Tag Archives: Harvoni

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.

 

U.S. FDA Approved Harvoni for More Patients

U.S. FDA Approved Harvoni for More PatientsIn the U.S,. the FDA approved Harvoni for more hep C patients today. Harvoni (ledipasvir/sofosbuvir), a FDA approved hepatitis C treatment, was also FDA approved to treat patients with advanced liver disease. The treatment was approved to be prescribed with ribavirin for 12 weeks for patients with:

  • Hep C genotypes 1 or 4 who are liver transplant recipients and who have compensated cirrhosis (Child-Pugh A) or don’t have cirrhosis;
  • Hep C genotype 1 with decompensated cirrhosis (Child-Pugh B or C), including those who have had liver transplants.

See today’s press release for more information about Harvoni in the U.S., the FDA approval, clinical trial results, and safety information for Harvoni (ledipasvir/sofosbuvir).

Harvoni in Canada

Harvoni is an all-oral (one pill daily), short-course (8 – 24 weeks), interferon-free, ribavirin-free, treatment for patients with chronic hep C genotype 1, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 93% of the patients who have been treated with Harvoni. Harvoni is listed by Canadian pharmacare programs. More information about the hep C treatment can be found here.

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.

New Viral Load Testing and Genotyping Recommendations

Viral Load Testing and Genotyping RecommendationsThe BC Centre for Disease Control’s New Viral Load Testing and Genotyping Recommendations

The BC Centre for Disease Control (BCCDC) has published new viral load testing recommendations for those taking one of the following hep C treatments:

BCCDC Recommends Viral Load Tests be Done:
  • No more than 6 months before starting treatment
  • Right after treatment
  • 12 weeks after treatment
  • 24 weeks after treatment
BCCDC Viral Load Testing Recommendations for those taking Pegylated Interferon and Ribavirin are:
  • No more than 6 months before starting treatment
  • Week 4 of treatment for those with hep C genotype 2
  • Week 4 and 12 of treatment for those with hep C genotype 3
  • Week 12 after treatment to confirm a cure
  • Week 24 after treatment to confirm a cure
BCCDC Hep C Genotyping Recommendations
  • Prior genotyping results for those with genotypes 2 – 6 should be considered valid
  • Patients with genotype 1 hep C should be retested before treatment. This is because genotyping done before May 2012 did not discriminate between genotypes 1a and 1b well enough.
  • When considering Galexos (simeprevir) for treatment, a Q80K resistance test is needed
  • Genotype testing should be done before retreating
BC Centre for Disease Control (BCCDC)

The BC Centre for Disease Control (BCCDC) provides provincial and national leadership in public health through surveillance, detection, treatment, prevention and consultation services. The Centre provides both direct diagnostic and treatment services for people with diseases of public health importance and analytical and policy support to all levels of government and health authorities.

For more information about hep C treatments please visit PHCN’s Hepatitis C Treatment Information Project or email.

PharmaCare Covered Hep C Treatments

PharmaCare Covered Hep C TreatmentsThe number of BC PharmaCare covered hep C treatments has been increasing and so has the information gathered by the Hepatitis C Treatment Information Project. The Hep C TIP now has new pages dedicated to BC’s PharmaCare and the treatments that are covered by it. These pages are:

Treatments Targeted Genotype
Ribavirin 1 – 3
Pegylated Interferon with Ribavirin (Pegasys RBV) 2 – 6
Victrelis (boceprevir) 1
Galexos (simeprevir) 1
Sovaldi (sofosbuvir) 1 – 3
Harvoni (ledipasvir and sofosbuvir) 1

For more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.

BC’s PharmaCare lists Harvoni and Sovaldi!

Galexos Sovaldi pictureWhat follows is PHCN‘s press release regarding the BC Ministry of Health offering Harvoni and Sovaldi, but we want to also say WOW!!!  To everyone who has been waiting so long and so patiently for this day – CONGRATULATIONS!!!!

Stay tuned for continuing updates on other new drugs in the pipeline.

Here is PHCN’s press release:

Pacific Hepatitis C Network Welcomes Decision to Provide Access to New Therapies

 

B.C. Ministry of Health to offer two new hepatitis C virus drugs to eligible patients

Vancouver, B.C. – (March 23th, 2015) – Pacific Hepatitis C Network (PHCN) today welcomed the B.C. Ministry of Health’s announcement that it will provide access to two new hepatitis C virus (HCV) therapies, Harvoni and Sovaldi. HCV 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.

“We are thrilled that these new therapies are now available to eligible patients,” says Daryl Luster, President of PHCN. “As a network and voice for those living with hepatitis C in British Columbia, these new treatments are a huge leap forward and will greatly change the outcome for those living with, and affected by, hep C.”

