Tag Archives: HOLKIRA PAK

Drug Pipeline

Viekira XR Received US FDA Approval

Viekira XR Received U.S. FDA ApprovalViekira XR has been FDA approved in America. Viekira XR is an extended-release version of the hepatitis C treatment Viekira Pak (American brand name Viekira Pak / Canadian brand name Holkira Pak). This extended-release version is for patients with chronic genotype 1 hepatitis C, including those with compensated cirrhosis (Child-Pugh A). The treatment includes 3 pills, taken daily with food, that may or may not be combined with ribavirin. It may be prescribed for 12 or 24 weeks of therapy.

An extended-release therapy is a treatment made up of pills that were created to slowly release over time. This slow release gives the drugs more time to work and may allow the levels of the drugs in the body to be more consistent than they may be with other treatment types. This may help lower side effects.

For more information about this FDA approval or about the hepatitis C treatment, please see the press release by AbbVie, the developer of Viekira Pak/Holkira Pak and Viekira XR.

Advocacy

Updated Recommendations

Updated Recommendations“All patients with CHC [a chronic hepatitis C] infection should be considered for treatment, regardless of fibrosis score. Given the potential impact on health system sustainability of treating all patients with CHC infection on a first-come basis, priority for treatment should be given to patients with more severe disease.” (CADTH Canadian Drug Expert Committee, page 2, May 18, 2016)

Updated CADTH Canadian Drug Expert Committee Recommendations

The Canadian Drug Expert Committee (CDEC) updated their recommendations for the hep C treatments: Harvoni, Holkira Pak, Sovaldi, and Daklinza. They now recommend that the liver fibrosis stage F2 or greater requirement for treatment through PharmaCare should be removed. Where once their clinical criteria for treatment with Harvoni, for example, read, “Patients must have a liver fibrosis stage of F2 or greater before they are eligible for PharmaCare coverage“, the same report sections for Harvoni now read:

Recommendation:

CDEC recommends that ledipasvir/sofosbuvir (LDV/SOF) be reimbursed for the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults, if the following conditions are met.

Conditions:
  • Treatment should be initiated by physicians with experience in the management of CHC patients.
  • Drug plan costs for LDV/SOF should not exceed the drug plan costs of other interferon (IFN)-free regimens for the treatment of CHC. (CDEC, May 2016)

Additional Noteworthy Updates

The CDEC also recommended/stated that:

  • Disease symptoms and other health concerns be considered when deciding to treat or not treat, or as it is written in the report, “Extrahepatic manifestations are additional considerations in defining disease severity.”
  • The more sever patients be treated first.
  • Treatment is likely cost-effective across all METAVIR scores. Detailed explanations of this are included in the recommendation reports (links below).

A Possible Next Step for Hep C Advocates

A possible next step for hep C advocates may be to highlight these changes and to ask governments, who follow the CDEC recommendations, to follow suit.

The Links to the Updated CADTH Canadian Drug Expert Committee Recommendations and Summary Reports on Drugs for Chronic Hepatitis C Infection

  • Harvoni (ledipasvir and sofosbuvir)
  • Holkira Pak (ombitasvir, paritaprevir, dasabuvir, and ritonavir)
  • Sovaldi (sofosbuvir)
  • Daklinza (daclatasvir)
  • Drugs for Chronic Hepatitis C Infection: Summary Report

About CADTH’s Canadian Drug Expert Committee (CDEC)

CADTH’s CDEC is an advisory board made up of experts and public members (for a lay perspective) that makes recommendations to the publicly funded drug plans about what and what not to cover and how to cover it.

 

Drug Pipeline

Holkira Pak approved to treat more patients

Holkira Pak approved to treat more patientsOn April 11, 2016, Health Canada approved Holkira Pak to treat patients who are HCV/HIV-1 co-infected and those with hep C (HCV) who have had liver transplants.

The efficacy and safety of Holkira Pak to treat patients with hep C genotype 1 co-infected with HIV-1 has been established. The efficacy and safety of Holkira Pak with ribavirin has also been proven when used to treat liver transplant recipients with normal hepatic function and a Metavir fibrosis score of ≤ 2, regardless of whether the virus is hepatitis C genotype 1a or 1b.

Holkira Pak

Holkira Pak is a treatment for patients with chronic genotype 1 hepatitis C without severe liver damage. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of those with genotype 1 hep C and was found to be well tolerated by patients. 98% of clinical trial participates completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to side effects were low (0.2%).

Holkira Pak for Patients HCV/HIV-1 Co-Infected

In the clinical trial Turquoise-I, 94% of patients who were HCV/HIV-1 co-infected were cured of hep C, achieved a sustained virologic response, with Holkira Pak and ribavirin.

