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4896357 tn?1360670904

All The Talk Of New Drugs, I'm Lost...

There has been so much talk about so many new drugs. Is there a new tx coming soon that does not include interferon and that shows promise for non-responders of triple therapy?
Best Answer
Avatar universal
Also head  it called "elastiscan" but "fibroscan" is same measures livers elasticity as whole and far better than biopsy I just started Sovaldi/RIBA 24 weeks as my liver genotype 3A and likely early cirrhotic so,can'  wait- what about Obamacare/ ACA they subsidize folks who cannot afford insurance and the insurers are covering the scandalous $1000 pill price as it is likely one  time,pay vs. say HIV meds at $40k/yr for life - hate Ribavirin but far better without the peg interferon alpha,I took in 2009' but got site infection and too many side effects- I cleared in. 4 weeks but stopping at week 6!4rebounded nd gt3 maybe easier to cure but its most aggressive so want to bite hand that may seme for killing Daclatasvir phase 3( the FDA ***** too for letting a 98% cure phase 3 be killed and hence people be killed for their rolling over)  
Yep- killing for dollars- evil bastards! Having fibroscan next week so will be good to know liver state- optimistic I will clear but wish I was getting Sovaldi/Daclatasvir or GS-5816. 12 weeks lower side effects! BitetheHand!
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4896357 tn?1360670904
Thank you again. Right now I am studying the tx info link you gave me. Yeah, I went out all night New Years Eve in Detroit and had 4 or 5 drinks. So shoot me. No more though until I treat and clear this virus. Can we make that toast apple cider? :)
Helpful - 0
683231 tn?1467323017
Hi Carl

Sure I understand about breaking the rules. I had a beer when having a family dinner 3 years ago after my older brother passed away.

I dont believe viral load has anything to do with alcohol consumption or even the level of liver damage. I have heard of people with low viral load and cirrhosis and high viral load and liver doing ok. Even liver function tests have little to do with extent of damage. I think of a slowly simmering pot not a lot of heat but the water is still slowly boiling away.

Best of luck to you and a root beer toast!

Cheers,
Lynn
Helpful - 0
Avatar universal
This is website that I consider the most informative and especially useful when dealing with doc or insurance....

HCVguidelines.org.....updated 3/21/2014

The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA) and the International Antiviral Society USA jointly issued new guidelines for the treatment of hepatitis C this week. The guidelines recommend how the newly licensed direct-acting antivirals sofosbuvir and simeprevir should be used in the treatment of all hepatitis C virus (HCV) genotypes. The guidelines will be updated regularly as new data and agents become available. New sections on eligibility for treatment, monitoring of treatment and management of acute infection will be added soon.

"It is important to keep in mind that FDA only will approve drugs that have gone through rigorous testing," said IAS-USA panel co-chair Michael Saag from the University of Alabama at Birmingham. "We cannot run a Phase 3 trial on every possible [drug] combination or every possible patient population. The website allows experts in the field to look at the emerging data and craft what we feel the evidence supports, [which] may fall short of what is specifically in an FDA-approved package insert."

"For genotype 1 patients who cannot take interferon, the panel recommends sofosbuvir plus the HCV protease inhibitor simeprevir (Olysio), with or without ribavirin, again for 12 weeks. This off-label regimen has not been through full Phase 3 testing, but performed very well in the Phase 2 COSMOS trial.
An alternative for this group is sofosbuvir plus ribavirin for 24 weeks, though the panel noted that it is not as effective as sofosbuvir plus simeprevir, especially for patients with liver cirrhosis."

"For patients infected with genotype 1a HCV, baseline resistance testing for the Q80K polymorphism may be considered. However, in contrast to using simeprevir to treat a genotype 1a HCV patient with PEG/RBV when the mutation markedly alters the probability of an SVR, the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir, because the SVR rate was high in patients with genotype 1a/Q80K infection (SVR12 rate for cohort 1 was 86% [24 of 28 patients]; SVR4 rate for cohort 2 was 90% [10 of 11 patients]). To date, virologic failure has not been observed in patients in either cohort infected with HCV genotype 1b and with HCV genotype 1a in the absence of the Q80K polymorphism. Thus Q80K testing can be considered but is not strongly recommended."

