Tag Archives: Epclusa

The PHCN’s News in Review Newsletter (06/04/17)

The PHCN's News in Review Newsletter (07/04/17)Welcome to the Pacific Hepatitis C Network (PHCN)‘s Hepatitis C News in Review Newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to a blog post about the importance of eliminating hepatitis C.

Hepatitis C Elimination is Possible and Essential

The group most impacted by hepatitis C, some 60,000 in B.C., are baby boomers, those who were born between 1945 and 1965. Many have lived with the infection for years but have never been tested or treated because they have never believed themselves to be at risk.  This is the time that everyone, including baby boomers, should be tested and treated for hepatitis C.

Relapse, Recurrence, Null & Partial Response/rs

In hepatitis C and hep C treatment there are three ‘R’s that are big, sad, and scary. They are the bringers of sadness that if doctors, friends, and communities could protect someone from, they would. Click the above link for more information.

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Coverage for four hepatitis C treatments has changed. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being or have been added to various provincial formularies across Canada.

Technivie and BC PharmaCare

Technivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Holkira Pak and BC PharmaCare

The hepatitis C treatment Holkira Pak was approved for use in Canada in March 2015 and then was later approved for BC PharmaCare coverage in July  2015. Although Holkira Pak is still approved for use in Canada and has an amazingly high cure rate, as of March 23, 2017, BC PharmaCare wont cover it.

Blog Posts by PHCN’s President Daryl Luster

Coming this Spring

Eh, starting this spring, Help-4-Hep helpline will be in Canada.  Help-4-Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Look for more details to come or call the American Help-4-Hep helpline all free of charge.

For more information about hepatitis C and its cures, please email or visit the Hepatitis C Treatment Information Project.

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded Coverage

Epclusa, Zepatier, Daklinza, and Sunvepra Expanded CoverageCoverage for four hepatitis C treatments is changing. The four new hepatitis C treatments (Epclusa, Zepatier, Daklinza, and Sunvepra) are being added to provincial formularies across Canada.

Treatment Coverage Across Canada

Treatment coverage across Canada is decided upon by each province and territory. This means that not only can treatments vary, and be compared to each other, but treatment coverage may vary from location to location as well.

For more information about what treatment is covered in your province, we have created an easy to understand webpage with links to more information.

This page is a quick summary of what hepatitis C treatments are covered, in some form or another, by the different provinces and territories across Canada. The links within the table will take you to information about the treatments and to information about treatment coverage.

Lastly, towards the bottom of the webpage, there are links to information about Canadian clinics and additional resources about hepatitis C treatment coverage outside of BC.

However, please note that one of the most important things to know when looking into hepatitis C and its treatment, far beyond what treatments are covered by your province now, is that being in contact with a healthcare practitioner, who is regularly monitoring your health, is essential.

PHCN’s Statement about the Successful Negotiations for 3 New Hepatitis C Treatments

PHCN's Statement about the Successful Negotiations for 3 New Hepatitis C Treatments‘No One Left Behind!’

Pacific Hepatitis C Network (PHCN) is very happy to learn that effective March 21, an extensive list of hepatitis C treatments will be available through BC PharmaCare – at far better prices than they previously had been. The high cost of hepatitis C treatment has effectively restricted the numbers of people living with hepatitis C who could access treatment.

Even with lower prices, those restrictions will remain in place until next year. Come March 2018, those restrictions (requiring a liver fibrosis stage of F2 or greater) will be lifted and hepatitis C treatment will be available to any person living with hepatitis C in BC, “regardless of the type and severity of their disease”.

The Province, via the Ministry of Health, co-led the negotiations for new, affordable prices and we at PHCN are both proud of that fact and sincerely grateful. We hope the same for new, hep C drugs that are currently in development and that improve even more on cure rates, tolerability, length of treatment, and treating more than one HCV genotype.

And with these new developments, our work continues! Now is the time to identify and address the barriers still in place that keep those living with hep C from accessing care and treatment: low levels of primary care provider awareness of hep C and treatments; believes about who deserves treatment and who doesn’t; patient education and outreach to those who were diagnosed years ago but are not engaged in care for their hep C. Stigma can and does underlay many of those barriers and must be addressed.

PHCN applauds the ushering in of the first critical step by BC’s Ministry of Health and we urge continued vigilance and collective planning and action to ensure ’No One Left Behind!’ when it comes to hepatitis C care and treatment in BC.

More information can be found here.

BC Ministry of Health Press Release: More Patients to Benefit from Hepatitis C Treatments

BC Ministry of Health Press Release: More Patients to Benefit from Hepatitis C TreatmentsCopied and Pasted from BC Ministry of Health on February 21, 2017.

