All-oral simeprevir-sofosbuvir superior to interferon-based treatment for HCV patients with compensated cirrhosis

All-oral simeprevir-sofobuvir superior to interferon-based treatment
All-oral simeprevir-sofobuvir superior to interferon-based treatment

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.”

References

  1. Pearlman BL et al. Gastroenterology. 2015; doi: http://dx.doi.org/10.1053/j.gastro.2014.12.027
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