Clinical Trials

Date: 2011-12-02

Type of information: Initiation of development program

phase: 2

Announcement: initiation of the trial

Company: BMS (USA) Tibotec Pharmaceuticals (J&J) (USA) Medivir (Sweden)

Product: simeprevir (TMC435) and daclatasvir

Action mechanism:

direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS3A) inhibitor/RNA polymerase (NS5A) inhibitor.. Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.
Daclatasvir is a NS5A replication complex inhibitor.

Disease:

genotype-1 chronic hepatitis C virus (HCV) infection

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news:

Medivir has announced that its development partner, Tibotec Pharmaceuticals, has entered into an agreement with BMS. TMC435, a once daily NS3/4A protease inhibitor (PI) for the treatment of genotype-1 chronic hepatitis C virus (HCV) infection will be investigated in combination with BMS´s investigational NS5A replication complex inhibitor, daclatasvir. Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012. TMC435 is currently being developed in three global phase III studies, QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. In parallel with these trials, phase III studies for TMC435 in Japan, in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients, are ongoing. These phase III studies are fully recruited.