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Why Sovaldi+Olysio at this point?

I think I've complained about my Gastroenterologist on here before. He seems to be a tad out of the loop. I just saw him and he is suggesting I go on Sovaldi/Olysio where he is saying I have a 60% chance of SVR. Why would I do that since Sovaldi+Ledipasvir is supposed to be out this Fall/Winter with significantly higher success rates. I am a GT 1a, IL28B=TT, Non responder to Interferion treatments 3 times, and Relapsed 6 months after EOT of Telapervir+Int+Rib, Liver Biopsy stage 2-3. So glad I'm on this blog, I feel like I know more than my Doc about my disease sometimes. I just want him to get me on S+L when it's available, and then maybe make a move if that doesn't work out.  Anybody have anythoughts?
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Avatar universal
I understand all too well your need for a backup plan in the event that this treatment doesn't clear the virus. Isn't it wonderful to know that there is an opportunity for you to have a backup plan!

My husband completed his treatment (Sovaldi/Low dose Ribavirin for 24 weeks) on July 30th. We have had a "backup plan" in place since day 1.
He is now waiting for his 4 week EOT HCV RNA test results. He is having a great week probably for the first time in many months. Labwork came back with improvements holding steady, no HE, appetite is back, and just feeling generally stronger.  So even if the virus does return, it was worth it.  

AND...we do have a backup plan!   :-)

Nan
Helpful - 0
Avatar universal
My bottom line thinking as I am in the midst of playing with insurance for Sovaldi/Olysio is that if the s/o fails me then I have Sovaldi/Ledipasvir as my backup. It would mean that if I started s/o mid-September, go 12 weeks, wait 12 weeks to determine SVR it will be mid-February when I could apply for Sovaldi/Ledipasvir and then wait another 4-8 week's for approval and it would then be March at the earliest for the new tx.
Hmmm, had not written that out until now.
Back to the drawing board... :)
Helpful - 0
Avatar universal
I just started Sovaldi/Olysio last week, and I really wanted to get the Sovaldi/Ledapasvir combo, but I missed out on a study and it is not yet FDA approved. My feeling is that as a 1a, treatment naïve with F1 that I have a shot here.  My concern is that after I finish this treatment, if I relapse that they will not give me another go with Ladapasvir.  But, here we go again with promises of a cure, and I have to take this shot.  Even if I relapse and have to wait months or the next greatest cure, it does buy me time.  I have lost a few friends to this monster in the past 41 years, so I think than anything I can do to keep going is the best I can do.  All I do know for sure is that everyone I know who has taken Riba or any of the interferon based "cures" has relapsed or become sicker.

I think it is still to early to know the relapse rate for a relatively small number of patients treated with S/O so far. I tend to go with real treated patients rather than studies because I believe many of the studies are dictated by the results they require to get the drugs approved, and keep the money train going for the manufacturers and doctors. Sorry, but I have seen too many people pushed into studies and drugs just for groups to get numbers, when it was doubtful they could be helped by what they were given.  10 years ago I was advised to go on a Peg Intron treatment, by a doctor who was doing a study. He knew I was 1a, but he still pushed. So I found another doctor who told me not to waste my time.  I didn't want to kill he good along with the bad, and he knew some new "stuff" was coming.

How can any of us know what will work. All we can do is take each day as a gift and trust that one of these combos will work.  I am confident, but cynical.  

L.
Helpful - 0
9662954 tn?1405606159
I have cirrhosis with portal hypertension and an enlarged spleen (my endoscopy was good enuf to forgo bands) and those were the drugs I was put on and only considered for? Sovaldi & olyssio. The drugs were approved in Nov and Dec 2013-- just not together.  The S&O treatment is off-brand re prescription...hence the need to get approval from insurance and funding from both insurance and pharm companies.  I believe I read Medicare approved this treatment specifically because of the "gold" standard of care.  However, like every single other treatment, extra time has always, despite the cost, been the better way to go for a SVR. I only did 12 weeks. My doc tried to get me approved for 24--I was turned down because it as still being debated.  That's already changed! The new treatment beginning Oct/Nov this fall, are 24 week/6 month treatment programs. If I do not have a sustained response on Sept 27th...that's where I will be for the next 6 months--la la land. I really hope not. However, knowing there are possibilities is nicer than what I went through last year!  Good luck you guys!  We are all in various stages and could do a study on al, of us to figure out what's what?  

