Tag Archives: sofosbuvir/velpatasvir

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

Have you been treated for hepatitis C? If so, your input is requested.

Have you been treated for hepatitis C? If so, your input is requested.If you have been treated for hepatitis C, please click here and answer a few very quick and easy questions about your treatment experience.

This survey will close September 9th, 2016.

Epclusa (generic name sofosbuvir / velpatasvir) is being considered for BC PharmaCare coverage. One of the questions BC PharmaCare asks patient groups is:

“What drugs or other treatments have the patients in your group used, or are currently using, for the condition or disease for which this drug is used? Please list all of the treatments used and tell us about the experience of the patients in your group with each treatment.”

In hopes of answering this question well, the Pacific Hepatitis C Network has put together a very quick and easy survey for those of you who have taken treatment for hepatitis C, any treatment for hep C. Please consider completing our survey.

Please Note: 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 BC PharmaCare. By completing the survey you accept that the Pacific Hepatitis C Network can use the information gathered by it in our patient group input report for BC PharmaCare.

Please email the Hepatitis C Treatment Information Project with any comments or concerns you have about Epclusa, the drug approval process, or about this survey.

Epclusa is under review. Send a message to BC PharmaCare.

Epclusa is under review. Send a message to BC PharmaCare.BC PharmaCare Review Questionnaires for Epclusa (Once on the page, scroll down until you see a colourful table. Links to questionnaires for Epclusa input are at the very bottom of the page/colourful table.)

Epclusa (generic name sofosbuvir / velpatasvir) is being considered for BC PharmaCare coverage. As part of this process, hep C patients, caregivers, and patient groups in BC have the opportunity to share their opinions and perspectives about hepatitis C treatments and Epclusa with the decision makers.

If you are interested in grabbing this opportunity, the link above will take you to the questionnaires. The above link will also take you to BC PharmaCare’s Epclusa Information sheet and to information about BC PharmaCare’s approval process.

The questionnaires will ONLY remain open until Wednesday, September 21, AT MIDNIGHT

Adding Your Voice to the BC PharmaCare Coverage Review for Epclusa

If you answer yes to any of the following questions, you are encouraged to give your input:

Epclusa

Epclusa is the first pan-genotypic hepatitis C treatment* to be approved for use in Canada against all six hep C virus types. It is a short-course (12 weeks), interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day. With or without ribavirin, it cured 83-98% of patients in clinical trials, and cured 94% of those with moderate to severe liver cirrhosis.

The Importance of Epclusa

Epclusa, the first hep C pan-genotypic treatment, is important as it has 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)

Also, Epclusa is the first treatment for patients with a hep C genotype 2 or 3 infection that doesn’t need ribavirin to achieve best treatment results.

More Information about Epclusa

For even more information, please contact BC PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

Take the time to voice your opinion and help advocate for a better tomorrow!

*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

Epclusa: An Information Sheet for an Approved Treatment

Epclusa: An Information SheetEpclusa (generic name sofosbuvir / velpatasvir) is the first pan-genotypic hepatitis C treatment* to be approved for use in Canada against all six hep C virus types! In celebration, the Hepatitis C Treatment Information Project has put together the following Epclusa information sheet.

Epclusa (PDF)

Treatment Description: Epclusa is a short-course, interferon-free, hepatitis C treatment. It is one pill taken once a day and can be prescribed with or without ribavirin.

Targeted Genotypes1-6

Doses and Treatment Lengths:

  • 12 weeks of the once-daily pill Epclusa for patients without liver cirrhosis and patients with compensated liver cirrhosis
  • 12 weeks of the once-daily pill Epclusa and ribavirin for patients with more serious liver cirrhosis

Possible Side Effects when Taken Without Ribavirin:

  • Headache
  • Fatigue (Tiredness)

Possible Side Effects when Taken With Ribavirin:

Fatigue (Tiredness) Anemia Nausea Headache
Insomnia (Can’t sleep) Diarrhea

Usage Warning: Patients with Bradycardia taking amiodarone can not take Epclusa. There have been reports of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart). Don’t take rifampin, St. John’s wort, or carbamazepine while taking Epclusa.

Clinical Trial Results for Epclusa

Clinical Trial Patients Treatment Regimen SVR
ASTRAL-1, ASTRAL-2, ASTRAL-3 1,035 with hep C genotypes 1-6 with or without cirrhosis (Child-Pugh A) EPCLUSA (12 weeks) 98%
ASTRAL-4 267 patients with genotype 1-6 hep C infection, with decompensated cirrhosis (Child-Pugh B) EPCLUSA with Ribavirin (12 weeks) 94%
EPCLUSA without Ribavirin (12 or 24 weeks) 83% or 86%

Momentum Support Program

Epclusa has been added to Gilead Canada’s Momentum Support Program. This support program provides information to patients and healthcare providers to help patients access Epclusa and Gilead’s other hepatitis C treatments. In Canada, please call 1-855-447-7977 for more information.

More Information

“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

*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

Epclusa: Approved treatment for all hep C types

Epclusa, the first hep C treatment for all virus types, is approved in CanadaEpclusa (generic name sofosbuvir / velpatasvir), the first pan-genotypic treatment*, has been approved for use in Canada against all six hep C virus types! Health Canada has issued Epclusa a Notice of Compliance!

