Tag Archives: technivie

The PHCN’s News in Review Newsletter (06/04/17)

The PHCN's News in Review Newsletter (07/04/17)Welcome to the Pacific Hepatitis C Network (PHCN)‘s Hepatitis C News in Review Newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to a blog post about the importance of eliminating hepatitis C.

Hepatitis C Elimination is Possible and Essential

The group most impacted by hepatitis C, some 60,000 in B.C., are baby boomers, those who were born between 1945 and 1965. Many have lived with the infection for years but have never been tested or treated because they have never believed themselves to be at risk.  This is the time that everyone, including baby boomers, should be tested and treated for hepatitis C.

Relapse, Recurrence, Null & Partial Response/rs

In hepatitis C and hep C treatment there are three ‘R’s that are big, sad, and scary. They are the bringers of sadness that if doctors, friends, and communities could protect someone from, they would. Click the above link for more information.

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Coverage for four hepatitis C treatments has changed. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being or have been added to various provincial formularies across Canada.

Technivie and BC PharmaCare

Technivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Holkira Pak and BC PharmaCare

The hepatitis C treatment Holkira Pak was approved for use in Canada in March 2015 and then was later approved for BC PharmaCare coverage in July  2015. Although Holkira Pak is still approved for use in Canada and has an amazingly high cure rate, as of March 23, 2017, BC PharmaCare wont cover it.

Blog Posts by PHCN’s President Daryl Luster

Coming this Spring

Eh, starting this spring, Help-4-Hep helpline will be in Canada.  Help-4-Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Look for more details to come or call the American Help-4-Hep helpline all free of charge.

For more information about hepatitis C and its cures, please email or visit the Hepatitis C Treatment Information Project.

Technivie and BC PharmaCare

Technivie and BC PharmaCareTechnivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Technivie is still an approved hepatitis C genotype 4 treatment in Canada. For more information about this, please contact the AbbVie Care program at: 1-844-471-2273.

Technivie (Ombitasvir / Paritaprevir / Ritonavir)

Technivie Background: Hepatitis C genotype 4 only accounts for about 13% of global hep C infections and isn’t as common in Canada as it is in the Middle East and Africa. However, due to increased travel and immigration, the population who have hep C genotype 4 and who live in high-income countries  is growing.

Targeted HCV Genotype:  4

Targeted Patients: Those without liver problems, or with Child-Pughs A, who have never tried hep C treatment or have previously tried peginterferon and ribavirin but weren’t cured by it.

Generic Name:  Ombitasvir / paritaprevir / ritonavir

Treatment Description:  Technivie is made up of 2 direct acting antivirals (ombitasvir and paritaprevir) and ritonavir, a booster for paritaprevir. It is taken without interferon.

Approximate Sustained Viral Response / Cure Rate:  100% with ribavirin, 91% without ribavirin

Daily Dose:  2 pills taken once in the morning with food + ribavirin taken once in the morning and once at night

Length of Treatment:  12 weeks

Thank you to all of those who wrote in for Technivie’s patient input reports that were sent to CADTH and BC PharmaCare. Thank you also to those who worked to develop Technivie, a treatment for hepatitis C genotype 4. Thank you for working in hopes of a better tomorrow for those with hepatitis C genotype 4.

Sunvepra, Technivie, Zepatier, and Drug Approval Negotiations

Sunvepra, Technivie, Zepatier, and drug approval negotiationsWhile the last step of the drug development and approval process in Canada and BC, the pan-Canadian Pharmaceutical Alliance (pCPA) negotiations, is taking place for three new hepatitis C treatments (SunvepraTechnivie,  and Zepatier), there is still a larger discussion going on that is “…exploring the need for a national formulary…”. (CMAJ, May 16, 2016)^

A formulary is a health insurance provider’s official list of pharmaceutical drugs that they have approved for coverage. (Merriam-Webster Dictionary)

The Pan-Canadian Pharmaceutical Alliance (pCPA) and the Current System of Individual Provincial / Territorial Drug Formularies

Steps Towards Listing a Treatment

Currently, within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, effectiveness, and how it’s made.

After this, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) then assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

Thirdly, according to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, individual provinces/territories may then negotiate with the manufacturer without pCPA or, if the pCPA steps in after deciding that joint pan-Canadian negotiations for the drug will occur, provinces/territories may negotiate collectively.* This happens about 80% of the time. (CMAJ, May 16, 2016)

A province/territory then assumes the lead in the pCPA negotiations, contacts the manufacturer, and starts negotiations. If an agreement about treatment prices is reached, the lead province, the manufacturer, and the other provinces/territories negotiating sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

After a Letter of Intent is signed, the participating jurisdictions will work with the manufacturer on their individual Product Listing Agreement (PLA), or work on a translation of the terms agreed to in the Letter of Intent. This translation is not a second negotiation. After this, the treatment is then listed.