Class 1
Conditions for which there is evidence and/or general agreement that a given diagnostic evaluation, procedure, or treatment is beneficial, useful, and effective
Level A
Data derived from multiple randomized clinical trials or meta-analysis

"Sofosbuvir is a prodrug of a nucleotide analogue inhibitor of the HCV NS5B RNA-dependent RNA polymerase. The phase 3 NEUTRINO trial evaluated sofosbuvir (400 mg daily) in combination with PEG (2a) (180 μg by subcutaneous injection weekly) and weight-based RBV (1000 mg to 1200 mg daily) for 12 weeks in 291 treatment-naive patients with chronic HCV genotype 1 infection. (Lawitz, 2013b) The SVR12 for patients with genotype 1 infection was 89%. SVR12 did not differ substantially by baseline characteristic but was lower in patients with cirrhosis (80%) than in those without cirrhosis (92%). (Lawitz, 2013b)"

Class 1
Conditions for which there is evidence and/or general agreement that a given diagnostic evaluation, procedure, or treatment is beneficial, useful, and effective
Level B
Data derived from a single randomized trial, or nonrandomized studies

"Alternative regimens for treatment-naive patients with HCV genotype 1 who are not eligible to receive IFN.
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [<75 kg] to 1200 mg [≥75 kg]) for 24 weeks is an acceptable regimen for IFN-ineligible persons with HCV genotype 1 infection, regardless of subtype; however, preliminary data suggest that this regimen may be less effective than daily sofosbuvir (400 mg) plus simeprevir (150 mg), particularly among patients with cirrhosis."

The American Association for the Study of Liver Diseases and the Infectious Diseases Society released Recommendations for Testing, Managing, and Treating Hepatitis C. Guidelines from these two medical associations carry huge weight, as many medical providers use this expert advice in their own practices. These guidelines are simply written and public, allowing patients access to the latest advice from leading authorities on hepatitis C.

Genotype 1 Hepatitis C Patients

New to Treatment
Those able to take pegylated interferon (PEG): Daily sofosbuvir and weight-based ribavirin (RBV) plus weekly PEG for 12 weeks

Those unable to take PEG: Daily sofosbuvir plus simeprevir with or without weight-based RBV for 12 weeks


Cosmos trial....

"All patients who completed treatment were HCV RNA undetectable at end of treatment and there were no viral breakthroughs in either cohort 1 or 2. The COSMOS study interim results show no benefit from adding ribavirin to simeprevir and sofosbuvir in this difficult to treat groups of hepatitis C patients and that 12 week treatment may confer similar clinical benefit to 24 week treatment."
Helpful - 0
4896357 tn?1360670904
Great info that I was looking for! Thank you. Still studying. I'm aware of the effects of alcohol. I decided to have a few drinks on New Years. I am staying completely dry until I can treat again so that I start out hopefully with a low VL. I never had a drinking problem, I just made a decision to break the rules one night and go out and have fun.
Helpful - 0
Avatar universal
Was happy to see GT1 for F3/4 with Q80K results was 100% w/o riba....

http://www.businesswire.com/news/home/20140412005023/en/Medivir-Final-Data-Phase-II-COSMOS-Study#.U0mY4GYo7rc

Cohort 2

Final results from cohort 2 of the phase II COSMOS study demonstrated that 93 percent of prior null responder and treatment-naïve patients with genotype 1 HCV and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks.

SVR12 Among Patient Subgroups with Genotype 1 HCV and Advanced Liver Fibrosis/Cirrhosis in Cohort 2 of the COSMOS Study*


12 Weeks of Treatment


Regimen Simeprevir/Sofosbuvir (%) Simeprevir/Sofosbuvir + Ribavirin (%)
Overall 93 93
Genotype 1a HCV without the Q80K polymorphism 88 93
Genotype 1a HCV with the Q80K polymorphism 100 88
Genotype 1b HCV 100 100
METAVIR F4 86 91
*Excluding non-virologic failures.
Helpful - 0
683231 tn?1467323017
I think you are thinking about the Q80K polymorphism. Olysio has a weakness there but when used together with Sovaldi off label the Solvaldi seems to help. My Dr didn't test me for Q80K as the reduction in effect seems to be a few percentage points one way or the other.

