Trials Set to Evaluate AbbVie's Experimental HCV Regimen

A biopharmaceutical company will begin an investigative clinical study of the safety and efficiency of a new hepatitis C virus (HCV) inhibitor.

There will be 6 global phase 3 clinical studies performed by AbbVie that will test how the HCV drugs ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, which are daily ribavirin-free oral treatments, perform in patients with HCV genotypes 1-6 (GT1-6).

This study will enroll approximately 1600 patients worldwide from 250 study sites in 27 countries.

The ENDURANCE or EXPEDITION studies will examine the rate of sustained virologic response at 12 weeks (SVR12). Four ENDURANCE studies will evaluate patients for up to 12 weeks who do not have cirrhosis.

ENDURANCE-1 will compare SVR in genotype 1 HCV patients from 8 to 12 weeks, who were given ABT-493 and ABT-530. ENDURANCE-2 will examine the function of the regimen versus placebo in genotype 2 patients.

ENDURANCE-3 will observe patients with genotype 3 hepatitis, who have never been treated or taken any antiretroviral therapy, and compare the regimen with sofosbuvir/daclatasvir. ENDURANCE-4 will evaluate HIV genotypes 4 through 6.

The other 2 trials in the EXPEDITION arm are evaluating the 12 week regimen in patients with chronic HCV infection who are difficult to treat.

EXPEDITION-1 will examine the regimen in genotype 1, 2, 4, and 6 HCV patients with compensated cirrhosis (Child-Pugh A), which is when the liver is heavily scarred but is still able to perform many important bodily functions. EXPEDITION-4 looks at genotypes 1-6 who have severe kidney impairment and end-stage renal disease (ESRD), kidney failure that can no longer live without dialysis, or a transplant, with or without compensated cirrhosis.

"We believe AbbVie's work in hepatitis C has contributed to the transformation of HCV care over the last few years," said executive vice president of AbbVie, Michael Severino, MD. "Our journey continues with the initiation of these Phase 3 studies, which we hope will help us meet the needs of an even broader range of patients living with hepatitis C."