When treated with simeprevir and sofosbuvir instead of peginterferon, ribavirin, and sofosbuvir, patients with compensated cirrhosis and chronic genotype 1 hepatitis C virus infections were more likely to clear their infections and had fewer adverse effects, results of a study published in Gastroenterology indicate.
“The efficacy and safety of interferon-free regimens for the treatment of chronic hepatitis C virus (HCV) infections require further evaluation and comparison with those of interferon-containing regimens,” noted Brian L. Pearlman, MD, of Emory School of Medicine in Atlanta, Georgia, and colleagues.
To compare a regimen of peginterferon, ribavirin, and sofosbuvir with a regimen of simeprevir and sofosbuvir in patients with HCV infection and unfavorable treatment features, the investigators performed a prospective open-label study of 82 patients with chronic HCV infection and Child’s grade A cirrhosis. Of the patients, 61% had not responded to treatment with peginterferon and ribavirin and 39% were therapy naïve.
The participants were randomly assigned to groups given simeprevir (150 mg/day) and sofosbuvir (400 mg/day) or peginterferon alfa 2b (1.5 mcg/kg/wk), ribavirin (1000 to 200 mg/day) and sofosbuvir (400 mg/day). Both regimens were assigned for 12 weeks.
Of the patients given simeprevir and sofosbuvir, 93% achieved undetectable HCV-RNA levels compared with only 75% of patients assigned the interferon-containing regimen (P=0.02). Patients assigned the interferon-containing regimen had a significantly higher rate of virologic relapse compared with patients given simeprevir and sofosbuvir (P=0.009), as well as worse self-reported outcomes and more side effects.
“Given that several new regimens for genotype 1 infection, including the sofosbuvir-ledipasvir combination pill, already have been approved, we believe that this study is very timely,” said Pearlman in a press release.
“Although these are not head-to-head comparisons, the 12-week simeprevir and sofosbuvir regimen in this trial may compare favorably with the SVR rates for 12 weeks of sofosbuvir/ledipasvir and 12 weeks of the regimen, paritaprevir/ritonavir, ombitasvir and dasabuvir plus ribavirin for patients with cirrhosis, particularly for prior nonresponders to older therapies, with the caveat that many more patients were studied in the registration trials.”