Tag Archives: daclatasvir

Sunvepra (Asunaprevir) Final Recommendation Sent to PharmaCare Plans

Sunvepra (asunaprevir) Final RecommendationSunvepra (generic name asunaprevir), developed by Bristol-Myers Sqibb, passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.

The Canadian Drug Expert Committee Final Recommendation is important within the Canadian drug approval process as it’s sent to the provinces and territories to help them decide on how they want to cover the treatment through their PharmaCare plans.

The CDEC Final Recommendation for Sunvepra (asunaprevir) when combined with Daklinza (daclatasvir)

The CDEC advocates that Sunvepra, in combination with Daklinza (daclatasvir), be listed by drug plans as a treatment for adults with chronic hepatitis C genotype 1b and with Daklinza, pegylated interferon, and ribavirin, for patients with hep C genotype 1 or 4, if the following criteria/conditions are met:

Recommended Clinical Criteria
  • None listed. This is the first CDEC report for a hep C treatment to not recommend that the treatment only be covered for patients who have a liver fibrosis stage of F2 or higher–this is a great omission.
Recommended Conditions
  • Drug plans should save money when comparing this treatment’s cost to the cheapest hep C treatment alternative.
  • Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C.

Reasons for the Above Sunvepra Recommendations
  1. A review of clinical trial results suggests that Sunvepra’s treatment response rates are comparable to success/cure rates of other interferon-free hep C treatments. However, it was noted that there are no trial results with direct comparisons to other treatments already covered by public drug programs. This has also been noted in CDEC recommendations for other hep C treatments.

  2. “There is uncertainty regarding the cost-effectiveness of ASV [Sunvepra] combination regimens…” when they are compared with other hepatitis C treatments.(CDEC)
Noted Discussion Points
  • Efficacy of these Sunvepra-based treatment combinations for patients with decompensated liver disease, hepatitis B, or HIV coinfection, malignancy, or recent drug use, remains uncertain. However, the current data indicates that Daklinza + Sunvepra is effective and safe for all of these patients.
  • The CDEC believes that there will be “limited use” of pegylated interferon with ribavirin-based treatments when there are interferon-free treatments available.
  • Further research into patients infected with hepatitis C with L31 or Y93 HCV NS5A-resistant variant at baseline is needed. (CDEC)

The Canadian Drug Expert Committee’s Final Recommendation for Sunvepra can be found here.

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed with other hepatitis C treatments/direct-acting antivirals (DAAs). It is a treatment for patients with chronic hepatitis C genotype 1 or 4.

Sunvepra, in combination with Daklinza, peginterferon, and ribavirin, has been tested on those with hep C genotype 1 or 4 who were non-responders (patients who tried treatment but it failed to achieve SVR/a cure) with great results. The cure rate when treating patients with hep C genotype 1 is 93.2%. The cure rate when treating patients with hep C genotype 4 is 100%. (Health Canada)

Lastly, doctors are able to prescribe Sunvepra to patients, but the hepatitis C treatment isn’t covered by PharmaCare yet.

Daklinza for historically difficult to treat patients

Daklinza (daclatasvir) for historically difficult to treat patientsMay 24, 2016 – Daklinza (daclatasvir), taken for 12 weeks (in combination with Sovaldi and with or without ribavirin), has been approved by Health Canada for the treatment of patients with chronic hepatitis C (genotype 1, 2, or 3) and with HIV co-infection, advanced liver cirrhosis, or post-liver transplant hep C recurrence.

This approval is good news as due to potential drug interactions between hep C treatments and HIV treatments or anti-rejection drugs for post-transplant, patients who are co-infected or have had  liver transplants have been historically difficult to treat. This difficulty hasn’t been good news as, for example, approximately 20% of Canadians with HIV also have hep C (HCV). When patients have both infections, hep C progresses much faster than it does in those infected with just HCV–progresses much faster to the point where HCV related liver disease is the leading cause of death for those who are co-infected. (BMS Canada)

These new Health Canada approvals, or treatment indications, were based on data from the clinical trials ALLY-1 and ALLY-2.

Click here to read the news release by Bristol-Myers Squibb Canada.

Daklinza (daclatasvir) with Sovaldi (sofosbuvir)

Daklinza taken in combination with other hep C antivirals, such as Sovaldi, was approved for Canadian use in August 2015.

