Tag Archives: sovaldi

Three Hepatitis C Researchers Win 2016 Lasker~DeBakey Award

Three Hepatitis C Researchers Win 2016 Lasker~DeBakey AwardSince 1945, the New York-based Albert and Mary Lasker Foundation has worked to raise public support for medical research. The Albert and Mary Lasker Foundation has done this through recognizing and celebrating breakthroughs in medical research, public education, and advocacy. One of the ways the foundation celebrates the most important breakthroughs in these fields is to annually reward the very best with the Lasker~DeBakey Clinical Medical Research Award.

This year, the Lasker~DeBakey Clinical Medical Research Award will be given to three hepatitis C researchers.  The award’s three co-winners will be Michael J. Sofia,  Ralf F.W. Bartenschlager, and Charles M. Rice.

Michael J. Sofia

Michael J. Sofia will receive the Lasker~DeBakey Clinical Medical Research Award  for his work on the hepatitis C drug sofosbuvir. He is sofosbuvir’s lead inventor and partial name-sake.

Sofosbuvir (brand name Sovaldi) is a treatment for hepatitis C. It can directly target the hep C virus and stop it from making copies of itself. The treatment works by attaching itself to the genetic information, called RNA, to block the virus from multiplying. It is able to cure hep C with shorter treatment times, better cure rates (curing more than 90% of patients), and less side effects than previous hep C treatments. Furthermore, sofosbuvir is also a part of Harvoni and Epclusa, two other new hep C treatments.

In an interview, Dr. Sofia remarked that “It’s pretty astounding to see how this drug has been able to transform people’s lives and certainly really change the future for” people with hepatitis C. (Peter Loftus, 2016)

Ralf F.W. Bartenschlager and Charles M. Rice

The Lasker~DeBakey Clinical Medical Research Award will also be awarded to Ralf F.W. Bartenschlager and Charles M. Rice for their work in developing a way to get the hep C virus to multiply inside lab-grown host cells. This system was then used by Dr. Michael J. Sofia and other researchers to test and create treatments.

The Lasker~DeBakey Clinical Medical Research Award comes with honorariums of $250,000 (USD) for each of the three winners and will be given out on September 23rd, in New York.

Sources: Scientists Honored for Hep C Research: Three medical researchers are among winners of Lasker Awards by Peter Loftus, published by The Wall Street Journal on September 13, 2016, the Albert and Mary Lasker Foundation’s website, and the 2016 Lasker~DeBakey Clinical Medical Research Award YouTube video by the Albert and Mary Lasker Foundation.

Treatments in the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineThere 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

Sunvepra (asunaprevir) + Daklinza (daclatasvir) +/- Pegylated Interferon with Ribavirin (PR) Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Epclusa (sofosbuvir / velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS3/4A Protease Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Step Within Canadian Drug Approval Pipeline Step 5 – Provincial Review
Currently Seeking Patient / Caretaker Input Has already been collected Has already been collected Has already been collected Has already been collected Has already been collected
Genotype (GT) Health Canada has Approved it for 1, 4 4 1 – 6 1, 4 3
Under BC PharmaCare Review for Genotype 1, 4 4 1 – 6 1, 4 3
Approximate SVR (Approx Rate of Cure) 93 – 100% 90% without RBV, 100% with RBV 94 – 100% 93 – 100% 91 – 100%
May Require PR* Yes No
May Not Require PR or RBV
Yes
Daily Pills 3 +/- PR 1 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 24 12 8, 12, or 24 8, 12, or 16 12
Most Common Side Effects** (Ribavirin can affect side effects)
  • Headache
  • Tiredness (fatigue)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • 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) Sunvepra is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Do not take Sunvepra without combining it with other hep C treatments. Please see Bristol-Myers Squibb Canada’s Sunvepra information page for 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.

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. If you have any side effects not listed here, contact your healthcare provider. Tell your healthcare provider 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 Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 AbbVie Care 1-844-471-2273
Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Sunvepra Technivie Epclusa Zepatier
Information about HCV / HIV Co-infection Sunvepra (by Bristol-Myers Squibb Canada) Technivie (by CATIE)

Epclusa (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.

Canadian drug approval pipeline and treatment information was gathered last week 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.

