Tag Archives: pan-genotypic treatment

Glecaprevir/Pibrentasvir Submitted to the US FDA

Glecaprevir/Pibrentasvir Submission to the FDAA New Drug Application was submitted to the U.S. Food and Drug Administration (FDA) late last year for glecaprevir/pibrentasvir, a hepatitis C treatment against all of the virus’s major genotypes. This application was submitted after the FDA grated glecaprevir/pibrentasvir a Breakthrough Therapy Designation (BTD) for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies last September. It also came just weeks after a New Drug Application was submitted for sofosbuvir/velpatasvir/voxilaprevir, another hep C treatment.

There has been no word as to when glecaprevir/pibrentasvir will be submitted for approval in Canada.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to the FDA as a once-daily three pill regimen for the treatment of patients with chronic hepatitis C virus (HCV). The treatment is taken without pegylated interferon or ribavirin. It has achieved high SVR/cure rates in patients with health concerns that limit hep C treatment options, such as those with severe chronic kidney disease. In as little as 12 weeks, it has also been effective for those historically difficult to treat, such as those not cured by other direct-acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Application to the U.S. FDA can be found here.

Sampling of Phase III Clinical Trials

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
ENDURANCE-1 GT1 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN) , and patients co-infected with HIV-1 8 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
ENDURANCE-3 GT3 without cirrhosis, never been treated G/P 95%
SURVEYOR-2 (Part 4) GT2, 4, 5, 6 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF) G/P 97%
*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. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

“The results we announced today bring us closer to providing a potential pan-genotypic, once-daily treatment option with 8 weeks of therapy for people living without cirrhosis and who are new to treatment,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

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.

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.