On ledipasvor

[Maxinezhou]

My mother is a HCV patient, genotype1 with cirrhosis and interferon intolerant. Gilead recommend 24 weeks of sofosbuvir+ribavirin. But I am afraid of low efficiently given the low SVR of only 10 % and high cost. I know that with ledipasvir added the SVR would be improved significantly. However how can I get it? Is it market available or still on trial stage? Anyone similar situation as my mother?

[Maxinezhou]

Thanks and I'll try to get information on Simeprevir+Sofosbuvir

[Maxinezhou]

thanks for your information. yes my mom is in China and there is no clinical trial here. It seems that I have to wait for FDA aprroval on sofosbuvir+ledipasvir.
Anyway, I'll try to consult with my mom's doc

[flyinlynn]

Not sure where you are getting the 10 % likelihood of successful treatment but I do know the Sovaldi (TM) AKA Sofosbuvir is more effective with interferon for genotype 1

Like your mom I also have genotype 1a with cirrhosis and am a null responder to previous treatment with interferon alone and interferon plus ribavirin. My Dr doesn't want to treat me with interferon as it doesn't work for me and has concerns I could decompensate from the medication.

I tried to get into the clinical trial listed above but the Dr's say I am not sick enough as I am only a Child Pugh score A. The trial is looking for Child B or C pretransplant or Child A, B & C post transplant only. Do you know your moms Child Pugh Score or her MELD score? Is she compensated or decompensated? Has she been treated before?

As to the new combo drug Sofosbuvir/Ledipasvir there was a press release today
Gilead to seek okay for combo hepatitis C pill in Q1

http://finance.yahoo.com/news/gilead-seek-okay-combo-hepatitis-162147627.html;_ylt=AwrTWfywzLFS8ywApw_QtDMD

After that we must wait for FDA approval.

Borrowed from HectorSF:

The new Sovaldi/peg-interferon/ribavirin treatment that has now been approved by the FDA recently for treatment of genotype 1 patients had its NDA submitted this year on April 8, 2013. It then took until December 6, 2013 for FDA approval. So we can expect it will take about 9 months for approval and then some additional time for insurance companies to cover the new treatment, doctors to learn how to treat with it and for the treatment medicine to be available locally to doctors and patients as we are now experiencing with the currently approved treatment.

Yes the new drugs are not too far off but it will still be quite a while.

If possible you could look for a clinical trial. It looks like you maybe are in China? I checked the clinical trials web page and I dont't see any there right now but hopefully your mom's Dr will have local information for you.

Your mom should be working with her Dr for the best information. Preferably, she should be seeing a Hepatologist associated with a transplant center for the best and most current information.

Best wishes to you both
Good luck
Lynn

[nan535]

Someone posted this Clinical Trial info

http://clinicaltrials.gov/ct2/show/study/NCT01938430?term=NCT01938430&rank=1&show_locs=Y#locn

Hope this is helpful to you.

Wishing all the best for your Mom.
Nan

[48weeks]

Sofosbuvir+Ledipasvir+Rib seems to be the magic treatment everyone like your mom and myself are waiting for and I don't think anyone has a clear picture of when that combination will be available or why it's taking so long for Ledipasvir but maybe you should look into trying to go off label with Simeprevir+Sofosbuvir. I'm not sure that will work with cirrhosis, but someone way more informed than myself will be along shortly. Best of luck for something soon.