Updated Recommendations

Updated Recommendations“All patients with CHC [a chronic hepatitis C] infection should be considered for treatment, regardless of fibrosis score. Given the potential impact on health system sustainability of treating all patients with CHC infection on a first-come basis, priority for treatment should be given to patients with more severe disease.” (CADTH Canadian Drug Expert Committee, page 2, May 18, 2016)

Updated CADTH Canadian Drug Expert Committee Recommendations

The Canadian Drug Expert Committee (CDEC) updated their recommendations for the hep C treatments: Harvoni, Holkira Pak, Sovaldi, and Daklinza. They now recommend that the liver fibrosis stage F2 or greater requirement for treatment through PharmaCare should be removed. Where once their clinical criteria for treatment with Harvoni, for example, read, “Patients must have a liver fibrosis stage of F2 or greater before they are eligible for PharmaCare coverage“, the same report sections for Harvoni now read:

Recommendation:

CDEC recommends that ledipasvir/sofosbuvir (LDV/SOF) be reimbursed for the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults, if the following conditions are met.

Conditions:
  • Treatment should be initiated by physicians with experience in the management of CHC patients.
  • Drug plan costs for LDV/SOF should not exceed the drug plan costs of other interferon (IFN)-free regimens for the treatment of CHC. (CDEC, May 2016)

Additional Noteworthy Updates

The CDEC also recommended/stated that:

  • Disease symptoms and other health concerns be considered when deciding to treat or not treat, or as it is written in the report, “Extrahepatic manifestations are additional considerations in defining disease severity.”
  • The more sever patients be treated first.
  • Treatment is likely cost-effective across all METAVIR scores. Detailed explanations of this are included in the recommendation reports (links below).

A Possible Next Step for Hep C Advocates

A possible next step for hep C advocates may be to highlight these changes and to ask governments, who follow the CDEC recommendations, to follow suit.

The Links to the Updated CADTH Canadian Drug Expert Committee Recommendations and Summary Reports on Drugs for Chronic Hepatitis C Infection

About CADTH’s Canadian Drug Expert Committee (CDEC)

CADTH’s CDEC is an advisory board made up of experts and public members (for a lay perspective) that makes recommendations to the publicly funded drug plans about what and what not to cover and how to cover it.

 

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.

Canadian Public Drug Plans Request Answers

Canadian Public Drug Plans Request AnswersSubmit Your Answers to the Following 2 Questions BY EMAIL

OR

Submit Your Answers to the Following 2 Questions BY ONLINE QUESTIONNAIRE

Only submit your answers once. Submit your answers before February 12, 2016.

Our Request

We are asking that you take a moment to send us your answers to the two questions below and any other information that may help us with this request for patient input.

CADTH’s Request for Patient Input

The public drug plans that seek advice from CADTH’s Canadian Drug Expert Committee (CDEC), such as BC PharmaCare, have requested guidance about aligning two sets of recommendations for four hepatitis C treatments (Daklinza, Harvoni, Holkira Pak, and Sovaldi). The two sets of recommendations that the drug plans want aligned are CADTH’s therapeutic review on drugs for hepatitis C and CDEC Final Recommendation for the four hepatitis C treatments. (More information about the four CDEC final recommendations is below.)

The response to this request may result in changes to the current CDEC recommendations or new CDEC Records of Advice for these treatments.

Therefore, the CDEC has asked for patient input about the four hep C treatments, specifically answers to the following two questions:

  • Question 1: “Is there anything the CADTH review team should be aware or reminded of, when updating individual recommendations for Harvoni, Holkira Pak, Sovaldi and/or Daklinza?”
  • Question 2: “How do patients or how do you view hep C treatments that require ribavirin?”

Question 2 has been asked due to mixed feelings regarding ribavirin that have been expressed by hep C organizations. Some groups have reported that patients regard ribavirin as an intolerable treatment that is just as bad as interferon, whereas others see it as “tolerable and acceptable, if only barely and temporarily.”

Therefore, how do you feel about ribavirin? Would ribavirin as part of a hepatitis C treatment make you hesitant about that treatment? Would you take ribavirin if it increased your chances of a hep C cure? What information would influence whether you would take ribavirin or not?

