Tag Archives: ZEPATIER

Drug Pipeline

In the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineCurrently, there are a couple of hepatitis C treatments making their way through the final steps of the Canadian drug approval pipeline. The following table was created to highlight these treatments and highlight the ways that you may be able to include your voice in their approval process.

Hepatitis C Treatments in the Final Steps of the Canadian Drug Approval Pipeline

Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Sovaldi (sofosbuvir) + Daklinza (daclatasvir) +/- RBV Sofosbuvir / Velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Steps in Canadian Drug Approval Pipeline Step 5 – Provincial Review Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review
Currently Seeking Patient Input No No Yes Yes Yes
Genotype (GT) Health Canada has Approved it for 4 1, 2, 3 This treatment has just begun the Canadian review process. Clinical trials have examined it on hep C genotypes 1-6. 1, 3, 4 3
Under BC PharmaCare Review for Genotype 4 Genotype 1, 2 or 3 without RBV, Genotype 2 or 3 with RBV Genotype 1, 3, 4 with or without RBV 3
Approximate SVR (Approx Rate of Cure) 90% without RBV, 100% with RBV 90 – 100% 94 – 100% 93 – 100% 91 – 100%
May Require PR* No
May Not Require RBV
 Yes
Daily Pills 1 +/- twice daily RBV 2 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 12 12 or 24 8, 12, or 24 8, 12, or 16 12
Limited Most Common Side Effects**  (Ribavirin can affect side effects)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Anemia
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
Drug Warnings (Healthcare providers, patient assistance programs, and/or online product monographs, links below, have more information)

Technivie is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Technivie should not be taken while taking: ethinyl estradiol-containing medicines, 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.

 Sovaldi is not for patients taking amiodarone. 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. Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.
General Hep C Treatment Usage Warning Do not take treatments while taking recreational drugs or over-the-counter drugs, such as St. John’s wort, without first talking with your healthcare provider as they may interact with each other. Tell your doctor if you may be or may become pregnant. The safety and efficacy of most of these treatments in children less than 18 years of age has not been established.
Patient Assistance Program Contact Information AbbVie Care 1-844-471-2273 Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Technivie Daklinza Zepatier
Information about HCV / HIV Co-infection Technivie (by CATIE) Daklinza (by CATIE)

Sovaldi / Velpatasvir (by hepmag)

 Zepatier (by CATIE)
*PR stands for pegylated interferon with ribavirin. It may be combined with other drugs for the treatment of hep C. RBV stands for ribavirin. **If patients experience treatment side effects, they are usually not severe enough to stop treatment. 

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Information was gathered from Health Canada’s Drug and Health Products sheets, BC PharmaCare Drug Information sheets,  CATIE, hepmag, product monographs, and the Hepatitis C Treatment Information Project within the past week.

Drug Pipeline

Victrelis (boceprevir) Voluntarily Discontinued

Victrelis (boceprevir) Voluntarily DiscontinuedVictrelis (boceprevir) and Victrelis Triple (Victrelis + pegylated interferon with ribavirin) were officially voluntarily discontinued in Canada yesterday, March 31st, 2016.

Victrelis, combined with pegylated interferon and ribavirin, was a first generation direct-acting antiviral hepatitis C treatment for adult patients with compensated liver disease, who were previously untreated or who had failed treatment. It was approved for use by Health Canada in July 2011.

In 2011, the standard treatment for all hepatitis C genotypes was the combination of pegylated interferon and ribavirin, taken for a year. Scrolling through PHCN’s blog post archive, there is a 2011 blog post about Victrelis and Incivek, another treatment that was approved that same year. In the blog post the new treatments were hailed as “important breakthroughs in the treatment of hepatitis C.”

Five years later, the decision to discontinue Victrelis was not based on safety or efficacy findings, but was based on scientific advancements, changes in treatment practices, and a decreased demand for the hep C treatment.

According to Merck, the treatment’s developer, it is believed that no one in Canada is still taking Victrelis. However, if more information about Victrelis or its discontinuance is required, one can still contact the Merck Care Program at 1-866-872-5773–although, the program is probably fielding less calls about Victrelis these days than it is about Merck’s new hepatitis C treatment, Zepatier*. The Hepatitis C Treatment Information Project certainly is.

