Tag Archives: sofosbuvir

Gilead Receives Health Canada Approval for VOSEVI™, the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment

Please note:  VOSEVI is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans).  VOSEVI is included in Gilead’s Momentum Patient Support Program (information, including contact information, is available below and here).

See the Hep C Treatment Diagram on the left hand side of this page (homepage has 2 versions) for a picture of Canada’s drug approval system and where hep C treatments are at in it.  VOSEVI is at Step 3 and will be progressing through the approval process.  That takes time.  VOSEVI will be added to the pipeline diagram the week of August 21 2017.  Please check back.

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Gilead Receives Approval in Canada for VOSEVI™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-treatment of Certain Patients with Chronic Hepatitis C Virus (HCV) Infection

VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments

MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ – Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor.  The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

“HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients.  However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option,” said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta.  “VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients.”

VOSEVI is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV infection, with the convenience associated with once-daily single-tablet regimens.  Since 2013, Gilead has brought to market four HCV treatments, including three single-tablet regimens. To date, more than an estimated 1.5 million patients worldwide have been prescribed sofosbuvir-based regimens.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said Kennet Brysting, General Manager, Gilead Canada. “The approval of VOSEVI in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030.”

The approval of VOSEVI is supported by Phase 3 data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 infection with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as Phase 3 data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3 or 4 infection with or without compensated cirrhosis who had failed prior treatment with a DAA-containing regimen that did not include an NS5A inhibitor.  In these populations across the two studies, 431 of the 445 patients treated with VOSEVI (97%) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (≥10 per cent of patients) among patients who received VOSEVI were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2 per cent for subjects who received VOSEVI for 12 weeks.

“As Canada moves forward with its World Health Organization commitment to eliminate hepatitis C by 2030, it is important for all patients to have the opportunity to access a cure, regardless if they are new to treatment, or they have failed a previous therapy,” said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital.  “Treatment should be an option for everyone, including to those still seeking a cure.  The CLF is pleased to see that additional effective therapies are available, and are becoming more accessible to all patients, regardless of where someone lives, or their ability to pay.”

Patient Support Program
To assist eligible HCV patients in Canada with access to VOSEVI, Gilead Canada has added VOSEVI to the Gilead Momentum Support Program™, which provides information to patients and healthcare providers to help facilitate patient access to medication.  For more information regarding the Momentum Support Program in Canada, please call 1-855-447-7977.

Important Safety Information
The VOSEVI Product Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX REGARDING THE RISKS OF HEPATITIS B VIRUS (HBV) REACTIVATION IN HCV/HBV CO-INFECTED PATIENTS.  For further details, please see the Canadian Product Monograph at www.gilead.ca.

Contraindications
VOSEVI is contraindicated with the following drugs products: dabigatran etexilate, phenobarbital, phenytoin, rifampin, rosuvastatin.  VOSEVI is also contraindicated with the herbal product, St. John’s wort.

Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with VOSEVI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Drug Interactions
Coadministration of VOSEVI is not recommended with carbamazepine, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, efavirenz, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir and/or voxilaprevir, and/or the other agent.

For additional important safety information for VOSEVI, including the complete warnings and precautions, adverse reactions and drug-drug interactions, please see the Canadian Product Monograph at www.gilead.ca.

About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases.  Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.  Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2006.

Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing VOSEVI for the treatment of adults with chronic HCV infection. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Canadian Product Monograph for VOSEVI, including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.gilead.ca.

VOSEVI is a trademark of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

SOURCE Gilead Sciences, Inc.

 

 

 

 

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

Three Hepatitis C Researchers Win 2016 Lasker~DeBakey Award

Three Hepatitis C Researchers Win 2016 Lasker~DeBakey AwardSince 1945, the New York-based Albert and Mary Lasker Foundation has worked to raise public support for medical research. The Albert and Mary Lasker Foundation has done this through recognizing and celebrating breakthroughs in medical research, public education, and advocacy. One of the ways the foundation celebrates the most important breakthroughs in these fields is to annually reward the very best with the Lasker~DeBakey Clinical Medical Research Award.

This year, the Lasker~DeBakey Clinical Medical Research Award will be given to three hepatitis C researchers.  The award’s three co-winners will be Michael J. Sofia,  Ralf F.W. Bartenschlager, and Charles M. Rice.

Michael J. Sofia

Michael J. Sofia will receive the Lasker~DeBakey Clinical Medical Research Award  for his work on the hepatitis C drug sofosbuvir. He is sofosbuvir’s lead inventor and partial name-sake.

Sofosbuvir (brand name Sovaldi) is a treatment for hepatitis C. It can directly target the hep C virus and stop it from making copies of itself. The treatment works by attaching itself to the genetic information, called RNA, to block the virus from multiplying. It is able to cure hep C with shorter treatment times, better cure rates (curing more than 90% of patients), and less side effects than previous hep C treatments. Furthermore, sofosbuvir is also a part of Harvoni and Epclusa, two other new hep C treatments.

In an interview, Dr. Sofia remarked that “It’s pretty astounding to see how this drug has been able to transform people’s lives and certainly really change the future for” people with hepatitis C. (Peter Loftus, 2016)

Ralf F.W. Bartenschlager and Charles M. Rice

The Lasker~DeBakey Clinical Medical Research Award will also be awarded to Ralf F.W. Bartenschlager and Charles M. Rice for their work in developing a way to get the hep C virus to multiply inside lab-grown host cells. This system was then used by Dr. Michael J. Sofia and other researchers to test and create treatments.

The Lasker~DeBakey Clinical Medical Research Award comes with honorariums of $250,000 (USD) for each of the three winners and will be given out on September 23rd, in New York.

Sources: Scientists Honored for Hep C Research: Three medical researchers are among winners of Lasker Awards by Peter Loftus, published by The Wall Street Journal on September 13, 2016, the Albert and Mary Lasker Foundation’s website, and the 2016 Lasker~DeBakey Clinical Medical Research Award YouTube video by the Albert and Mary Lasker Foundation.

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.