When Negotiations Fail to Reach an Agreement

However, if negotiations are closed without reaching an agreement, as recently happened with Daklinza (daclatasvir), a treatment for those infected with hep C genotype 1, 2, or 3, provinces/territories involved in the pCPA negotiations can not restart negotiations with the manufacturer on their own.

Once pCPA negotiations are closed, future requests by the provinces/territories for re-consideration start with the treatment’s file being resubmitted to pCPA for further review through their office. In the future, if a manufacture believes that it is “able to provide the value needed by the jurisdictions”**, the manufacturer can also submit an unsolicited offer to the pCPA office and possibly restart negotiations that way. When this happens, provinces/territories are not bound to re-enter pCPA negotiations for the treatment.**

The Current Discussion about Changing the System of Provincial / Territorial Drug Formularies to a National Formulary

Currently, there is talk about changing the system of provincial/territorial drug formularies into a more national pharmacare system. The below are recent articles and videos about this discussion:

*The pCPA also negotiates for military and RCMP employees, First Nations and Inuit people. It is estimated that the pCPA has saved $490 million since 2010. (CMAJ, May 16, 2016)

**The source of this information was a requested email from the Pan-Canadian Pharmaceutical Alliance and the links within this post.

^Some of this post was originally published in May 2016. As there are now three hepatitis C treatments being examined by pCPA, instead of two, we believed that the subject matter was important and current enough to publish it again.

Treatments in the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineThere 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

Sunvepra (asunaprevir) + Daklinza (daclatasvir) +/- Pegylated Interferon with Ribavirin (PR) Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Epclusa (sofosbuvir / velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS3/4A Protease Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Step Within Canadian Drug Approval Pipeline Step 5 – Provincial Review
Currently Seeking Patient / Caretaker Input Has already been collected Has already been collected Has already been collected Has already been collected Has already been collected
Genotype (GT) Health Canada has Approved it for 1, 4 4 1 – 6 1, 4 3
Under BC PharmaCare Review for Genotype 1, 4 4 1 – 6 1, 4 3
Approximate SVR (Approx Rate of Cure) 93 – 100% 90% without RBV, 100% with RBV 94 – 100% 93 – 100% 91 – 100%
May Require PR* Yes No
May Not Require PR or RBV
Yes
Daily Pills 3 +/- PR 1 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 24 12 8, 12, or 24 8, 12, or 16 12
Most Common Side Effects** (Ribavirin can affect side effects)
  • Headache
  • Tiredness (fatigue)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • 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) Sunvepra is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Do not take Sunvepra without combining it with other hep C treatments. Please see Bristol-Myers Squibb Canada’s Sunvepra information page for 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.

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. If you have any side effects not listed here, contact your healthcare provider. Tell your healthcare provider 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 Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 AbbVie Care 1-844-471-2273
Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Sunvepra Technivie Epclusa Zepatier
Information about HCV / HIV Co-infection Sunvepra (by Bristol-Myers Squibb Canada) Technivie (by CATIE)

Epclusa (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.

Canadian drug approval pipeline and treatment information was gathered last week 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.

Technivie, Zepatier, pCPA, and the Drug Approval Process

Technivie, Zepatier, and the pCPAWhile pan-Canadian Pharmaceutical Alliance (pCPA) negotiations are taking place for two new hepatitis C treatments, Technivie (ombitasvir / paritaprevir / ritonavir) and Zepatier (elbasvir / grazoprevir), there is a bigger discussion going on in Canada that is “…exploring the need for a national formulary…” (CMAJ, May 16, 2016)

A formulary is a health insurance provider’s official list of pharmaceutical drugs that they have approved for coverage. (Merriam-Webster Dictionary)

The Pan-Canadian Pharmaceutical Alliance (pCPA) and the Current System of Individual Provincial / Territorial Drug Formularies

Steps Towards Listing a Treatment

Currently, within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, effectiveness, and how it’s made.

