great news!

[Jeff88]

Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C

http://www.gilead.com/pr_1804362

It came out even sooner than most of us expected.
Hopefully, it is a start of a new era in Hep C treatment!

[orphanedhawk]

"I know people have much more serious illnesses than HepC, especially children dying of cancer. "

Of course children dying of cancer is sad and tragic however, I'd like to comment that although for many people hep C is not a killer ( the virus affects people differently ) it is responsible for more deaths in the U.S. than AIDs. It's the number one cause of liver transplants and liver cancer and I would be among the fatal casualties of this insidious virus if not for a transplant.

[susan400]

This is great news if you are a treatment naive pt or are a genotype 2 or 3.  However, if you are a non-responder genotype 1, I can't see where this article says that those of us who fall into that category.., will be approved.  My doctors won't prescribe anything this expense and new, off-label-which is what it would definitely be for me.  For those of you who don't know, I have never cleared, never gone undetected-despite treating over 10 times.  Add to that-I'm also a Telaprevir failure pt.  Even the trial sites won't take me on-anymore because of my lack of response/Telaprevir failure, etc.  Fortunately, for me, my disease has not progressed and I've stayed pretty stable with regards to my liver disease.  I have just slightly elevated LFT's and minimal damage to my liver, even though, I've never cleared.  But, if I was a naive pt and a genotype 2 or 3, I'd be one of the first in line to take the Sofosubir.   Susan400

[ChrisDDD]

I've been thinking the same way.  I don't want to discourage anyone, but I've gotten my hopes up all three treatments I went through, only to be withdrawn for various reasons.  I don't want to get too technical.  First treatment Interferon-only and non-response.  Second treatment Peg-intron and Riba, no response.  Third treatment Infergen and Riba, retinal hemmorhaging and (guess what? ah-hah!), no response.

This is not to discourage anyone but to give a good, clear picture of what treatment was like.  I know people have much more serious illnesses than HepC, especially children dying of cancer.  I hope the new drugs work and all of us get well.

[ChrisDDD]

good point

[timothy141]

That is the info I grave!!! Cant seem to extrapolate it for myself, I feel so we-todd-id. Thank you and pooh. For your patience dealing with such a knucklehead as myself!  

[ActingBrandNew]

Indeed!

[nuhepper]

Thats encouraging! Surely we could adjust to a treatment without interferon and poly glycol (anti-freeze).  :-)

[ActingBrandNew]

Even though you are a G3 like myself...keep in mind that if you or I do relapse (God forbid) Sofosbuvir + Ribavirin are.....wait for it.....interferon FREE!

AND my friend...the study I posted above boasted a 62 percent SVR after only 16 weeks of therapy. I mean...it beats a blank.

I don't know...call me mister optimist....

[pooh55811]

I agree that getting an 8 week VL won't change Tx plans. I was DET at week 4 and would have done 48 weeks regardless. But it was sure encouraging to know that I was UND at week 8.

I can understand your concern about relapse and wondering what Tx is available if you do. Currently, I don't think there is another Tx available other than those that are now in trials.

I do know that low maintenance interferon was used in the past but I do not think it is currently being used as maintenance Tx. Someone will correct me if I am wrong about that.

I also know that, in the past, some people, when they have failed treatment, lost weight and lowered their insulin resistance in order to correct or change some of the negative host factors that may have been affecting Tx outcome. Some also treated longer and with higher doses. Whether any of that is an option for you, I do not know. I just know that some people have done it in the past.  

[nuhepper]

Thank you Pooh.


I know you had a DET VL at 4 weeks. Did you have an 8 week VL test? If so, what was the VL? Also, were you able to increase your Ribavirin dose to 1200 mg a day.

My doctor said it wouldn't make any difference if we got a vl test at 8 weeks because it wouldn't change his tx plans. We will get a vl test at 12 wks.  He did up the riba from 800 to 1000 after the 4 wk vl test.  Both he and his nurse are so much better than the Gastro place that I first went to that it just doesn't seem right to push very hard on alternate directions.  He was encouraged that the vl load had come down as far as it had given my age, weight and liver condition.

Actingbrandnew was concerned about his gen 3 virus coming back when his treatment ended.  That made me wonder what if it does and what then?

I wonder why we couldn't go on a low maintenance dose of tx just to keep the vl load low.  Or, is there another treatment to try?

You are most kind and helpful.  Thanks again

nuhepper

[pooh55811]

"What is copeg?"
------------------------------------------

Copegas is Ribavirin.


"If 48 weeks of inf and riba doesn't achieve SVR, then what tx is available? "
------------------------------------------

There are several trials which are testing new drugs and/or old drugs in various combinations and hopefully one or more of them will be effective in treating Genotype 3.

I am providing some links to articles on Genotype 3. They may not give you the answers you seek but they are informative and may give you a better idea of the possibilities.

http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02715.x/full

http://www.medscape.com/viewarticle/739955

The following link has several articles on which you can click:

http://www.hepatitiscnewdrugresearch.com/genotype-3hcv-treatment.html


I know you had a DET VL at 4 weeks. Did you have an 8 week VL test? If so, what was the VL? Also, were you able to increase your Ribavirin dose to 1200 mg a day.

While I know it is very concerning and nerve wracking, try to do the best you can to get through treatment and hopefully succeed in attaining SVR. We are all in the same boat so we do understand how serious and how concerning the treatment and the waiting can be.

