Holkira Pak

Holkira Pak Holkira Pak (ombitasvir / paritaprevir / ritonavir + dasabuvir) – General Information (PDF)

*Effective March 23, 2017, BC PharmaCare will no longer approve new requests for coverage.

For patients whose coverage was approved before March 23, 2017, BC PharmaCare will continue coverage until their current Special Authority expires. More information here.

 

Targeted Genotype: 1 a/b

Approved by Health Canada and Covered by BC PharmaCare:   Yes

Treatment Description: Holkira Pak is a treatment made up of 3 direct-acting antivirals (ombitasvir, paritaprevir, and dasabuvir) and ritonavir. Ritonavir is a booster for paritaprevir. It boosts it by slowing down the liver’s break down of paritaprevir so that it stays in the body longer or at higher levels.

Direct-Acting Antivirals (DAAs) Class of DAA Very Roughly What They Do*
Ombitasvir NS5A Inhibitors NS5A Inhibitors block a virus protein, NS5A, that HCV needs to reproduce and for various stages of infection.
Paritaprevir NS3/4A Protease Inhibitors (PI) NS3/4A protease inhibitors work by blocking a viral enzyme (protease) that enables the virus to survive and replicate in host cells.
Dasabuvir Non-Nucleoside NS5B Polymerase Inhibitors They work to stop HCV from reproducing by inserting themselves into the virus so that other pieces of it cannot attach.
*Hep C Treatment includes a list of resources that explain this information further.

Usage Warning: Holkira Pak should not be taken with/by the following:

  • Those with moderate to severe liver impairment (Child-Pughs B and C);
  • Ethinyl estradiol-containing medicines (such as some birth control products);
  • Drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations;
  • Strong CYP2C8 inhibitors and inducers;
  • Moderate or strong inducers of CYP3A;
  • Recreational drugs.

Daily Dose: 4 pills +/- ribavirin pills

  • Ombitasvir / Paritaprevir / Ritonavir: 2 pills in the morning
  • Dasabuvir: 1 pill in the morning and 1 pill in the evening
  • Ribavirin (1 pill in the morning and 1 pill in the evening) is added to treatments for those who have hep C genotype 1a OR have compensated cirrhosis. Ribavirin isn’t added for non-cirrhotic patients with a genotype 1b infection.

Sustained Viral Response (SVR)/”Cure Rate”: Above 90%

Length of Treatment:

Genotype Previously Treated Cirrhosis Treatment # of Weeks
1a Yes or No No 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV* 12
1b Yes or No No 2 pills once daily + 1 pill twice daily 12
1a/1b No Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 12
1a Yes Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 24**
*RBV stands for ribavirin. Holkira Pak with ribavirin is recommended for patients with an unknown genotype 1 subtype or with mixed genotype.
**24 weeks of Holkira Pak + ribavirin is recommended for patients with genotype 1a infection with cirrhosis who previously didn’t respond to pegylated interferon and ribavirin (PR).

Common Side Effects:

  • Can’t sleep (insomnia)
  • Diarrhea
  • Headache
  • Itchiness
  • Nausea
  • Tiredness

PharmaCare Eligibility for Holkira Pak +/- Ribavirin

Holkira Pak with or without ribavirin is a PharmaCare limited coverage drug accessed through a Special Authority request. Special Authority requests are usually filled out by specialists.

Holkira Pak with or without ribavirin is covered by BC PharmaCare for the treatment of chronic hepatitis C genotype 1 in patients with or without compensated cirrhosis and who have:

  • Never tried to treat their hepatitis C (treatment naive) without liver cirrhosis

OR

  • Tried treatment but the virus came back (relapsed) without liver cirrhosis

OR

  • Tried treatment or haven’t tried treatment with compensated cirrhosis (compensated cirrhosis is defined as cirrhosis with a Child Pugh Score=A (5-6))

AND have ALL of the following:

  • Lab-confirmed hepatitis C 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

AND NOT

HIV/HCV co-infected patients are covered under the criteria listed above.

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.

AbbVie Care

Canadians prescribed Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) can request to be enrolled in AbbVie Care. The program is designed to provide services such as reimbursement assistance, education, and ongoing disease management support. AbbVie Care not only supports people living with genotype 1 hep C but healthcare professionals as well. For more information call: 1-844-471-2273.