Secondly, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) then assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

Thirdly, according to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, individual provinces/territories may then negotiate with the manufacturer without pCPA or, if the pCPA steps in after deciding that joint pan-Canadian negotiations for the drug will occur, provinces/territories may negotiate collectively.* This happens about 80% of the time. (CMAJ, May 16, 2016)

A province/territory then assumes the lead in the pCPA negotiations, contacts the manufacturer, and starts negotiations. If an agreement about treatment prices is reached, the lead province, the manufacturer, and the other provinces/territories negotiating sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

After a Letter of Intent is signed, the participating jurisdictions will work with the manufacturer on their individual Product Listing Agreement (PLA), or work on a translation of the terms agreed to in the Letter of Intent. This translation is not a second negotiation. After this, the treatment is then listed.

When an Agreement isn’t Reached

However, if negotiations are closed without reaching an agreement, as recently happened with Daklinza (daclatasvir), a treatment for those infected with hep C genotype 1, 2, or 3, provinces/territories involved in the pCPA negotiations can not restart negotiations with the manufacturer on their own.

Once pCPA negotiations are closed, future requests by the provinces/territories for re-consideration start with the treatment’s file being resubmitted to pCPA for further review through their office. In the future, if a manufacture believes that it is “able to provide the value needed by the jurisdictions”**, the manufacturer can also submit an unsolicited offer to the pCPA office and possibly restart negotiations that way. When this happens, provinces/territories are not bound to re-enter pCPA negotiations for the treatment.**

The Current Discussion about Changing the System of Provincial / Territorial Drug Formularies to a National Formulary

Currently, there is talk about changing the system of provincial/territorial drug formularies into a more national pharmacare system. The below are recent articles and videos about this discussion:

*The pCPA also negotiates for military and RCMP employees, First Nations and Inuit people. It is estimated that the pCPA has saved $490 million since 2010.  (CMAJ, May 16, 2016)

**The source of this information was a requested email from the Pan-Canadian Pharmaceutical Alliance and the links within this post.

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, not anymore. No, not anymore. No, not anymore. No, not anymore. No, not anymore.
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. 

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.

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.

BC PharmaCare Seeking Input for Technivie

Notice of BC PharmaCare Coverage Review for TechnivieTechnivie is being considered for BC PharmaCare coverage. Therefore, PharmaCare is collecting input between Wednesday, January 20th, and Wednesday February 17, 2016 AT MIDNIGHT—nowfor this process.

If you are a BC resident and answer YES to any of the following questions, BC’s health care system wants to hear from you:

A link to BC PharmaCare’s questionnaires for Technivie can be found at PharmaCare’s Your Voice (scroll down towards the bottom of the page).

About Technivie

Information about Technivie can be found at  Technivie (Ombitasvir / Paritaprevir / Ritonavir) Facts, BC PharmaCare Drug Information, or in CTAC’s Technivie Youtube video. CTAC’s video uses the name 2D instead of Technivie. It is the same treatment, its Canadian brand name just hadn’t been assigned when the video was created in September 2015.

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

BC PharmaCare Coverage Review for Technivie

Advanced Notice of BC PharmaCare Coverage Review for TechnivieTechnivie will soon be considered for BC PharmaCare coverage. Therefore, your input will soon be sought.

Tentatively, patient and caregiver input into Technivie’s approval process will be requested from Wednesday January 20, 2016 to Wednesday February 17, 2016 AT MIDNIGHT.

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

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:

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

Technivie

Information about Technivie can be found at Technivie (Ombitasvir / Paritaprevir / Ritonavir) Facts or in CTAC’s Technivie Youtube video.

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

AbbVie Holkira Pak and Technivie – Product Information Update

Holkira Pak and TechnivieFurther to our blog yesterday Hep C TIP wishes to clarify information regarding Holkira Pak and Technivie:

  • The Health Canada warning does not change how Holkira Pak and Technivie are prescribed in Canada
  • Holkira Pak and Technivie are still available and recommended for hepatitis C treatments for HCV G1 and G4 in Canada (in British Columbia, only Holkira Pak is listed with BC PharmaCare)
  • AbbVie’s current product monograph (description of the drug, who it can be used for and who it cannot be use for, side effects, and warnings) state that both Holkira Pak and Technivie:
    • should not be used in patients with moderate hepatitis impairment (Child-Pugh B) and,
    • is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

At the time of Health Canada’s warning, AbbVie provided information to Hep C TIP regarding the work they would be doing with Health Canada to update their product monographs, stating that AbbVie’s top priority is patient safety.

Pacific Hepatitis C Network believes that people living with hep C and all practitioners (GPs, specialists, nurse practitioners) must understand all of the treatments available and in the approval process for hepatitis C. That understanding is crucial to ensuring the best chance for curing hepatitis C with few or no side effects or long-term impacts from treatment.

Accuracy is very important to us. Please be in touch at hepctip@pacifichepc.org with any questions or comments you have about the information you find here.