Tag Archives: BC PharmaCare

Sunvepra (asunaprevir) Facts

Sunvepra (asunaprevir) FactsSunvepra (generic name asunaprevir) is being considered for BC PharmaCare coverage. As part of this process, BC patients, caregivers, and patient groups have the opportunity to become a part of this drug review and share their opinions and perspectives with the decision makers.

The below treatment fact sheet was designed to give you more information about Sunvepra (asunaprevir). and to encourage you to submit your opinions about the hep C treatment and other treatments.

Sunvepra (asunaprevir) Facts

BC PharmaCare is considering Sunvepra as a treatment for the hep C genotype 1, 1b, or 4 infection.

Treatment Description: Sunvepra is a NS3/4A protease inhibitor that works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. It works in combination with other treatments, such as Daklinza (daclatasvir).

  • Sunvepra +
  • Daklinza +/-
  • Pegylated interferon with ribavirin

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 

  • 90.6% in treatment-naïve patients
  • 82.4% in prior non-responders to pegylated interferon with ribavirin patients (hard to treat patients)
  • 82.6% in pegylated interferon intolerant/ineligible patients (hard to treat patients)
  • 93.2%-95.5% in patients with hep C genotype 1
  • 100% in patients with hep C genotype 4 (Health Canada)

Daily Dose:
Sunvepra is taken orally twice daily

Genotype Treatment Usual Dose
1b Sunvepra with Daklinza Twice daily with Daklinza taken once daily
1 or 4 Sunvepra with Daklinza and peginterferon and ribavirin Twice daily with Daklinza taken once daily, peginterferon taken once weekly, ribavirin twice daily

Possible Length of Treatment: 24 weeks

HCV/HIV Co-infection: The safety and efficacy of Sunvepra have not been studied in HCV patients co-infected with HIV.

Common Side Effects of Sunvepra with Daklinza Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

Drugs Sunvepra Should Not Be Taken With:

  • Dependent on the cytochrome P450 enzyme 2D6 (CYP2D6) for clearance and for which elevated plasma concentrations are associated with serious health issues.
  • Moderate or strong inducers and inhibitors of CYP3A.
  • Strong inhibitors of organic anion transporting polypeptide (OATP) 1B1 or 2B1.

Please see Sunvepra’s product monograph for more information.

Sampling of Clinical Trials for Sunvepra with Daklinza:

Clinical Trial Patients Treatment Regimen SVR12*
HALLMARK QUAD GT 1 prior non-responders (partial and null responders) Sunvepra + Daklinza + Pegylated Interferon with Ribavirin 93.2%
GT 4 prior non-responders (partial and null responders) 100%
HALLMARK-DUAL GT 1b treatment naive Sunvepra + Daklinza 90%
GT 1b pegylated interferon with ribavirin (PR) non responder 82%
GT 1b PR ineligible/intolerant 82%
GT 1b with cirrhosis 84%
GT 1b without cirrhosis 85%
*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.

Additional Resources about Sunvepra with Daklinza:

The above resources were used to create this treatment fact sheet.

Please email or visit the Hepatitis C Treatment Information Project for more information about Sunvepra, Daklinza, or any other hep C treatment.

Another Step Towards Approval for Sunvepra

Another Step Towards Approval for SunvepraSunvepra (asunaprevir) will soon be considered for BC PharmaCare coverage. Therefore, your input will again soon be sought.

Tentatively, patient and caregiver input into Sunvepra’s approval process will be requested from Wednesday May 18, 2016 to MIDNIGHT ON Wednesday June 15, 2016.

How to Add Your Voice to the BC PharmaCare Coverage Review for Sunvepra (asunaprevir)

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 Sunvepra (asunaprevir) input tentatively wont be available for another two weeks. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/’cure’) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

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

*Health Canada granted Sunvepra a Notice of Compliance (NOC) on March 9th, 2016. A CADTH Common Drug Review for Sunvepra began in 2015 and patient input was sent in by Canadian patient groups, including the Pacific Hepatitis C Network, for this review then. After the input was sent, the CADTH Common Drug Review was temporarily suspended as the manufacturer, Bristol Myers Squibb Canada Inc., requested time to provide additional information. This temporary suspension was lifted on March 15th, 2016.