Hmmm? Best, dbzc
Helpful - 0
9662954 tn?1405606159
Did you get tested for fibromyalgia? I did. It's what I picked up from three rounds of interferon. Aug 2012 and that pain has never gone away.  I was told myelin sheaths on nerves were stripped.  So bare nerves! The pain varies but def has a sappy electrical feel too. I changed my diet and added several B vitamins which helped but not ever fully gone. It seems this happens a lot post interferon...also joint and pain in general. I'm on low dose pain meds that I just take to avoid and extremes.  My liver doc had me see a pain management doc.  I'm glad I did this, finally, this past Dec. it sure helped me with the S&O therapy! My only biggie was crazy brain fog.  My memory is a bit messed up too, but that happened before the S&O. I was told that's a side effect of cirrhosis and stress.

Anyway, given how I felt before the S&O therapy, I feel a lot better! Yay! So so far so good.  I did find out it's three months, not 12 weeks post S&O to get the "big" SVR test.  So, that would be Sept 27th.  No more tests til then. :  )
Take care!

Compared to the previous treatments, S&O really was not that bad.  I had a nice mental break, since I couldn't think! You don't hold grudges, and each day is kind of ground-hog day...you just start over! Do take notes! Especially sleep, food, pills and mood for each day.  It also helped me keep track of what day it was and then I go look back if I forgot something.  I look at it now and am amazed at some of the stuff I wrote and as my daughter said, it started out nice and neat and morphed into telephone doodle-style!  My hair loss did increase, and eye sight got weird.  Like I said before the first four weeks were the worst for me, then things evened out and got much better--especially my sun-sensitivity!  Best wishes! Dbz
Helpful - 0
Avatar universal
"Was it ever considered to add Oyslio to your husbands mix? "

My husband's new liver already has signs of decompensation (portal hypertension and hepatic encephalopathy, CTP Class B). Recurrent Hepatitis C over the last two years since his transplant has caused the damage.

The hcv guidelines do not recommend a simeprevir based regimen for patients with signs of decompensation. His doctor told us he was not a candidate for the sovaldi-olysio treatment because of this.  For this reason he was put on the Sovaldi/Ribavirin treatment for 24 weeks. Though he may not reach SVR, it di stop the damage to his liver over these 6 months for which we are grateful.

Nan
Helpful - 0
Avatar universal

Having had x3 tx failures must be disheartening to say the lease. Being a non-responder to PegINF + Riba and Triple Therapy illustrates how insidious and difficult  to eradicate HCV can be for some. Have faith and fight the good fight on your next tx attempt.

You were treated in the past with 1st gen protease inhibitor (Teleprevir). The next gen of PI i.e. Olysio suppose to be more effective in attacking the NS3/4 protein. However, being tx with the newer class of PI may not be effective since you try PI in the past and relapsed after EOT. Some hcv clinicians have questioned using PI for a 2nd time when there was evident of virus break through during tx and/or hcv VL rebounding after EOT.

You seemed to be well informed since you've questioned your treating physician's selection of sofosbuvir and simeprevir. The choice is yours to make. I agree with HectorSF to go with SOF/LDV FDC. It haven't been approved yet but perhaps your doctor can make a case for SOF/LDV through compassionate use.

If you're Child A with a low MELD score, imo you can wait till fall. However, that's a call you and your doctor needs to make. If your liver has decompensated go for tx ASAP don't wait.