[nuhepper]

Two questions for you.  What is copeg?

If 48 weeks of inf and riba doesn't achieve SVR, then what tx is available?

I am on tenth week of double tx and would like to know some probabilities.

nuhepper

[timothy141]

Okay so my attitude is really horrible...I get it. All of this is really hard to grasp, and that is worse than anything. I have been one who deals with absolutes, and in this there seem to be none.
My reality, I'm trying to understand how this nasty little bug can hide and come back after 48 weeks of peg/copeg  tx.
And of course that is so much undue stress, since I am truly only in week 19 of 48. My biggest fear is that I will not achieve SVR and at that point I will no longer be naive...I don't see anything related to G3's who are NOT naive with this new tx.  More undue stress...I just need to complete this tx, which is my goal and my hope. No to be a fly in the ointment.

[timothy141]

I don't get it, I still feel like Lil Timmy asking, " Please sir can I have some more....? The deeper we go the less likely am I to feel any better about being a G3 than I was before. I have come to find from the very beginning the misconception out there, is, being a G3 is some how different and easier than any other. The only difference I have come to recognize is we are screwed at a some what deeper level.    

[aqua1917]

Very witty commentary  today...feel free... :). I am sending good thoughts your way. Aqua

[jules2551]

Click on the above link from Cando

Hi Cando!

[hope1315]

thank you all for invaluable information!we learn so much from you!
thanks Jeff88 for the clarification!
i suppose there have not been any trials with the 3 drugs(sofosbuvir + riba + IFN) for GT1 null responders patients so we do not know any results

[can-do-man]

And interesting thread going on right now about geno 1 and treatments.

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

[Jeff88]

Just to clarify:

" Two groups of patients with HCV genotype 1 infection received sofosbuvir and ribavirin for 12 weeks: 10 patients with no response to prior treatment and 25 with no previous treatment."

They treated 10 patients who previously did not response with sofosbuvir and ribavirin ONLY. This treatment regime (sofosbuvirin +riba for 12 weeks) was not effective for previous non-responders (only 1 SVR out of 10). This regime (2 drugs), however, had a better response (84%) from 25 treatment naive GT 1 patients.  So for all GT 1 patients they recommend treatment with 3 drugs (sofosbuvir + riba + IFN) and this is how they file to FDA for GT 1.

[pooh55811]

Thanks for that data and information. This data ties in with what I have been reading so far. Looks like the new drugs are effective for some but not so great for others.

[can-do-man]

"and 1 of 10 with no response to previous therapy (10%) had a sustained virologic response at 24 weeks."

Yikes........ Thanks Jules

[jules2551]

Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C.
Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM.
Source

New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand. ***@****
Abstract
BACKGROUND:

The standard treatment for hepatitis C virus (HCV) infection is interferon, which is administered subcutaneously and can have troublesome side effects. We evaluated sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, in interferon-sparing and interferon-free regimens for the treatment of HCV infection.
METHODS:

We provided open-label treatment to eight groups of patients. A total of 40 previously untreated patients with HCV genotype 2 or 3 infection were randomly assigned to four groups; all four groups received sofosbuvir (at a dose of 400 mg once daily) plus ribavirin for 12 weeks. Three of these groups also received peginterferon alfa-2a for 4, 8, or 12 weeks. Two additional groups of previously untreated patients with HCV genotype 2 or 3 infection received sofosbuvir monotherapy for 12 weeks or sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks. Two groups of patients with HCV genotype 1 infection received sofosbuvir and ribavirin for 12 weeks: 10 patients with no response to prior treatment and 25 with no previous treatment. We report the rate of sustained virologic response 24 weeks after therapy.
RESULTS:

Of the 40 patients who underwent randomization, all 10 (100%) who received sofosbuvir plus ribavirin without interferon and all 30 (100%) who received sofosbuvir plus ribavirin for 12 weeks and interferon for 4, 8, or 12 weeks had a sustained virologic response at 24 weeks. For the other patients with HCV genotype 2 or 3 infection, all 10 (100%) who received sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks had a sustained virologic response at 24 weeks, as did 6 of 10 (60%) who received sofosbuvir monotherapy. Among patients with HCV genotype 1 infection, 21 of 25 previously untreated patients (84%) and 1 of 10 with no response to previous therapy (10%) had a sustained virologic response at 24 weeks. The most common adverse events were headache, fatigue, insomnia, nausea, rash, and anemia.
CONCLUSIONS:

Sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection. (Funded by Pharmasset and Gilead Sciences; ClinicalTrials.gov number, NCT01260350.).

www.ncbi.nlm.nih.gov/pubmed/23281974

[willbb]

Follow  the links (below). The info you are looking for in the clinical trails  are there ..

Basically the results showed:
Incivek:

For prev partials :   59%
and
nulls:   32 %

and Victrelis : partials: 40-52% (depending on time doing tx.)

These statistics are just that ..statistics garnered from clinical trials..

In -practice results are variable ,given many factors(race ,age,amount of liver damage as well as some others)

Best....

Will

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm



http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

[hope1315]

thanks so much can-do -man for your immediate answers!i am new to all this input and my poor english makes understanding things more difficult!
does anybody know what is the SVR rate for null or partial responers g1 of previous tx?