Janssen R&D Ireland announced new results from cohort 2 of the Phase 2 COSMOS study demonstrating that 93% of patients with the hepatitis C virus (HCV) and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir administered once daily with Gilead Sciences Inc.’s sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks. The final data, along with an additional analysis from cohort 1 of COSMOS, were presented at The International Liver Congress 2014 of the European Association for the Study of the Liver (EASL) in London.“The combination of simeprevir and sofosbuvir demonstrated efficacy, including in patients with more advanced liver fibrosis,” said Eric Lawitz, simeprevir clinical trial investigator, medical director at The Texas Liver Institute and professor of medicine at University of Texas Health Science Center. “I look forward to seeing the results of the recently announced Phase 3 OPTIMIST trials, which will further evaluate simeprevir and sofosbuvir without interferon or ribavirin.”
The COSMOS study examined the efficacy and safety of simeprevir and sofosbuvir in chronically-infected HCV genotype 1 patients who did not respond to prior therapy with pegylated interferon and ribavirin or who were treatment naïve. Patients enrolled in the trial were randomized to receive 150 mg of simeprevir and 400 mg of sofosbuvir once daily with or without ribavirin for either 12 or 24 weeks.
The most common adverse events reported during the study were fatigue, headache, nausea, anemia, pruritus, dizziness, rash and photosensitivity. One patient discontinued treatment due to adverse events.
Previously presented data from cohort 1 demonstrated that 93% and 96% of patients with METAVIR F0-F2 scores treated with simeprevir and sofosbuvir with or without ribavirin, respectively, for 12 weeks achieved SVR12.
In genotype 1a patients with the Q80K polymorphism at baseline, 89% and 83% achieved SVR12 after 12 weeks of treatment with and without ribavirin, respectively. Rapid virologic response (RVR, defined as undetectable HCV RNA at Week 4 of treatment) was not found to be predictive of achieving SVR. In patients receiving simeprevir and sofosbuvir alone for 12 weeks, 93% achieved SVR, while 57% achieved RVR. The most common adverse events in both treatment arms were fatigue, headache, nausea and insomnia. Two patients discontinued treatment due to adverse events.
“The COSMOS data presented at The International Liver Congress 2014 add to the growing body of data demonstrating the efficacy and safety of simeprevir-based treatment regimens,” said Gaston Picchio, hepatitis disease area leader, Janssen Research & Development. “Janssen remains committed to exploring the utility of simeprevir in these different combinations.”
Date: April 12, 2014
Source: Janssen