Thousands of British Columbians living with hepatitis C will have better access to treatment as a result of successful negotiations brokered by the pan-Canadian Pharmaceutical Alliance (pCPA).

“This agreement changes the landscape for hepatitis C patients living in B.C.,” said Health Minister Terry Lake. “Not only are there four new treatment options for what is now a curable virus, but the savings that were negotiated will allow us to cover treatment options for all hepatitis C patients – rather than just those in more advanced stages of the disease.”

British Columbia and Ontario co-led the negotiations with the drug manufacturers on behalf of the pCPA. The alliance helps provinces and territories leverage their collective buying power and negotiate better prices for new drugs.

The collaborative effort resulted in a significant cost savings to drug plans for participating provinces and territories. The agreement also allows access to treatment for all eligible patients in a fiscally sustainable manner. Prices and terms for this negotiation are confidential.

The list cost to the health system for hepatitis C treatment has ranged from $45,000 to over $100,000 per patient, depending on the drug and disease progression.

Agreements with the pCPA were reached with Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada to provide several hepatitis C drugs at an improved cost:

  • Daklinza (daclatasvir) – new
  • Epclusa (sofosbuvir/velpatasvir) – new
  • Harvoni (ledipasvir/sofosbuvir)
  • Sovaldi (sofosbuvir)
  • Sunvepra (asunaprevir) – new
  • Zepatier (elbasvir/grazoprevir) – new

PharmaCare is expanding the criteria in March 2017 to provide coverage to more patients living with hepatitis C. Physicians can apply for coverage of the new drugs on behalf of their patients on or around March 21, 2017. Starting in 2018-19, PharmaCare will provide coverage for any British Columbian living with chronic hepatitis C, regardless of the type or severity of their disease.

Up to 75,000 British Columbians are estimated to be living with hepatitis C. Approximately 24% of those exposed to the virus are able to clear it on their own. However, when left untreated, it can cause serious complications such as liver failure and liver cancer. The new modern hepatitis C therapies are highly effective, with the ability to clear the virus at rates over 95%.

If untreated, hepatitis C virus infection can be a life-threatening communicable disease. Risk and harm reduction practices are strongly encouraged for those who may be at higher risk for re-acquiring the virus after successful treatment, including people who inject drugs, men who have sex with men, and commercial sex workers.

Hepatitis C is the most-frequent cause of premature death among reportable infectious diseases in North America, and has become the most-frequent cause of premature death among people living with both hepatitis C and HIV.

Quick Facts:

  • Hepatitis C is a serious, communicable disease that is spread through direct contact with the blood of a person living with the virus. Symptoms may include fatigue, jaundice, abdominal pain and joint pain. In some people, it can cause liver damage (cirrhosis) or liver cancer.
  • Up to 75,000 people are estimated to be living with hepatitis C in British Columbia. However, many people with the virus have no symptoms. About one-quarter of people living with hepatitis C do not know they have it.
  • About one-quarter of people with hepatitis C do not need treatment, as their body fights off the infection.
  • Once someone is successfully treated and cured of hepatitis C infection, they are no longer able to pass the disease on to others.
  • Currently, there is no vaccine to prevent hepatitis C infection.
  • From March 2015 to December 2016, PharmaCare coverage was provided to about 3,800 people in B.C. for medication used to treat chronic hepatitis C.

Learn More:

For more information on the pan-Canadian Pharmaceutical Alliance:
http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance

For more information about B.C.’s PharmaCare program:
http://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents

Successful Negotiations for Three New Hepatitis C Treatments

Successful Negotiations for Three New Hepatitis C TreatmentsDirectly copied statement from the pan-Canadian Pharmaceutical Alliance

TORONTO, Feb. 21, 2017 /CNW/ – On behalf of participating federal, provincial and territorial public drug plans, the pan-Canadian Pharmaceutical Alliance (pCPA) has concluded successful negotiations with three drug manufacturers to help jurisdictions expand access to publicly funded medications for the treatment of chronic hepatitis C.

Hepatitis C is a communicable liver disease that is caused by an infection with the hepatitis C virus. Seventy-five per cent of people who have contracted hepatitis C cannot spontaneously clear the virus. This leads to chronic hepatitis C infection. Although many of the estimated 250,000 infected Canadians may have no symptoms for decades, if left untreated, chronic hepatitis C can lead to serious complications such as liver failure and liver cancer.