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*Zepatier is a new hep C treatment being developed by Victrelis’ creator, Merck. Zepatier is an all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for hep C genotype 1, 3, or 4. The treatment is currently being reviewed for BC PharmaCare coverage. Please click this link for more information about the BC PharmaCare review. It is not too late to include your voice.

Drug Pipeline

Input Requested for Zepatier’s BC PharmaCare Review

Input Requested for Zepatier's BC PharmaCare ReviewZepatier’s BC PharmaCare Review Questionnaires (Once on the page, scroll down until you see a colourful table.)

Zepatier (elbasvir – grazoprevir) is being considered for BC PharmaCare coverage. As part of this process, BC PharmaCare has given BC patients, caregivers, and patient groups the opportunity to become a part of this drug review and share their opinions and perspectives with the decision makers.

If you are interested in grabbing this opportunity to voice your opinions, the link above will take you to the questionnaires. The link will also take you to BC PharmaCare’s Drug Information sheet and to information about BC PharmaCare’s approval process.

The questionnaires will ONLY remain open until MIDNIGHT ON Wednesday April 20, 2016.

Adding Your Voice to the BC PharmaCare Coverage Review for Zepatier

If you answer yes to any of the following questions, you can give your input:

  • Do you have hep C?
  • Are you a caregiver/loved one to someone who has hep C?
  • Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input? (Learn more about registering your organization).

Zepatier (elbasvir – grazoprevir)

Zepatier is a Health Canada approved, all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for hep C genotype 1, 3, or 4. The treatment can be prescribed with or without ribavirin and with or without Sovaldi. It has a high cure rate.

Links to Additional Information about Zepatier

For more information, please contact BC PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

Take the time to voice your opinion and help advocate for a better tomorrow!

Drug Pipeline

Add Your Voice for Zepatier

Add Your Voice for ZepatierAdd your voice. Zepatier will soon be considered for BC PharmaCare coverage. Therefore, your input may soon be sought.

Tentatively, patient and caregiver input into Zepatier’s approval process will be requested from Wednesday March 23, 2016 to MIDNIGHT ON Wednesday April 20, 2016.

How to Add Your Voice to the BC PharmaCare Coverage Review for Zepatier

If you are a BC resident and answer yes to any of the following questions, you can give your input into whether or not the treatment should be covered by BC PharmaCare:

  • Do you have hep C?
  • Are you a caregiver/loved one to someone who has hep C?
  • Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input? (Learn more about registering your organization).

Please note that PharmaCare’s questionnaire for Zepatier input tentatively wont be available for another week. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Zepatier in Canada

Zepatier is an approved all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for genotypes 1, 3, or 4 hep C. It can be taken with or without ribavirin and with or without Sovaldi.

Links to Additional Zepatier Information

For more information, please contact BC PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

Advocacy

Recent Updates to Patient Support Programs

Recent Updates to Patient Support ProgramsPharmaceutical Company Patient Support Programs

Pharmaceutical companies have financial assistance programs for people undergoing their specific treatments. Two of these assistance programs have been updated to include two new hep C treatments, Technivie and Zepatier. These treatments are available for use in Canada but are not currently covered by PharmaCare.

For more information about these programs, call the numbers provided or talk with your healthcare provider about eligibility requirements.

AbbVie Care Canadians prescribed Technivie can request to be enrolled in AbbVie Care. The program is designed to provide a wide range of customized services including reimbursement assistance, education, and ongoing disease management support. AbbVie Care will not only support people living with hepatitis C throughout their treatment but healthcare professionals as well. For more information, contact your doctor, nurse, or call the program at: 1-844-471-2273.

Merck Care Program For those who are prescribed Zepatier, Merck has Merck Care Program. For more information, contact your doctor, nurse, or call the program at: 1-866-872-5773.

A list of all of the pharmaceutical company patient support programs can be found at Pharmaceutical Company Assistance Programs.

Drug Pipeline

Zepatier Receives FDA Approval

Zepatier Receives FDA ApprovalZepatier (pronounced ZEP-ah-teer), taken with or without ribavirin, was approved by the U.S. Food and Drug Administration (FDA) yesterday for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4 and little or no liver damage (Child-Pugh A).

