Date: 2011-11-07
Type of
information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the American Association for the Study of Liver Diseases (AASLD) meeting
Company: Tibotec Pharmaceuticals-J&J (Ireland - USA) Medivir (Sweden)
Product: simeprevir (TMC435)
Action
mechanism:
- direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS5B) inhibitor/RNA polymerase (NS5A) inhibitor. Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.
Disease:
Therapeutic
area: Infectious diseases
Country: 13 countries in Europe, North America, and Australasia.
Trial
details:
- The PILLAR study [Protease Inhibitor TMC435 trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen] (TMC435-C205; NCT00882908) was a five-arm, global phase 2b randomized, double-blind, placebo controlled study in 386 treatment-naive patients. TMC435 was administered in doses of 75mg or 150mg q.d. for either 12 weeks or 24 weeks in combination with 24 or 48 weeks of peg-interferon and ribavirin (PR). Patients in the placebo arm receive 24 weeks of placebo plus peg-interferon and ribavirin followed by 24 additional weeks of peg-interferon and ribavirin treatment. The primary endpoint of the study was sustained virologic response at Week-72 (SVR week 72).
Latest
news:
- Medivir’s partner Tibotec has announced that final SVR24 results from phase IIb PILLAR study of TMC435 have been presented at the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco. Results from the final PILLAR analysis showed that TMC435 administered in combination with peginterferon -2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR.
In the two TMC435 treatment groups who received TMC435 75mg, between 75 and 82 percent of patients achieved SVR24, and in the two TMC435 treatment groups who received TMC435 150mg, between 81 and 86 percent of patients achieved SVR24. This is compared to 65 percent of patients in the placebo arm who achieved SVR24. In addition, 79 to 86 percent of patients in the TMC435 treatment arms had a shortened treatment duration of 24 weeks, compared to a 48 weeks treatment duration for patients who received placebo plus P/R. In TMC435 arms, 68 to 76 percent of patients achieved rapid virologic response [RVR; HCV RNA<25 (undectectable)], of whom 88 to 95 percent achieved SVR24. There were no significant differences for adverse events between TMC435 treatment groups and placebo.
TMC435 150mg administered once daily (q.d.) is being investigated in phase 3 trials in treatment-naive patients and in patients who experienced a viral relapse after being treated with interferon-based therapy. TMC435 is being developed by Tibotec Pharmaceuticals. Medivir AB has commercialization rights for TMC435 for the Nordic countries, Janssen has commercialization rights for TMC435 in the rest of the world.
Patients receiving TMC435 were allowed to stop all treatment at week 24 if they met both response-guided criteria: a) detectable or undetectable HCV RNA levels (< 25 IU/mL) at week 4 and b) undetectable HCV RNA at weeks 12, 16 and 20. Patients who did not meet the above response-guided criteria continued with peg-interferon and ribavirin until Week-48.
Is
general: Yes
