Hep C Drug Pipeline Treatments

Hep C Drug Pipeline TreatmentsThe following summarizes hep C treatments currently in the Canadian drug approval system. Some of these treatments are far enough along in the approval system that they have been approved for use in Canada. None are far enough along to be approved for PharmaCare coverage.

The hep C treatments that are covered by BC PharmaCare, and for the most part other provincial PharmaCare systems, have their own pages dedicated to them. Look for them in the drop-down menu under BC’s PharmaCare Covered Treatments or Treatment Coverage Across Canada.

Treatments Currently Within the Canadian Drug Approval Process

Pharmaceutical Companies Treatments (brand names first with generic names in brackets unless a brand name hasn’t yet been assigned in Canada) Targeted Genotypes
AbbVie Holkira Pak (ombitasvir / paritaprevir / ritonavir + dasabuvir) 1
Technivie (ombitasvir / paritaprevir / ritonavir) 4
Maviret 1-6
Gilead Vosevi 1-6
Janssen Galexos (simeprevir) + Sovaldi (sofosbuvir) 1

Maker: AbbVie

Treatment: Holkira Pak

Targeted Genotype: 1

Treatment Description: Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

  • Ombitasvir / Paritaprevir / Ritonavir +/-
  • Ribavirin

Daily Dose: 4 pills +/- ribavirin pills

Sustained Viral Response (SVR)/”Cure Rate”: 95 – 100% with ribavirin

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.

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 Reported in Clinical Trials:

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

Availability: Approved for use in Canada. However, BC PharmaCare no longer covers it.

Additional Information:

Treatment: Technivie

Targeted Genotype: 4

Treatment Description: Technivie is made up of 2 direct-acting antivirals (ombitasvir and paritaprevir) and ritonavir, a booster for paritaprevir.

  • Ombitasvir / Paritaprevir / Ritonavir +/-
  • Ribavirin

Sustained Viral Response (SVR)/”Cure Rate”: 95 – 100% with ribavirin

Daily Dose: 2 pills taken once in the morning +/- 2 pills of ribavirin

Length of Treatment: 12 weeks

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Insomnia
  • Nausea
  • Tiredness (fatigue)
  • Weakness (asthenia)

Usage Warning: Technivie 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 are associated with serious adverse reactions
  • Strong CYP2C8 inhibitors and inducers
  • Moderate or strong inducers of CYP3A

Availability: Approved for use in Canada and can be prescribed but is not covered by PharmaCare systems, including BC PharmaCare. Negotiations that may have led to PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA.

Additional Information:

Treatment: Maviret

Targeted Genotype: 1-6

Treatment Description: Maviret is made up of 2 direct-acting antivirals. Glecaprevir is a NS3/4A protease inhibitor and pibrentasvir is a NS5A inhibitor, Together these drugs are achieving great clinical trial results without having to be combined with ribavirin. If approved, they may provide a shorter treatment duration for patients without liver cirrhosis, AbbVie is working to have the treatment available in Canada this fall.

  • Glecaprevir +
  • Pibrentasvir

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 97 − 100%

Possible Daily Dose: 3 pills once daily

Possible Length of Treatment: 8 or 12 weeks

Common Side Effects Reported in Clinical Trials:

  • Diarrhea
  • Headache
  • Tiredness (fatigue)

Usage Warning: Maviret should not be taken by those with moderate to severe liver impairment (Child-Pughs B and C).

Step in Drug Approval Pipeline: Step 3 – Notice of Compliance + Drug Identification Number/NOC + DIN. Has not applied for BC PharmaCare coverage.

Availability: Approved for use in Canada and can be prescribed but is not covered by PharmaCare systems, including BC PharmaCare

Additional Information:

Maker: Gilead

Treatment: Vosevi

Targeted Genotype: 1-6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with Sovaldi-containing regimen without an NS5A inhibitor

Treatment Description:

  • Sovaldi (Sofosbuvir) +
  • Velpatasvir +
  • Voxilaprevir

Daily Dose: 1 pill

Sustained Viral Response (SVR)/”Cure Rate”: 90-100%

Common Side Effects Reported in Clinical Trials (>6%):

  • Asthenia
  • Diarrhea
  • Headache
  • Insomnia
  • Tiredness

Usage Warning: Do not take Sovaldi in any combination while taking Amiodarone or with bradycardia. Vosevi is contraindicated with the following drugs products: dabigatran etexilate, phenobarbital, phenytoin, rifampin, rosuvastatin. Vosevi is also contraindicated with the herbal product, St. John’s wort.

Step in Drug Approval Pipeline: Step 3 – Notice of Compliance + Drug Identification Number/NOC + DIN. Has not applied for BC PharmaCare coverage.

Availability: Approved for use in Canada and can be prescribed but is not covered by PharmaCare systems, including BC PharmaCare

Additional Information:

Maker: Janssen

Treatment: Galexos + Sovaldi

Targeted Genotype: 1

Treatment Description:

Sustained Viral Response (SVR)/”Cure Rate”: 94%

Daily Dose: 1 pill of Galexos + 1 pill of Sovaldi

Length of Treatment:

Patients Treatment # of Weeks
Have or haven’t been treated without cirrhosis Galexos + Sovaldi 12
Have or haven’t been treated patients with cirrhosis Galexos + Sovaldi 24

Common Side Effects Reported in Clinical Trials:

  • Anemia
  • Dizziness
  • Headache
  • Itchiness
  • Nausea
  • Sensitivity to sunlight (photosensitivity)
  • Skin rash
  • Tiredness

Usage Warning: Galexos (simeprevir) should not be taken by patients who have moderate or severe liver damage. Do not take Sovaldi in any combination while taking Amiodarone or with bradycardia.

Step in Drug Approval Pipeline: Step 3 – Notice of Compliance + Drug Identification Number/NOC + DIN. Has not applied for BC PharmaCare coverage.

Availability: Approved for use in Canada and can be prescribed but is not covered by PharmaCare systems, including BC PharmaCare

Additional Information:

Glecaprevir Janssen Janssen AbbVie Daklinza Gilead AbbVie Sunvepra Gilead Epclusa Zepatier

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