In the pursuit to cure* chronic hepatitis C virus (HCV) genotype 1 infection…Consider OLYSIO® for your patients who want to discuss treatment duration
97% (170/176) of patients without cirrhosis achieved cure* and 3% (5/175) experienced viral relapse in the 12-week groups
IFN- and RBV-free treatment option = OLYSIO® + sofosbuvir (SOF)
- 12 weeks of treatment duration for patients without cirrhosis
Use with RBV
- Results from treatment arms containing RBV in addition to OLYSIO® and sofosbuvir in the COSMOS trial are not shown because efficacy was similar with or without RBV, and thus addition of RBV to OLYSIO® and sofosbuvir is not recommended.
IFN=interferon; P/R=peginterferon/ribavirin; RBV=ribavirin.
*Virologic cure (SVR12) was defined as sustained virologic response 12 weeks after actual (OPTIMIST-1) or planned (COSMOS) end of treatment (EOT).
‡Viral relapse rates are calculated with a denominator of subjects with undetectable (or unconfirmed detectable) HCV RNA at EOT. In addition to five subjects with viral relapse, one subject failed to achieve SVR12 due to missing SVR12 data. No subjects experienced on-treatment virologic failure.
COSMOS & OPTIMIST-1: IFN-Free study design and baseline demographics
IFN- and RBV-free treatment option = OLYSIO® + SOF
COSMOS: open‑label, randomized Phase 2 trial to investigate the efficacy and safety of 12 or 24 weeks of OLYSIO® in combination with SOF without or with RBV in HCV genotype 1‑infected prior null responders with METAVIR fibrosis score F0‑F2, or treatment‑naïve subjects and prior null responders (to P/R therapy) with METAVIR fibrosis score F3‑F4 and compensated liver disease.
OPTIMIST-1: open-label, randomized Phase 3 trial to investigate the efficacy and safety of 12 weeks of OLYSIO® in combination with SOF without RBV in HCV genotype1-infected subjects without cirrhosis.
- OLYSIO® 150 mg once daily + SOF 400 mg once daily
- Primary endpoint: SVR12: sustained virologic response 12 weeks after planned (COSMOS) or actual (OPTIMIST-1) end of treatment [EOT]
IFN=interferon; P/R=peginterferon/ribavirin; RBV=ribavirin; SOF=sofosbuvir.
*This case is representative of a patient in the COSMOS and OPTIMIST-1 clinical trials. The image is not of an actual patient studied.
Baseline demographic and disease characteristics in OLYSIO® + SOF without RBV arms
In COSMOS, 19%, 31% and 22% had METAVIR fibrosis scores F0-F1, F2 and F3, respectively, and 29% had METAVIR fibrosis score F4 (cirrhosis).
‡ Includes only null responders to prior Peg-IFN/RBV therapy.
† Includes relapsers and non-responders to prior Peg-IFN-based therapy (with or without RBV), and IFN-intolerant subjects.