Author Topic: A Hep C Treatment for All Genotypes (Read 24148 times)

Hep Editors · « **on:** December 14, 2015, 03:46:44 pm »

Gilead Sciences appears poised to continue its dominance of the hepatitis C treatment market in 2016 after achieving excellent results from several large Phase III studies of a new regimen that treats all genotypes of the virus. The four studies looked at a once-daily, single-tablet combination of Sovaldi (sofosbuvir) and the investigational drug velpatasvir for the treatment of genotypes 1 through 6 of hep C. In October, Gilead filed for U.S. Food and Drug Administration approval of the combination regimen.

For more information, read this: http://www.hepmag.com/articles/treatment_genotypes_2996_28119.shtml

FutureThinker · « **Reply #1 on:** December 27, 2015, 03:02:06 pm »

Any guess as to when the FDA could approve this new combo, w/ Gilead submitting the application in late October? Does anyone know how long the FDA took to approve Harvoni after application submission.....6 months? Thanks, FT

chino1969 · « **Reply #2 on:** January 19, 2016, 09:38:01 am »

I saw my Hepatologist who is close to the research last week. He indicated this new 'tweaked' Harvoni is in the wings and will be approved in the very near future. There are also new medications being developed for those with fibrosis.

FutureThinker · « **Reply #3 on:** January 19, 2016, 11:22:18 am »

Thanks chino1969, looks like the FDA will make a decision on this new drug the end of June. FT

Flnscrd · « **Reply #4 on:** January 27, 2016, 12:32:40 am »

Hello lm new.Does anyone know if they will treat Someone with geno type 3 if they have NASH and diabeties /high blood pressure I found out on my own that hep c and NASH are two different diseases.My Insurane (state,county)diagnosed me in 2004 but wouldn't treat me saying I didn't have it bad enough?? I told them wouldn't it be better to treat me now before it gets untreatable!It seems like they hold us hostage and force us to go into a trial study without even being compensated for further possible injury or better yet being the unlucky one getting the sugar pills!The insurance says they have to treat chronic diseases with preventive meds I feel being treated would prevent all the later stage problems that come with a death sentence.It kills me the insurance I have will pay for abortions no prior authorization needed and reconstructive surgery after a mastectomy but wount cover Hep C treatment or HIV treatment but pays for outpatient hospice!Im sorry I'm just very frustrated!Thanks for letting me vent!!

tmf2 · « **Reply #5 on:** June 01, 2016, 07:09:55 pm »

Quote from: chino1969 on January 19, 2016, 09:38:01 am

I saw my Hepatologist who is close to the research last week. He indicated this new 'tweaked' Harvoni is in the wings and will be approved in the very near future. There are also new medications being developed for those with fibrosis.

My hep Doc was conducting trials for this combo and said it is what is the preferred treatment for me as I failed Harvoni
due to resistance and also I'm F4 so it is indeed for those with fibrosis. I was told approval would be somewhere mid June /end of July and the Liver Ctr will have me undergo blood work for pre-approval.

Dennis

FutureThinker · « **Reply #6 on:** June 01, 2016, 07:35:26 pm »

tmf2, thanks for the update, as I was just browsing online looking for any new info on the approval of that new Gilead drug. I'd read that the FDA deadline is June 28th, so sounds like it may well be the ticket for you! I recently completed my 12 weeks of Harvoni and get a 2 wk EOT test tomorrow, and then the big test in August, so am glad to hear more options are coming out in the event of relapse. Best to you and keep us posted, FT

gnatcatcher · « **Reply #7 on:** June 01, 2016, 07:45:45 pm »

Quote from: tmf2 on June 01, 2016, 07:09:55 pm

My hep Doc was conducting trials for this combo and said it is what is the preferred treatment for me as I failed Harvoni due to resistance and also I'm F4 so it is indeed for those with fibrosis. I was told approval would be somewhere mid June /end of July and the Liver Ctr will have me undergo blood work for pre-approval.