Daklinza and Sovaldi’s BC PharmaCare Decision

Daklinza and Sovaldi's PharmaCare DecisionBC PharmaCare has posted notice that it will not cover Daklinza (generic name daclatasvir) when it is combined with Sovaldi (generic name sofosbuvir) for the treatment of chronic hepatitis C genotype 3 infection, in their list of covered treatments.

BC PharmaCare listed the following three reasons for their decision:

  • “The available clinical evidence included only a small number of genotype 3 patients treated, and did not provide sufficient evidence to demonstrate efficacy compared to current sofosbuvir plus ribavirin (RBV) regimen. There are no comparative head-to head trials with sofosbuvir plus RBV or other combinations. Therefore, there is no evidence that daclatasvir plus sofosbuvir is more effective or safer than sofosbuvir plus RBV.” (BC PharmaCare)
  • “At the submitted confidential price, daclatasvir plus sofosbuvir 12-week regimen is less costly than the transparent price of a 24-week course of sofosbuvir plus RBV.” (BC PharmaCare)
  • “The Ministry of Health engaged in discussions with the manufacturer for daclatasvir through the pan-Canadian Pharmaceutical Alliance (pCPA), but the pCPA participating jurisdictions agreed that the parameters required for negotiations by both the manufacturer and the participating jurisdictions cannot be achieved through negotiations at this time.” (BC PharmaCare)

More information about this decision can be found in the treatment’s Drug Coverage Decision for B.C. PharmaCare.

Daklinza and Sovaldi

Daklinza and Sovaldi is a Health Canada approved treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment.

A sustained viral response (SVR12), or ”cure”, has been achieved by  ~90% of patients infected by hep C genotype 3 who have been treated with Daklinza and Sovaldi. The treatment has had higher success rates when treating hep C genotypes 1 or 2. (Health Canada)

More information about the treatment combination and its Health Canada approval can be found on Health Canada’s Summary Basis of Decision for Daklinza page.

Bristol-Myers Squibb Canada’s CLAIRE Program

Canadians and British Columbians prescribed the Health Canada approved treatment Daklinza and Sovaldi, with, in some cases, ribavirin, can still request to be enrolled in the CLAIRE patient support program. The CLAIRE patient support program was designed to help patients seek coverage and provide access to a customized list of services. It was designed so that one person will take care of each patient through the program’s duration. For more information, contact your doctor, nurse, or contact the program at: 1-844-HCV-2559 (phone number), 1-844-FAX-2559 (fax number), info@claireprogram.ca (email address).

*BMS has stated that this decision to not cover Daklinza included treatment for other hep C genotypes as well. It will not be covered by BC PharmaCare. We will continue to track Daklinza and report on any further news.

Input Requested for Zepatier’s BC PharmaCare Review

Input Requested for Zepatier's BC PharmaCare ReviewZepatier’s BC PharmaCare Review Questionnaires (Once on the page, scroll down until you see a colourful table.)

Zepatier (elbasvir – grazoprevir) is being considered for BC PharmaCare coverage. As part of this process, BC PharmaCare has given BC patients, caregivers, and patient groups the opportunity to become a part of this drug review and share their opinions and perspectives with the decision makers.

If you are interested in grabbing this opportunity to voice your opinions, the link above will take you to the questionnaires. The link will also take you to BC PharmaCare’s Drug Information sheet and to information about BC PharmaCare’s approval process.

The questionnaires will ONLY remain open until MIDNIGHT ON Wednesday April 20, 2016.

