Date: 2015-04-08
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) taking place in Vienna from April 22-26
Company: Medivir (Sweden) Janssen Pharmaceuticals, a J&J company (USA - NJ)
Product: simeprevir (Olysio®) in combination with sofosbuvir and daclatasvir
Action
mechanism: direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS5B) inhibitor/nonstructural protein 5A (NS5A) inhibitor Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir. Daclatasvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle by suppressing viral replication. This nucleotide NS5B polymerase inhibitor is developed by Gilead Sciences.
Disease: patients with hepatitis C genotype 1 and 4 infection and decompensated liver disease
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On April 8, 2015, Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) taking place in Vienna from April 22-26. Several key presentations will report on the efficacy and tolerability of simeprevir in interferon-free combination regimens in Phase 2, Phase 3 and real-world clinical settings.
* On October 10, 2014, Medivir announced that its partner Janssen recently initiated patient enrolment in a phase II study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and BMS NS5A replication complex inhibitor daclatasvir. The study includes treatment-naïve and treatment-experienced patients with hepatitis C genotype 1 and 4 infection and decompensated liver disease. In the phase II, open label IMPACT study, patients will receive the once-daily combination of simeprevir 150 mg, sofosbuvir 400 mg and daclatasvir 60 mg, for 12 weeks. The primary efficacy endpoint in the study is the proportion of patients achieving sustained virologic response 12 weeks after the end of treatment (SVR12). The IMPACT study represents the first phase II study of the combination of simeprevir, sofosbuvir and daclatasvir in a regimen without pegylated interferon and ribavirin.