Wishing you long term svr with your next tx. Be positive. You can beat this beast. Peace.
Helpful - 0
Avatar universal
i think that the LDV combo will be early fall.. just a hunch considering how fast Sov was in the drug store livelife777

I was going to wait for it but since i am suffering from some unknown pain syndrome for 3 years now.. 1a treatment naive F2
i hope to reach SVR on Sov/Oly and maybe i will feel better.
I will feel better I will feel better…!

and they have more in the pipe line.. so keep the faith that one of the combos will work and with no side effects!

i researched a lot of pharm and bio companies, and a lot of the ones that were working on HCV meds in 2011 and 2012 were bought by Gilead. and the stock keeps going up!  wish we had money to invest a few years ago.unfortunatly I have not been able to work finch spring of 2011... the rich get richer…

but we will be cured! We will have a good life…who need lots of money?
just enough is ok and having good health and love is worth more than cash and material things.
best to everyone!
Helpful - 0
Avatar universal
Someone mentioned that a BMI of <25 during treatment was a factor in achieving SRV. That's were I was when I started the S/O treatment back in March and wasn't the case when I was on the triple therapy two years ago. I also took my dose at 6:30 in the evening and went and worked out for an hour at the gym usually two hours later. I'm a compensated cirrhotic 1a and keeping my fingers crossed, was UND at 7 weeks post EOT. Three more weeks to go for my 12 week.

Someone posted that Sovaldi is at it's peak two hours after taking the dose. It might be that by reducing the miles of capillaries that the drugs are being distributed through and also by exercising at peak hours might be a factor in achieving SRV. I knew someone that cleared the virus years and years ago while on the old duo therapy. After every shot of interferon, then 3 days a week he got on his bike and road 12 miles. He lost a lot of weight during the treatment and his doctor took him off the treatment in just a couple of months.

It's looking as though for a lot of advanced patients the data is leaning towards adding ribivarin to the mix to boost the SRV numbers with the new drugs coming out later this year and the next. The test below is from a study that was conducted in New Zeland.

"Perfect Results for Sovaldi/Ledipasvir, But Only With Ribavirin"

"Similarly, a group of participants with genotype 1 and decompensated or Child-Turcotte-Puge Class B cirrhosis who also did not take ribavirin only had a cure rate of 65 percent (13/20). Finally, those with genotype 1 who had failed a previous attempt at therapy with Sovaldi and ribavirin were all cured (19/19) with triple therapy.

Thus, it would appear that, at least for the subgroups treated in this study who fared more poorly without the drug, ribavirin may remain a necessary adjunct to a 12-week course of Sovaldi/ledipasvir therapy."
Helpful - 0
Avatar universal
Great article Nan.  Was it ever considered to add Oyslio to your husbands mix?  
48 weeks, looks like a slam dunk on the fall approval.
Gibson girl.   I had Sovaldi in my hand Jan 15th
Sovaldi13, looks like you have your best shot with the proper meds
Glen. Again so sorry, but you're also looking good for the fall
Seems like alot of trial and error in the past
...Kim
Helpful - 0
Avatar universal

when was Sovaldi available at the pharmacy?

Gilead applied for LDV approval via break through therapy in Feb and the FDA has 60 days to approve or deny, then they should be making the medications as we speak..

although i can't find it here..

http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM380724.pdf




here is the SOF approval Dec 6th
http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM376885.pdf
Helpful - 0
446474 tn?1446347682
Yes, why Sovaldi/Olysio now? Based on all of your "host factors" that you mention...(GT 1a, IL28B=TT, Non responder to Interferon treatments 3 times, and Relapsed 6 months after EOT of Telaprevir+Int+Rib as well as having stage 2-3 liver disease) you would have a much higher chance of SVR (based on trial data) if you were to treat with ledipasvir/sovaldi.

The ledipasvi/sovaldi ION 2 study had individuals with host factors much like yours... GT 1a, PI treatment failure and non-CC IL28B. .

