AbbVie’s Six Hepatitis C Clinical Trials Now Enrolling Patients

AbbVie’s Six Hepatitis C Clinical Trials Now Enrolling Patients

AbbVie has announced it will initiate six global Phase 3 clinical studies to evaluate the safety and efficacy of two drug candidates: ABT-530, an NS5A inhibitor, and ABT-493, an NS3/4A protease inhibitor, in patients with genotypes 1-6 (GT1-6) chronic hepatitis C virus (HCV) infection.

AbbVie’s HCV clinical development program aims to improve the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily therapies for 12 weeks.

The investigational regimen includes 120 mg of ABT-530 and 300 mg of ABT-493.

The EXPEDITION and ENDURANCE studies are part of AbbVie’s Phase 3 HCV pipeline program and are expected to recruit nearly 1,600 patients at 250 study sites in 27 countries. The primary efficacy endpoint of all six trials is the rate of sustained virologic response at 12 weeks, post-treatment.

The EXPEDITION studies will assess AbbVie’s investigational regimen for 12 weeks in difficult to treat patients with chronic HCV infection:

All four ENDURANCE studies will investigate AbbVie’s regimen in cirrhosis-free patients for up to 12 weeks:

“We believe AbbVie’s work in hepatitis C has contributed to the transformation of HCV care over the last few years,” Michael Severino, M.D., AbbVie executive vice president, research and development, and chief scientific officer, said in a press release. “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.”

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