Holkira Pak for Liver Transplant Recipients

Holkira Pak cured 97% of liver transplant recipients in clinical trial. Those clinical trial results and additional information about the trial can be found in The New England Journal of Medicine.

For more information about Holkira Pak, hep C treatments for those HCV/HIV co-infected, or for those who have had liver transplants, please visit PHCN’s Hepatitis C Treatment Information Project or email.

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

Canadian Public Drug Plans Request Answers

Canadian Public Drug Plans Request AnswersSubmit Your Answers to the Following 2 Questions BY EMAIL

OR

Submit Your Answers to the Following 2 Questions BY ONLINE QUESTIONNAIRE

Only submit your answers once. Submit your answers before February 12, 2016.

Our Request

We are asking that you take a moment to send us your answers to the two questions below and any other information that may help us with this request for patient input.

CADTH’s Request for Patient Input

The public drug plans that seek advice from CADTH’s Canadian Drug Expert Committee (CDEC), such as BC PharmaCare, have requested guidance about aligning two sets of recommendations for four hepatitis C treatments (Daklinza, Harvoni, Holkira Pak, and Sovaldi). The two sets of recommendations that the drug plans want aligned are CADTH’s therapeutic review on drugs for hepatitis C and CDEC Final Recommendation for the four hepatitis C treatments. (More information about the four CDEC final recommendations is below.)

The response to this request may result in changes to the current CDEC recommendations or new CDEC Records of Advice for these treatments.

Therefore, the CDEC has asked for patient input about the four hep C treatments, specifically answers to the following two questions:

  • Question 1: “Is there anything the CADTH review team should be aware or reminded of, when updating individual recommendations for Harvoni, Holkira Pak, Sovaldi and/or Daklinza?”
  • Question 2: “How do patients or how do you view hep C treatments that require ribavirin?”

Question 2 has been asked due to mixed feelings regarding ribavirin that have been expressed by hep C organizations. Some groups have reported that patients regard ribavirin as an intolerable treatment that is just as bad as interferon, whereas others see it as “tolerable and acceptable, if only barely and temporarily.”

Therefore, how do you feel about ribavirin? Would ribavirin as part of a hepatitis C treatment make you hesitant about that treatment? Would you take ribavirin if it increased your chances of a hep C cure? What information would influence whether you would take ribavirin or not?

Summaries of the CDEC Final Recommendations for Daklinza, Harvoni, Holkira Pak, and Solvaldi

Treatment Targeted Genotypes Recommended Criteria Suggested Conditions for Coverage
Daklinza in combination with Sovaldi*

(CDEC Final Recom-mendation Published Sept 21, 2015)

 1, 2, 3
  • Treatment
    experienced patients
    without cirrhosis who have not responded to
    pegylated
    -interferon plus ribavirin (PR).
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Drug plan cost of a treatment course with daclatasvir plus sofosbuvir should not exceed the drug plan cost of a treatment course with sofosbuvir plus ribavirin.
Harvoni*

(CDEC Final Recom-mendation Published Feb 18, 2015)

 1
  • A fibrosis stage of F2 or higher
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Substantially reduced price
Holkira Pak*

(CDEC Final Recom-mendation Published May 21, 2015 and updated July 22, 2015)

 1
  • A fibrosis stage of F2 or higher
  • Pescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Price should not exceed the drug plan costs of other interferon-free hep C treatments
Sovaldi + Pegylated Interferon with Ribavirin (PR)

(CDEC Final Recom-mendation Published Aug 18, 2014)

 1
  • A fibrosis stage of F2, F3, or F4
  • Have never been treated
  • Funding should not exceed a duration of 12 weeks for the treatment of patients with
    genotype 1 or 2 hep C and 24 weeks for the treatment of patients with genotype 3 hep C
  • Reduced price
Sovaldi + Ribavirin (RBV)*

(CDEC Final Recom-mendation Published Aug 18, 2014)

 2
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
3
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
*These treatments have possible pegylated interferon and/or ribavirin free options. Click their links for more information about the treatments. Our Basic Hep C Treatment Terms page also has more information about terms some may not be familiar with. Our Comparing Hep C Treatments page has additional information about the treatments except for Daklinza in combination with Sovaldi.
Request for Advice Regarding CDEC Recommendations for Hepatitis C Drugs

About CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

About CADTH’s Canadian Drug Expert Committee (CDEC)

CADTH’s CDEC is an advisory board made up of experts and public members (for a lay perspective) that makes recommendations to the publicly funded drug plans about what and what not to cover and how to cover it.

