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Faldaprevir/PEG-IFN plus ribavirin increases SVR12 likelihood in treatment-naive HCV patients
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In the STARTVerso1 phase 3 clinical study, patients with hepatitis C genotype 1 virus infection treated with faldaprevir and pegylated interferon plus ribavirin showed increased likelihood of achieving a sustained virologic response at 12 weeks vs. patients treated with pegylated interferon plus ribavirin, according to published study data.
Researchers randomly assigned treatment-naive patients with HCV genotype 1 infection to regimens with PEG-IFN plus ribavirin with either placebo for 24 weeks (n = 132), 120 mg of faldaprevir (Boehringer Ingelheim) per day for 12 or 24 weeks (n = 259) or 240 mg per day of faldaprevir for 12 weeks (n = 261). If patients in the faldaprevir groups achieved early treatment success, therapy was stopped at 24 weeks. All other patients continued to receive PEG-IFN plus ribavirin through 48 weeks if early success was not achieved. The primary endpoint was SVR at 12 weeks post-treatment.
Overall, SVR12 was achieved by 52% of patients in the placebo group, 79% of patients who received 120 mg of faldaprevir and 80% of patients who received 240 mg of faldaprevir. Eighty-seven percent of patients who received 120 mg of faldaprevir reached early treatment success, as well as 89% of patients who received 240 mg of faldaprevir. The SVR12 rates were 86% and 89% for patients who received 120 mg of faldaprevir and 240 mg of faldaprevir, respectively.
“SVR12 rates were similar with the 120 mg and 240 mg doses of faldaprevir and significantly higher than with PEG-IFN and ribavirin alone,” the researchers wrote.
Five patients who received placebo, 10 patients dosed with 120 mg of faldaprevir and 14 dosed with 240 mg of faldaprevir discontinued treatment due to adverse events. Ten patients dosed with faldaprevir discontinued treatment (2/259 in the 120-mg group and 8/261 in the 240-mg group). The most common adverse events that led to discontinuation of faldaprevir were nausea, vomiting, jaundice and rash, according to the research.
“The results of the current study mark an important milestone in HCV therapeutics, demonstrating the commitment of patients and investigators to HCV research and attesting to the rapid pace at which the field has evolved,” the researchers concluded. – by Melinda Stevens
Disclosures: Ferenci reports serving as an advisory board member or review panelist for Roche, Pfizer, Novartis, Vertex, Salix, Madaus Rottapharm, Tibotec, Boehringer Ingelheim and Achillion; serving as a speaker for Roche, Gilead and Salix; and receiving grants or research support from Vertex and Madaus Rottapharm. Please see the full study for a list of all other authors’ relevant financial disclosures.
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