Dennis

Dennis, it's great to hear from you again! So glad you've got a leading-edge doc who is going to bat for you to get the treatment you need for a cure.

Gnatty

Lynn K · « **Reply #8 on:** June 02, 2016, 12:01:59 am »

Quote from: Flnscrd on January 27, 2016, 12:32:40 am

Hello lm new.Does anyone know if they will treat Someone with geno type 3 if they have NASH and diabeties /high blood pressure I found out on my own that hep c and NASH are two different diseases.My Insurane (state,county)diagnosed me in 2004 but wouldn't treat me saying I didn't have it bad enough?? I told them wouldn't it be better to treat me now before it gets untreatable!It seems like they hold us hostage and force us to go into a trial study without even being compensated for further possible injury or better yet being the unlucky one getting the sugar pills!The insurance says they have to treat chronic diseases with preventive meds I feel being treated would prevent all the later stage problems that come with a death sentence.It kills me the insurance I have will pay for abortions no prior authorization needed and reconstructive surgery after a mastectomy but wount cover Hep C treatment or HIV treatment but pays for outpatient hospice!Im sorry I'm just very frustrated!Thanks for letting me vent!!

I see no one noticed your comment I hope you have been able to get treatment by now. There are many here who have suggestions on how to appeal a decision by your insurance and alternate ways to get treatment if if comes to that. Hope you see my post and let us know how it is going.

morab · « **Reply #9 on:** June 02, 2016, 04:52:00 pm »

Flnscrd
Keep after your physician and ins. co. Sounds like you need to be treated really soon with all you have going on.
Good luck and keep us posted
Morab

Rosie13 · « **Reply #10 on:** June 08, 2016, 05:00:43 pm »

Finscrd, the good news is that you have insurance. They will deny you a few times but eventually you will get treatment if you keep after it. I know it's hard because the disease makes you weary but life will be so great when you are cured. I called Patient Access Network & got a caseworker who was the reason it all went through. They push for you! You can go online or post again & I'll find their number for you .Good luck !!!!!

tmf2 · « **Reply #11 on:** June 16, 2016, 06:48:01 pm »

The liver center called and requested I get a ultrasound and blood work done for pre approval of this new combo which they believe will be FDA approved in a couple of weeks. The liver center has its own specialty pharmacy and works hard to get the medication needed. I'm nervous that my insurance company will refuse as when I applied for a second round of Harvoni they denied me although this was through a local Gastro that would not advocate for my meds. Thus I traveled 500 miles to a hep specific doc and liver center. Hopefully the liver centers request for meds will not result in a lot of resistance. At F4 I need to be treated asap.

Dennis

FutureThinker · « **Reply #12 on:** June 16, 2016, 08:19:08 pm »

Tmf2, GREAT NEWS FOR YOU!!!!!!!!!! So glad to hear this is moving in the right direction and you'll soon be getting back on the path to SVR. Keep us posted; fingers crossed and prayers said! FT

gnatcatcher · « **Reply #13 on:** June 16, 2016, 08:36:48 pm »

Dennis, so glad you found a way to travel the 500 miles to the liver center. The staff at such centers have lots of experience getting good outcomes from insurance companies. If your insurer turns out to be uncooperative, Rosie13 and some others here on Hep Forums know who the terrific patient-assistance people are.

Rosie13 · « **Reply #14 on:** June 16, 2016, 11:35:30 pm »

