Starting Sovoldi and riba without interferon Geno 1b

[Upbeat]

Doc says this is going to work for me but I don't know.  I told him I thought I needed Olysio as well and he said no. I don't believe he was aware of the Cosmos trial with both togeather.  BCBS has approved 48 weeks.  Who know how this will play out

[Tekelcat]

I guess you don't have time on your side. If you did, you could wait for the sofosbuvir/ledipasvir with/without riba to go through FDA. I wish you all the best.

[Willy50]

I was going to PM this but.....
it is worth a consideration for anyone else
=========
IMHO, at issue is the efficacy rate.

The TX w/ Sovaldi and riba "worked" to *clear* (achieve undetectable) I think in nearly all, but did not work in achieving SVR in all

If you do the double TX (as planned, Sovaldi and riba) I actually think your odds of success are quite good.  

I just don't think it would have as high a cure rate (as aforementioned triple) , the known outcome would be delayed dramatically and the relative unknown about the effects of riba are somewhat of a wild card.

I did 21 weeks of Sovaldi, Ledipasvir and riba and suffered some sides that remain (even w/ a riba dose reduction at week 12.5).  I know some people might not be able to maintain 48 weeks of riba without reduction.

What happens to the efficacy of dual therapy for 48 weeks in the population that dose reduces or shortens TX? (I don't believe this would be a large group, but there is little actual data, the best would be the 24 week G-3 extended gilead arm)

Just to be clear, I think that the Sovaldi with riba is a very good treatment, particularly with your G-1b status.

Regarding adding an additional drug after resistance is formed to existing drugs, it would be sub-optimal timing, IMHO.

Understand, I provide only discussion of concepts, not a suggestion of what you should do, since I don't know enough to make such suggestions. : )
It's a great idea to vette ideas with doctors, on boards and accumulate information, conviction and then action. : )

Good luck, I'm pulling for you.
willy

[Upbeat]

Thanks for the imput. It is greatly appreciated.  Hector and I talk.  He is my view into my future.  I am on the transplant list in Tucson and at Mayo in phoenix. My biggest problem is the different approaches I receive from different liver docs. everyone has a different opinion on how to usr the new daa's. I was thinking if I started Sovoldi and it did not work maybe i could include Oysio later.  I asked Gilead about it but never got a reply.  Anyhow thanks again, I will continue on my Journey and see where it leads me

[Willy50]

George Burns used to say; "timing is everything"

http://www.medhelp.org/posts/Hepatitis-Social/Travelmom--Amandawere-back-/show/2082106

: )

willy

[Willy50]

I don't sense disagreement with what I wrote.  The point is that the dual TX (sovaldi & riba) is not 100% effective.  
I am in no way saying that Hector or his doctors make a poor choice in TX; they made an excellent choice and perhaps the only choice available at that time. I believe Hector wrote that he may have held the record for being on that drug combo longer than anyone, perhaps in the world.  Sometimes the best, merely isn't *quite* good enough.

The question may be for Upbeat..... are there any other superior options available?

It may also be true that as a 1b Upbeat may not require the longest or strongest form of TX to clear or cure (Hector by comparison was a past null responder)  but given the presence of HCC it seems to me that it is more critical that success is achieved than perhaps compared with a generic stage 2 treating who has ample time to retreat if a treatment fails.

I've no issue with what anyone else posted, I'm just introducing another possible line of thought on an alternative TX option. (and one that Upbeat also considered and mentioned)

There are daclatasvir/sovaldi trials also starting but HCC would rule out participation, so at present, the method I suggested may be the only dual antiviral available with FDC approved drugs and some limited clinical trials data.

In Europe they are strongly considering the compassionate use in critical cases of these DAA drugs, and I would suggest that this case may also be analogous.

I would still consider Hector a great resource, no matter what form of TX Upbeat is able to use, or for the issues of HCC or transplant. : )

willy

[can-do-man]

"Given that you may also be walking the same path that Hector did, you might also write him for his recommendations."

Hector was in the above trial for people awaiting transplants that Pooh posted and had a very fast response to treatment and stayed und through the 48 weeks. But as we all know he was not able to get transplanted and soon relapsed. But Hector and his team of doctors felt it bought him enough time. Hector as we also all know has since had his TP. I'm sure he will be gearing up for another round ASAP.

[Willy50]

You have HCC and you need to treat NOW and it needs to be successful the first time out, if at all possible.

First off.... the sooner you clear.... and by that I mean totally as in SVR.... not merely below quant, below detection the better. You must be aware that your chances are good with the combo (SOV and RBV), but there is still a risk of not clearing completely.

I also have to wonder; wouldn't the cost of triple therapy (Sov, Oly, riba.... for 12 weeks?) be less than the cost of 48 weeks Sovaldi and RBV?