Harvoni and Sovaldi are two new therapies that, along with multiple other provinces in Canada, will be available to eligible patients in B.C. as of March 24th. Harvoni is a substantial step forward in HCV treatment because it is a highly curative, low-side effect therapy that is simple to take and is both ribavirin and interferon-free.

“In contrast with therapies used until now, this breakthrough hep C treatment has a cure rate of close to 100 per cent, with few or no side effects, as well as a shortened treatment cycle and is ribavirin-free,” says Daryl Luster. “The B.C. Government should be congratulated for taking this significant step forward that will help to eliminate hepatitis C in a generation.”

Often heralded as a “silent epidemic” because of its few or asymptomatic characteristics, HCV seriously affects the liver and can be difficult to treat. In fact, many Canadians living with HCV are unaware of their infection, primarily within the baby boomer demographic, which highlights the importance of implementing hep C screening processes across the nation.

Equally important as the availability of these new treatments and intensive hep C screening processes are monitoring, counseling and engaging with care to help prevent high numbers of HCV patients requiring intensive health care for advanced liver disease.

About the Pacific Hepatitis C Network

The Pacific Hepatitis C Network (PHCN) is a non-profit community-based organization that was founded in March 2007. PCHN is a voice for those living with hep C and works as an advocacy group to bring together people living with, affected by and at-risk for the hep C infection, including people living with hepatitis C, health care providers, community-based service providers and community and government stakeholders. PCHN works alongside individuals, groups and organizations in efforts to strengthen our collective response to hepatitis C in BC. For more information please visit: http://ww.pacifichepc.org/, the Pacific Hepatitis C Network, or http://www.hepctip.ca/, PHCN’s Hepatitis C Treatment Information Project.

  • 30 –

For more information or interview requests, please contact:

Deb Schmitz

Pacific Hepatitis C Network

deb@pacifichepc.org

604 740 1092

Here is the link to the Minister’s announcement:  http://www.newsroom.gov.bc.ca/2015/03/bc-covers-two-curative-hepatitis-c-drugs.html

Did you spot yesterday’s typo?

sq_drugsBlog Entry Correction

Yesterday’s blog post about Harvoni passing its Common Drug Review this week stated that one of the Canadian Drug Expert Committee’s recommendations was that liver fibrosis should be “stage 2 or lower“. The post should have read “Liver fibrosis stage ≥ 2” or “Liver fibrosis stage 2 or higher.

I apologize for the typo. I may have been a wee  excited about the Harvoni news.

Harvoni Passed Common Drug Review

ledipasvir, sofosbuvir, HarvoniHarvoni, created by Gilead Sciences, passed its Common Drug Review this week with the Canadian Drug Expert Committee (CDEC)’s Final Recommendation. The CDEC’s Final Recommendation advocates that Harvoni, ledipasvir/sofosbuvir, be listed for the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults. It recommended 3 conditions for this.

The 3 conditions recommended by the Canadian Drug Expert Committee were:

  • Liver fibrosis be at stage 2 or higher
  • Treatment should be initiated by physicians experienced with treating chronic hep C
  • A substantial reduction in price

Reasons for the Recommendations were:

The CDEC’s report also covered such information as the treatment’s background, efficacy, side effects, and cost and cost-effectiveness.

The website for BC’s PharmaCare now lists Harvoni’s Drug Review Start Date as March 18th, 2015.

Footnote:

When I read the report, I found an interesting note under “Other Discussion Points”. It said that although the ION trials didn’t look at patients coinfected with HCV and HIV, the committee did and cited that ERADICATE, a recently completed trial, demonstrated similar SVR12 rates (98%) in patients coinfected with HCV and HIV to those reported in the three ION trials.

Notice of Compliance for ledipasvir/sofosbuvir

sq_drugsGilead Sciences, Inc. announced yesterday that Health Canada has issued a Notice of Compliance for ledipasvir/sofosbuvir (Harvoni), the first ?irketleri once-daily single tablet regimen for the treatment of chronic hepatitis C genotype Dr.SiLnT 1 infection in adults. The technical tablet combines wholesale NFL jerseys the NS5A inhibitor ledipasvir with the Wholesale Miami Dolphins Jerseys nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi) cheap NFL jerseys for a 8, 12, or 24 week treatment duration.

The press release programa that Gilead Sciences posted TAKERS! regarding this ledipasvir/sofosbuvir development also includes information about Gilead’s Momentum Support Program in wholesale jerseys Canada.

For more information about currently approved hep C treatments in BC, new and Winter, emerging drugs, ASAP! the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.