Daklinza with Sovaldi and with or without ribavirin is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis, and now with HIV co-infection, advanced cirrhosis, or post-liver transplant hep C recurrence. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment.

“With this expanded label for Daklinza, we are proud to provide an option that helps bridge what has been a challenging treatment gap for these patients.” –Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada.

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.

In the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineCurrently, there are a couple of hepatitis C treatments making their way through the final steps of the Canadian drug approval pipeline. The following table was created to highlight these treatments and highlight the ways that you may be able to include your voice in their approval process.

Hepatitis C Treatments in the Final Steps of the Canadian Drug Approval Pipeline

Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Sovaldi (sofosbuvir) + Daklinza (daclatasvir) +/- RBV Sofosbuvir / Velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Steps in Canadian Drug Approval Pipeline Step 5 – Provincial Review Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review
Currently Seeking Patient Input No, not anymore. No, not anymore. No, not anymore. No, not anymore. No, not anymore.
Genotype (GT) Health Canada has Approved it for 4 1, 2, 3 This treatment has just begun the Canadian review process. Clinical trials have examined it on hep C genotypes 1-6. 1, 3, 4 3
Under BC PharmaCare Review for Genotype 4 Genotype 1, 2 or 3 without RBV, Genotype 2 or 3 with RBV Genotype 1, 3, 4 with or without RBV 3
Approximate SVR (Approx Rate of Cure) 90% without RBV, 100% with RBV 90 – 100% 94 – 100% 93 – 100% 91 – 100%
May Require PR* No
May Not Require RBV
Yes
Daily Pills 1 +/- twice daily RBV 2 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 12 12 or 24 8, 12, or 24 8, 12, or 16 12
Limited Most Common Side Effects**  (Ribavirin can affect side effects)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Anemia
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
Drug Warnings (Healthcare providers, patient assistance programs, and/or online product monographs, links below, have more information)

Technivie is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Technivie should not be taken while taking: ethinyl estradiol-containing medicines, drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations are associated with serious adverse reactions, strong CYP2C8 inhibitors and inducers, moderate or strong inducers of CYP3A.

Sovaldi is not for patients taking amiodarone. Tell your doctor if you are taking CYP3A inhibitors or P-gp, OATP 1B1, 1B3, BCRP, phenytoin, carbamazepine, rifampin, or St. John’s wort (Hypericum perforatum) as they limit Daklinza’s effectiveness. Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

General Hep C Treatment Usage Warning Do not take treatments while taking recreational drugs or over-the-counter drugs, such as St. John’s wort, without first talking with your healthcare provider as they may interact with each other. Tell your doctor if you may be or may become pregnant. The safety and efficacy of most of these treatments in children less than 18 years of age has not been established.
Patient Assistance Program Contact Information AbbVie Care 1-844-471-2273
Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Technivie Daklinza Zepatier
Information about HCV / HIV Co-infection Technivie (by CATIE) Daklinza (by CATIE)

Sovaldi / Velpatasvir (by hepmag)

Zepatier (by CATIE)
*PR stands for pegylated interferon with ribavirin. It may be combined with other drugs for the treatment of hep C. RBV stands for ribavirin. **If patients experience treatment side effects, they are usually not severe enough to stop treatment. 

Information was gathered from Health Canada’s Drug and Health Products sheets, BC PharmaCare Drug Information sheets,  CATIE, hepmag, product monographs, and the Hepatitis C Treatment Information Project within the past week.

U.S. FDA Approves Expanded Use of Daklinza

U.S. FDA Approves Expanded Use of DaklinzaIn the U.S., Daklinza (daclatasvir) plus Sovaldi (sofosbuvir), a FDA approved hepatitis C treatment for those with hep C genotype 3, is now also FDA approved to treat hep C genotype 1 or 3 patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of hep C. The treatment is approved to be prescribed on its own or combined with ribavirin.

See yesterday’s press release for more information about the FDA approval, suggested treatment lengths, and clinical trial results for Daklinza and Sovaldi.

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb, in the company’s press release.

Daklinza in Canada

In Canada, Daklinza was approved for use with Sovaldi last August. Daklinza with Sovaldi, when prescribed in Canada, is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment for patients with chronic hep C genotype 1, 2, or 3, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.

