Tag Archives: technivie

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.

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.

Holkira Pak and Technivie Health Canada Update

Health Canada*Please see AbbVie’s response to Health Canada’s Information Update below.

Health Canada’s Information Update

 

November 10, 2015
For immediate release

OTTAWA – In response to new international safety information, Health Canada is advising Canadians that it is working with the manufacturer of Holkira Pak and Technivie to update drug labels (product monographs) to include new information regarding serious liver injury.

Holkira Pak and Technivie are both used to treat chronic Hepatitis C viral infection that can lead to serious liver and health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying, which may slow down the disease.

International safety data has indicated that cases of serious liver injury (such as hepatic failure, including cases that resulted in liver transplantation or death) have been reported in patients treated with Holkira Pak or Technivie. Most patients with these serious outcomes had evidence of advanced liver disease (cirrhosis) prior to initiating therapy.

While Health Canada is working to update the product monographs, healthcare providers are reminded that Holkira Pak and Technivie should not be used in patients with severe hepatic impairment (Child-Pugh Class C) or moderate hepatic impairment (Child-Pugh Class B).

Patients should not stop taking these medications without first talking to their healthcare provider as stopping these medications early may result in drug resistance to other hepatitis C medicines.
Information for Patients and Caregivers

Immediately consult your healthcare provider if:

You experience fatigue, weakness, lack of appetite, nausea and vomiting, as well as yellowing of your skin or eyes, darkening of your urine or discolored feces while on treatment with Holkira Pak or Technivie.

Information for Health Care Professionals

Holkira Pak (fixed dose combination of ombitasvir/paritaprevir/ritonavir; and dasabuvir) and Technivie (fixed dose combination of ombitasvir/paritaprevir/ritonavir) are contraindicated in patients with severe hepatic impairment (Child-Pugh Class C) and should not be used in patients with moderate hepatic impairment (Child-Pugh Class B).

Closely monitor for signs and symptoms of worsening of liver disease such as ascites, hepatic encephalopathy, and/or increases in direct bilirubin in the blood.

Holkira Pak and Technivie should be discontinued if there are clinical signs of liver inflammation that are accompanied by persistent elevations in transaminases, direct bilirubin or international normalized ratio (INR).

Report health or safety concerns

Call toll-free at 1-866-234-2345
Visit MedEffect Canada’s web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Media enquiries

Health Canada
613-957-2983
Public enquiries

613-957-2991
1-866-225-0709

AbbVie’s Response Issued November 11, 2015

AbbVie’s top priority is patient safety. We are committed to providing comprehensive information on the efficacy and safety of our medicines for health care professionals and patients to make informed treatment decisions.

On November 10, Health Canada issued an Information Update regarding HOLKIRA™ PAK and TECHNIVIE™. AbbVie is currently working closely with Health Canada to update the product monographs. As such, the Product Monographs for HOLKIRA PAK (date of revision: October 14, 2015) and TECHNIVIE (date of preparation: October 20, 2015) remain unchanged at this time.

As per the current product monographs, HOLKIRA PAK and TECHNIVIE should not be used in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

Patients should contact their health care provider if they have any concerns.

Thank you for Your Input

grazoprevir / elbasvirThank you to all of you who completed PHCN’s grazoprevir / elbasvir patient input survey and the earlier Technivie  patient input survey. Thank you also for sharing them with others. It was truly an honour to read your responses and to use them to write the patient group input report for the Canadian Agency for Drugs and Technologies in Health (CADTH) on your behalf.

The patient group input reports requested by CADTH are an important step towards getting new treatments for hep C more widely available in Canada and BC.

The patient input about grazoprevir / elbasvir was sent in this morning. We now wait to hear the outcome of the treatment submissions.

The Hepatitis C Treatment Information Project will keep you apprised of any news and is here to answer any questions you may have.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

FDA Holkira Pak and Technivie Warning

Holkira Pak and TechnivieThe U.S. Food and Drug Administration (FDA) sent out a warning yesterday that the hepatitis C treatments Holkira Pak and Technivie “can cause serious liver injury mostly in patients with underlying advanced liver disease.”

As a result, the FDA is requiring that the two hep C treatments add information about this safety risk to their labels in the States and are advising patients taking these treatments to speak to their health care provider immediately if they experience signs of liver damage.

Signs of liver damage can be fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools.

The FDA does not advise patients to stop treatment without talking to their health care provider first as this may result in drug resistance to hep C treatments.

The complete FDA safety announcement can be found on the FDA’s website.

