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ION-2: High rates of response to sofosbuvir/ledipasvir
Treatment with a once-daily, fixed-dose combination regimen of sofosbuvir/ledipasvir led to high rates of sustained virologic response in patients infected with hepatitis C virus genotype 1, according to the results of the ION-2 trial published in The New England Journal of Medicine.
“Among the estimated 170 million people in the world who have chronic hepatitis C virus (HCV) infection, approximately 60% have the genotype 1 strain of the virus,” the researchers wrote. “The treatment of patients infected with HCV genotype 1 is evolving rapidly.”
ION-2, whose researchers include HCV Next Editorial Board members Mark Sulkowski, MD, of Johns Hopkins University School of Medicine, and Paul Kwo, MD, of Indiana University, is a phase 3, randomized, open-label trial involving 440 patients who had not responded to prior treatment with pegylated interferon and ribavirin, with or without a protease inhibitor. Patients were assigned a daily dose of 400 mg sofosbuvir (Sovaldi, Gilead) and 90 mg ledipasvir for 12 or 24 weeks, with or without ribavirin.
Mark Sulkowski
SVR rates were high across all treatment groups, the researchers said. SVR12 was 94% (95% CI, 87-97) in patients who received sofosbuvir/ledipasvir without ribavirin and 96% (95% CI, 91-99) in those who received the combination treatment with ribavirin. SVR24 was achieved in 99% (95% CI, 95-100) of those who did and did not receive ribavirin.
Sofosbuvir/ledipasvir also had a favorable safety profile. No patient discontinued treatment as a result of an adverse event. According to the researchers, the most common adverse events were fatigue, headache and nausea.
In February, Gilead Sciences submitted a new drug application to the FDA for the combination treatment.
Paul Kwo
“These rates of response are among the highest reported to date for HCV genotype 1 infection,” the researchers wrote.
Disclosure: The study was funded by Gilead Sciences. See the study for a full list of financial disclosures.