Summaries of the CDEC Final Recommendations for Daklinza, Harvoni, Holkira Pak, and Solvaldi

Treatment Targeted Genotypes Recommended Criteria Suggested Conditions for Coverage
Daklinza in combination with Sovaldi*

(CDEC Final Recom-mendation Published Sept 21, 2015)

1, 2, 3
  • Treatment
    experienced patients
    without cirrhosis who have not responded to
    pegylated
    -interferon plus ribavirin (PR).
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Drug plan cost of a treatment course with daclatasvir plus sofosbuvir should not exceed the drug plan cost of a treatment course with sofosbuvir plus ribavirin.
Harvoni*

(CDEC Final Recom-mendation Published Feb 18, 2015)

1
  • A fibrosis stage of F2 or higher
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Substantially reduced price
Holkira Pak*

(CDEC Final Recom-mendation Published May 21, 2015 and updated July 22, 2015)

1
  • A fibrosis stage of F2 or higher
  • Pescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Price should not exceed the drug plan costs of other interferon-free hep C treatments
Sovaldi + Pegylated Interferon with Ribavirin (PR)

(CDEC Final Recom-mendation Published Aug 18, 2014)

1
  • A fibrosis stage of F2, F3, or F4
  • Have never been treated
  • Funding should not exceed a duration of 12 weeks for the treatment of patients with
    genotype 1 or 2 hep C and 24 weeks for the treatment of patients with genotype 3 hep C
  • Reduced price
Sovaldi + Ribavirin (RBV)*

(CDEC Final Recom-mendation Published Aug 18, 2014)

2
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
3
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
*These treatments have possible pegylated interferon and/or ribavirin free options. Click their links for more information about the treatments. Our Basic Hep C Treatment Terms page also has more information about terms some may not be familiar with. Our Comparing Hep C Treatments page has additional information about the treatments except for Daklinza in combination with Sovaldi.

About CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

About CADTH’s Canadian Drug Expert Committee (CDEC)

CADTH’s CDEC is an advisory board made up of experts and public members (for a lay perspective) that makes recommendations to the publicly funded drug plans about what and what not to cover and how to cover it.

Please email hepctip@pacifichepc.org for more information about this CDEC request.

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

New Hep C Treatment Recommendations

New Hep C Treatment RecommendationsThere is excitement over CADTH’s new hepatitis C treatment recommendations report, CADTH Therapeutic Review, Drugs for Chronic Hepatitis C Infection: Recommendations Report, by the Canadian Drug Expert Committee (CDEC).

The report comes after Canadian patient groups, such as PHCN, CTAC,  and Action Hepatitis Canada (AHC), were asked to provide feedback to a draft of the recommendations this summer.

Action Hepatitis Canada has written about the new report and is very pleased that patient groups were asked for input, as are we, and that recommendations are in line with some of their feedback. For example, AHC highlighted the first recommendation which reads:

Recommendation 1: CDEC recommends that all patients with CHC infection should be considered for treatment, regardless of fibrosis score. Given the potential impact on health system sustainability of treating all patients with CHC infection on a first-come basis, priority for treatment should be given to patients with more severe disease.

Recommendation 4 stood out for us as the insufficient evidence seemed surprising. It reads:

Recommendation 4: CDEC considered there to be insufficient evidence to make a recommendation for patients with CHC genotype 5 or 6 infection.

Hep C Treatment Recommendations 2, 3, and 5 are as follows:

Recommendation Targeted Patients Preferred Treatment
2 Those with genotype 1 (GT1) hepatitis C who have never tried treatment (treatment naive) regardless of liver cirrhosis stage Harvoni or Holkira Pak +/- ribavirin for same duration as approved by Health Canada
Those with GT1 hep C who have tried treatment (treatment experienced) regardless of cirrhosis stage Pegylated interferon + ribavirin (PR) for same duration as approved by Health Canada
3 GT2
Sovaldi + ribavirin (12 weeks)
Those with GT3 hep C without cirrhosis Daklinza + Sovaldi (12 weeks)
Those with GT3 hep C with cirrhosis Sovaldi + ribavirin (12 weeks)
Those with GT4 hep C who are treatment naive and don’t have liver cirrhosis Sovaldi + PR (12 weeks)
Those with GT4 hep C who are treatment experienced or have liver cirrhosis regardless of treatment history Insufficient evidence to make a recommendation
5 Those with GT1 hep C who have already tried
a protease inhibitor-PR regimen regardless of cirrhosis stage
Harvoni
Treatment experienced with an all-oral DAA treatment Insufficient evidence to make a recommendation

Recommended condition for all patients being treated for hep C: Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C. The report also includes recommendations for liver transplant recipients starting on page 22.

For more information, please see the full report, visit PHCN’s Hepatitis C Treatment Information Project, or email us.

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.

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.