Hep C Drug Pipeline Treatments

Hep C Drug Pipeline TreatmentsThe following summarizes the hep C treatments currently within 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. However, none of them 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.

Also, our NEW Next Generation Treatments page is dedicated to the hepatitis C treatments that are coming. These treatments are currently still within the very early stages of clinical trials and may or may not be successfully approved for use and, if they are approved, may take a number of years to do so.

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 Technivie (ombitasvir, paritaprevir, ritonavir) 4
Bristol-Myers Squibb Daklinza (daclatasvir) 1, 2, 3
Daklinza (daclatasvir) + Sovaldi (sofosbuvir)
Sunvepra (asunaprevir) 1, 4
Gilead Epclusa (sofosbuvir / velpatasvir) 1-6
GS-9857 1
Janssen Galexos (simeprevir) + Sovaldi (sofosbuvir) 1
Merck Zepatier (elbasvir / grazoprevir) 1, 3, 4
*Velpatasvir and GS-9857 haven’t been assigned Canadian brand names yet.

Maker: AbbVie

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

Steps in Drug Approval Pipeline:  Step 5 – Provincial Review for the treatment of hep C genotype 4

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

Additional Information:

Maker: Bristol-Myers Squibb

Treatment: Daklinza (daclatasvir)

(Drug Pipeline Diagram)

Targeted Genotypes: 1, 2, 3

Treatment Description: Daklinza (daclatasvir) is a direct acting antiviral, a hep C drug, that works against hep C with other direct acting antivirals. It is progressing through the Canadian drug approval process on its own, however, it needs to be combined with other drugs to be used. Currently, it is being paired with Sovaldi (sofosbuvir).

Availability:  Approved for use in Canada and can be prescribed but is not covered by PharmaCare systems, including BC PharmaCare. More information about funding treatments is on our Financial Support page.

Treatment: Daklinza (daclatasvir) + Sovaldi (sofosbuvir)

Targeted Genotypes: 1, 2, 3

Also Approved for:

  • Co-infected with hep C and HIV type 1 (HIV-1);
  • Patients with decompensated cirrhosis (Child-Pugh score A, B or C); and
  • Patients with hep C recurrence after liver transplantation.

Sustained Viral Response (SVR)/”Cure Rate” with or without ribavirin:

Patients Average SVR
Treatment naive with hep C genotype 1 99%
Treatment experienced* with genotype 1 100%
Treatment naive with genotype 2 96%
 Treatment naive with genotype 3 89%
*Treatment experienced/failure with either telaprevir or boceprevir.

Daily Dose:  1 pill of Daklinza + 1 pill of Sovaldi taken together +/- 2 pills of ribavirin

Length of Treatment: 

Patients # of Weeks
Genotype 1 and genotype 3 patients without cirrhosis 12
Genotype 1 and 3 patients with cirrhosis 24
Genotype 2 patients with or without cirrhosis 24

Co-infected with HIV:  Same dose and length of treatment required

Common Side Effects Reported in Clinical Trials: 

  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)

Usage Warning: Patients with Bradycardia taking amiodarone can not take Sovaldi (sofosbuvir) in any combination. There have been reports of severe heart issues. Tell your doctor if you are taking CYP3A inhibitors or P-gp, OATP 1B1, 1B3, BCRP, phenytoin, carbamazepine, rifampin, or St. John’s wort (Hypericum perforatum) as they limit Daklinza’s effectiveness.

Approved for:

Step in Drug Approval Pipeline:  BC PharmaCare has posted notice that it will not cover Daklinza

Availability:  Approved for use in Canada and can be prescribed but is not covered by PharmaCare systems, including BC PharmaCare. More information about funding treatments is on our Financial Support page.

Additional Information:

Treatment: Sunvepra (asunaprevir)

Targeted Genotype: 1, 4

Treatment Description: Sunvepra is a NS3/4A protease inhibitor that works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. It is to be taken in combination with other hep C direct-acting antivirals/treatments.

  • Sunvepra +
  • Daklinza +/-
  •  Pegylated interferon with ribavirin

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 93 – 100%

Daily Dose:  1 pill twice daily +  Daklinza taken once daily +/- pegylated interferon with ribavirin

Length of Treatment: 

Patients Treatment # of Weeks
Genotype 1b treatment-naive or treatment-experienced with or without compensated cirrhosis Sunvepra + Daklinza 24
Genotype 1 or 4 treatment-naive or treatment-experienced with or without compensated cirrhosis Sunvepra + Daklinza + Pegylated Interferon with Ribavirin 24
Treatment-experienced is defined here as those who failed prior therapy with an interferon-based regimen, including null or partial response, or intolerant to or ineligible for interferon-based therapy

Co-infected with HIV:  The safety and efficacy of Sunvepra have not been studied in HCV patients co-infected with HIV.

