Tag Archives: hep c genotype 1

Sunvepra (asunaprevir) Approved in Canada

Sunvepra (asunaprevir) Approved in CanadaSunvepra (asunaprevir) has been approved as a hepatitis C treatment in Canada!* Health Canada granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C, genotype 1 or 4, in adult patients with compensated liver disease, including liver cirrhosis (liver scarring).

Health Canada has stated that Sunvepra is to be taken in combination with other hep C direct-acting antivirals/treatments. It has also stated that:

  • Treatment with Sunvepra should be initiated and monitored by a physician experienced in treating hep C.
  • Sunvepra must not be administered by itself.
  • Treatment length depends on the viral genotype and subtype.
  • Sunvepra has not been studied in treatment experienced patients who have tried to treat their hep C already with a treatment regimen that included Sunvepra or other hep C protease inhibitors.
  • Sunvepra should not be taken by those with moderate or severe hepatic impairment (Child-Pugh B or C, score 7 or greater) and by patients with decompensated liver disease.

For more information, please see Sunvepra’s product monograph, available through Health Canada, or Health Canada’s Summary Basis of Decision (SBD) document for Sunvepra.

What a Notice of Compliance (NOC) Means for Sunvepra (asunaprevir)

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 it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/cure) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

*Health Canada granted Sunvepra a Notice of Compliance (NOC) on March 9th, 2016. A CADTH Common Drug Review for Sunvepra began in 2015 and patient input was sent in by Canadian patient groups, including the Pacific Hepatitis C Network, for this review then. After the input was sent, the review was temporarily suspended as the manufacturer, Bristol Myers Squibb Canada Inc., requested time to provide additional information. This temporary suspension was lifted in early 2016.

Grazoprevir / Elbasvir CTAC Patient Input Group Webinar

CTAC Patient Input Group WebinarOn November 2 @ 11am PST / 1pm EST, the Canadian Treatment Action Council (CTAC) will be hosting a CTAC Patient Input Group Webinar about the exciting new hep C treatment grazoprevir / elbasvir.

The patient input survey that will follow CTAC’s grazoprevir / elbasvir webinar is different from PHCN’s patient input survey or PHCN’s loved ones / caregivers survey. Please consider filling out the PHCN survey that was created for you as well as CTAC’s survey.

Registration for the CTAC webinar is required to attend
. Click here to register or for more information about the webinar.

About the Canadian Treatment Action Council (CTAC)

CTAC is a Canadian non-governmental organization led by and for people living with HIV and HIV/HCV co-infection. Since 1996, they have been working to secure and ensure equitable, affordable, and timely access to treatment and care and support for people in Canada living with HIV and HIV/HCV co-infection.

Grazoprevir / Elbasvir Patient Input Surveys

Grazoprevir / Elbasvir Survey DotTake this survey if you are living with hep C/if you have had hep C.

Take this survey if you are a caregiver or loved one of someone who is living with hep C/had hep C.

Grazoprevir / elbasvir information is here.

The survey links will only remain open until November 4th so please complete a survey and share the survey links with others ASAP.

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently seeking patient input for grazoprevir / elbasvir and, therefore, the Pacific Hep C Network (PHCN) needs your thoughts, opinions, and experiences for our patient group input report.

PHCN’s Grazoprevir / Elbasvir Patient Input Surveys

There are two PHCN Input Surveys

The first survey was written for those with hep C or those who have had hep C. It includes 14 questions, some multiple choice, and is divided into 4 sections. The most important of these sections are ‘Section 2 of 4: Your Expectations of grazoprevir / elbasvir’ and ‘Section 3 of 4: Your Experience with grazoprevir / elbasvir’, if you have been treated with grazoprevir / elbasvir. If you haven’t taken grazoprevir / elbasvir, the survey lets you skip this section.

The second survey was written for loved ones or caregivers of those living with hep C/have had hep C. It includes 7 questions divided into 2 sections.

If the surveys don’t focus on something you would like to add, please use a textbox and include it as one of your answers. Some of the questions require answers but others were written to, hopefully, help you share your experiences or voice your opinion.

Survey responses are anonymous (we don’t know your name or other information about you). The information gathered will be used as part of a patient group input report for CADTH. By completing the survey you accept that PHCN can use the information gathered by it in our patient group input report for CADTH.

The survey links will only remain open until November 4th so please complete a survey and share the survey links with others ASAP.

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about grazoprevir / elbasvir.

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

Zepatier (grazoprevir / elbasvir) Facts

Zepatier (grazoprevir / elbasvir)*This Zepatier (grazoprevir / elbasvir) treatment facts sheet was updated January 21, 2016. It was originally put together in October 2015, while CADTH was seeking input for it from patient groups. This sheet is made up of Canadian treatment details. We will keep you updated as the treatment proceeds through the Canadian drug approval process.