Just a few years ago, hepatitis C patients took a combination of pills and injections for almost a year and these earlier drugs had lower rates of treatment success. Today’s newer therapies are more effective, available in oral form and require substantially shorter durations of treatment.

These benefits, however, come at a substantial cost. Depending on the drug and disease progression, the list cost for hepatitis C treatments ranged from $45,000 to over $100,000 per patient. Although these costs were made more affordable with previous agreements, the funding of hepatitis C treatments has resulted in significant cost pressures.

Recently, multiple products have become available, creating a more competitive environment for hepatitis C treatment price negotiations.

The pCPA’s approach to hepatitis C treatment negotiations was guided by the following:

  • goal of providing treatment for patients regardless of genotype and disease severity
  • financial affordability and sustainability
  • a fair approach in negotiating value among multiple drugs and manufacturers.

Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada were able to reach an agreement through the pCPA to provide hepatitis C drugs at an improved cost. These agreements will help increase publicly funded access for most patients with hepatitis C.

As with all pCPA drug negotiations, individual participating jurisdictions will be responsible for implementing changes under their respective public drug plans.

SOURCE Pan Canadian Pharmaceutical Alliance (pCPA)

For further information: For more information (media): David Jensen, Ministry of Health and Long-Term Care, 416-314-6197

Month by Month 2016 Hepatitis C Drug Pipeline Highlights

2016 Hepatitis C Drug Pipeline HighlightsA lot happened in 2016 within the hepatitis C drug pipeline. Some treatments sought approval to be used in Canada and other treatments sought to be listed on PharmaCare’s formulary. The following highlights just some of their 2016 milestones:

2016 Hepatitis C Drug Pipeline Highlights

January
February
March
April
May
June
July
August

October

December

Have we missed any events in our list of 2016 hepatitis C drug pipeline highlights that you feel should be included? Send us an email and we may update this post.

Our Top 2016 Hepatitis C Treatment Posts as Clicked by You

Our top 2016 hepatitis C treatment posts as clicked by you are as follows:

Our Top 2016 Hepatitis C Treatment Posts as Clicked by YouThe Top 5 Blog Posts Read in 2016

The Top 5 Facebook Posts that Received the Most Reactions/Clicks in 2016

The Subjects of the Top 5 Tweets Posted in 2016

The Top Email Subjects Received by the Hepatitis C Treatment Information Project in 2016

  • I am thinking about starting treatment and am wondering if you can answer the following questions?
  • I am thinking about starting treatment and am wondering about BC PharmaCare’s liver fibrosis stage F2 or greater treatment eligibility cut off.

May 2017 be a year just as full of exciting hep C headlines and developments as 2016 was. Happy New Year from all of us at the Pacific Hepatitis C Network!

The Pacific Hepatitis C Network‘s News in Review Newsletter

The Pacific Hepatitis C Network‘s News in Review NewsletterWelcome to the Pacific Hepatitis C Network (PHCN)‘s very first hepatitis C news in review newsletter. This is where we review all of the major issues and events around hepatitis C and hep C treatments. It is an email that includes links to all of our recent blog posts—including the blog post about the big news surrounding the hep C treatment Epclusa (generic name: sofosbuvir/velpatasvir).

EPCLUSA RECOMMENDED BY CADTH

Epclusa (generic name: sofosbuvir/velpatasvir), developed by Gilead Sciences Canada, Inc., just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation. Click here to read more about their recommendation sent to the provinces and territories to help them decide on whether or not to cover the treatment and how to cover it.

HEPATITIS C ADVOCACY HIGHLIGHTS

In October, Daryl Luster wrote two blog posts for the Pacific Hepatitis C Network. Daryl is a hep C advocate who is PHCN’s president, a member of the Executive Steering Committee for Action Hepatitis Canada (AHC), a counselor for the Help-4-Hep helpline, and the administrator of multiple peer support groups. In 2010, Daryl was cured of hep C while participating in a clinical trial. The two blog posts he wrote were:

DAAs: Long Term Effects
AHC BC Regional Meeting: October 18-19

HEP C ABSTRACT HIGHLIGHTS TO BE PRESENTED AT THE LIVER MEETING 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held in a week. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

To celebrate the meeting and all of the amazing discoveries that will be presented, the Hepatitis C Treatment Information Project wrote the following blog posts summarizing and highlighting some of what will be presented about hep C treatments:

The Liver Meeting 2016 Hep C Abstract Highlights (Part1)
The Liver Meeting 2016 Hep C Abstract Highlights (Part2)
Live Stream Sessions from The Liver Meeting 2016

THE BASICS SERIES

The Basics Series by the Hepatitis C Treatment Information Project is a series of blog posts about the very basics about hep C and hep C treatments. So far, the series has five issues, entitled the following:

For more information about the topics in this newsletter, please click on the links, visit PHCN’s Hepatitis C Treatment Information Project, or email us.