Hi Gnatty & Dennis! I am going to throw down some numbers that were key to getting it all started. Dennis, so happy you traveled like I did to the people who know how to get you the help. I drove about 250 miles but in the end my insurance wouldn't let Mayo use their own pharmacy. Seemed ridiculous at the time but I realized that BCBS has made deals with 2 other specialty pharmacies & so they were great too.
Gilead Sciences : mysupportpath.com 855-769-7284
Patient Advocate Foundation : www.hepatitisc.pafcareline.org 800-532-5274 $10,000
Patient Access Network : 866-316-7263 ANGELS! highly recommend $15,000
Bonnie Morgan Foundation for HCV: 877-359-7235
Genetech : another support arm for Gilead 877-505-6986 (approved me for $23,625)
Health Well Foundation: 800-675-8416 ( insurance has to pay for @ least 50% to qualify)
Assistance Foundation Fund: 877-845-3663
Chronic Disease Fund : 877-968-7233
Patients Services Inc.: 800-366-7741 (pays for hospital bills & Drs. bills)
Diplomats Copay Assistance Navigation Program : 877-977-9118 ext. 89864
HEPC Helpline : 800-465-4837 Talked to Nancy ,who was cured, & I got chills & inspiration from her!
Good luck & keep posting!

FutureThinker · « **Reply #15 on:** June 17, 2016, 01:21:40 pm »

Rosie13, thanks so much for this valuable info in one convenient spot -- just printed it off for my files. I'm not at SVR12 yet, so you never know......... FT

Rosie13 · « **Reply #16 on:** June 17, 2016, 04:19:35 pm »

Future Thinker, I have a notebook that I depended on due to my brain fog at the time . I still may need some of these as my final bills are coming in & I have not met deductibles for 2016. It was like a big puzzle that each time I called one the person would give me another resource! I called it " dialing for dollars". The help is out there it's just not in neon lights!!! Hoping that in the future it just is covered like any other disease & this battle won't be necessary. DREAMING!!!

FutureThinker · « **Reply #17 on:** June 17, 2016, 07:54:45 pm »

Rosie, I just lucked out that my state ins. board overturned the ins. denial, or else I would have been putting together a notebook like yours. I wrote them a very heartfelt thank you letter after I got my first bottle of Harvoni; it was the least I could do!

We may be dreaming ----- but we are dreaming BIG!! I believe we'll be looking back @ all this nonsense some day and know we had an important role in the treatment of HCV. FT

Rosie13 · « **Reply #18 on:** June 18, 2016, 10:13:09 am »

Future Thinker, so you only got 1 denial & the state insurance board stepped in? If that's the case we are making progress! When I was in the pre tx days only last summer I was reading on the forum that a lot of us were getting several denials before the appeals worked. The Patient Access Network & the Mayo Clinic did conference calls with me & the BCBS insurance to force the issue. Gilead was instrumental also in paying for at least one month. I will never forget the looks on my Drs. faces when I returned for the 24 week labs & Fibroscan. The F score went from F2-3 to F0! Expecting to not see my liver go to normal in such a short time. They had told me initially it took a few years but without the inflammation it was doing very well. Dreaming does work!

FutureThinker · « **Reply #19 on:** June 18, 2016, 01:39:35 pm »

Rosie, sorry I didn't make myself clear, I had 2 denials before my doctor's office recommended we submit an application to the state ins. board. But --- it only took them ~ 5 weeks to overturn BS's decision, so it is definitely an option for those who are going thru the denial nonsense.

And your F scores ---- WOW!!!!!!! Now THAT'S what I'm talking about with big dreams that do come true!! So very happy for you, hope my F score improves over time, too. But first, I need to get that SVR 12 under my belt. On my way! FT

Rosie13 · « **Reply #20 on:** June 18, 2016, 03:33:36 pm »

You got this !

FutureThinker · « **Reply #21 on:** June 28, 2016, 06:41:41 pm »

Gilead's latest drug, Epclusa, just got FDA approval today for all 6 genotypes at a price of $74,760 for 12 wks. While that's ~ $20,000 less than Harvoni, still too high a price for good access for the masses....... FT

Rosie13 · « **Reply #22 on:** June 29, 2016, 01:55:02 am »

it's $20,000 less. going in the right direction...when the generic appears it will be wonderful.

tmf2 · « **Reply #23 on:** July 27, 2016, 09:19:00 pm »

I have one of the top docs and liver center in the US., he prescribed Epclusa due to Harvoni
failure (resistance) My insurance denied treatment and I'm F4... I believe the center will advocate for me on appeal..........I CANNOT BELIEVE THIS AGAIN !!

