2017 Hepatitis C Treatment News

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Feb 2017 Hepatitis C Drug Coverage to be Expanded

February 2017
The pan-Canadian Pharmaceutical Alliance (pCPA) has negotiated price adjustments that will result in expanded drug coverage to those affected by hepatitis C.

The pCPA negotiated with Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada for reduced costs on the following drugs:

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

For British Columbia this means that starting March 21 2017, physicians can apply for new drugs. Then, starting 2018-2019, BC PharmaCare will provide drug coverage for people in BC living with chronic hepatitis C, regardless of the extent of liver damage.

Stay tuned for more information of hepatitis C drug coverage across Canada.

For more information, visit: BC Government News

 

2016 Hepatitis C Treatment News

Sept 2016 EASL updated hepatitis C treatment recommendations

September 2016

The European Association for the Study of the Liver updated their hepatitis C treatment recommendations in September.
[EASL Summary of Recommendations]

Jul-14 Pan-genotypic hepatitis C anti-viral medication, Epclusa, approved in Canada

Jul 14, 2016

Health Canada has issued a Notice of Compliance to Gilead Sciences Canada, Inc. (Gilead Canada) for EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg). EPCLUSA is a once-daily, pan-genotypic single tablet 12 week regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection for use in patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin for patients with decompensated cirrhosis.  It is the first single tablet regimen without the need for ribavirin approved for the treatment of patients with HCV genotype 2 and 3.

For more information, see:
Gilead Epclusa press release Jul 14, 2016

2016 Updated Canadian HIV/Hepatitis C Adult Guidelines for Management and Treatment

Jul 7, 2016

The standing working group convened by The Canadian Institute of Health Research HIV Trials Network to review recently published HCV antiviral data has updated Canadian HIV-HCV Coinfection Guidelines. Recommendations include that all coinfected individuals should be assessed for interferon-free, Direct Acting Antiviral HCV therapy.

For more information, see:
2016 Updated Canadian HIV/Hepatitis C Adult Guidelines for Management and Treatment

Updated: AASLD HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C

Jul 7, 2016

AASLD updated the HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. The update reflects several important developments, including the recent approval of sofosbuvir/velpatasvir, together with new information regarding the use of testing for HCV resistance associated variants.

For more information, see:
AASLD Update HCV Guidance Jul 6, 2016

All-oral pan-genotypic treatment for hepatitis C approved in U.S.

June 29, 2016

The U.S. Food and Drug Administration has approved Epclusa (sofosbuvir and velpatasvir) to treat those with hepatitis C (HCV) genotypes 1-6, with or without cirrhosis (Epclusa + Ribavirin for those with decompensated cirrhosis). In clinical trials, cure rates were:

  • 98% for 3 clinical trials (1,015 of 1,035 patients cleared the virus)
  • 94% for those with decompensated cirrhosis (Epclusa + Ribavirin for 12 weeks)
  • 83% for those with decompensated cirrhosis (Epclusa alone for 12 weeks)

 

For more information, see:
Gilead Epclusa Press Release (June 28, 2016)
FDA Epclusa News Release (June 28, 2016)

New Hepatitis C Care and Treatment Guidelines from WHO

April 15, 2016

The World Health Organization (WHO) released "Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection" (April 2016).

The new guidelines include recommendations about screening, prevention, care and treatment. It also presents global prevalence estimates, the natural history of hepatitis C and summaries of treatment studies.

For the PDF report see WHO: Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection.

Health Canada Safety Review for Simeprevir

February 17, 2016
Health Canada has reported receiving 11 Canadian reports of severe liver problems, and two deaths, that MAY be associated with simeprevir (Galexos). A confirmed link between simeprevir and liver problems has not been made due to limited information, but the manufacturer recommends health care providers:

  • Check for liver function before and during treatment
  • Should not use simeprevir with patients that have moderate or severe liver damage

For more details see Health Canada’s Summary Safety Review for simeprevir.

Zepatier approved by Health Canada

January 25, 2016

Health Canada recently approved Zepatier (elbasvir + grazoprevir). This all-oral, interferon-free treatment is for people over the age of 18 years living with hepatitis C genotype 1, 3, or 4 and has overall cure rates of 92-97%.

Depending on a person’s genotype, treatment history, liver health (e.g., presence of cirrhosis), treatment with Zepatier can range from 8 to 16 weeks and it may be given:

  • without ribavirin
  • with ribavirin, or
  • with sofosbuvir

Very common side-effects (occurring in more than 10% of those treated) include headache and feeling tired. See patient information page for a detailed list of common side-effects (occurring in 1 to 10% of those treated).