The Importance of a Notice of Compliance (NOC)

Receiving a Notice of Compliance from Health Canada 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).

The Importance of Epclusa

Epclusa, the first hep C pan-genotypic treatment, is amazing as it has 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)

Also, Epclusa is the first treatment for patients with a hep C genotype 2 or 3 infection that doesn’t need ribavirin to achieve best treatment results.

Response by the Pacific Hepatitis C Network’s President, Daryl Luster

“The Pacific Hepatitis C Network is certainly pleased to hear that the first hepatitis C pan-genotypic, single pill, treatment has been approved for use in Canada.” said Daryl Luster, president of the Pacific Hepatitis C Network. “It is our hope that this approval signifies an end to interferon-based therapies. We also hope that this drug approval will lead to more people being able to access interferon-free treatment, regardless of their hep C genotype, treatment histories, or their access to local hepatitis C specialists.”

Epclusa

Epclusa is a short-course (12 weeks), interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day. With or without ribavirin, it cured 83-98% of patients in clinincal trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

Sofosbuvir/Velpatasvir CTAC Webinar

Sofosbuvir/Velpatasvir CTAC Patient Group Input WebinarThis Monday, May 2nd, from 11 AM to 12 PM (PDT/in BC) / 2 PM to 3 PM (EDT/in Ontario), the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the exciting new hep C treatment sofosbuvir/velpatasvir.

Following the webinar, there will be a survey to collect information that will help them write a patient input report for sofosbuvir/velpatasvir’s Common Drug Review. CTAC’s sofosbuvir/velpatasvir survey is different from PHCN’s patient input survey or PHCN’s loved ones/caregivers survey. Please consider filling out the still available 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 and for more information about the webinar.

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.

Patient Group Input Reports Requested by CADTH’s Common Drug Reviews

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then 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.

 Sofosbuvir/Velpatasvir

Sofosbuvir/velpatasvir is an all-pill, short-course (sometimes only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Take this survey. Sofosbuvir / Velpatasvir Input Requested.

The above survey links will only remain open until April 27th, 2016, so please complete a survey and share the survey links with others ASAP.

The Drug Approval Process is Seeking Patient and Caregiver Input

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently reviewing the hep C treatment sofosbuvir / velpatasvir. As part of their review, they are seeking patient and caregiver input about hep C and hep C treatments from Canadian patient groups. Therefore, we, the Pacific Hep C Network (PHCN), are seeking your thoughts, opinions, and experiences for our patient group input report.

More information about CADTH and patient group reports is below.

PHCN’s Sofosbuvir / Velpatasvir 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 Sofosbuvir / Velpatasvir’ and Take this survey. Sofosbuvir / Velpatasvir Input Requested.‘Section 3 of 4: Your Experience with Sofosbuvir / Velpatasvir’, if you have been treated with sofosbuvir / velpatasvir. If you haven’t taken sofosbuvir / velpatasvir, 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 and 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 the sofosbuvir / velpatasvir 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 April 27th, so please complete a survey and share the survey links with others ASAP.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then 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 are a part of the drug review process!

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about sofosbuvir / velpatasvir.

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

Sofosbuvir / Velpatasvir is up for Review

Sofosbuvir / Velpatasvir is up for ReviewSofosbuvir / velpatasvir is up for review. This morning the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for sofosbuvir / velpatasvir. Sofosbuvir / velpatasvir is an all-pill, short-course, interferon-free treatment for those with chronic hepatitis C, genotype 1, 2, 4, 5, or 6.

Please keep your eyes open for a blog post with more information about sofosbuvir / velpatasvir and a link to PHCN’s patient input survey. They will be finalized and sent out in the next few days.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then 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 are a part of the drug review process!

Please email or visit the Hepatitis C Treatment Information Project for more information about sofosbuvir / velpatasvir or any other hep C treatment.

Sofosbuvir / Velpatasvir submitted for approval in the US

Sofosbuvir / VelpatasvirA New Drug Application for the combination hep C treatment sofosbuvir / velpatasvir (SOF/VEL) was submitted to the U.S. Food and Drug Administration (FDA) yesterday. It was assigned a Breakthrough Therapy designation, which is granted in America to investigational medications that may offer major advances in treatment over current treatment options.

Sofosbuvir / velpatasvir is a pill taken once a day. It is made up of the nucleotide NS5B polymerase inhibitor sofosbuvir, brandname Sovaldi, and velpatasvir, an investigational pan-genotypic NS5A inhibitor. The combination was submitted for approval as a treatment for hep C genotype 1-6 infections.

Sofosbuvir/Velpatasvir Clinical Trial Results
Clinical Trial Patients Treatment Regimen Treatment Duration SVR12
ASTRA-1, -2, -3 Genotypes 1-6, with or without cirrhosis SOF/VEL 12 weeks 98%
ASTRA-4 Genotypes 1-6 all with Child-Pugh class B (decompensated) cirrhosis SOF/VEL with ribavirin 12 weeks 94%
SOF/VEL 12 weeks 83%
24 weeks 86%

The most common side effects experienced during clinical trials were headache, fatigue, and nausea.

Sofosbuvir / velpatasvir is not approved for use in Canada.

More information can be found on the Hepatitis C Treatment Information Project or in Gilead’s News Release.