The ION 2 study evaluated the sofosbuvir/ledipasvir fixed-dose combination with and without ribavirin in 440 treatment-experienced genotype 1 patients. Importantly, patients who had failed treatment with the first-generation PIs, telaprevir and boceprevir, were eligible for inclusion in the study.

Patients were randomized to receive 12-week and 24-week therapy durations, the same design as the ION 1 study. Twenty percent of participants had cirrhosis, 41% to 46% were previous null responders, and 46% to 61% across arms had failed a PI.

Results:
12 weeks of treatment
LDV/SOF = 94% SVR
LDV/SOF/RBV = 97% SVR

24 weeks of treatment
LDV/SOF = 98% SVR
LDV/SOF/RBV = 100% SVR

"No significant differences in SVR12 by sex, race, baseline body mass index (BMI), HCV genotype, IL28B genotype, baseline HCV RNA, cirrhosis status, type of previous HCV therapy."

Due to these potential negative host factors and not having advanced liver disease, you might want to consider the waiting for more effective treatment(s) that will be available later this year or next.

Good luck.
Hector
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Avatar universal
I found the article very informative and thought it would be help to clarify some things for some of you out there. With so much information coming out, it can certainly get confusing on what is best.

I wish you the best in reaching SVR. Please keep us posted.

Nan

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Avatar universal
My husband has 13 days left on his Sovaldi/Ribavirin 24 week treatment.
He is GT 1a but was ineligible for interferon. He has F3/F4 fibrosis of his new liver due to recurrent Hep C .  Should he fail to reach SVR, the Sovaldi/Led is his backup plan also.  We're praying it won't be necessary.

Nan
Helpful - 0
Avatar universal
This certainly caught my eye from that article up there ^^^ thanks so much for posting.

"Therefore, in genotype 1b patients, I recommend sofosbuvir plus simeprevir, and in patients with genotype 1a, I recommend sofosbuvir plus simeprevir with ribavirin."

I'm 1b with low liver damage, guess I made the right choice treating now with Sovaldi Olysio, time will tell and/or I'll do the next deal....
Helpful - 0
Avatar universal
Thanks for that and that's kind of what I'm basing my thoughts on, I hope to treat with Sovaldi + Led this year.
Helpful - 0
Avatar universal
I think this is a timely article for you to read.  Another excellent post by "can-do-man" led me to find this article, written by his hepatologist, Dr. Paul Kwo. In it, he recommends the addition of Ribavirin in GT 1a's who are taking Sovaldi + Olysio. Continue reading below.

Post-EASL Update: Reconsidering Whether to Treat Genotype 1 HCV Patients or Wait for All-Oral Therapy
Paul Y. Kwo, MD - 5/12/2014  

http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/London%202014/Clinical%20Thoughts/CT%201.aspx

Excerpt from this article:
"In the United States, high SVR rates can currently be achieved in genotype 1 HCV–infected patients who are treatment naive and interferon eligible with the use of peginterferon, ribavirin, and sofosbuvir. This combination resulted in an overall SVR rate of 89% with a 12-week treatment course in the phase III NEUTRINO study. For patients who have been treated previously with peginterferon/ribavirin and those who are interferon ineligible, the combination of sofosbuvir and simeprevir with or without ribavirin has been recommended as a therapeutic option in the 2014 AASLD/IDSA treatment guidelines based on high SVR rates demonstrated in the phase II COSMOS study.

How I’m Currently Managing Genotype 1 Patients
In my practice, all genotype 1 patients are candidates for therapy at this time, although histologic disease severity strongly guides my treatment recommendations. For genotype 1 patients, we offer peginterferon, ribavirin, and sofosbuvir as first-line therapy, but we strongly encourage patients to consider waiting for the all-oral regimens that are likely only months away from FDA approval, particularly those individuals with mild disease (F0-F2) in whom deferral of therapy is unlikely to lead to adverse clinical outcomes. Given the phase III data that have been presented, I find that virtually all patients with milder disease wish to defer therapy in order to have the opportunity to achieve SVR without interferon. Moreover, patient monitoring is significantly less complicated without use of interferon, even with the shorter treatment courses currently recommended for genotype 1 patients. This approach also applies to patients with milder disease (F0-F2) who have previously failed treatment.