Final Recommendation for Daklinza (daclatasvir)

Daklinza (daclatasvir)Daklinza (generic name daclatasvir), developed by Bristol-Myers Sqibb, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

The Canadian Drug Expert Committee (CDEC) Final Recommendation is important within the Canadian drug approval process as it is sent to the provinces and territories to help them decide on PharmaCare coverage.

The CDEC’s Final Recommendation advocates for Daklinzain combination with Sovaldi (sofosbuvir) to be listed as a treatment for adults with chronic hepatitis C genotype 1, 2, or 3 if the following criteria is met:
Clinical Criteria
  • Treatment experienced patients without cirrhosis who have not responded to pegylated interferon with ribavirin (PR).
    The report highlighted that this does not mean that patients who haven’t been treated, are treatment-naive, should be treated with pegylated interferon with ribavirin (PR) first.
Conditions
  • Treatment should be started by hepatologists or physicians experienced with treating chronic hep C.

  • Drug plans should not pay more for Daklinza than they do for Sovaldi (sofosbuvir) plus ribavirin.

Reasons for the Daklinza Recommendations
  1. The clinical trial ALLY-3 results showed high rates of sustained virologic response (SVR12), cure, for treatment experienced patients with chronic hep C genotype 3.

  2. The manufacturer’s pharmacoeconomic evaluation showed that Daklinza plus Sovaldi was a cost-effective option, when it was compared with 24 weeks of Sovaldi plus ribavirin for patients with hep C genotype 3 who are treatment experienced and don’t have liver cirrhosis. However, Daklinza plus Sovaldi was not a cost-effective option for patients with hep C genotype 3 who are treatment naive and/or have cirrhosis.

Reported Research Gaps
  • There aren’t any comparisons between Daklinza and sofosbuvir and the other hep C direct-acting antivirals that are currently used in Canada.
  • There is limited data on patients who have cirrhosis, are co-infected with other diseases, such as AIDS, or who have been treated with other hep C direct-acting antivirals but who weren’t cured.
Other Highlighted Information
  • Four groups responded to CADTH’s call for input from patient groups. This input successfully explained what it’s like to have hep C, what stigma surrounds hep C, what side effects are like, and the importance of having access to inferferon free/low toxicity treatments with shorter treatment durations and no drug interactions.
Daklinza (daclatasvir)

Daklinza is approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.

Daklinza with Sovaldi is a 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 more than 90% of the patients who have been treated with Daklinza and Sovaldi.

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), info@claireprogram.ca (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.

Health Canada Approves Daklinza (daclatasvir)

Daklinza with SovaldiThose with hepatitis C genotypes 1, 2, or 3 now have a new treatment option!

Health Canada has granted the treatment Daklinza (daclatasvir) a Notice of Compliance (NOC) for treating adult patients with hep C genotypes 1 and 2 with compensated liver disease, including cirrhosis, and a Notice of Compliance with conditions (NOC/c) for the treatment of genotype 3 patients with compensated liver disease.

Notice of Compliance and Notice of Compliance with Condition

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

A Notice of Compliance with conditions (NOC/c) is issued when Health Canada allows a drug to be marketed in Canada, with the condition that the manufacturer of the treatment undertakes additional studies to verify the treatment’s efficacy (how well it works). In this case, it was issued pending the submission of final clinical study results from the clinical trial ALLY-3.

Daklinza (daclatasvir) with Sovaldi (sofosbuvir)

Daklinza is now approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.

Daklinza with Sovaldi is a 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 more than 90% of the patients who have been treated with Daklinza and Sovaldi.

Patients prescribed Daklinza will be supported by Bristol-Myers Squibb Canada’s Claire Patient Support Program. More information about the program will follow shortly.

This is a link to Bristol-Myers Squibb Canada’s press release about today’s Daklinza approval.

“This is another important milestone for hepatitis C patients across genotypes. But the significance of this approval is the impact it will have on the one in five patients who have genotype 3 and are being treated but not achieving cure rates like we’re seeing with those living with other genotypes. This gives them a chance to hear the very same words that many of us are being told – you are cured.” –Joan King, Vice President of a hepatitis C patient group in Canada

For more information about Daklinza (daclatasvir), or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

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.