Dennis

badbradley · « **Reply #24 on:** July 28, 2016, 09:16:03 am »

Hi tmf2, GS5816 (NS5A component of Epclusa) has potent activity against clinically significant Geno type 1 NS5A Polymorhisms and RAV's

Has potent activity against common Geno type 2 and Geno type 3 Polymorphisms and RAV's

GS5816 is fully active against NS3 PI, NS5B NI, and NS5B NNI RAV's

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&cad=rja&uact=8&ved=0ahUKEwjdm82hlpbOAhVDw4MKHZGCB5oQFggoMAE&url=http%3A%2F%2Fwww.natap.org%2F2013%2FEASL%2FEASL_34.htm&usg=AFQjCNEeZLypi_KdnQtXwSrKasOd3LyXlA&sig2=lfn5UwM8ZkgDxOzRl4ijfA

Resistance is not a legit reason for denial when retreating with the second generation NS5A med. I am sure your Doc is aware of this. You may want to write your own letter of appeal as well and include this information along with anything else you think may be relevant. Sorry you have to go through this. Keep on them. It sounds like you're very proactive in your treatment so I have no doubt you will be approved. Best of luck.

FutureThinker · « **Reply #25 on:** July 28, 2016, 12:19:13 pm »

tmf2 ---- makes me so mad we are continuing to have to thru this @$^* for our medical needs! Since you are F4, I am confused as to why this isn't being approved quickly, as that has been their excuse for a long time now, not high enough of a F score.

Just keep fighting them, write your own letter and get together with your doctor's staff to be SURE they put EVERYTHING possible in your appeal letter. It is so draining, I remember all too well -- but you need this medication and they need to pay for it!

I had to take my denials to my state ins. board; is that an option for you? Also -- I wonder if and when this will be available in generic form? Anyone have any info on that? FT

tmf2 · « **Reply #26 on:** July 28, 2016, 01:08:23 pm »

Quote from: FutureThinker on July 28, 2016, 12:19:13 pm

tmf2 ---- makes me so mad we are continuing to have to thru this @$^* for our medical needs! Since you are F4, I am confused as to why this isn't being approved quickly, as that has been their excuse for a long time now, not high enough of a F score.

Just keep fighting them, write your own letter and get together with your doctor's staff to be SURE they put EVERYTHING possible in your appeal letter. It is so draining, I remember all too well -- but you need this medication and they need to pay for it!

I had to take my denials to my state ins. board; is that an option for you? Also -- I wonder if and when this will be available in generic form? Anyone have any info on that? FT

It is so frustrating Allegiance acts as a management for self Insured county workers... they are quick to point out they are not an insurance company, but yet they are the ones denying treatment, so the state Ins board has their hands tied. I went all through this on trying to get approved for re-treatment of Harvoni. Did a letter pointed out ASLD guidelines etc (was denied on appeal) prior to my Resistance bloodwork which resulted in RAVS thus I dropped the second appeal. Maybe they think I will roll over again and forget the issue. Not going to happen !

Dennis

Dennis

FutureThinker · « **Reply #27 on:** July 28, 2016, 02:01:37 pm »

I am so sorry to hear this re: the mgt. co., as I know that Blue Shield wouldn't have budged if the state had not told them to pay for my Harvoni. I have not yet received the "cured" label yet, have my SVR12 blood work due in 2 weeks, and I seriously doubt that if I happen to show a relapse, they will cover a round 2 as I am a F1-2. So I could be in your same boat in the near future...... adds a lot of unnecessary stress to our lives, doesn't it?

There have been several patient advocates recommended on this forum, if you browse around I am sure you can find them. I think both Coach Mike and Lucinda Porter have given names, so check that out.

