with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.
In May 2013, AbbVie's regimen with and without ribavirin for HCV genotype 1 was designated as a “breakthrough therapy” by the Food and Drug Administration.
Source: AbbVie; January 31, 2014