AbbVie has announced the successful results of an EXPEDITION-1 Phase III study that evaluated 12 weeks of treatment with glecaprevir/pibrentasvir (G/P).
Of 146 patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) who were enrolled in the study, 99 percent reached a sustained virologic response at 12 weeks post treatment (SVR12). Patients who achieve SVR12 are considered cured of hepatitis C. One patient had a relapse.
"We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin," Dr. Xavier Forns, head of the Hospital Clinic de Barcelona hepatitis unit, said. "The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes."
The results of the clinical trial were presented at The International Liver Congress in Amsterdam. AbbVie also presented data on patients suffering from chronic kidney disease and HIV infection as well as post transplant patients and those who had received direct-acting antiviral (DAA) treatments.
While G/P is still an investigational treatment, the European Medicines Agency has granted it accelerated assessment. The U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare have given G/P priority review designations.
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