Date: 2013-06-06
Type of information:
phase: 3
Announcement: presentation of primary efficacy and safety data from four phase III Japanese studies at The Japan Society of Hepatology
Company: Medivir (Sweden) Janssen Pharmaceuticals (J&J - USA)
Product: simeprevir (TMC435)
Action mechanism: Simeprevir is a NS3/4A protease inhibitor jointly developed by Medivir and Janssen for the treatment of chronic hepatitis C in adult patients with compensated liver disease.
Disease: patients with genotype 1 hepatitis C
Therapeutic area: Infectious diseases
Country: Japan
Trial details: Janssen’s phase III clinical program for simeprevir in Japan consists of four studies in patients with genotype 1 HCV: CONCERTO-1 in treatment-naïve patients, CONCERTO-2 and -3 in prior non-responders or patients who relapsed after prior interferon-based treatment, and CONCERTO-4 using different pegylated interferon treatments (pegylated interferon alfa-2b) in a broad patient population.
Latest
news: SVR12 in the CONCERTO Trials Trial Patient Type Treatment + pegylated interferon and ribavirin Proportion of Patients Achieving SVR12 (%) CONCERTO-1 Treatment-naïve Simeprevir (12 weeks) 89 Placebo (12 weeks) 62 CONCERTO-2 Prior Non-responder Simeprevir (12 weeks) 53 Simeprevir (24 weeks) 36 CONCERTO-3 Prior Relapser Simeprevir (12 weeks) 96 CONCERTO-4 Treatment-naïve Simeprevir (12 weeks) 92 Prior Relapser Simeprevir (12 weeks) 100 Prior Non-responder Simeprevir (12 weeks) 39 The most common adverse events seen in patients receiving simeprevir plus pegylated interferon and ribavirin in CONCERTO-1 were similar to those observed with pegylated interferon and ribavirin alone and were also similar in the other studies (decreased white blood cell count, fever, anemia, decreased neutrophil count, malaise, headache and rash). Treatment discontinuation rates due to an adverse event in CONCERTO-1 were five percent in the simeprevir arm and 8 percent in the placebo arm, four percent in CONCERTO-2, four percent in CONCERTO-3 and one percent in CONCERTO-4.* On June 6, 2013, Medivir has reported that its partner Janssen Pharmaceutical R&D Ireland (Janssen) has announced primary efficacy and safety results from four Japanese phase III clinical studies demonstrating that the use of simeprevir led to sustained virologic response 12 weeks after the end of treatment (SVR12) in patients with genotype 1 hepatitis C, when administered once daily with pegylated interferon and ribavirin.
The four studies examined the use of simeprevir in genotype 1 chronic hepatitis C patients who were treatment naïve, as well as patients who were non-responders to prior therapy or relapsed following treatment with pegylated interferon with or without ribavirin. The CONCERTO studies supported the new drug application for simeprevir, which was submitted to Japanese regulatory authorities in February 2013.