Also please no more alcohol ever not even a glass of wine for New Years. Alcohol works synergistically with the hep c virus as in poring gas on a fire adding more fire and more gas. The effect on the liver of hep c or alcohol alone is multiplied exponentially when together. If you have financial difficulty now imagine the effect of liver failure and hoping to get a transplant and the the costs of transplant.

How you feel physically is not an indication of how well your liver is functioning. But the time you have symptoms you liver disease is well advanced. I felt fine the year they told me I had cirrhosis. Working out at the gym working full time went on a back packing trip that summer.

An nan mentioned in a post the cost of Sovaldi and Olysio are high. Specifically Sovaldi costs to buy it straight out 84,000 dollars for a 12 week treatment while Olysio costs 66,360 for the same amount of time.

I am thinking if there is some way you could get insurance it could cost you less in the long run. Also both drug companies have help lines to provide information about how to get the medicines you need.

Best of luck
Lynn
Helpful - 0
Avatar universal
Yes, the fact that you failed triple tx (as did my husband), is a strong indicator that you respond poorly to interferon.
Your best course of action is to see if your doctor will prescribe sovaldi/olysio or wait for sovaldi/ledipasvir in the fall/end of the year.

Advocate1955
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4896357 tn?1360670904
I think so too. Does this affect my future possible response to peg-interferon & ribivirin with one of the new drugs? I know there is a genetic factor but I cannot get that test.
Helpful - 0
683231 tn?1467323017
Some definitions of response to HCV treatment from the FDA


Populations described in FDA Draft HCV Guidance

Naïve: received no prior therapy for HCV (including interferon or pegylated interferon monotherapy)

Null Responder: less than 2 log10 reduction in HCV RNA at week 12 of a Peg Interferon/RBV regimen

Partial Responder: greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a Peg-Interferon/RBV regimen

Responder Relapser: HCV RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow-up

So from this I would think you are a partial responder

Helpful - 0
4896357 tn?1360670904
Also, I never achieved und but came very close. Then it went back up so technically I guess I am a null responder. And the reason that I did 26 weeks of tx was that it took 2 weeks to get the 24 week VL test results.
Helpful - 0
4896357 tn?1360670904
Thanks again for the responses. I'm just freaking out a little because of some symptoms I'm experiencing. Maybe it's mostly just anxiety. IDK. I was able to obtain the meds free through compassionate care at no cost to the government. Insurance will hit me with big deductibles and co-pays. I will discuss assessing my liver condition and the insurance mess with my doctor. Sorry about the delay in responding. I'm not on here everyday. I do read and study and consider every response.
Helpful - 0
Avatar universal
There is an extreme likelihood of two seperate IFN free forms of treatment approved in about one year.  
I think the gilead Sovaldi/ledipasvir combo will be approved 4th quarter 2014 (under a year)
The abbvie TX will also be along in that time fram, maybe a tad later, but close.

When used with RBV both will have a success rate of 95-100%, and I infer you are a responder, not a null responder, so your chances will be very good of success.

I am not certain you really need a biopsy, since it will not radically change your treatment. However if you were in a hurry the Sovaldi with SOC is currently available right now.  

At the risk of introducing the affordable healthcare act..... why not look into buying insurance and treating that way? You might do a cost comparison between the two methods.

I believe there will be a similar program for assistance, there is currently for Sovaldi (although some may fall short or between the cracks)

There are and there will be more trials.....once more option.  My trial included a free biopsy (since I tested for near cirrhosis several ways) which revealed showed stage 2 damage.

No real answers, but a few ideas....

willy
Helpful - 0
Avatar universal
Possibly talk with your physician about having a "fibroscan (recently FDA approved) in conjuction with a "fibrosure' blood test .

