Drugs Xagena
The FDA ( Food and Drug Administration ) has approved Olysio ( Simeprevir ), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with Pegylated Interferon and Ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
Olysio may benefit patients with chronic hepatitis C, including those who are treatment naïve or who have failed prior interferon-based therapy.
Olysio works by blocking the viral protease enzyme that enables the hepatitis C virus ( HCV ) to replicate in host cells. The goal of treatment for chronic hepatitis C is cure, also known as sustained virologic response ( SVR ), which is defined as undetectable levels of HCV in the patients’ blood 12 to 24 weeks after the end of treatment. For treatment-naïve and prior-relapser patients, a fixed treatment regimen of 12 weeks of Olysio combined with 24 weeks of PegInterferon and Ribavirin is recommended. For prior partial- and null-responder patients, a treatment regimen of 12 weeks of Olysio combined with 48 weeks of Pegylated Interferon and Ribavirin is recommended.
Olysio is a prescription medicine used with other antiviral medicines, PegInterferon and Ribavirin, to treat genotype 1 chronic hepatitis C in adults with stable liver problems. Olysio must not be taken alone. The efficacy of Olysio in combination with Peginterferon and Ribavirin is greatly decreased in patients who have genotype 1a Q80K. It is not known if Olysio is safe and effective in children under 18 years of age.
The New Drug Application ( NDA ) for Olysio was based in part on efficacy and safety results from three pivotal Phase 3 studies – QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior Interferon-based treatment – as well as data from the Phase 2b ASPIRE study in prior non-responder patients. Each of the studies evaluated Olysio dosed once daily in combination with Pegylated Interferon and Ribavirin versus treatment with placebo plus Pegylated Interferon and Ribavirin.
Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80% of treatment-naïve patients in the group receiving Olysio achieved sustained virologic response 12 weeks after the end of treatment ( SVR12 ), compared with 50% of patients in the placebo groups. In PROMISE, 79% of prior-relapser patients in the Simeprevir group of the study achieved SVR12 compared with 37% of patients in the placebo group. Results from ASPIRE demonstrated that use of Olysio led to sustained virologic response 24 weeks after the end of treatment ( SVR24 ) in 65% of prior partial-responder patients and 53% of prior-null responder patients compared with 9% and 19% of prior partial- and null-responder patients in the placebo groups, respectively.
In the QUEST-1 and QUEST-2 studies, among genotype 1a treatment-naïve patients receiving Olysio who had the Q80K polymorphism ( a naturally occurring variation in the HCV NS3/4A protease enzyme ), 58% achieved SVR12 versus 84% of patients without the Q80K polymorphism. In the placebo arm, 52% of patients with the Q80K polymorphism achieved SVR12. In the PROMISE study, among prior-relapser patients with the Q80K polymorphism who received Olysio, 47% achieved SVR12 versus 78% of patients without the polymorphism. In the placebo arm, 30% of patients with the Q80K polymorphism achieved SVR12. ( Xagena )
Source: Janssen Pharmaceuticals, 2013
XagenaMedicine_2013