Yesterday’s Press Releases about Zepatier’s FDA Approval

  • The FDA’s News Release about the treatment’s approval
  • The Press Release about the approval by Merck, Zepatier’s developer

Zepatier

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

In clinical trials, Zepatier (with or without ribavirin) cured an overall 94% – 97% of patients with hep C genotype 1, and 97% – 100% of hep C genotype 4 patients.

Zepatier in Canada

On January 22nd, Health Canada approved Zepatier for use in Canada for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring). In Canada, it was approved for use with or without ribavirin and with or without Sovaldi.

More information about Zepatier in Canada can be found at Zepatier Approved in Canada or by visiting PHCN’s Hepatitis C Treatment Information Project.

Drug Pipeline

Zepatier Approved in Canada

ZepatierZepatier (grazoprevir / elbasvir) is now an approved hepatitis C treatment in Canada! Health Canada has granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring).

When Zepatier will be prescribed to patients, the treatment’s regimen will depend on the genotype/type of hepatitis C virus one has, whether or not one has liver cirrhosis, and one’s treatment history (whether or not treatment has already been tried without success).

See Zepatier (grazoprevir / elbasvir) Facts for more information about Zepatier.

What a Notice of Compliance (NOC) Means for Zepatier

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information about Zepatier (grazoprevir / elbasvir), or any other new and emerging hep C treatments, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Drug Pipeline

Zepatier (grazoprevir / elbasvir) Facts

*This Zepatier (grazoprevir / elbasvir) treatment facts sheet was updated January 21, 2016. It was originally put together in October 2015, while CADTH was seeking input for it from patient groups. This sheet is made up of Canadian treatment details. We will keep you updated as the treatment proceeds through the Canadian drug approval process.

Zepatier (grazoprevir / elbasvir)

Targeted Genotypes: 1, 3, 4

Treatment Description: Zepatier (grazoprevir / elbasvir) is made up of two direct-acting antivirals. Grazoprevir is a NS3/4A protease inhibitor. It works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. Elbasvir is a NS5A inhibitor. It blocks a virus protein, NS5A, that the virus needs to reproduce and for various stages of infection.

The treatment has been studied with ribavirin and Sovaldi (sofosbuvir) for multiple hep C genotypes and in patients with difficult-to-treat conditions, such as HIV/HCV co-infection and advanced chronic kidney disease.

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

Daily Dose: 1 pill of Zepatier at the same time every day +/- Sovaldi +/- ribavirin
Zepatier can be taken with or without food.

Possible Length of Treatment:  8 – 16 weeks

Without Ribavirin:

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

Availability:  Zepatier is approved for use in Canada

Common Side Effects Reported During Clinical Trials:

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

If you experience any side effects listed or not listed here, contact your healthcare professional.

Usage Warning: Do not take Zepatier if you have moderate or severe liver problems (Child-Pugh B or C). Tell your doctor about any medication (over the counter, prescribed, or recreational) you are taking before taking Zepatier.

See our Sovaldi and ribavirin pages for more information about their possible side effects and usage warnings.

Co-infected with HIV:  Same dose and length of treatment required. Tell your doctor about any medication (over the counter or prescribed) you are taking before taking Zepatier.

More Information:

  • Health Canada’s Summary Basis of Decision (SBD) documents that provide information related to the original authorization of a product.

Sampling of Phase II/III Clinical Trials for Zepatier:

Clinical Trial Patients Treatment Regimen Duration in Weeks
 SVR12*
C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients) GT 1, 4, 6 treatment naive with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80%
GT 1, 4, 6 HIV/HCV co-infected with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100%
GT 1, 4, 6 treatment- experienced with or without cirrhosis ZEPATIER +/- Ribavirin (RBV) 16 92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75%
97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100%
C-SALVAGE (looked at retreat duration)
 GT 1, previously failed with PR + a DAA**, with or without cirrhosis ZEPATIER + RBV 12 96% (total)
94% (cirrhosis)
C-SURFER (still ongoing) GT 1, treatment-naïve and patients who failed pegylated interferon, with or without cirrhosis, chronic kidney disease stages 4 or 5 ZEPATIER 12 99%
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped.

**The direct antiviral agents listed were Incivek (telaprevir), Victrelis (boceprevir), and Galexos (simeprevir).