Sulkowski MS, et al. - In phase 2, open-label ACCORDION study, researchers investigated the efficacy, safety and pharmacokinetics of a 6- or 8-week regimen of simeprevir, daclatasvir and sofosbuvir in treatment-naïve patients with chronic hepatitis C virus (HCV) genotype (GT) 1 infection and either early-stage fibrosis or compensated cirrhosis. They noted that in these patients, the 3 direct-acting antiviral regimens of simeprevir, daclatasvir and sofosbuvir were safe and well tolerated.

Methods

• In accordance to the fibrosis stage, patients were assigned to treatment groups; early-stage fibrosis: simeprevir 150 mg, daclatasvir 60 mg, sofosbuvir 400 mg once daily for 6 weeks; compensated cirrhosis: same regimen for 8 weeks.
• Sustained virologic response 12 weeks after the end of treatment (SVR12) was the primary endpoint.
• Researchers investigated safety, tolerability and pharmacokinetics of simeprevir, daclatasvir and sofosbuvir.

Results

• Treatment of 68 patients was performed (6-week group: n = 59; 8-week group: n = 9).
• Among patients with early-stage fibrosis, SVR12 was achieved by 86.4% (51/59) and among patients with cirrhosis, SVR12 was achieved by 100% (9/9).
• In the 6-week group, the main reason for not achieving SVR12 was viral relapse (11.9%; 7/59).
• Due to an early withdrawal, 1 patient showed on-treatment failure (lost to follow-up due to incarceration).
• At post-treatment week 24, 1 patient with SVR12 in the 6-week group showed a late viral relapse.
• Researchers noted no clinically significant drug-drug interactions.
• In 63.2% of patients (43/68), adverse events were reported; these were mainly grade 1/2.
• None of these resulted in treatment discontinuation.