Click here for manufacturer’s patient information page.
Click here for more manufacturer’s product monograph.

2015 Treatment News

Daclatasvir/Sofosbuvir/Ribavirin - Cure rates as high as 89% for GT-3 Cirrhotic

December 2, 2015
Results from the Phase 3 Ally-3+ trial results were presented at AASLD in mid-November. For patients with cirrhosis who were treated with daclatasvir (Daklinza), sofosbuvir and ribavirin for 16 weeks, SVR rates were 89% (83% for those treated for 12 weeks). SVR rates were 100% for those with F3 fibrosis scores (12 or 16 weeks of treatment).

Common side-effects included  insomnia (30%), fatigue (26%) and headache (24%)*.

Daclatasvir was approved by Health Canada August 13, 2015 for the treatment of hepatitis C.

For more detailed information, see:

Gilead U.S. application for pangenotypic HCV treatment

October 28, 2015
Gilead announced it has submitted a drug application to the U.S. Food and Drug Administration for a hepatitis C treatment regime for six genotypes of hepatitis C.

The new treatment:

  • is all oral
  • contains sofosbuvir and velpatasvir
  • is for patients with HCV genotypes 1-6
  • is expected to be 12 weeks in duration
  • can be for patients with decompensated cirrhosis (with ribavirin)

Click here for Gilead's news release.

Harvoni Coverage in Canada Update

August 27, 2015

Harvoni, an highly effective and well-tolerated therapy for the treatment of hepatitis C,  is now listed on almost all provincial/territorial formularies:

Getting treatment can take time as several steps are involved (e.g., knowing one's hepatitis C genotype, having appointments with providers and/or specialists, having an assessment for the extent of liver damage).

For table summaries of hepatitis C treatment recommendations by the Canadian Association for the Study of the Liver (CASL 2015) click here.

July 28, 2015

BC Pharmacare now covers HOLKIRA PAK (ombitasvir, paritaprevir, ritonavir and dasabuvir) for hepatitis C treatment (genotype 1)

The British Columbia government announced today that HOLKIRA PAK (ombitasvir, paritaprevir, ritonavir and dasabuvir) will be covered by BC Pharmacare. People with hepatitis C genotype 1 can now apply for coverage. Cure rates are reported to be over 90%.

For more information, see

July 25, 2015

FDA approves TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) for the treatment of patients with genotype 4 chronic hepatitis C

The U.S. Food and Drug Administration (FDA) approved TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with historically difficult to treat GT4 chronic HCV infection.

This treatment for GT4 has reported cure rates of 100% at 12 weeks post-treatment in patients without cirrhosis who took TECHNIVIE with ribavirin (RBV) for 12 weeks.

For more detailed information, see manufacturer information:

July 24, 2015

FDA approves Daklinza (daclatasvir) for the treatment of patients with hepatitis C genotype 3

Daklinza, in combination with sofosbuvir, is the first 12-week, all-oral therapy that offers SVR12 for most genotype 3 patients. Hepatitis C genotype 3 is one of the most difficult-to-treat genotypes. This is the first approval of Daklinza in the United States (See Bristol-Myers Squibb Company press release).

Reported SVR12 for the Daklinza plus sofosbuvir regimen was 90% for treatment-naïve and 86% for treatment-experienced chronic HCV genotype 3 patients. SVR12 rates were higher (96%) in genotype 3 patients without cirrhosis, regardless of treatment history. In the more difficult-to-treat patients with cirrhosis, SVR12 rates were reduced (63%). These SVR12 rates were achieved with 12 weeks of therapy without the use of ribavirin.

For more detailed information, see manufacturer information:

July 24, 2015

Holkira Pak is now available in Quebec

In addition to Prince Edward Island and Ontario, Holkira Pak (ombitasvir/paritaprevir/ritonavir tablets and dasabuvir tablets) is now available in Quebec (See Régie de l'assurance maladie du Québec).

This interferon-free treatment for hepatitis C genotype 1 has reported cure rates of over 95%. Duration of treatment ranges from 12 to 24 weeks.

To compare Holkira Pak with other hepatitis C genotype 1 treatments, see CASL Recommended HCV Treatment Genotype 1.

For a summary of Holkira Pak contents and use, see CATIE Holkira Pak Fact Sheet.

For more detailed information, see manufacturer information for:

June 30, 2015

Holkira Pak is now available in Ontario

In addition to Prince Edward Island, Holkira Pak (ombitasvir/paritaprevir/ritonavir tablets and dasabuvir tablets) is now available in Ontario (See Ontario Exceptional Access Program (EAP)).

