Tag Archives: ledipasvir

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.

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

Did you spot yesterday’s typo?

sq_drugsBlog Entry Correction

Yesterday’s blog post about Harvoni passing its Common Drug Review this week stated that one of the Canadian Drug Expert Committee’s recommendations was that liver fibrosis should be “stage 2 or lower“. The post should have read “Liver fibrosis stage ≥ 2” or “Liver fibrosis stage 2 or higher.

I apologize for the typo. I may have been a wee  excited about the Harvoni news.

Harvoni Passed Common Drug Review

ledipasvir, sofosbuvir, HarvoniHarvoni, created by Gilead Sciences, passed its Common Drug Review this week with the Canadian Drug Expert Committee (CDEC)’s Final Recommendation. The CDEC’s Final Recommendation advocates that Harvoni, ledipasvir/sofosbuvir, be listed for the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults. It recommended 3 conditions for this.

The 3 conditions recommended by the Canadian Drug Expert Committee were:

  • Liver fibrosis be at stage 2 or higher
  • Treatment should be initiated by physicians experienced with treating chronic hep C
  • A substantial reduction in price

Reasons for the Recommendations were:

The CDEC’s report also covered such information as the treatment’s background, efficacy, side effects, and cost and cost-effectiveness.

The website for BC’s PharmaCare now lists Harvoni’s Drug Review Start Date as March 18th, 2015.

Footnote:

When I read the report, I found an interesting note under “Other Discussion Points”. It said that although the ION trials didn’t look at patients coinfected with HCV and HIV, the committee did and cited that ERADICATE, a recently completed trial, demonstrated similar SVR12 rates (98%) in patients coinfected with HCV and HIV to those reported in the three ION trials.

Notice of Compliance for ledipasvir/sofosbuvir

sq_drugsGilead Sciences, Inc. announced yesterday that Health Canada has issued a Notice of Compliance for ledipasvir/sofosbuvir (Harvoni), the first ?irketleri once-daily single tablet regimen for the treatment of chronic hepatitis C genotype Dr.SiLnT 1 infection in adults. The technical tablet combines wholesale NFL jerseys the NS5A inhibitor ledipasvir with the Wholesale Miami Dolphins Jerseys nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi) cheap NFL jerseys for a 8, 12, or 24 week treatment duration.

The press release programa that Gilead Sciences posted TAKERS! regarding this ledipasvir/sofosbuvir development also includes information about Gilead’s Momentum Support Program in wholesale jerseys Canada.

For more information about currently approved hep C treatments in BC, new and Winter, emerging drugs, ASAP! 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.

THANK YOU LEDIPASVIR/SOFOSBUVIR SURVEY TAKERS!

sq_homePacific Hepatitis C Network (PHCN) would like to thank all of those who completed our ledipasvir/sofosbuvir (Harvoni) survey.

The survey was completed wholesale jerseys by dünya! more members than pastor expected and the opinions and experiences that were shared were not just invaluable while writing the patient group input report for the Canadian Agency for Drugs and Technologies in Health (CADTH), but will also be invaluable while creating future surveys.

Yes, there will be future surveys and future blog posts similar to the last post, requesting survey takers, and this post, thanking survey takers. Our task is not done! New hep C treatments are currently making their way through the wholesale jerseys China drug pipeline and we have to be a part of this process!

As we use your comments and suggestions to tweak the ledipasvir/sofosbuvir participants (Harvoni) survey for possible future use, we wait in great anticipation for the next time patient input is cheap jerseys requested by CADTH. Please join us in this anticipation and keep a look out for future requests for survey participants as new treatments are coming and CADTH will again need to hear about our experiences with hep C and our opinions about treatments.

For more information about currently approved hep C фундамент treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or resources to help wholesale mlb jerseys in getting ready for gegen treatment, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.

Survey participants needed ASAP!

Ledipasvir/Sofosbuvir (Harvoni) Survey LogoTwo cheap jerseys months cheap nba jerseys into cheap jerseys PHCN‘s Yet Treatment Information K?benhavns Project and the information embodying the resource has been changed and updated numerous times. One Friday afternoon, for example, was spent updating the project’s Drug Pipeline Diagram, only to realize that the new updates were already out of dated and that the work had to be redone.

With all of the changes taking place around treatment for hepatitis C, it’s an exciting time to be following the upcoming drugs through the drug approval process in Canada and BC.

During the past summer, for example, one of the drugs, Incivek, which had once emerged with promise in the fight against hepatitis C but required interferon, was discontinued by its maker, Vertex, as newer, improved therapies, not requiring interferon, advanced.

This announcement came on the heels of Vertex’s earlier announcement that it was ending its hep C research and development program.

But it’s not just an exciting time to watch and wait as the next generation of therapies advance through the drug pipeline, it’s also a great time to get involved, have your voice heard, and possibly help as decisions are made regarding newly emerging drugs!

On that note, PHCN requires survey participants with hep C or living with/caring for someone with hep C ASAP!

The survey’s link is: http://www.fluidsurveys.com/s/CADTH_Led_Sof_PHCN/

The survey includes 36, mostly multiple choice, questions that are divided into 5 sections. The sections that don’t pertain to you can be easily skipped. The survey’s 5 sections ask about:

  • The impact of hep C on your life (8 questions)
  • Your experience with current hep C treatments (9 questions)
  • The impact on caregivers (4 questions)
  • Your expectations and experience with Harvoni (ledipasvir/sofosbuvir) after taking the treatment (10 questions)
  • Your expectations of (Harvoni) ledipasvir/sofosbuvir (5 questions)

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 about the above topics for the Canadian Agency for Drugs and Technologies in Health (CADTH). By completing the survey you accept that Pacific Hepatitis C Network (PHCN) can use the information gathered in the survey in our patient group input report for CADTH.

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. You can be a part of this process!

Please email hepctip@pacifichepc.org for more information.

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