Tag Archives: sofosbuvir

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.

Galexos Sovaldi Combination Earns Notice of Compliance

Galexos Sovaldi pictureThe combination of Janssen’s Galexos (simeprevir) and Gilead’s Sovaldi (sofosbuvir), for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease, has received  a notice of compliance.

the news

Receiving a notice of compliance allows the treatment to be sold in Canada with official approval. If a drug has a notice of compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. At this stage private insurers each decide company coverage of the new drug (ie. what percentage of the drug costs they will cover).

Janssen’s Galexos has also been issued non-conditional approval for use in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

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.

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!