Galexos (simeprevir)

Galexos (simeprevir) – General Information (PDF)

Targeted Genotype: 1 a/b

Approvals: Please see below information about Galexos treatment combinations.

Treatment Description: Galexos (simeprevir) is a NS3/4A protease inhibitor (PI). NS3/4A PIs work by blocking a hep C enzyme (protease) that enables the virus to survive and make copies of itself in host cells – the liver in this case.

Usage Warning: Galexos (simeprevir) should not be taken by patients who have moderate or severe liver damage.

Galexos Treatment Combinations

Galexos + Pegylated Interferon with Ribavirin (PR)

  • Approvals: Federal/Canada: Yes   PharmaCare: Yes

Galexos + Sovaldi

Galexos + Pegylated Interferon with Ribavirin (PR)

Dose: 1 pill of Galexos daily + 1 pegylated interferon injection weekly + 2 pills of ribavirin daily

SVR: 84% (without the Q80K genetic mutation)

Length of Treatment:

Patients HCV RNA at Week 4* Galexos + peginterferon + ribavirin (PR) Peginterferon + ribavirin (PR) Total # of Weeks
Haven’t been treated OR have relapsed Undetectable First 12 weeks Additional 12 weeks 24
<25 IU/mL detectable* First 12 weeks Additional 36 weeks 48
Tried treatment but didn’t respond OR only partially responded undetectable or <25 IU/mL detectable* First 12 weeks Additional 36 weeks 48
*Viral load tests determine how much virus (HCV RNA) is in the blood. If their results are higher than certain amounts, or if there is more virus in the blood than a certain amount, longer or additional treatments may be recommended. The IU/ml mean International Units per milliliter and is used in reporting viral load test results. In this case, for patients with a level of hep C virus of < 25 IU/ml at 4 weeks of treatment, an additional 36 weeks of treatment would be prescribed as shorter durations have higher relapse rates.

Common Side Effects:

  • Constipation
  • Increased bilirubin levels in one’s blood
  • Sensitivity to sunlight (photosensitivity)
  • Skin rash

BC’s PharmaCare Eligibility for Galexos + PR

Galexos in combination with pegylated interferon with ribavirin (PR) is a limited coverage drug. In order to qualify for coverage for it, patients must have:

  • Never tried to treat their hepatitis C (treatment naive)

OR

  • Tried treatment and the virus came back (relapsed)

OR

  • Tried treatment but weren’t cured (non-responder)

AND have ALL of the following:

  • Lab-confirmed hepatitis C with genotype 1
  • Detectable levels of hep C in the last 6 months
  • A liver fibrosis stage F2 or greater
  • A Special Authority request completed by a specialist or experienced physician
  • Recent lab-confirmation of NS3 Q80K polymorphism negative for patients with hep C genotype 1a subtype or genotype 1 with indeterminate subtype. Retesting is required for all those who had their genotype tested before May 1, 2012.

AND NOT

In exceptional cases, requests that do not meet the above criteria may receive special consideration for coverage if the physician provides additional documentation of disease progression and/or for other patient-specific considerations. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews all requests for coverage of exceptional cases.

Talk to your healthcare provider for more information or to start the treatment process.

Galexos: Bioadvance Program

Janssen has created the Galexos: Bioadvance Program, a patient support program designed to provide health information and reimbursement assistance for patients who have been prescribed Galexos. This program doesn’t cost anything and is completely confidential. For more information, contact your doctor, nurse, or call the program at: 1-855-512-3740.