Tag Archives: Viekira 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.

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.

Holkira Pak, CADTH, and the pCPA

Holkira PakHolkira Pak (generic name: ombitasvir / paritaprevir / ritonavir and dasabuvir) has been listed on the pan-Canadian Pharmaceutical Alliance‘s most recent table of active drug product negotiations. Negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA), a negotiations team from different provinces and territories that works to get the best value for brand name and generic drugs for publicly funded drug programs, and Holkira Pak’s manufacturer, AbbVie, are currently underway.

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) assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

For Holkira Pak, CADTH started this step on November 3rd, 2014, when it called for patient input. Although, Holkira Pak’s submission for a Common Drug Review is listed as only being accepted on December 3rd, 2014, one month later.

According to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, the pCPA may then step in after deciding that joint pan-Canadian negotiations for the drug will occur. A province/territory then assumes the lead in negotiations, contacts the manufacturer, and negotiations get underway. If an agreement is reached about treatment prices, the lead province, the manufacturer, and the other jurisdictions all sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

Provinces/territories then make their own final decisions about funding the drug or not through their healthcare plans. If they choose to do so, they then sign a product listing agreement with the manufacturer.

This is where it gets a bit more interesting. Currently, Holkira Pak is listed by CADTH as still undergoing a CADTH Common Drug Review (CDR). The last step listed as completed on the CDR’s Submission Status sheet for Holkira Pak is dated May 28th, 2015. On May 28th, the CDR reports and the recommendation by the Canadian Drug Expert Committee (CDEC), the committee of experts who review all of the data and analyses involved, were sent to the provincial/territorial drug plans and the drug’s manufacturer. A target date for the final CDEC recommendations being sent to drug plans and manufacturer is tentatively listed as 15 business days after that, June 18th.

The pan-Canadian Pharmaceutical Alliance’s most recent table of active drug product negotiations, the one that lists Holkira Pak as a new drug product undergoing negotiations, was dated April 30th, 2015.

And so, we wait. We wait for news from all three parties currently involved, AbbVie (Holkira Pak’s manufacturer), CADTH, and the pan-Canadian Pharmaceutical Alliance.

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, the pan-Canadian Pharmaceutical Alliance, or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

BC PharmaCare Considering Holkira Pak

Holkira Pak Survey LogoHolkira Pak (generic name: ombitasvir/paritaprevir/ritonavir/dasabuvir) is being considered for BC PharmaCare coverage. The dates for input into this process are Wednesday, April 22nd, to Wednesday, May 20th—now.

If you are a BC resident and answer yes to any of the following questions for Holkira Pak, BC’s Health Care system wants to hear your input:

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

Links to input questionnaire for Holkira Pak can be found at PharmaCare’s Your Voice.

The Hepatitis C Treatment Information Project includes more information about Holkira Pak and Holkira Pak clinical trial results.

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

PharmaCare Drug Coverage Review for Holkira Pak

Holkira PakThe Hepatitis C Treatment Information Project received an advance notification from BC’s Ministry of Health that Holkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir) will soon be considered for PharmaCare coverage. The tentative dates for input into this process are from Wednesday, April 22nd, to Wednesday, May 20th.

If you are a BC resident and answer yes to any of the following questions for Holkira Pak, you can give your input:

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

Please note that PharmaCare’s questionnaire for Holkira Pak may not be available for another couple of weeks.

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

HOLKIRA PAK Approval

holkira pak trialsThis morning Health Canada approved AbbVie’s HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir and dasabuvir) for the treatment of patients with chronic genotype 1 hep C, including those with cirrhosis.

HOLKIRA PAK is an all-oral, short-course, interferon-free treatment. It can be taken with or without ribavirin (RBV).

In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 hep C patients, and 98 percent of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of discontinuation due to adverse reactions were low (0.2 percent).

The recommended treatment regimens and durations for HOLKIRA PAK are:

Patient

Treatment

Duration

Genotype 1a, without cirrhosis HOLKIRA PAK + ribavirin 12 weeks
Genotype 1b, without cirrhosis HOLKIRA PAK 12 weeks
Genotypes 1a and 1b, with cirrhosis HOLKIRA PAK + ribavirin 12 weeks*
*24 weeks of HOLKIRA PAK + ribavirin is recommended for patients with genotype 1a-infection with cirrhosis who have had a previous null response to pegylated interferon (pegIFN) and ribavirin.
Note: HOLKIRA PAK with ribavirin is recommended in patients with an unknown genotype 1 subtype or with mixed genotype

 

Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir

sq_drugsAs there seems to be a lot happening around ombitasvir / paritaprevir / ritonavir and dasabuvir (known in Canada as Holkira Pak and Viekira Pak in the USA), with CADTH seeking patient group input reports and PHCN putting out a call for patient input and survey participants, the Hepatitis C Treatment Information Project has put together the following treatment summary:

OMBITASVIR / PARITAPREVIR / RITONAVIR & DASABUVIR (HOLKIRA PAK)
Maker: AbbVie

3 DAA Co-formulated Drugs for Genotype 1:

  • Ombitasvir / paritaprevir / ritonavir +
  • Dasabuvir +/-
  • Ribavirin (RBV)

Adult Daily Doses:  4 pills per day +/- ribavirin

  • Ombitasvir / paritaprevir / ritonavir: 2 pills in the morning
  • Dasabuvir: 1 pill in the morning and 1 pill in the evening
  • Ribavirin (RBV): 1 pill in the morning and 1 pill in the evening

Length of Treatment:

12 or 24 weeks

Summary of Phase III Clinical Trial Results:

Clinical Trial Patients Treatment Regimen SVR12*
PEARL-II(12 weeks) Genotype 1bTreatment-experienced AbbVie regimen + RBV 97%(85/88)
AbbVie regimen only 100%(91/91)
PEARL-III(12 weeks) Genotype 1bTreatment-naive AbbVie regimen + RBV 99%(209/210)
AbbVie regimen only 99%(207/209)
PEARL-IV(12 weeks) Genotype 1aTreatment-naive AbbVie regimen + RBV 97%(97/100)
AbbVie regimen only 90%(185/205)
TURQUOISE-II(12 & 24 weeks) Genotype 1Treatment-naive & treatment-experienced with

compensated cirrhosis

AbbVie regimen + RBV, 12 weeks 92% (191/208)
AbbVie regimen + RBV, 24 weeks 96%(165/172)
SAPPHIRE-I(12 weeks) Genotype 1Treatment-naive AbbVie regimen + RBV 96%(455/473)
SAPPHIRE-II(12 weeks) Genotype 1 treatment-experienced AbbVie regimen + RBV 96%(286/297)

*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. SVR12 or SVR24 means that the treatments can achieve this response after 12 or 24 weeks of therapy.

Side Effects:

During the clinical trials, some reported side effects including headaches, fatigue, itchy skin, nausea, insomnia, and/or diarrhea. Headaches and fatigue were reported similarly by those taking the AbbVie regimen without ribavirin (RBV) and those taking it with ribavirin (RBV).

PHCN’s Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir Survey

Please email hepctip@pacifichepc.org for more information about the survey or visit PHCN’s Hepatitis C Treatment Information Project for more information about ombitasvir / paritaprevir / ritonavir and dasabuvir and the different hep C treatments within the drug approval process.