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:
- A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1) – EXPEDITION-1 evaluates AbbVie’s investigational regimen in Genotype 1, 2, 4, 5 or 6 chronic HCV-infected patients with compensated cirrhosis (Child-Pugh A);
- A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-4) – EXPEDITION-4 evaluates Genotype 1-6 chronic HCV-infected patients with severe renal impairment and end-stage renal disease, with or without compensated cirrhosis.
All four ENDURANCE studies will investigate AbbVie’s regimen in cirrhosis-free patients for up to 12 weeks:
- A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection (ENDURANCE-1) – ENDURANCE-1 compares SVR in GT1 chronic HCV-infected patients who received ABT-493/ABT-530 treatment for eight to 12 weeks;
- A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection (ENDURANCE-2) – ENDURANCE-2 evaluates AbbVie’s investigational regimen versus placebo in GT2 chronic HCV-infected patients;
- A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection (ENDURANCE-3) – ENDURANCE-3 compares AbbVie’s investigational regimen with sofosbuvir/daclatasvir in treatment-naïve patients with Genotype 3 chronic HCV infection;
- The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4) – ENDURANCE-4 evaluates GT4-6 chronic HCV-infected patients;
“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.”