By contrast, patients with advanced fibrosis, including those with F3/F4 fibrosis, are given the option of receiving therapy now. These individuals require careful assessment of the degree of advanced fibrosis as they are at risk for decompensating and are also screened regularly for hepatocellular cancer. In a subanalysis of the phase III NEUTRINO study, high SVR rates were reported across all degrees of fibrosis following treatment with 12 weeks of sofosbuvir, peginterferon, and ribavirin, with patients having proven histologic cirrhosis by biopsy demonstrating an SVR rate of 78% whereas those with F3 fibrosis demonstrated an SVR rate of 89%. By historical standards, these are excellent SVR rates but are still numerically lower than rates reported from recent phase III all-oral therapy trials. After careful assessment, if I am confident that a patient’s fibrosis level is F3, I can tell them that they can safely defer therapy if they wish and that they will be followed closely, or they are offered peginterferon, ribavirin, and sofosbuvir or simeprevir with sofosbuvir, if available to them.

In my practice, patients with cirrhosis are all offered therapy. The phase II COSMOS study demonstrated high SVR rates with 12 weeks of sofosbuvir plus simeprevir with or without ribavirin in patients with F3/F4 fibrosis (94% to 100% in F3 fibrosis and 86% to 91% in F4) in both treatment-naive patients and null responders, and this is my preferred regimen in this population given the numerically higher SVR rates, regardless of whether the patient can tolerate interferon or not. In the COSMOS study, relapse was only seen in patients with genotype 1a HCV, of whom 2 of 3 relapsers had the Q80K polymorphism that is present in almost one half of genotype 1a individuals in North America and reduces susceptibility to simeprevir. Therefore, in genotype 1b patients, I recommend sofosbuvir plus simeprevir, and in patients with genotype 1a, I recommend sofosbuvir plus simeprevir with ribavirin. This option is particularly beneficial in patients with greater degrees of advanced fibrosis and portal hypertension, who are less likely to tolerate interferon, and in whom the CUPIC cohort study recently demonstrated that platelet count < 100,000/mm3 and albumin < 3.5 g/dL were associated with a significant risk of decompensation and/or severe infections.

There are of course circumstances that may necessitate immediate therapy initiation in patients with milder histologic disease, such as those who have significant extrahepatic manifestations of HCV infection (such as membranoproliferative glomerulonephritis). In addition, some patients do not wish to defer, regardless of disease severity. In my practice, these individuals are offered either peginterferon, ribavirin, and sofosbuvir or simeprevir plus sofosbuvir, if available to them. It is estimated that there are at least 500,000 individuals with advanced fibrosis in the United States, and it is this group that represents the highest priority for initiating therapy now. However, those with genotype 1 HCV will likely have FDA-approved all-oral therapies available to them by the end of 2014, with SVR rates that could not have been imagined 5 years ago."

Hope this was helpful in some way.

Nan
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Avatar universal
I'm sorry to hear about your relapse. I think I felt the same way last October when I relapsed from the Telaprevir treatment. Hope we both get SVR soon and I'm definately waiting, I have way to many negatives.
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Avatar universal
I am now a non believer in S&O for geno 1a's.I am seeing too many relapses for 1a's on this treatment.I didn't even have a chance to finally enjoy being negative when I saw my 1 month post treatment bloodwork and it was back(which I already knew due to my side effects)I was told by the lady that draws my blood that she had 2 more relapsers the previous day doing the same treatment.On that note I will leave the ball in your court.
                           Good luck    Glen
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