Please email [email protected] for more information about this CDEC request.

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

Drug Pipeline

New Hep C Treatment Recommendations

New Hep C Treatment RecommendationsThere is excitement over CADTH’s new hepatitis C treatment recommendations report, CADTH Therapeutic Review, Drugs for Chronic Hepatitis C Infection: Recommendations Report, by the Canadian Drug Expert Committee (CDEC).

The report comes after Canadian patient groups, such as PHCN, CTAC,  and Action Hepatitis Canada (AHC), were asked to provide feedback to a draft of the recommendations this summer.

Action Hepatitis Canada has written about the new report and is very pleased that patient groups were asked for input, as are we, and that recommendations are in line with some of their feedback. For example, AHC highlighted the first recommendation which reads:

Recommendation 1: CDEC recommends that all patients with CHC infection should be considered for treatment, regardless of fibrosis score. Given the potential impact on health system sustainability of treating all patients with CHC infection on a first-come basis, priority for treatment should be given to patients with more severe disease.

Recommendation 4 stood out for us as the insufficient evidence seemed surprising. It reads:

Recommendation 4: CDEC considered there to be insufficient evidence to make a recommendation for patients with CHC genotype 5 or 6 infection.

Hep C Treatment Recommendations 2, 3, and 5 are as follows:

Recommendation Targeted Patients Preferred Treatment
2 Those with genotype 1 (GT1) hepatitis C who have never tried treatment (treatment naive) regardless of liver cirrhosis stage Harvoni or Holkira Pak +/- ribavirin for same duration as approved by Health Canada
Those with GT1 hep C who have tried treatment (treatment experienced) regardless of cirrhosis stage Pegylated interferon + ribavirin (PR) for same duration as approved by Health Canada
3 GT2
Sovaldi + ribavirin (12 weeks)
Those with GT3 hep C without cirrhosis Daklinza + Sovaldi (12 weeks)
Those with GT3 hep C with cirrhosis Sovaldi + ribavirin (12 weeks)
Those with GT4 hep C who are treatment naive and don’t have liver cirrhosis Sovaldi + PR (12 weeks)
Those with GT4 hep C who are treatment experienced or have liver cirrhosis regardless of treatment history Insufficient evidence to make a recommendation
5 Those with GT1 hep C who have already tried
a protease inhibitor-PR regimen regardless of cirrhosis stage		 Harvoni
Treatment experienced with an all-oral DAA treatment Insufficient evidence to make a recommendation

Recommended condition for all patients being treated for hep C: Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C. The report also includes recommendations for liver transplant recipients starting on page 22.
For more information, please see the full report, visit PHCN’s Hepatitis C Treatment Information Project, or email us.
Drug Pipeline

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 [email protected] with any questions or comments you have about the information you find here.

Drug Pipeline

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.

Drug Pipeline

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.”

Drug Pipeline

Updates to Patient Support Programs

Updates to Patient Support ProgramsBristol-Myers Squibb Canada’s CLAIRE Patient Support Program

The CLAIRE patient support program is now available to Canadians prescribed Daklinza (daclatasvir), Sovaldi (sofosbuvir), and in some cases ribavirin. The program was designed to help patients seek treatment coverage and provide access to a customized list of services.

It was setup to have a single point of contact for each patient so that they don’t have to navigate through different people each time they call or make an inquiry. One person will take care of them through the program’s duration.

For more information, contact your healthcare provider or the program at: 1-844-HCV-2559 (phone number), 1-844-FAX-2559 (fax number), [email protected] (email address).

Non-Insured Health Benefits Program for First Nations and Inuit

To support First Nations people and Inuit in reaching an overall health status similar to other Canadians, Health Canada’s  Non-Insured Health Benefits (NIHB) Program for First Nations and Inuit provides coverage for a limited range of goods and services when they are not insured elsewhere.

Hep C treatments covered by NIHB are labeled as limited use drugs, or drugs effective in specific circumstances. For drugs in this category, specific criteria must be met to be eligible for NIHB coverage.

When specific criteria is met, NIHB covers the following hep C treatments:

Please see the Hepatitis C Treatment Information Project’s Non-Insured Health Benefits Program for First Nations and Inuit page for more information about eligibility or contact Health Canada’s Non-Insured Health Benefits for First Nations and Inuit Program. The program’s number in BC is 604-666-3331 or 1-800-317-7878 (toll-free).

Correctional Services Canada (CSC)

Holkira Pak has also been listed by Correctional Services Canada (CSC). This is great news for a population with an increased chance of having hep C.