Tag Archives: sofosbuvir

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.

Patient Group Input sent for Sofosbuvir / Velpatasvir

Patient Group Input sent for Sofosbuvir / VelpatasvirPatient group input was just sent in for the hep C treatment sofosbuvir / velpatasvir. Thank you to all of you who completed PHCN’s sofosbuvir / velpatasvir survey and shared it with others. It was truly an honour to read your responses and to use them to write the patient group input report for the Canadian Agency for Drugs and Technologies in Health (CADTH) on your behalf.

The patient group input reports requested by CADTH are an important step towards getting new treatments for hep C more widely available in Canada and BC.

The sofosbuvir / velpatasvir report was sent in last night. We now wait to hear the outcome of the treatment’s submission. The Hepatitis C Treatment Information Project will keep you apprised of any news.

Sofosbuvir / Velpatasvir

Sofosbuvir / velpatasvir is an all-pill, short-course (possibly 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.

Hepatitis C Treatment Information Project

PHCN’s Hepatitis C Treatment Information Project is a source of information that doesn’t post a ‘site last modified date’ because it is truly forever changing. Pay it a visit for more information about currently approved hep C treatments, new and emerging drugs, or resources to help in getting ready for treatment. You can also email us your questions about hep C treatments.

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

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 Fact Sheet

Sofosbuvir / Velpatasvir Facts SheetThe below treatment fact sheet was designed to give you more information about sofosbuvir / velpatasvir and to encourage you to help us, PHCN, with our sofosbuvir / velpatasvir patient group input report for CADTH. The fact sheet was put together in hopes that you will help us advocate on behalf of those with hep C and their loved ones.

Sofosbuvir / velpatasvir, an exciting new hepatitis C treatment, is currently being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Therefore,  CADTH is seeking patient input about hep C, hep C treatments, and  sofosbuvir / velpatasvir.

PHCN’s Sofosbuvir / Velpatasvir Surveys

Sofosbuvir / Velpatasvir Facts

Genotypes Tested Against1 – 6

Treatment Description: Sofosbuvir / velpatasvir is made up of two direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir (brand name Sovaldi) is a nucleotide NS5B polymerase inhibitor that “…targets the hep C virus to stop it from making copies of itself in the liver. Sofosbuvir attaches itself to the genetic information (RNA) to block the virus from multiplying.” (Gilead)

Velpatasvir is a pan-genotypic NS5A inhibitor that blocks a virus protein, NS5A, that the hep C virus needs for reproducing and various stages of infection.

Approximate Sustained Viral Response (SVR)/”Cure Rate”:  94 – 100%

Daily Dose:  1 pill +/- ribavirin

Possible Length of Treatment:  8, 12, or 24 weeks

Common Side Effects Reported in Clinical Trials: 

  • Headache
  • Nausea
  • Tiredness (fatigue)

Usage Warning: Do not take sofosbuvir in any combination while taking Amiodarone or with bradycardia.

Step in Drug Approval Pipeline:  Step 4 – Common Drug Review by CADTH

 Availability:  Not approved for use in Canada

Sampling of Phase II/III Clinical Trials for Sofosbuvir / Velpatasvir:

Patients
Treatment Regimen
Duration in Weeks
SVR12
ASTRAL-1: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naïve and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without cirrhosis (Abstract LB-2 from AASLD’s Liver Meeting 2015)
Genotype (GT) 1, 2, 4, 5, 6 Hepatitis C with and without cirrhosis; 740 patients Sofosbuvir / Velpatasvir (SOF/VEL)
12 Overall: 99% (618/624)

GT1: 98% (323/328)

GT2: 100% (104/104)

GT4: 100% (116/116)

GT5: 97% (34/35)

GT6: 100% (41/41)

Placebo 116 patients received placebo, experienced similar adverse effects, SVR12 0%
ASTRAL-2 and ASTRAL-3: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
GT 2, 3 HCV; treatment naive and treatment experienced; including patients with compensated cirrhosis GT2 14% with cirrhosis SOF/VEL 12 99% (133/134)
Sofosbuvir + ribavirin (RBV) 94% (124/132)
GT3 30% with cirrhosis SOF/VEL 12 95% (264/277)
Sofosbuvir + RBV 24 80% (221/275)
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
Genotypes 1-6 All with Child-Pugh class B (decompensated) cirrhosis SOF/VEL 12 83% (75/90) Overall (GT1 88% GT2 100% GT3 50% GT4 100%)
SOF/VEL + RBV 94% (82/87) Overall (GT1 95% GT2 100% GT3 84% GT4 100%)
SOF/VEL 24 86% (77/90) Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)

Additional Facts about Sofosbuvir / Velpatasvir can be Found in the Following Resources:

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

U.S. FDA Approved Harvoni for More Patients

U.S. FDA Approved Harvoni for More PatientsIn the U.S,. the FDA approved Harvoni for more hep C patients today. Harvoni (ledipasvir/sofosbuvir), a FDA approved hepatitis C treatment, was also FDA approved to treat patients with advanced liver disease. The treatment was approved to be prescribed with ribavirin for 12 weeks for patients with:

  • Hep C genotypes 1 or 4 who are liver transplant recipients and who have compensated cirrhosis (Child-Pugh A) or don’t have cirrhosis;
  • Hep C genotype 1 with decompensated cirrhosis (Child-Pugh B or C), including those who have had liver transplants.

See today’s press release for more information about Harvoni in the U.S., the FDA approval, clinical trial results, and safety information for Harvoni (ledipasvir/sofosbuvir).