This interferon-free treatment for hepatitis C genotype 1 has reported cure rates of over 95%. Duration of treatment ranges from 12 to 24 weeks.

To compare Holkira Pak with other hepatitis C genotype 1 treatments, see CASL Recommended HCV Treatment Genotype 1.

For a summary of Holkira Pak contents and use, see CATIE Holkira Pak Fact Sheet.

For more detailed information, see manufacturer information for:

June 10, 2015

British Columbia announces new recommendations for HCV viral load testing and genotyping

The British Columbia Centre for Disease Control (BCCDC) has announced new HCV viral load testing and genotyping recommendations when treating with Sofosbuvir (Sovaldi) and Ledipasvir-Sofosbuvir (Harvoni).

 

Highlights include:

  • Recommended schedule for HCV viral load testing
  • No benefit to week 4 or week 12 viral load testing
  • Repeat genotyping before treatment for:
    • treatment naïve geno 1 patients with genotyping performed before May 2012 (for Ledipasvir-Sofosbuvir treatment)
    • all treatment experienced patients if re-infection is a consideration (for all treatment regimes)

     

    For full details and schedules see Hepatitis C Virus (HCV) Viral Load Testing and Genotyping (BCCDC June 9th, 2015)

April 27, 2015

Bristol-Myers Squibb announces acceptance of new drug application for investigational daclatasvir for FDA review for the treatment of hepatitis C genotype 3

On March 12, 2015 Bristol-Myers Squibb (BMS) announced that the resubmitted new drug application for daclatasvir, has been accepted for review by the U.S. Food and Drug Administration (FDA) for use in combination with sofosbuvir for the treatment of chronic hepatitis C genotype 3. [see BMS news]

April 27, 2015

Grazoprevir / Elbasvir highly effective in previously untreated hepatitis C

On friday April 24, 2015 at the Interntaional Liver Congress in Vienna, Austria, results of the C-EDGE trial were presented that showed a 12-week course of the combination of grazoprevir and elbasvir cured 95% of previously untreated people with genotypes 1, 4 or 6 hepatitis C virus. [see: New and Experimental Hepatitis C Treatment]

EASL Recommendations on Treatment of Hepatitis C 2015

April 27, 2015

The European Association for the Study of the Liver (EASL) released recommendations on Treatment of Hepatitis C  at the International Liver Congress. These recommendations outline optimal management for patients with acute and chronic HCV infections.

Update on Harvoni availability in Canada

April 22, 2015

Harvoni, an highly effective and well-tolerated drug with cure rates of over 90%, is now available in the following provinces/territories*:

Quebec is not formally part of the pCPA discussions, but negotiations are in progress. The following territories will list according to the Non-Insured Health Benefits (NIHB) formulary (to be updated soon)**:

  • Northwest Territories
  • Nunavut

Getting treatment can take time as several steps are involved (e.g., knowing one's hepatitis C genotype, having appointments with providers and/or specialists, assessment for extent of liver damage).

Negotiations with the drug company that manufactures Harvoni were done through the Pan-Canadian Pharmaceutical Alliance (pCPA).

*Listing criteria not yet available online for all provinces/territories
**Source Canadian Liver Foundation (CLF), March 25, 2015, Personal Communication.
Also see CLF News Release.

WARNING: Harvoni or Sovaldi + DAA NOT to be combined with amiodarone

March 30, 2015

HEALTH WARNING: Very serious slowing of the heart rate "can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection" (U.S. Food and Drug Administration safety alert, March 24, 2015.) [click on FDA reference for more details]

Harvoni availability across much of Canada!*

March 25, 2015

Across much of Canada, Harvoni (ledipasvir/sofosbuvir) is, or will soon be, available for the treatment of people with :

  • hepatitis C genotype 1
  • specific treatment histories,  and
  • a minimum level of liver damage (e.g., fibrosis stage 2 or higher; may vary by province/territory)

Harvoni is a highly effective and well-tolerated drug with cure rates of over 90% and treatment durations of up to 24 weeks. Negotiations with the drug company that manufactures Harvoni were done through the Pan-Canadian Pharmaceutical Alliance (pCPA).

However, the public needs to be aware that getting treatment can take time as several steps are involved (e.g., knowing one's hepatitis C genotype, having appointments with providers and/or specialists, assessment for extent of liver damage).

Harvoni availability dates by Province/Territory (note: listing criteria not yet available online for all provinces/territories)

The following territories will list according to the Non-Insured Health Benefits (NIHB) formulary (to be updated soon):

  • Northwest Territories
  • Nunavut

The following provinces are part of the pCPA and discussions, and negotiations are in progress. Decisions are expected soon in most cases.