Epclusa Recommended by CADTH Canadian Drug Expert Committee If

Epclusa Recommended by CADTH Canadian Drug Expert Committee IfEpclusa (generic name: sofosbuvir/velpatasvir), developed by Gilead Sciences Canada, Inc., just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) compares the drug’s clinical and cost-effectiveness to those of other treatments. This recommendations report is then sent to the provinces and territories to help them decide on coverage.

The Canadian Drug Expert Committee’s Final Recommendation Advocates for Epclusa to be Reimbursed as a Treatment for Chronic Hepatitis C if the Following Conditions are Met:
Criterion:
  • Treatment should be started by physicians experienced managing patients w chronic hep C.
Conditions:
  • Reduced price.
The Canadian Drug Expert Committee’s Reasons for their Epclusa Recommendations
  1. Very good SVR/cure rates seen for all genotypes and among treatment-naive and patients who have already, unsuccessfully, tried treatment. The ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4 clinical trials showed that treatment with Epclusa achieved high rates of SVR12 (cure at 12 weeks) for all types of hep C patients, including those who have been considered hard to treat.
  2. “There is insufficient evidence that the new treatment is superior
    to the least costly alternative.”
  3. “The true incremental cost-effectiveness of SOF/VEL versus other interferon (IFN)-free regimens is uncertain in the various patient populations considered.”
Other Noted Discussion Points
  • “The drug plan cost of treatment with the drug under review should not exceed the drug plan cost of treatment with the least costly alternative interferon-free option.”
Reported Research Gaps

Research should look into the following as a high priority:

  • Patients who were activity using drugs and co-infected with HIV or hepatitis B were excluded from the trials submitted to this review.
  • Resistance-associated variants (RAVs) should be examined more as they may influence future coverage criteria.

Epclusa

Epclusa (generic name sofosbuvir / velpatasvir) is the first pan-genotypic hepatitis C treatment, treatment for all 6 hep C virus types, to be approved for use in Canada against all 6 hep C virus types.

Epclusa is made up of 2 direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir is a nucleotide NS5B polymerase inhibitor that directly targets the hep C virus to stop it from making copies of itself in the liver. They attach themselves onto the genetic information, called RNA, to block the virus from multiplying.  Velpatasvir is a NS5A inhibitor that blocks a virus protein, NS5A, that the virus needs for reproducing and various stages of infection.

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

“We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history.” ~Dr. Jordan Feld

Pan-Genotypic Hepatitis C Treatments: The Basics

Pan-Genotypic Hepatitis C Treatments: The BasicsHepatitis C Genotypes

Based on its genetic (RNA) makeup, the hepatitis C virus has different types/variations/strains. These types are referred to as genotypes.

There are six common hep C genotypes, with several different subtypes, identified throughout the world. The most common hep C genotype in Canada is known as the hepatitis C virus genotype 1 (HCV GT1 or just GT1).

A person can become infected with more than one of these genotypes, so prevention (following the basic rules for staying healthy) and harm reduction are always important. Knowing one’s hep C genotype is also important as it affects the type of treatment prescribed, the treatment’s duration, and the treatment’s success.

Hepatitis C Genotypes and Hep C Treatment

The type of hep C infection one has doesn’t determine how bad their hep C symptoms may be. For example, having genotype 1 hep C doesn’t mean that a person will experience less hep C symptoms than someone with genotype 2 hep C. However, hep C genotypes do effect a treatment’s possible success and its side effects. Therefore, each hep C genotype has its own treatments and set of treatment lengths that work best against it.

Pan-Genotypic Hepatitis C Treatments

However, there are now pan-genotypic hep C treatments in the Canadian approval process that are able to treat all virus genotypes. These new treatments are important as they have the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explained, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

Possible Pan-Genotypic Hepatitis C Treatments in Development or the Approval Process

Treatments*
Epclusa (sofosbuvir / velpatasvir)
Glecaprevir / Pibrentasvir
Sofosbuvir / Velpatasvir + Voxilaprevir
AL-335 + Odalasvir (ACHN-3102) + Simeprevir
*An additional name for the drug glecaprevir is ABT-493. An additional name for pibrentasvir is ABT-530. An additional name for voxilaprevir is GS-9857. Epclusa is the only one so far to be approved for use in Canada.

Interesting Online Articles and Resources