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Simeprevir, PEG-IFN/ribavirin therapy led to SVR in hepatitis C patients
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A majority of patients with hepatitis C virus tolerated treatment with simeprevir and pegylated interferon and ribavirin, and achieved sustained virologic response after 12 weeks, according to results from a phase 3 trial.
Researchers conducted a double blind clinical trial with 393 patients positive for hepatitis C (HCV) genotype 1 infection who had relapsed after at least 24 weeks of interferon-based therapy. Patients were randomly assigned 150 mg simeprevir plus pegylated interferon alfa-2a and ribavirin (PR) once daily (n=260) or placebo and PR (n=133) for 12 weeks. Patients in the placebo group were then given PR alone for an additional 36 weeks, while the simeprevir group was given PR for either 12 or 36 additional weeks.
According to data, 79.2% of patients in the simeprevir group achieved sustained virologic response at 12 weeks (SVR12) compared with 36.1% of the placebo group (P<.001). Among the simeprevir group, 92.7% of patients fulfilled the response-guided treatment (RGT) protocol and completed PR at 24 weeks, and of those eligible, 83% achieved SVR12.
Patients assigned simeprevir has lower relapse rates compared with placebo patients (18.5% vs. 48.4%), and HCV RNA was not found in 77.2% of simeprevir patients at 4 weeks compared with 3.1% of patients in the placebo group. Serious adverse events at 12 weeks were experienced by 1.2% of patients in the simeprevir group compared with 2.3% of placebo patients.
“The majority of simeprevir-treated patients met RGT criteria, enabling a shorter, 24-week overall duration of PR treatment,” the researchers wrote. “The addition of simeprevir to PR generally was well tolerated, with safety and tolerability similar to PR alone. Ongoing studies are investigating simeprevir in both PEG-IFN-a and IFN-free combinations, including all oral regimens.”
Disclosure: See the study for a full list of relevant financial disclosures.