Common Side Effects Reported in Clinical Trials: 

  • Headache
  • Tiredness

Steps in Drug Approval Pipeline:  Step 5: Provincial Review

Availability:  Sunvepra is approved for use in Canada when taken in combination with other hep C direct-acting antivirals/treatments

Additional Information:

Maker: Gilead

Treatment: Epclusa

Targeted Genotypes: 1-6

Treatment Description: Epclusa is made up of 2 direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir is a nucleotide NS5B polymerase inhibitor that directly targets the hep C virus to stop it from making copies of itself in the liver. They attach themselves onto the genetic information, called RNA, to block the virus from multiplying.  Velpatasvir is a NS5A inhibitor that blocks a virus protein, NS5A, that the virus needs for reproducing and various stages of infection.

  • Epclusa
  • +/-Ribavirin

Sustained Viral Response (SVR)/”Cure Rate”:  94 – 100%

Daily Dose:  1 pill +/- ribavirin

Length of Treatment:  12 weeks

Common Side Effects: 

  • Headache
  • Tiredness (fatigue)

Usage Warning: Patients with Bradycardia taking amiodarone can not take Epclusa. Don’t take rifampin, St. John’s wort, or carbamazepine while taking Epclusa.

Step in Drug Approval Pipeline:  Step 4 – Common Drug Review by CADTH

 Availability:  Approved for use in Canada

Additional Information:

Treatment: GS-9857

Targeted Genotype: 1

Potential Combination:

Sustained Viral Response (SVR)/”Cure Rate”:  80 – 90%

Length of Treatment:  6 weeks

Common Side Effects Reported in Clinical Trials: 

  • Headache
  • Nausea
  • Tiredness

Step in Drug Approval Pipeline:  Step 2 – Clinical Trials/New Drug Submission

Availability:  Not approved for use in Canada

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: 

Maker: Merck

Treatment: Zepatier

(Drug Pipeline Diagram)

Targeted Genotypes: 1,3, 4

Treatment Description: Zepatier is a pill taken once-daily that is made up of elbasvir and grazoprevir, two direct-acting antivirals. It is an all-oral, short-course (8, 12, or 16 weeks), interferon-free hep C treatment that can be taken with or without ribavirin. and with or without Sovaldi.

Potential Combinations:

    • Zepatier +/-
    • Sovaldi +/-
    • Ribavirin

Daily Dose: 1 pill of Zepatier +/- 1 Sovaldi pill +/- ribavirin

Sustained Viral Response (SVR)/”Cure Rate”: 90% – 98%

Possible Length of Treatment: 8 – 16 weeks

Without Ribavirin:

Patients # of Weeks
With hep C genotype 1 or 4 who have never tried treatment or have tried treatment with peginterferon and ribavirin (PR) but relapsed 12
With hep C genotype 1 who has tried treatment with a protease inhibitor but relapsed 12
With hep C genotype 1b who has never tried treatment and doesn’t have liver cirrhosis 8
With hep C genotype 1b who has tried treatment with peginterferon or PR but experienced on-treatment virologic failures 12

With Ribavirin:

Patients # of Weeks
With hep C genotype 1a who has tried treatment with peginterferon (PI) or with peginterferon and ribavirin (PR) but experienced on-treatment virologic failures 16
With hep C genotype 4 who have tried treatment with PR but experienced on-treatment virologic failures 16

With Sovaldi:

Patients # of Weeks
With hep C genotype 3 who have never tried treatment 12

Co-infected with HIV:  Same dose and length of treatment required

Common Side Effects Reported in Clinical Trials:

  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Trouble sleeping

Usage Warning: Do not take Zepatier if you have moderate or severe liver problems (Child-Pugh B or C). Patients with Bradycardia taking amiodarone can not take Sovaldi in any combination.

Tell your doctor if you take any of the following medicines as they may interact with Zepatier:

  • Tracleer: for pulmonary arterial hypertension
  • Alertec: to help people who cannot stay awake
  • Ketoconazole: to treat fungal infections
  • Tacrolimus: to stop organ transplant rejection
  • Elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate: a drug combination to treat HIV
  • Treatments for high cholesterol

Step in Drug Approval Pipeline: Step 5 – Provincial Review. Has applied for BC PharmaCare coverage for Zepatier with or without ribavirin for genotype 1, 3 or 4, and Zepatier + Sovaldi for genotype 3.

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

Additional Information:

Janssen Janssen AbbVie Bristol Gilead AbbVie Bristol Gilead Janssen Merck

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The information on this website is meant as a resource only and is not intended to replace qualified medical attention. Please seek advise and guidance from your health practitioners when considering your hep C treatment options.

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