Sofosbuvir plus simeprevir or daclatasvir highly effective in hepatitis C genotype 4 infection
The combination of sofosbuvir with either simeprevir or daclatasvir is safe and very effective for the treatment of hepatitis C virus (HCV)-genotype 4 (GT4) infection, reports a new study. In addition, treatment response is not affected by cirrhosis and failure of prior interferon-based therapy.
This real-life, prospective, observational study evaluated HCV-GT4 patients (n=96; mean age, 49±14.6 years; 59.4 percent men) in two groups based on the 12-week treatment regimen they received. Patients in group 1 (n=56) were administered sofosbuvir and simeprevir±ribavirin, while those in group 2 (n=40) received sofosbuvir and daclatasvir±ribavirin.
Sustained virologic response 12 weeks after the end of treatment (SVR12) was the primary efficacy endpoint, and the primary safety endpoint was drug discontinuation or occurrence of grade 3 or 4 adverse events.
Cirrhosis was present in 53.6 percent of patients in group 1 and 35.0 percent in group 2. On the other hand, 27 patients (48.3 percent) and 21 patients (52.5 percent) in groups 1 and 2, respectively, had failed prior interferon-based treatment.
The median pretreatment HCV-RNA log10 was 6.1 (3.6–7.0) IU/mL in group 1 and 6.0 3.6–7.2 IU/mL in group 2. Seventeen patients (30.4 percent) in group 1 and two patients (5 percent) in group 2 received ribavirin. All patients (100 percent) achieved SVR12.
Although adverse events (grade 1 and 2) were reported in 32 percent of patients, none discontinued treatment. There was one death recorded in the simeprevir group, but it was not treatment-related.
“The combination of sofosbuvir with simeprevir or daclatasvir is very effective in treating HCV infection, particularly genotype 1. However, the data on GT4 are very limited,” the authors said. This study supports the efficacy of these combination treatments on HCV-GT4.