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1765684 tn?1333819168

Maybe taking another shot at it in November

Hello all, I've not been around for a while.  Quit tx after discovering I was in the placebo group (which has since been confirmed) of a trial.  I won't be doing another trial anytime soon...  So what is available now in Canada?  Where are the all oral meds at now?

Thanks,

Sue
12 Responses
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Avatar universal
Sue..

SOC now is considered INF/Riba and either INCI or Vic....

However as I said in my post above it is being speculated here that the sec.generation protease Simeprevir will be approved and avail. here sometime late this year or possibly early 2014.

At Western they believe this will be aprroved ,prior to  anything "all oral".

Simeprivir has shown very good results in trial . The dosing regime and side effect profile would along with the excellent results is possibly worth talking to Dr Wong about (if you have not already) or discussion with him about treating currently with one of the approved proteases(INCI or Vic)

Also as you know in the mix is the 'all oral " therapy that hopfully will be avail with in the next year or two.

There are options and current stage of your liver damage I would imagine comes into play in any discussion with the doctor on how to proceed.

Good luck..
Will
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1765684 tn?1333819168
Goodness...  I really can't hold onto this job just for the insurance forever.  Paying 2013 bills on a 2003 salary blows.  "But we give you benefits and 7 weeks vacation a year paid."

Great.  But can I afford to actually do anything with all that vacation time?  

I'm not opposed to interferon and ribavirin.  I just don't want to do SOC again.  What is available for 24 week treatment with SOC now?  In Canada?  Has anything been approved in the last year?
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1815939 tn?1377991799
Good to see you on the forum. Just wanted to say hi and wish you the best with future treatments.
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Avatar universal
Hi Sue..
There will not be anything here(approved ) other than possibly a second generation Protease .still with INF/Riba until later next year or early 2015 at the earliest ..according to Wong.

He feels we may see the sec.generation protease  somtime  in 2014

He has his ear close to the ground as you know ,,however still just ones opinion

Good to see you..

Will
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1765684 tn?1333819168
Well, with HCV and a couple of expensive auto immune diseases, insurance is worth a lot to me.  Thanks for the well wishes.  And hey Jules!!!
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1669790 tn?1333662595
Hey Sue, whatever you decide on your tx options, I wish you the best of luck for the next round.  Hope all goes well for you.  
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Avatar universal
  Yes, it is a good idea to Treat with the job that has the good Insurance. That is why I stuck with my low-paying job all these years, and I was grateful that my Treatment was payed for, and I was able to keep working when I Treated.
    I hope Canada quickly follows the U.S. with approving the All Orals~ good luck
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Avatar universal
Hi SueZQ!  Good to see you back around.  I just wanted to say HI!

Jules
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446474 tn?1446347682
I wish you the best of luck with your treatment.

Hector
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1765684 tn?1333819168
Thanks for the responses.

I don't -have to- treat now but I want to.  I've had the same job since 2000 and have very good insurance. However, I work for a non-profit and haven't had a raise since 2003.  I need to find a new job, can't survive on 2003 money anymore.  Well, I can, but I don't want to.  So I want to do this while I still have that good insurance and an understanding employer.  They were very good to me when I went through the challenges of tx the first time.
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446474 tn?1446347682
There are no new treatments available on the market in the US or anywhere else. All new treatments will use peg-interferon and ribavirin in 2014 for genotype 1 patients.
The only all oral treatment will be Gilead's treatment for genotypes 2 and 3 in early 2014. I am not exactly sure when it will be available in Canada. Probably later in 2014.

All oral treatments for genotype 1s are expected to be available in 2015.

Do you have to treat now?
What stage is your liver disease?
Better treatments are not two far away and if you have little liver damage and no extrahepatic symptoms.

