Hepatitis Forums
Hepatitis C Main Forums => Hepatitis C Research News & Studies => Topic started by: HHburme on April 26, 2016, 11:49:47 pm
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http://hepatitiscnewdrugs.blogspot.com/2016/04/ilc2016-sofosbuvirvelpatasvir-and.html
This happens to be the study that I'm in.
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I sincerely hope it works for you.
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Really hopes it works for all of us who need it or will need it
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SVR12......cured . the trial worked and had little side effects
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HHburme, do you know how many people were in this study or how many reached SVR12 with it? This is such fantastic news, so very happy research has finally reached this point!! FT
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Stage 3, 320 people, 50% placebo. 99% cure rate for all GT. One pill a day, 3 meds.
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320 , I don't know if that's USA only or worldwide. Specifically for patients treated with DAA that failed. Only 4 patients in Chicago are where I participated and I was first one finished. In Europe a 99% SVR rate. Epclusa plus a third drug in the pill. I experienced some achy joints, so little SE .
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Thanks! This could be the game changer in this fight against HCV. Looking forward to seeing the final results when they are in. Congrats again!!! FT
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Any idea of anticipated FDA approval for this?
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New med SOF/VEL/VOX should be approved within next few months. I was in the clinical trial study for this med after relapsing at SVR12 lab test following 12 weeks of Harvoni treatment. This time SVR12 was UD and SVR24 labs have been drawn but have not yet received yet. Been assured by medical team that it will be UD, but still waiting for final test to be UD. Fingers crossed, feel fine. I experienced aches in my joints, specifically my knees, but really minor sides.
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Very good news, HH
And thank you for volunteering in that trial.
Since Sof/Vel/Vox in pangenotype, with such high success rates, and with mild side effects, it might well be the cutting edge treatment for HCV.
I know they're also looking into 8 week versus 12 weeks for selected patients
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HH, FANTASTIC NEWS!! So glad to hear you reached SVR 12 and likely SVR 24. It was quite the journey for you, but it's now in your past.
Time for a new journey!! Keep us posted on the SVR 24, FT
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Great news HH.... I failed 8 weeks Harvoni treatment. Relapse at 12 week post treatment testing. I had resistance testing and have F2 fibro score 1.2mil count. Geno 1a. Dr. suggested i wait 6 months and wait for new DAA drug. This may be the one I'm waiting for. Hopefully it gets approved. Happy to hear it worked for you and good that you did the trial to test a new drug.
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FT, thx and I'll keep you posted.
E.G., this drug will be the one ! You have similar story . I relapsed after 12 wks of Harvoni and was resistant to DAA's also. I was hopeless until this trial came along. Just be patient, as I'm told this drug should be approved soon.
The reasons I posted any of this was to hopefully let people like us know that there was hope for us.
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I gather theres little information yet as to whether this sof/vel/vox would be useful for those who fail/relapse on Epclusa. Since Epclusa has only been out a few months. Outside of the clinical trials, there might not be no such reports as of now, since it wasnt approved until end of June 2016. From the Phase III Epclusa trials, there were only 13 virological failures I believe..
But down the road, I'm hoping this works as well for Epclusa failures as for Harvoni failures. Does anyone if they're planning that?
I'm also thinking this might come to be be the drug used initially, rather than Epclusa. Since a "response guided" approach would allow shortening the time frame to eight weeks for many on it. Possibly depending on rapidity of response. It also seems to have even higher success rate. For some genotypes. Hard to improve much on the 100% for GT2 , though often real life situations arent as great as in clinical settings
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Alright HH so very happy for you!
Your awesome news has made my day!
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Gilead has now formally filed a New Drug Application with the FDA
http://www.healio.com/infectious-disease/hepatitis-c/news/online/%7B238deccc-9464-4015-ab81-d6bab9697d8e%7D/gilead-submits-nda-for-investigational-treatment-of-hcv (http://www.healio.com/infectious-disease/hepatitis-c/news/online/%7B238deccc-9464-4015-ab81-d6bab9697d8e%7D/gilead-submits-nda-for-investigational-treatment-of-hcv)
Question: :
How likely is insurance here to cover this if used as salvage therapy for previously covered DAA treatment?
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SVR24 !!!!! I finally made it !!!
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FANTASTIC God Bless :) :) :)
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Congratulations HHburme
Thank you again for volunteering for that trial. Seems quite effective for re-treatment of DAA failures
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HHburme --- SVR 24 !!!!! HAPPY NEW YEAR TO YOU AND YOURS!! Hope you have a great 2017, you deserve it!! The future is very bright, FT
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Wow woo whooooo!
Congrats on finally beating the dragon that is wonderful news so happy for you!!!!!
:)
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After failing Harvoni 8 weeks treatment my Doctor advised waiting six months for a new drug that would be effective treatment on geno type 1a for those with resistant variants. I'm just looking for updates or success stories with similar results. I know many people have been through failed treatment and it's tough waiting after such a let down.
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It does have high success rate for those who failed Harvoni
One question though: Why did the doctor want you to wait six months? Was it a medical reason, or to wait till FDA approval?
Gilead applied for FDA approval for this last month
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I believe Dr. is waiting for new drug approval. How long does it take for FDA approval after big Pharma submits the drug to the FDA? As soon as I find that a drug is approved I will be calling my Dr. Hopefully in less than six months.
Thanks.
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I read this one is expected to be approved~ mid 2017. Please keep us posted
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Do you know the name of the medicine you are waiting to be approved? This thread is discussing SOF/VEL trade name Epclusa which was approved Jun 28th 2016.
http://www.gilead.com/news/press-releases/2016/6/us-food-and-drug-administration-approves-gileads-epclusa-sofosbuvirvelpatasvir-for-the-treatment-of-all-genotypes-of-chronic-hepatitis-c
For a timeline Gilead submitted Epclusa for approval in October 2015 and was granted priority review status Jan 4th 2016 so from original application to approval was 8 months but that was faster than normal because of the priority review status.
http://www.gilead.com/news/press-releases/2016/1/gilead-announces-us-fda-priority-review-designation-for-sofosbuvirvelpatasvir-for-treatment-of-all-genotypes-of-chronic-hepatitis-c-infection
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Vesovi is the name that Gilead gave to my trial drug. Now over 13 months SVR
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Glad 13 months and SVR you are free HH. Take care :)
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Hey HH congrats on 15 months SVR wow!
I found some info
Vosevi (Sofosbuvir, Velpatasvir and Voxilaprevir)
This is a combination medicine that has been approved to treat adults with chronic HCV, either with no cirrhosis or with compensated cirrhosis, who have already had certain treatments.
Epclusa (Sofosbuvir-velpatasvir)
Pulled this from your study information
ILC2016 Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed
Looks like it was approved in Jul 2017. Cutting edge stuff wow!