Tag Archives: Viekirax

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, 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.