These two in conjuction are a relatively good diagnostic tool for fibrosis used more frequently now by many physicians..

best to you.....
Will
Helpful - 0
4896357 tn?1360670904
I don't know the condition of my liver other than the fact that an abdominal CT scan was normal. A biopsy would be difficult to swing as I may need to pay for all of that cost and if there are no tx options for me then why bother. If there is a tx then I would make it happen. My Dr had mentioned an ultra-sound but I don't think that would be conclusive enough.
Helpful - 0
Avatar universal
Here is a clinical trial which may or may not be good for your particular condition. It's for patients with advanced liver disease and/or transplant patients. There are many participating locations.

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

Good luck

Nan
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Avatar universal
Your question:
Is there a new tx coming soon that does not include interferon and that shows promise for non-responders of triple therapy?

I think the most responsible answer to your question is how long can your liver wait?  What condition is your liver in?

From what I've been reading, the best possibility for a cure is  new drug combo that will not be out until late 2014 at best.  The trials are showing a 90+ SVR. The findings suggest that the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV, irrespective of treatment history or the presence of compensated cirrhosis.

If your liver can't wait for a pill that may or may not be available in late 2014, then your best bet may be sofosbuvir + ribavirin for 24 weeks which is available now. That is what my husband will be starting soon.  

Perhaps others will respond with other possible options for you.

I wish you the best.
Hang in there.

Nan
Helpful - 0
4705307 tn?1447970322
I really don't know.and it seems to me no one knows for sure. All I do know is what is and has happened to me. At times I feel as if I am talking to pharmaceutical sales people.
I would imagine the shoe business would not be going so well at this time, with the weather and all.
I am sorry to hear your VL stayed so high after 6 months.
Also I was told if I were not UND by week 12 ( 3 months ) there was no reason to continue to tx. Strange they let you go so long with such horrible results. Seems you suffered alot for nothing.
As far as what to speak to you gastro dr about, that truly is another issue.
I was supposed to be scope from both ends. Never made my PCP and Hep C Dr. agree, waiting for anymore invasive tx was a good idea.
It is true though when a person losses hope then nothing can save them.
Happy New Year, keep up the good fight!!!!
Before long you'll be able to go out on your boat and relax, good luck in finding a crew.
Tim
    
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4896357 tn?1360670904
I never achieved undetectable after 6 months of ribavirin, peg-interferon and victrellis. My final viral load test was around 12,000 if I remember right. I paid for the viral load tests and CBCs. The drugs were sent free through a compassionate care program from Merck. The expense was a hardship in this tough economy which has my business way down but I have credit lines. I do not know the extent of my liver damage. Let me worry about the cost. I'm just wondering if there is anything out there for me that I should discuss with my gastroenterologist. I see him in less than two weeks.
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4705307 tn?1447970322
It's true there are out, but your next concern is the cost. According to my PCP, this is going to be problematic especially if can't even afford the VL tests as I recall was a basic problem some months ago. But might I asked have you relapsed? And if so what is your VL?
Helpful - 0
Avatar universal
"non-responders of triple therapy"  Peg/Riba  + VICTRELIS® (boceprevir) or INCIVEK® (telaprevir)?
What genotype?  cirrhosis statis? other liver etc conditions are all relevant
Coming soon  3 months 6 month? - Off label and trials(clinicaltrials.gov)
In 9 to 15  months hopefully FDA will approve one or more

You can look trough the topics at this site as other members have posted about it

also
check News and Updates at
Hepatitis C New Drug Research And Liver Health
2014 HCV - Interferon-free combinations - at: http://hepatitiscnewdrugresearch.com/2014-hcv-interferon-free-combinations.html


Not sure about for non-responders of triple therapy
-from SOVALDI prescribing info
SOVALDI in combination with ribavirin for 24 weeks can be
considered for CHC patients with genotype 1 infection who are
interferon ineligible.
 Should be used in combination with ribavirin for treatment of CHC
in patients with hepatocellular carcinoma awaiting liver
transplantation for up to 48 weeks or until liver transplantation,
whichever occurs first.
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