  • Alberta
  • Saskatchewan
  • Nova Scotia
  • Newfoundland
  • Prince Edward Island

Quebec is not formally part of the pCPA discussions, but negotiations are in progress.

*Source Canadian Liver Foundation (CLF), March 25, 2015, Personal Communication.
Also see CLF News Release.

A cure for hepatitis C now in reach for many Canadians!

March 24, 2015

Many provinces and territories now cover (or will soon) Harvoni and Sovaldi for the treatment of people with certain hepatitis C genotypes and treatment histories. PEI will also cover Holkira Pak. These highly effective and well-tolerated* medications are now accessible to many Canadians.

The provincial/territorial status for coverage for Harvoni (for the treatment of those with genotype 1) is as follows:

*Sovaldi and Holkira Pak may be used in combination with ribavirin or interferon in some cases (e.g., certain genotypes, treatment history). In these cases, side-effects may be more pronounced.

For more information, also see:

Sovaldi and Harvoni now available through BC PharmaCare!

March 24, 2015

As of today, BC PharmaCare will cover two new drugs for the treatment of hepatitis C: Harvoni (genotype 1) and Sovaldi (genotypes 1, 2 3).

Eligibility for coverage depends on meeting certain criteria, such as:

  • No previous treatment for hepatitis C, or
  • Failed treatment with older drugs

"This begins the path to eliminate hepatitis C in British Columbia", says Dr. Mel Krajden, medical head, hepatitis, BC Centre for Disease Control (source: BC Ministry of Health, News Release)
For more details see:

CASL has released new chronic HCV management recommendations!

February 6, 2015

The Canadian Association for the Study of the Liver (CASL) has released new guidelines for the management of chronic hepatitis C.Recommendations were published in the January/February 2015 volume of the Canadian Journal of Gastroenterology and Hepatology.

The guidelines include:

  • Routine testing of patients with chronic hepatitis C (HCV)
  • When peginterferon and ribavirin should not be used in treatment (contraindications)
  • Treatment recommendations with newly approved antiviral agents, interferon-free alternatives, and interferon-containing alternatives for patients:

- with HCV genotypes 1 thru 6
- that are treatment naive or experienced, and
- whose liver is cirrhotic or noncirrhotic

 

Harvoni and HOLKIRA PAK approved by Health Canada

January 16, 2015

Health Canada recently approved Harvoni (ledipasvir + sofosbuvir) and HOLKIRA Pak (ombitasvir/paritaprevir/ritonavi/dasabuvir). Both are all-oral, short-course, interferon-free treatments for people over the age of 18 with the genotype 1 hepatitis C virus, including those with cirrhosis. Cure rates for both treatments are more than 90%.

Common side effects for both treatments (without ribavirin): Headache and Fatigue

Click here for more information on Harvoni
Click here for more information on HOLKIRA PAK.
Click here for health care provider treatment resources (University of Washington)

2014 Treatment News

BC PharmaCare approves SIMEPREVIR

Oct 31, 2014

BC Pharmacare approves SIMEPREVIR for the treatment of hepatitis C. For more details visit BC PharmaCare Formulary and type "Simeprevir" in the "Generic/brandname" box.

Health Canada approves Harvoni

Oct 16, 2014

Health Canada Issues Notice of Compliance for Harvoni™ (Ledispasvir/Sofosbuvir) for the Treatment of genotype 1 chronic hepatitis C.

European Medicines Agency approves Sovaldi

Sept 26, 2014

European Medicines Agency (EMA) approves Sovaldi for the treatment of chronic hepatitis C.


Treatment Related Resources


Treatment Options

Patient treatment interactive Patients enter three facts to see their personal CASL and AASLD recommended options. Last update June 2016.


PDF: CASL Hepatitis C Treatment Recommendations

CASL Rx Recommendations for Genotype 1

Click image for genotypes 1 to 6
(French and English versions)


Video: Getting ready for hepatitis C treatment

Web Video - Guide Getting Ready EnglishAn 11 minute video designed to help people get ready for hepatitis C treatment.


Booklet: Getting ready for hepatitis C treatment

Web Resource - Getting ready coverA companion to the video, this booklet helps you to keep track of what you need to do to get ready for hepatitis C treatment (12 pages).


Video: Unmet Needs - Hepatitis C Stories

Resources - Bordered - English- Unmet NeedsThis 31-minute documentary style video includes patient and provider views on hepatitis C care and treatment.