DO NOT GIVE UP!!!!! Keep us posted, FT

FutureThinker · « **Reply #28 on:** July 28, 2016, 05:45:08 pm »

tmf2, here are the resources I mentioned earlier..... they are apparently the same organization:

From Lucinda: hepatitis.pafcareline.org 800-532-5274

From Coach Mike: Brendan Bietry, Case Mgr.
Patient Advocate Foundation
POB 635158
San Diego, CA 92163
patientadvocate.org
same phone # above

FT

elias · « **Reply #29 on:** September 25, 2016, 06:15:17 pm »

I see that AbbVie is running Phase II of its own pan-genotype combination as of April 2016:

Quote

AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress

See more details at:

https://hepatitiscnewdrugs.blogspot.com/2016/04/abbvie-abt-493-and-abt-530-forgenotypes.html

Was presented at the International Liver Congress in Barcelona back in April 2016

Note the very high SVR-12 rates for GT2 and GT3. I realize its still at early phase

But. I'm thinking if this pans out, it will not only give more options for other GTs, but perhaps lead to lower cost for Epclusa. Does that make much sense?

Does anyone know if they have begun Phase III with this yet? Are there ongoing Clinical Trial Studies? I can't find anything on this more recent than April

andrew j · « **Reply #30 on:** September 27, 2016, 05:51:59 pm »

You could contact AbbVie.

elias · « **Reply #31 on:** September 27, 2016, 08:30:18 pm »

Yes. It does seem this AbbVie pan-genotype combo is in now in Phase 3

Seems they divided it into several studies based on the respective GT. So there are several going on concurrently. Unfortunately, they are no longer recruiting new participants. Its good thats its sort of in the pipeline, but no clue how long before it gets approved . if ever. Phase 2 results were remarkable, as far as I could tell!!

Heres link to the Phase 3 study for GT2:

https://www.clinicaltrials.gov/ct2/show/study/NCT02640482?term=NCT02640482&rank=1

elias · « **Reply #32 on:** October 13, 2016, 11:37:05 am »

Yet another reason for pan-genotypals.

https://www.dovepress.com/consequences-of-inaccurate-hepatitis-c-virus-genotyping-on-the-costs-o-peer-reviewed-article-CEOR

So not only might someone have more than one genotype, but the testing itself may at times yield erroneous GT.

It would seem the pan-genotypals are the way to go.

Strike5223 · « **Reply #33 on:** November 01, 2016, 12:57:01 pm »

First treatment:
On my 5th week of Epclusa, GT-3. Don't even know I'm taking anything! - no side effects(maybe a few more naps

Just got 4 week lab tests and the Hep C Virus is UNDETECTABLE already

Rosie13 · « **Reply #34 on:** November 01, 2016, 01:18:56 pm »

Strike5223 ! Excellant news! your liver says Thanks..I can relax a little now!May the rest of your journey be smooth sailing.Happy for you!

KimInTheForest · « **Reply #35 on:** November 05, 2016, 02:51:02 pm »

Quote from: Strike5223 on November 01, 2016, 12:57:01 pm

First treatment:
On my 5th week of Epclusa, GT-3. Don't even know I'm taking anything! - no side effects(maybe a few more naps
Just got 4 week lab tests and the Hep C Virus is UNDETECTABLE already

Good going, Strike 5223! I was GT-3 also. Wish Epclusa had been around when I started treating the previous May (2015). We didn't even have Sovaldi+Daklinza at that time. So I did Harvoni+ribavirin. It worked but did a number on me health-wise that I am still unraveling. Mainly the riba, I think.

Wishing you continued good results on your road to being cured!
kim

Strike5223 · « **Reply #36 on:** November 05, 2016, 03:58:42 pm »

Thank you, I am grateful I decided to get treatment when I did! I was diagnosed in Oct 2007 and the doctor handed me a kit for injections! The side effects and the fact that I am an alcoholic, kept me from getting treatment. I have been hospitalized several times in the last 2 years and quit drinking this April. The doctor told me there was a new pill and here I am.

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Author Topic: A Hep C Treatment for All Genotypes (Read 24148 times)