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FDA Updates Olysio Label to Include East Asians with HCV Genotype 1

The FDA announced updates to Olysio’s label that included clinical data depicting the safety and efficacy of the drug for treatment-naive adults of East Asian descent with chronic hepatitis C virus genotype 1 infection, according to an FDA press release.

The updates are indicative of phase 3 clinical data from the TIGER study conducted in China and South Korea where Olysio (simeprevir, Janssen Therapeutics) in combination with pegylated interferon alfa-2a and ribavirin produced high sustained virologic response rates among Asians with HCV genotype 1.

In the trial, 152 patients received 150 mg of the simeprevir combination regimen for 12 weeks followed by an additional 12 or 36 weeks of treatment with PEG-IFN a-2a and ribavirin, and 152 patients received placebo plus PEG-IFN a-2a and ribavirin for 12 weeks followed by an additional 36 weeks of treatment with PEG-IFN a-2a and ribavirin, according to the release.

Of the patients, 49% were men with a median age of 45 years. All were East Asians (81% were enrolled in China, 19% in South Korea); 84% had baseline HCV RNA levels greater than 800,000 IU/mL; 82% had METAVIR fibrosis scores between F0 and F2; 12% had a METAVIR fibrosis score of F3; 6% had a METAVIR fibrosis score of F4; and 99% had HCV genotype 1b.

Following treatment, 91% of patients treated with simeprevir (n = 138) and 76% treated with placebo (n = 115) achieved SVR12.

The safety of the combination regimen was similar to the safety profile in other East Asian patients from a pooled phase 3 population from global trials. However, researchers observed a higher incidence of hyperbilirubinemia in patients receiving the simeprevir combination regimen compared with patients who received placebo, according to the release.

Elevated total bilirubin was observed in 66% of all patients treated with simeprevir (n = 99) and in 26% of patients treated with placebo (n = 40). Bilirubin elevations were mainly grade 1 or 2, with 9% of patients in the simeprevir-treated group showing grade 3 elevations (n = 13) and in 1% of patients treated with placebo (n = 2). No grade 4 elevations were observed. The bilirubin elevations were not associated with increased liver transaminases and were reversible after the end of treatment, according to the release.

The release further stated that patients of East Asian ancestry tend to show higher simeprevir plasma exposures compared with non-Asians. In a pooled phase 3 population, researchers have found the mean plasma exposure of simeprevir in East Asian patients with HCV was 2.1-fold higher compared with non-Asian patients with HCV. Despite this, no dosage adjustment is required based on race, according to the release.

For more information: View the full label at drugs@fda.

The FDA announced updates to Olysio’s label that included clinical data depicting the safety and efficacy of the drug for treatment-naive adults of East Asian descent with chronic hepatitis C virus genotype 1 infection, according to an FDA press release.

The updates are indicative of phase 3 clinical data from the TIGER study conducted in China and South Korea where Olysio (simeprevir, Janssen Therapeutics) in combination with pegylated interferon alfa-2a and ribavirin produced high sustained virologic response rates among Asians with HCV genotype 1.

In the trial, 152 patients received 150 mg of the simeprevir combination regimen for 12 weeks followed by an additional 12 or 36 weeks of treatment with PEG-IFN a-2a and ribavirin, and 152 patients received placebo plus PEG-IFN a-2a and ribavirin for 12 weeks followed by an additional 36 weeks of treatment with PEG-IFN a-2a and ribavirin, according to the release.

Of the patients, 49% were men with a median age of 45 years. All were East Asians (81% were enrolled in China, 19% in South Korea); 84% had baseline HCV RNA levels greater than 800,000 IU/mL; 82% had METAVIR fibrosis scores between F0 and F2; 12% had a METAVIR fibrosis score of F3; 6% had a METAVIR fibrosis score of F4; and 99% had HCV genotype 1b.

Following treatment, 91% of patients treated with simeprevir (n = 138) and 76% treated with placebo (n = 115) achieved SVR12.

The safety of the combination regimen was similar to the safety profile in other East Asian patients from a pooled phase 3 population from global trials. However, researchers observed a higher incidence of hyperbilirubinemia in patients receiving the simeprevir combination regimen compared with patients who received placebo, according to the release.

Elevated total bilirubin was observed in 66% of all patients treated with simeprevir (n = 99) and in 26% of patients treated with placebo (n = 40). Bilirubin elevations were mainly grade 1 or 2, with 9% of patients in the simeprevir-treated group showing grade 3 elevations (n = 13) and in 1% of patients treated with placebo (n = 2). No grade 4 elevations were observed. The bilirubin elevations were not associated with increased liver transaminases and were reversible after the end of treatment, according to the release.

The release further stated that patients of East Asian ancestry tend to show higher simeprevir plasma exposures compared with non-Asians. In a pooled phase 3 population, researchers have found the mean plasma exposure of simeprevir in East Asian patients with HCV was 2.1-fold higher compared with non-Asian patients with HCV. Despite this, no dosage adjustment is required based on race, according to the release.

For more information: View the full label at drugs@fda.