Facts of Olysio Simeprevir Capsules 150 mg ?
- Medicine Name: OLYSIO
- Generic Name: SIMEPREVIR
- Date of Approval: 25.11.2013
- Company Name: Johnson & Johnson’s pharmaceutical division Janssen Pharmaceutica.
What is Olysio Simeprevir Capsules 150 mg ?
Olysio is Indicated for treatment of chronic hepatitis C (CHC); efficacy has been established in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection with compensated liver disease (including cirrhosis)
What are the indications and usage? ?
OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
- OLYSIO efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1 infected subjects with compensated liver disease (including cirrhosis).
- OLYSIO must not be used as monotherapy. (
- Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.
What is the treatment duration?
- In all patients, simeprevir should be initiated in combination with peginterferon alfa and ribavirin and should be administered for 12 weeks
- All treatment-naïve and prior relapser patients, including those with cirrhosis, should receive an additional 12 weeks of peginterferon alfa and ribavirin after completing 12 weeks of treatment with simeprevir, peginterferon alfa and ribavirin (total treatment duration of 24 weeks)
- All prior nonresponders (including partial and null-responders and those with cirrhosis), should receive an additional 36 weeks of peginterferon alfa and ribavirin after completing 12 weeks of simeprevir, peginterferon alfa and ribavirin (total treatment duration of 48 weeks)
Discontinue if inadequate virologic response:
- Monitor HCV RNA levels to determine virologic response
- It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients
- HCV-RNA levels at week 4 ≥25 IU/mL: Discontinue simeprevir, peginterferon alfa, and ribavirin
- HCV-RNA levels at week 4 ≥25 IU/mL: Discontinue simeprevir, peginterferon alfa, and ribavirinHCV-RNA levels at week 12 ≥25 IU/mL: Discontinue peginterferon alfa and ribavirin (treatment with simeprevir completed at week 12), and ribavirin
- HCV-RNA levels at week 24 ≥25 IU/mL: Discontinue peginterferon alfa and ribavirin