Harvoni in Canada

Harvoni is an all-oral (one pill daily), short-course (8 – 24 weeks), interferon-free, ribavirin-free, treatment for patients with chronic hep C genotype 1, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 93% of the patients who have been treated with Harvoni. Harvoni is listed by Canadian pharmacare programs. More information about the hep C treatment can be found here.

Ribavirin, Sovaldi, and PharmaCare

Ribavirin (brand name Ibavyr)Ribavirin (brand name Ibavyr) as a stand-alone pill is now being used with Sovaldi (sofosbuvir) to create an interferon-free combination.

A patient support program, the Ibavyr Patient Support Program, is available to Canadians who have been prescribed ribavirin as part of their hep C treatment.

More information about BC’s PharmaCare eligibility for Sovaldi and ribavirin, including information about  the Ibavyr Patient Support Program, can be found on the Hep C Treatment Information Project’s newest page Ribavirin (Ibavyr).

Traditionally, ribavirin has been part of a treatment combination with pegylated interferon (Pegasys). However, with Sovaldi, it now  creates an interferon-free treatment combination for genotype 2 and 3 hep C. This combination is covered by BC’s PharmaCare as a limited coverage drug.

Length of Treatment:
Patients Treatment # of Weeks
Genotype 2 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR)* Sovaldi + ribavirin 12
Genotype 3 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried PR Sovaldi + ribavirin 24
*Genotype 2 or 3 patients who have tried treatment are patients who have previously been treated with pegylated interferon with ribavirin and did NOT receive adequate responses. Similar treatment lengths are also used to treat genotype 2 or 3 HCV patients co-infected with HIV.

Ribavirin is a nucleoside analogue. Proposed mechanisms of ribavirin against the hep C virus include hindering viral replication and adjusting the body’s immune response to a desired level (immunomodulation). It is used in combination with other agents, such as Sovaldi, to stop viruses from reproducing and spreading.

PharmaCare Covered Hep C Treatments

PharmaCare Covered Hep C TreatmentsThe number of BC PharmaCare covered hep C treatments has been increasing and so has the information gathered by the Hepatitis C Treatment Information Project. The Hep C TIP now has new pages dedicated to BC’s PharmaCare and the treatments that are covered by it. These pages are:

Treatments Targeted Genotype
Ribavirin 1 – 3
Pegylated Interferon with Ribavirin (Pegasys RBV) 2 – 6
Victrelis (boceprevir) 1
Galexos (simeprevir) 1
Sovaldi (sofosbuvir) 1 – 3
Harvoni (ledipasvir and sofosbuvir) 1

For more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.

BC’s PharmaCare lists Harvoni and Sovaldi!

Galexos Sovaldi pictureWhat follows is PHCN‘s press release regarding the BC Ministry of Health offering Harvoni and Sovaldi, but we want to also say WOW!!!  To everyone who has been waiting so long and so patiently for this day – CONGRATULATIONS!!!!

Stay tuned for continuing updates on other new drugs in the pipeline.

Here is PHCN’s press release:

Pacific Hepatitis C Network Welcomes Decision to Provide Access to New Therapies

 

B.C. Ministry of Health to offer two new hepatitis C virus drugs to eligible patients

Vancouver, B.C. – (March 23th, 2015) – Pacific Hepatitis C Network (PHCN) today welcomed the B.C. Ministry of Health’s announcement that it will provide access to two new hepatitis C virus (HCV) therapies, Harvoni and Sovaldi. HCV is considered one of the most serious public health issues facing Canadians, causing more years of life lost than any other infectious disease in the country.

“We are thrilled that these new therapies are now available to eligible patients,” says Daryl Luster, President of PHCN. “As a network and voice for those living with hepatitis C in British Columbia, these new treatments are a huge leap forward and will greatly change the outcome for those living with, and affected by, hep C.”

Harvoni and Sovaldi are two new therapies that, along with multiple other provinces in Canada, will be available to eligible patients in B.C. as of March 24th. Harvoni is a substantial step forward in HCV treatment because it is a highly curative, low-side effect therapy that is simple to take and is both ribavirin and interferon-free.

“In contrast with therapies used until now, this breakthrough hep C treatment has a cure rate of close to 100 per cent, with few or no side effects, as well as a shortened treatment cycle and is ribavirin-free,” says Daryl Luster. “The B.C. Government should be congratulated for taking this significant step forward that will help to eliminate hepatitis C in a generation.”

Often heralded as a “silent epidemic” because of its few or asymptomatic characteristics, HCV seriously affects the liver and can be difficult to treat. In fact, many Canadians living with HCV are unaware of their infection, primarily within the baby boomer demographic, which highlights the importance of implementing hep C screening processes across the nation.

Equally important as the availability of these new treatments and intensive hep C screening processes are monitoring, counseling and engaging with care to help prevent high numbers of HCV patients requiring intensive health care for advanced liver disease.

About the Pacific Hepatitis C Network

The Pacific Hepatitis C Network (PHCN) is a non-profit community-based organization that was founded in March 2007. PCHN is a voice for those living with hep C and works as an advocacy group to bring together people living with, affected by and at-risk for the hep C infection, including people living with hepatitis C, health care providers, community-based service providers and community and government stakeholders. PCHN works alongside individuals, groups and organizations in efforts to strengthen our collective response to hepatitis C in BC. For more information please visit: http://ww.pacifichepc.org/, the Pacific Hepatitis C Network, or http://www.hepctip.ca/, PHCN’s Hepatitis C Treatment Information Project.

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For more information or interview requests, please contact:

Deb Schmitz

Pacific Hepatitis C Network

deb@pacifichepc.org

604 740 1092

Here is the link to the Minister’s announcement:  http://www.newsroom.gov.bc.ca/2015/03/bc-covers-two-curative-hepatitis-c-drugs.html