Adding Your Voice to the BC PharmaCare Coverage Review for Zepatier

If you answer yes to any of the following questions, you can give your input:

Zepatier (elbasvir – grazoprevir)

Zepatier is a Health Canada approved, all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for hep C genotype 1, 3, or 4. The treatment can be prescribed with or without ribavirin and with or without Sovaldi. It has a high cure rate.

Links to Additional Information about Zepatier

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

Take the time to voice your opinion and help advocate for a better tomorrow!

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.

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

BC PharmaCare Considering Daklinza. This is Not a Drill.

Daclatasvir (DAKLINZA) Survey LogoBC PharmaCare’s Daklinza (daclatasvir) Survey

Daklinza (generic name daclatasvir)* is being considered for BC PharmaCare coverage! Your input is wanted.

Input from patients, caregivers, and patient groups into Daklinza’s PharmaCare approval process is being gathered from Wednesday July 22, 2015 to MIDNIGHT on Wednesday August 19, 2015.

If you are a BC resident and answer YES to any of the following questions, you can add your input into whether or not Daklinza should be covered by BC PharmaCare:

Additional Information about Daklinza (daclatasvir)

For more information about Daklinza (daclatasvir) or the PharmaCare surveys, please contact PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

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

*Daklinza (daclatasvir) hasn’t received a Notice of Compliance from Health Canada yet and, therefore, still can not be bought in Canada. Also, according to Advanced Notices sent out by BC PharmaCare a couple of weeks ago, there were plans to collect patient input for Sunvepra (asunaprevir) as well. The Hepatitis C Treatment Information Project will keep you informed of any of its developments.

Advance Notice for Sunvepra and Daklinza 2

Sunvepra and DaklinzaSunvepra (asunaprevir) and Daklinza (daclatasvir)** will soon be considered for BC PharmaCare coverage. Therefore, your input will soon be sought.

Tentatively, patient and caregiver input into Sunvepra and Daklinza’s approval process will be requested from Wednesday July 22, 2015 to MIDNIGHT on Wednesday August 19, 2015.

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 treatments should be covered by PharmaCare:

Please note that PharmaCare’s questionnaire for Sunvepra and Daklinza input tentatively wont be available for another three weeks. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Additional information about Sunvepra (asunaprevir) and Daklinza (daclatasvir) can be found at Asunaprevir and Daclatasvir Advance, a blog post written in January when the Canadian Agency for Drugs and Technologies in Health (CADTH) began reviewing the treatments.

The Canadian Treatment Action Council (CTAC) also has a webinar, created in February 2015, that explains Sunvepra (asunaprevir) and Daklinza (daclatasvir). It includes much more information.

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

**Sunvepra (asunaprevir) and Daklinza (daclatasvir) have not yet received Notices of Compliance from Health Canada. They still can not be bought in Canada and are still being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Click here for more information about the drug approval process.

Advance Notice for Sunvepra and Daklinza

Sunvepra and DaklinzaThe Hepatitis C Treatment Information Project just received an advance notification from BC’s Ministry of Health that Sunvepra (asunaprevir) and Daklinza (daclatasvir)** will soon be considered for BC PharmaCare coverage. The tentative dates for input into this process are from Wednesday June 17, 2015 to midnight on Wednesday July 15, 2015*.

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 treatments should be covered by PharmaCare:

  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 Sunvepra and Daklinza input tentatively wont be available for another two weeks. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Additional information about Sunvepra (asunaprevir) and Daklinza (daclatasvir) can be found at Asunaprevir and Daclatasvir Advance, a blog post written in January when the Canadian Agency for Drugs and Technologies in Health (CADTH) began reviewing the treatments.

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

*This process for Sunvepra (asunaprevir) and Daklinza (daclatasvir) has been rescheduled by BC PharmaCare until possibly the end of July. Please see  Advance Notice for Sunvepra and Daklinza 2 for more information

**Sunvepra (asunaprevir) and Daklinza (daclatasvir) have not yet received Notices of Compliance from Health Canada. They still can not be bought in Canada and are still being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Click here for more information about the drug approval process.