Good luck to you.
Hector
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Avatar universal
  This is all I can come up with,a t the moment, but some of our Canadian "old-timers" should come along soon, with more info~

The HCV candidate is under priority review in the U.S. (target date: Dec 8, 2013). We note that the U.S. Food and Drug Administration generally reviews those drugs, which offer major advances in treating diseases over existing therapies, on a priority basis. Sofosbuvir is also under review in the EU. Gilead is also seeking approval for the candidate in other countries such as Canada, Switzerland, Turkey and Australia.


and I pulled the link from this site~
http://finance.yahoo.com/news/gilead-seeks-fda-approval-idelalisib-143003613.html

   Also, on a side note, since medical advances are making such quick head-way,  many of the Trials are now in "Phase 3" and the all oral Trial my husband participated in had no placebo category. I will give you some info on the meds he took:

PRESS RELEASE

Abbott Announces Phase 3 Hepatitis C Program Details
Interferon-free Hepatitis C Regimens will be Studied in Broad Patient Populations across Multiple Countries
November 13, 2012

Abbott Park, Illinois (NYSE: ABT) — Abbott today released details on its phase 3 hepatitis C registrational program following promising results from its phase 2b clinical trial, known as Aviator, presented at the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston. The phase 3 clinical trials are designed to evaluate safety and efficacy of a 12-week regimen of three direct acting antivirals (DAA), with and without ribavirin, for the treatment of HCV in genotype 1 (GT1) non-cirrhotic, treatment-naïve and treatment-experienced patients. An additional phase 3 trial will study triple-DAAs, with ribavirin, in patients with cirrhosis for 12 or 24 weeks.

The phase 3 program, which is currently open for enrollment, will include more than 2,000 patients with HCV genotype 1, with trial sites in 29 countries. The DAAs in the studies include ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor). Treatment duration will be 12 weeks in non-cirrhotic patients, and 12 or 24 weeks in cirrhotic patients. All patients will be followed for 48 weeks post-treatment. Co-formulated tablets of ABT-450/r and ABT-267 will be used in the phase 3 trials.

More information on the trials is available at www.clinicaltrials.gov.

"Abbott is committed to investigating a short-course HCV therapy without the use of interferon to achieve high SVR rates," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "Our trial enrollment strives to reflect a broad range of populations, including those that have been difficult to treat. We have been very encouraged by the data from the phase 2 studies, and look forward to confirming the findings in our phase 3 program."

Topline intent-to-treat results from the 12-week, triple-DAA regimens with ribavirin presented at the AASLD meeting this week found that 97.5 percent (77 of 79) of treatment-naïve GT1 patients and 93.3 percent (42 of 45) in GT1 null responder patients achieved SVR12.

About the Hepatitis C Virus

Hepatitis C is a liver disease affecting as many as 170 million people worldwide. The virus is primarily spread through direct contact with the blood of an infected person. HCV increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death; and liver disease associated with HCV infection is growing rapidly.

Of the six main genotypes of hepatitis C, genotypes 1, 2 and 3 are the most widespread. Genotype 1 is the most common genotype in the U.S. and the most difficult to treat with interferon based therapies. Patients with genotypes 2 and 3 are more likely than individuals with genotype 1 to respond to therapy with peg-interferon or the combination of peg-interferon and ribavirin.

About Abbott's HCV Development Programs

Abbott's HCV portfolio includes investigational medicines with three different mechanisms of action, including protease (ABT-450/r), polymerase (ABT-333) and NS5A (ABT-267) inhibitors, currently being studied in clinical trials. ABT-450 is being developed with low-dose (non-therapeutic) ritonavir which enhances the pharmacokinetic properties of ABT-450. The use of ritonavir 100mg with ABT-450 for the treatment of HCV is investigational.

ABT-450 was discovered during the course of a collaboration between Abbott and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by Abbott for use in combination with Abbott's other investigational medicines for the treatment of HCV. Abbott is well-positioned to explore combinations and co-formulations of these medicines.

  I believe these Phase 3 Abbott Trials may have ended here in the U.S., but perhaps they are still availble in Canada~  good luck
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