OCTOBER 23 UPDATE / CLARIFICATION:

All drugs and health products have benefits and risks. Although medical treatments are carefully tested before they are allowed to be used, some reactions become evident only after the drug is being used by the general population. Health care systems monitor drugs closely after they are approved for use and change labels and send out warnings when need be.

The American label change was a result of this and possibly the treatments being prescribed to patients with cirrhosis with Child Pugh Scores of B or C. Health Canada’s website states that the treatments are only approved for those with a Child Pugh Score of A (5-6), as: “The safety and efficacy of Holkira Pak have not been established in HCV-infected patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C). Therefore, Holkira Pak should not be used in these patients.”

Technivie Now Approved for Use

TechnivieTechnivie (ombitasvir/paritaprevir/ritonavir) with ribavirin  is now an approved hepatitis C treatment in Canada!

Health Canada has granted the treatment Technivie with ribavirin a Notice of Compliance (NOC) for treating adult patients with chronic hep C genotype 4 without cirrhosis and who have never tried treatment or who have previously been treated with pegylated interferon and ribavirin.

A Notice of Compliance

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 combination is still not available on public drug plans, like BC PharmaCare. 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 Technivie (ombitasvir/paritaprevir/ritonavir), or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Technivie (Ombitasvir / Paritaprevir / Ritonavir) Facts

TechnivieTechnivie (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.

Currently, those in BC with hep C genotype 4 have two treatment options. The first treatment option is pegylated interferon and ribavirin. It is covered by BC’s PharmaCare for genotype 4, but only has a SVR, or “cure rate”, of up to 65% as a genotype 4 treatment. It is a treatment known for poor tolerability, multiple side effects, and high rates of patients deciding to stop treatment early.

The second treatment option for those with hep C genotype 4 is Sovaldi in combination with pegylated interferon and ribavirin. This option is more successful, however, it isn’t covered by BC’s PharmaCare for genotype 4 and it includes pegylated interferon with ribavirin and its side effects.

Therefore, AbbVie, the creator of Technivie (ombitasvir / paritaprevir / ritonavir), is working to add a new treatment option to BC PharmaCare’s formulary.* This new treatment option, Technivie, has been approved for use by Health Canada and the FDA in the States.***

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. Those who have not had a severe skin rash after taking ritonavir.

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.

  • Ombitasvir / paritaprevir / ritonavir +
  • Ribavirin

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

The Most Common Side Effects Reported During Technivie Clinical Trials:

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

No one in the Pearl-I clinical trial discontinued treatment because of side effects.

Availability:  Technivie is approved for use in Canada

Clinical Trials for Technivie:

Clinical Trial Patients Treatment Regimen SVR12
PEARL-I* (12 weeks) Genotype (GT) 4 treatment naive, without cirrhosis Technivie 91%
Technivie + Ribavirin 100%
GT4 treatment experienced without cirrhosis Technivie + Ribavirin 100%
AGATE-I** (12, 16, or 24 weeks) This randomized study evaluates the safety and efficacy of Technivie with ribavirin in adults with hep C genotype 4 and cirrhosis who are treatment naive or treatment experienced. The study opened in October 2014. Ongoing but not recruiting
AGATE-II This study evaluates the efficacy and safety of Technivie with ribavirin in those with hep C genotype 4 Ongoing in Egypt
*Pearl-I was a trial which looked at hep C genotype 1 and 4, treatment-naive and -experienced patients. This trial didn’t include those with cirrhosis or a ribavirin free treatment option for those who were treatment experienced.
**In the Agate-I clinical trial treatment experienced patients had already been treated with Sovaldi in combination with pegylated interferon and ribavirin or Sovaldi with ribavirin.

More information about this and other emerging hep C treatments can be found at PHCN’s Hepatitis C Treatment Information Project or by emailing hepctip@pacifichepc.org.

*Technivie is currently approved for use in Canada and is being reviewed for BC PharmaCare coverage. (January 20, 2016)

**The Hepatitis C Treatment Information Project has a hep C treatment vocabulary page that defines words that are commonly used when  hep C treatment is discussed.

***The background information was from CATIE’s TreatmentUpdate 202 (March/April 2014): Simeprevir + interferon + ribavirin in HCV genotype 4 infection, World Federation of Science Journalists’ Hepatitis C: A Worldwide Health Story, FDA News Release: FDA approves Technivie for treatment of chronic hepatitis C genotype 4, Official Technivie, and ‘Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial’ published by The Lancet, March 31, 2015.