Drug: Olysio (oh li see oh)
Olysio (simeprevir) is a protease inhibitor that is taken in combination with and without ribavirin. It is also combined with Sovaldi (sofosbuvir) a polymerase inhibitor manufactured by Gilead Sciences Inc. The combination is approved by the Food and Drug Administration to treat adults infected with hepatitis C genotype 1 patients:
- Treatment-naïve or treatment-experienced patients without cirrhosis. Treatment duration is 12 weeks.
- Treatment-naïve or treatment-experienced patients with cirrhosis. Treatment duration is 24 weeks.
Note: Olysio is also approved in combination with pegylated interferon plus ribavirin to HCV genotype 1 and 4 patients. I will only discuss Olysio plus Sovaldi with and without ribavirin to treat genotype 1.
The wholesale acquisition cost (WAC) for Olysio is $66,360.00. The wholesale acquisition cost for Sovaldi is $84,000 for a 12-week course of therapy. It is taken for 12 or 24 weeks based on clinical trial data approved by the FDA.
Patient Assistance Programs:
Janssen: 877-CarePath(877-227-3728) – www.janssenprescriptionassistance.com/olysio-cost-assistance
Gilead: Support Path – 1-855-769-7284 – www.mysupportpath.com
Common Drug Interactions: The herb St. John’s wort should be avoided. Antacids and other products to relieve heartburn (stomach problems) can affect how well the medications work. Talk to your medical provider about any medications, supplements, herbs or over-the-counter medications you are taking to prevent any possible problems that may interfere how well the medications will work.
See the Highlights of Prescribing Information for a complete listing of drug interactions.
Note: The Food and Drug Administration (FDA) is requiring that hepatitis C (HCV) medication guides (package inserts) list a warning about a possible risk of hepatitis B (HBV) reactivation while on HCV antiviral therapy. Reactivation of HBV can cause possible liver damage. However, the risk is extremely rare. The reactivation has been reported with interferon and direct-acting antiviral medications.
Patients should talk to their medical providers about the hepatitis B tests and vaccination prior to starting HCV treatment.
Side Effects: The most common side effects of Olysio plus Sovaldi that occurred in the 12 or 24 week clinical trials were fatigue, headache and nausea.
Pregnancy: There are no studies of Olysio and Sovaldi in pregnant women. Ribavirin can cause birth defects and miscarriages. If you are a male taking ribavirin you and your female sexual partner must use two types of effective birth control. Your female sexual partner will have to take a pregnancy test before and during treatment and 6 months after treatment ends. If you are a female taking ribavirin you and your male sexual partner must use two types of effective birth control. You will also have to take a pregnancy test before, during and 6 months after treatment ends.
Pediatric Patients: Olysio and Sovaldi are not approved to treat children.
HIV/HCV Coinfection: The dosage recommendation is the same for people coinfected as for those who are monoinfected with HCV
Recommended Treatment Duration – Cure Rates
|Olysio plus Sovaldi – 12 weeks||Olysio plus Sovaldi – 24 weeks|
|Patients F0-F3*||95% (20/21 pts)||95% (20/21 pts)|
86% (6/7 pts)
100% (10/10 pts)
* F0-F3 – patients from a scale with no fibrosis to severe fibrosis
** F-4 – patients with compensated cirrhosis.
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