Six and eight-week regimens of simeprevir, daclatasvir, and sofosbuvir proved highly effective for treatment-naive patients with hepatitis C virus (HCV) genotype 1 (GT1) and early-stage liver fibrosis or compensated cirrhosis, according to a study published in the Journal of Viral Hepatitis.
ACCORDION (ClinicalTrials.gov Identifier: NCT02349048) was a phase 2, open-label, multicenter study conducted at 8 sites in the United States and Canada between January 21, 2015, and May 5, 2016. Participant eligibility was based on the following criteria: confirmed chronic HCV GT1 infection with early-stage liver fibrosis or compensated cirrhosis, a body mass index of 18 kg/m2 to 35 kg/m2, plasma HCV RNA >10 000 IU/mL at screening, naive to treatment for HCV, and eligible for treatment with pegylated interferon and ribavirin. Study participants with early-stage fibrosis were given simeprevir 150 mg, daclatasvir 60 mg, and sofosbuvir 400 mg once daily for 6 weeks, and participants with compensated cirrhosis were given the same regimen for 8 weeks.
The study aimed for a sample size of 60 participants in the 6-week group and 30 in the 8-week group, but only 68 patients met the stipulated FibroSURE™ and APRI [aspartate aminotransferase to platelet ratio index] score cut-offs in the study protocol. As a result, there were 59 patients included in the 6-week group and 9 patients in the 8-week group.