Tag Archives: Velpatasvir

New Drug Application Submitted for Sofosbuvir/Velpatasvir/Voxilaprevir

New Drug Application Submitted to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir~ A New Drug Application has been submitted to the FDA. If Approved, Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Would Be the First Once-Daily Single Tablet Regimen Available as a Treatment Resorted to when Preferred Therapies have been Tried, or a Salvage Treatment,  for Patients with Hep C Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors ~

The creator of the hepatitis C treatment SOF/VEL/VOX, Gilead, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the hep C treatment. SOF/VEL/VOX has been submitted as an once-daily single pill regimen for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients.

The Data Submitted in the New Drug Application (NDA)

The data submitted in the NDA, see below, supports the use of the regimen for 12 weeks in DAA treatment experienced patients with genotype 1 to 6 hep C who have or don’t have liver cirrhosis.

Clinical Trial Patients Genotype Duration Treatment SVR12
POLARIS-1 455 patients, including those who failed prior treatment with an NS5A-containing regimen, 41 percent (172/415) had cirrhosis 1-6 12 weeks SOF/VEL/VOX 96%
Placebo 0%
POLARIS-4 DAA-experienced (No NS5A inhibitor), 46 percent (153/333) had cirrhosis 1-4 12 weeks SOF/VEL/VOX 97%
SOF/VEL 90%
POLARIS-2 DAA-naive, 18 percent (174/941) had cirrhosis 1-6 8 weeks SOF/VEL/VOX 95%
12 weeks SOF/VEL 98%
POLARIS-3 DAA-naive, All had cirrhosis 3 8 weeks SOF/VEL/VOX 96%
12 weeks SOF/VEL 96%

Patients treated with SOF/VEL/VOX for 12 or 8 weeks experienced side effects similar to those treated with placebos. The most common side effects from SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

No news on or how the treatment may be submitted to Health Canada.

More Information

“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead.

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

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.

Is Epclusa soon-to-be considered for BC PharmaCare coverage?

Epclusa soon-to-be considered for BC PharmaCare coverage?YES. The Hepatitis C Treatment Information Project just received an advance notification from BC’s Ministry of Health that the hepatitis C treatment Epclusa (generic name sofosbuvir / velpatasvir) will soon be considered for BC PharmaCare coverage.

Wednesday August 24, 2016 to MIDNIGHT ON Wednesday September 21, 2016 is tentatively when input will be sought.

Submitting Input to BC PharmaCare about Hepatitis C Treatments and Epclusa

The BC PharmaCare approval process seeks input from patients and caregivers or loved ones of those who have or have had hepatitis C. If you are a BC resident and answer YES to any of the following questions, you can complete a questionnaire and send BC PharmaCare your input into whether or not they should cover Epclusa:

  1. Do you have hep C?
  2. Are you a caregiver to someone who has hep C?
  3. Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input? (Learn more about registering your organization).

Please note that PharmaCare’s questionnaire for Epclusa input wont tentatively be available for another two weeks. The Hepatitis C Treatment Information Project will send the questionnaire’s link out when BC PharmaCare makes it available.

Epclusa

Epclusa is the first pan-genotypic hepatitis C treatment to be approved for use in Canada against all six hep C virus types. 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.

More Information about Epclusa

For more information, please contact Your Voice or the Hepatitis C Treatment Information Project.

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.

Global and CTV News Report that Health Canada has Approved Epclusa

Global and CTV News Reports Health Canada Approved EpclusaGlobal News and CTV News are reporting that Health Canada has approved the hepatitis C treatment sofosbuvir / velpatasvir (American brand name Epclusa) for use in Canada. If this news is correct, Health Canada has just approved the first hep C treatment that can cure all 6 hep C virus types with high success rates!

A treatment able to cure all virus types 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, explains, 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)

News Reports Remain Unverified

The Hepatitis C Treatment Information Project tried to double check that this treatment has indeed been approved, and approved as the articles have said. However, we were unable to reach Gilead, the treatment’s developer, and Health Canada before this blog post was published. This failure to reach the two parties was probably because it was early evening in BC and so passed business hours in the East when this post was written.

We will follow this story and share additional information as it becomes available.

Sofosbuvir / Velpatasvir

Description: Sofosbuvir / velpatasvir is a short-course, interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day.

Treatment Lengths Approved in America:

  • 12 weeks for patients without liver cirrhosis and patients with compensated liver cirrhosis (Child-Pugh A)
  • 12 weeks for patients with more serious  liver cirrhosis (Child-Pugh B or C) when it is combined with ribavirin.

Most Common Side Effects when Treatment is Taken Without Ribavirin:

  • Headache
  • Fatigue (Tiredness)

Most Common Side Effects when Treatment is Taken With Ribavirin:

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

Clinical Trial Results for Sofosbuvir / Velpatasvir

In Phase III clinical trials, the treatment’s safety and effectiveness as a 12 week treatment was evaluated on 1,558 patients without liver cirrhosis or with mild cirrhosis. With or without ribavirin, it cured 95–99% of those patients. In trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

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

U.S. FDA Approved Epclusa (Sofosbuvir/Velpatasvir)

U.S. FDA Approved Epclusa (Sofosbuvir/Velpatasvir)Epclusa (sofosbuvir / velpatasvir), the first hepatitis C treatment able to cure six types of the hep C virus with high success rates against all of the six types, has been approved for use in America for all of those six types!

The hep C treatment sofosbuvir / velpatasvir (American brand name Epclusa) was approved by the U.S. Food and Drug Administration (FDA) yesterday. It was approved for the treatment of adult patients with a chronic hepatitis C virus infection, genotype 1, 2, 3, 4, 5, or 6. This approval means that it can be prescribed to those with or without liver cirrhosis and can be prescribed with or without the drug ribavirin (prescribed with ribavirin for patients with liver cirrhosis, Child-Pugh B or C).

Yesterday’s Press Releases about Sofosbuvir / Velpatasvir’s FDA Approval

Sofosbuvir / Velpatasvir (American Brand Name Epclusa)

Description: Sofosbuvir / velpatasvir is a short-course hep C interferon-free treatment that can be prescribed with or without ribavirin. It is a pill taken once a day.

It is the first once daily pill treatment for patients with hep C genotype 2 and 3, without the need for ribavirin.

Approved for in the States: Epclusa taken for 12 weeks was approved in patients without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with more serious  liver cirrhosis (Child-Pugh B or C).

Common Side Effects: The most common side effects of sofosbuvir / velpatasvir are headache and fatigue. However, If it is combined with ribavirin, patients may experience side effects from the ribavirin.

Sofosbuvir / Velpatasvir in Canada

Sofosbuvir / velpatasvir isn’t approved for use in Canada yet.

Clinical Trial Results for Sofosbuvir / Velpatasvir

In Phase III clinical trials, the treatment’s safety and effectiveness as a 12 week treatment was evaluated on 1,558 patients without liver cirrhosis or with mild cirrhosis. With or without ribavirin, it cured 95–99% of those patients. In trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

“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.