Wouldn't the cure rate be more certain?  The treatment shorter? The allied risks due to 48 weeks of RBV, less?

It's just a thought. (I realize I am preaching to the choir since you already mentioned it)

One other thought; they can also test for resistant subspecies prior to TX. If your subspecies are "X" you may be in like flint.  OTOH, if they are "Y" it may reduce your chances of success.

I guess my point is that you cannot afford any window in a reduction of treatment effectiveness.

I am sorry to hear about the HCC and I hope that you get this beat, and soon.

Given that you may also be walking the same path that Hector did, you might also write him for his recommendations.

best,
Willy

[pooh55811]

I did not know your entire situation. I am sorry that you have HCC. I know you have a difficult road ahead but hopefully things will work out for you.

I also second Can-do's sentiments.

Maybe your doctor is trying to get you Undetectable for your liver transplant, if that is what is in the plans. Sofosbuvir and Ribavirin do work for that reason. They have worked well to get people Undetectable for transplants. Then the transplant takes place while the person is still Undetectable and hopefully, after the transplant, the person stays Undetectable. From the articles I have read, this works.

Perhaps you have read these articles, but if not, here is the information on pre transplant treatment with Sofosbuvir and Ribavirin:

http://www.natap.org/2013/AASLD/AASLD_31.htm


"Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation
SOVALDI was studied in HCV-infected subjects with hepatocellular carcinoma prior to undergoing liver transplantation in an open-label clinical trial evaluating the safety and efficacy of SOVALDI and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection. The primary endpoint of the trial was post-transplant virologic response (pTVR) defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks post-transplant.  HCV-infected subjects, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria (defined as the presence of a tumor 5 cm or less in diameter in patients with single hepatocellular carcinomas and no more than three tumor nodules, each 3 cm or less in diameter in patients with multiple tumors and no extrahepatic manifestations of the cancer or evidence of vascular invasion of tumor) received 400 mg SOVALDI and weight-based 1000-1200 mg ribavirin daily for 24-48 weeks or until the time of liver transplantation, whichever occurred first. An interim analysis was conducted on 61 subjects who received SOVALDI and ribavirin; 45 subjects had HCV genotype 1; 44 subjects had a baseline CPT score less than 7 and all subjects had a baseline unadjusted MELD score ≤14. Of these 61 subjects, 41 subjects underwent liver transplantation following up to 48 weeks of treatment with SOVALDI and ribavirin; 37 had HCV RNA < LLOQ at the time of transplantation. Of the 37 subjects, the post-transplant virologic response (pTVR) rate is 64% (23/36) in the 36 evaluable subjects who have reached the 12 week post-transplant time point. The safety profile of SOVALDI and ribavirin in HCV-infected subjects prior to liver transplantation was comparable to that observed in subjects treated with SOVALDI and ribavirin in Phase 3 clinical trials."

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm


Best of luck. Let us know how things go.

[can-do-man]

Well guy you just got to stay "upbeat" in your situation. I remember you have treated before but don't remember if you relapsed or was a non-responder? I do know you've been here awhile and sure deserve to become SVR. I really feel for you long timers fighting this crap.

Best of luck to you.

[Upbeat]

Its a little more involved with my situtation.  I have hcc  and  who knows how it will work for someone like me,  I had a heck of a time getting BCBS to cover Sovaldi  I can't amagin trying off label.  Then there is convincing the doc I need both and there is some problem with Oysio and the anti rejection drugs after transplant.  For the most part this is all trial and error at this point.

[pooh55811]

OC treated with Sofosbuvir, Ribavirin, and interferon for 12 weeks.

http://www.medhelp.org/posts/Hepatitis-C/Gilead-Rollover-Study/show/1922935

[pooh55811]

The approved Sofosbuvir regimen for Genotype 1 includes Sofosbuvir, Ribavirin, and Interferon.

Sofosbuvir and Ribavirin without Interferon are not approved as a treatment regimen for Genotype 1.

"For patients with genotypes 1 and 4, the FDA ruled, the drug should be used in combination with interferon and ribavirin"

http://www.medpagetoday.com/InfectiousDisease/Hepatitis/43305

And from Gilead:

Genotype 1 or 4            

Sovaldi + peg-interferon alfa + ribavirin          12 weeks duration
           
http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c


If you do not want to do Interferon, then your doctor can treat off label with Sofosbuvir and Simeprevir   (Sovaldi and Oysio).


OC treated with Sofosbuvir, Ribavirin, and interferon for 12 weeks.

[48weeks]

There is at least one guy in this forum who is a 1b who just celebrated 24 week SVR after doing Sovaldi for just 12 weeks.  Here is a link to his thread and his moniker is OC, GOOD LUCK!!

http://www.medhelp.org/posts/Hepatitis-C/24-weeks-post---SVR/show/2079041#post_9861759