Tag Archives: HOLKIRA PAK

Holkira Pak and BC PharmaCare

Holkira Pak and BC PharmaCareThe 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 has decided not to approve new requests for coverage.

For patients whose coverage was approved before March 23, 2017, BC PharmaCare will continue coverage until their current Special Authority expires. For more information about this change, please contact your doctor, nurse, or call the AbbVie Care program at: 1-844-471-2273.

From all of the BC residents who were able to access Holkira Pak and, therefore, may have been cured of the hepatitis C virus, we would like to thank all of the people who work within the hepatitis C approval pipeline who made their recovery possible.

Holkira Pak

Treatment Description: Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

  • Ombitasvir / Paritaprevir / Ritonavir +/-
  • Ribavirin

Daily Dose: 4 pills +/- ribavirin pills

Sustained Viral Response (SVR)/”Cure Rate”: 95 – 100% with ribavirin

Usage Warning: Holkira Pak 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;
  • Strong CYP2C8 inhibitors and inducers;
  • Moderate or strong inducers of CYP3A;
  • Recreational drugs.

Length of Treatment:

Genotype Previously Treated Cirrhosis Treatment # of Weeks
1a Yes or No No 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV* 12
1b Yes or No No 2 pills once daily + 1 pill twice daily 12
1a/1b No Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 12
1a Yes Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 24**
*RBV stands for ribavirin. Holkira Pak with ribavirin is recommended for patients with an unknown genotype 1 subtype or with mixed genotype.
**24 weeks of Holkira Pak + ribavirin is recommended for patients with genotype 1a infection with cirrhosis who previously didn’t respond to pegylated interferon and ribavirin (PR).

Common Side Effects Reported in Clinical Trials:

  • Can’t sleep (insomnia)
  • Diarrhea
  • Headache
  • Itchiness
  • Nausea
  • Tiredness

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.

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.

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.

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.

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.”

PharmaCare Covers Holkira Pak

Holkira Pak and BC PharmaCareVancouver, B.C. – (July 28th, 2015) – On World Hepatitis Day, Pacific Hepatitis C Network (PHCN) welcomed the B.C. Ministry of Health’s announcement that it will provide coverage for a new hepatitis C virus (HCV) treatment, Holkira Pak.

The hepatitis C virus is considered one of the most serious public health issues facing Canadians, causing more years of life lost than any other infectious disease in the country. In B.C. alone, for example, there are about 80,000 people currently living with hepatitis C.

Therefore, “the Pacific Hepatitis C Network applauds the addition of new treatments like Holkira Pak to the PharmaCare formulary here in B.C.,” said Daryl Luster, president of the board of the Pacific Hepatitis C Network. “I can say with great certainty that lives will be saved, and the quality of life for thousands of people living with hepatitis C, and their families will be impacted in the most positive of ways due to this action by the Government of British Columbia.”

Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. 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 genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

Holkira Pak is the third new hepatitis C drug to be covered by BC’s PharmaCare this year. The other two treatments covered were Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).

For more information about Holkira Pak, please visit PHCN’s Hepatitis C Treatment Information Project or email.

The B.C. Ministry of Health’s Holkira Pak Press Release can be found at: https://news.gov.bc.ca/releases/2015HLTH0053-001186

Holkira Pak

International Symposium on Viral Hepatitis and Liver Diseases

15th International Symposium on Viral Hepatitis and Liver DiseasesThe 15th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD) was held last weekend, June 26 – 28th, in Berlin, Germany. Symposium topics ranged from hep A to hep E treatments and cures  to the history of hepatitis to clinical trial results.

For example, AbbVie, creator of Holkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir), announced that their clinical trial Turquoise-III, testing Holkira Pak without ribavirin, cured 100% of the trial’s 60 patients. The 60 patients all had chronic genotype 1b hep C and compensated liver cirrhosis and were either treatment-naïve (had never tried treatment) or treatment-experienced (failed previous treatment with pegylated interferon and ribavirin). None of the trial’s patients discontinued treatment due to side effects.

A quote from AbbVie’s press release stated: “Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens,” said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. “The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks.”

For more information about hep C treatments please visit PHCN’s Hepatitis C Treatment Information Project or email.

Holkira Pak Recommendations

Holkira PakHolkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir), developed by AbbVie, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) compares the drug’s clinical and cost-effectiveness to those of other treatments. This assessment report is then sent to the provinces and territories to help them decide on coverage.

The CDEC’s Final Recommendation advocates for Holkira Pak to be listed as a treatment for adults with genotype 1 hep C if the following criteria is met:
Clinical Criteria
Conditions
  • Treatment should be started by physicians experienced with treating chronic hep C.
  • Drug plans should not pay more for Holkira Pak than they do for other hep C interferon-free treatments.
Reasons for the Holkira Pak Recommendations
  1. 6 randomized clinical trials (Sapphire I, Sapphira II, Pearl II, Pearl III, Pearl IV, and Turquoise II) showing that treatment with Holkira Pak, with or without ribavirin (RBV), achieved high rates of SVR12 (cure at 12 weeks) for both those who have and those who haven’t already tried treatment.
  2. Holkira Pak’s results (quality-adjusted life years) and costs are similar to other hep C treatments, such as Harvoni. Provinces will have to consider drug plan and health care system sustainability when deciding whether or not to cover newly available expensive hep C treatments.
  3. CDEC couldn’t evaluate the cost-effectiveness of Holkira Pak according to liver fibrosis stage due to limitations in the manufacture’s pharmacoeconomic evaluation.
Other Reported Discussion Points
  • Holkira Pak may offer a greater range of therapeutic options to some patients, but it requires more pills be taken than Harvoni.
  • There may be a greater chance of drug interactions while taking Holkira Pak than while taking Harvoni.
  • A phase 2 clinical trial (TURQUOISE I) tested hep C patients co-infected with HIV with 12 or 24 weeks of Holkira Pak and ribavirin (RBV). SVR12 rates were 93.5% and 90.6% for the 12 and 24 week groups.
Reported Research Gaps
  • There isn’t a comparison between Holkira Pak and Harvoni.
  • The consequences of reinfection following treatment with hep C direct-acting antiviral require further study.
Holkira Pak

Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, 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 genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

For more information about Holkira Pak, CADTH,  or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.