Zepatier (grazoprevir / elbasvir)

Targeted Genotypes: 1, 3, 4

Treatment Description: Zepatier (grazoprevir / elbasvir) is made up of two direct-acting antivirals. Grazoprevir is a NS3/4A protease inhibitor. It works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. Elbasvir is a NS5A inhibitor. It blocks a virus protein, NS5A, that the virus needs to reproduce and for various stages of infection.

The treatment has been studied with ribavirin and Sovaldi (sofosbuvir) for multiple hep C genotypes and in patients with difficult-to-treat conditions, such as HIV/HCV co-infection and advanced chronic kidney disease.

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 90% – 98%

Daily Dose: 1 pill of Zepatier at the same time every day +/- Sovaldi +/- ribavirin
Zepatier can be taken with or without food.

Possible Length of Treatment:  8 – 16 weeks

Without Ribavirin:

Patients Weeks
With hep C genotype 1 or 4 who have never tried treatment or have tried treatment with peginterferon and ribavirin (PR) but relapsed 12
With hep C genotype 1 who has tried treatment with a protease inhibitor but relapsed 12
With hep C genotype 1b who has never tried treatment and doesn’t have liver cirrhosis 8
With hep C genotype 1b who has tried treatment with peginterferon or PR but experienced on-treatment virologic failures 12

With Ribavirin:

Patients Weeks
With hep C genotype 1a who has tried treatment with peginterferon (PI) or with peginterferon and ribavirin (PR) but experienced on-treatment virologic failures 16
With hep C genotype 4 who have tried treatment with PR but experienced on-treatment virologic failures 16

With Sovaldi:

Patients Weeks
With hep C genotype 3 who have never tried treatment 12

Availability:  Zepatier is approved for use in Canada

Common Side Effects Reported During Clinical Trials:

  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Trouble sleeping

If you experience any side effects listed or not listed here, contact your healthcare professional.

Usage Warning: Do not take Zepatier if you have moderate or severe liver problems (Child-Pugh B or C). Tell your doctor about any medication (over the counter, prescribed, or recreational) you are taking before taking Zepatier.

See our Sovaldi and ribavirin pages for more information about their possible side effects and usage warnings.

Co-infected with HIV:  Same dose and length of treatment required. Tell your doctor about any medication (over the counter or prescribed) you are taking before taking Zepatier.

More Information:

Sampling of Phase II/III Clinical Trials for Zepatier:

Clinical Trial Patients Treatment Regimen Duration in Weeks
SVR12*
C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients) GT 1, 4, 6 treatment naive with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80%
GT 1, 4, 6 HIV/HCV co-infected with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100%
GT 1, 4, 6 treatment- experienced with or without cirrhosis ZEPATIER +/- Ribavirin (RBV) 16 92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75%
97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100%
C-SALVAGE (looked at retreat duration)
GT 1, previously failed with PR + a DAA**, with or without cirrhosis ZEPATIER + RBV 12 96% (total)
94% (cirrhosis)
C-SURFER (still ongoing) GT 1, treatment-naïve and patients who failed pegylated interferon, with or without cirrhosis, chronic kidney disease stages 4 or 5 ZEPATIER 12 99%
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped.

**The direct antiviral agents listed were Incivek (telaprevir), Victrelis (boceprevir), and Galexos (simeprevir).

Grazoprevir/Elbasvir Announcement

Grazoprevir/elbasvirYesterday the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for the hep C treatment grazoprevir/elbasvir, developed by Merck.

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is a once-daily, single-pill hep C treatment made up of grazoprevir, a NS3/4A protease inhibitor, and elbasvir, a NS5A inhibitor. It is being tested on patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, or advanced liver cirrhosis or inherited blood disorder.

In April, the Food and Drug Administration (FDA) in America gave the treatment Breakthrough Therapy designation to treat patients with hep C genotype 1 with end stage renal disease on hemodialysis, and patients with hep C genotype 4 or 6. The Breakthrough Therapy designation helps fast-track treatments through the American drug approval process when they treat serious diseases and their clinical trial results show that the drug may be a large improvement over existing therapies.

In Canada, Health Canada is currently reviewing the treatment. It has not been approved for use yet.

Additional grazoprevir/elbasvir information can be found on the Hepatitis C Treatment Information Project’s Hep C Drug Pipeline Treatments and Clinical Trial Results pages.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.

They help ensure that patients and their loved ones can be a part of the drug review process!

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.