Sofosbuvir and daclatasvir combination therapy (SOF/DCV) is safe and effective for real-world treatment of patients with liver cirrhosis associated with hepatitis C virus (HCV) genotype 4, according to a study published in Alimentary Pharmacology & Therapeutics.
The randomized, multicenter, open-label study took place in 2016 at 4 separate clinical settings in Egypt. A total of 551 patients with hepatitis C virus genotype 4 and related liver cirrhosis were included in the study; 119 (21.6%) had been previously treated and 432 (78.4%) were naive to treatment.
Patients were treated according to recommendations set by the European Association for the Study of the Liver in 2015, completing 12-week treatment regimens with SOF 400 mg and DCV 60 mg once daily, with the addition of daily weight-based dosages of ribavirin (RBV). When RBV was contraindicated, duration of treatment was extended to 24 weeks.
Treatment efficacy was determined by HCV RNA level screenings done at the end of treatment and again 12 weeks later. Achievement of SVR12, defined as serum concentrations lower than 25 IU/mL, was the primary virological outcome, and virological failure was defined as nonresponse or relapse.
Rates of SVR12 were 90.4% in previously treated patients and 94% in treatment-naive patients, with a mild rate of adverse effects that investigators believe were more likely related to the underlying cirrhosis than to the drug regimen. The addition of ribavirin increased SVR12 rates (P <.003).
This study is one of the largest to date assessing the use of antiviral regimens for patients with liver cirrhosis related to HCV genotype 4 infection, and the findings demonstrate the efficacy and safety of SOF/DCV combination therapy with or without ribavirin, regardless of baseline HCV RNA level or previous treatment experience.
El-Khayat H, Fouad Y, Mohamed HI, et al. Sofosbuvir plus daclatasvir with or without ribavirin in 551 patients with hepatitis C-related cirrhosis, genotype 4 [published online February 7, 2018]. Aliment Pharmacol Ther. doi: 10.1111/apt.14482