When Will We See GS 7977 with Riba on the market?

[Doofus_jones]

I have been reading such good things about the Gilead Sciences GS 7977 trials. Do any of you amazing HEP C Sleuths out there have any info about WHEN this drug is likely to come into general public usage? OR does anyone have experience on how to track down and get into a trial of the drug?

Good luck to you all, and me!

Pete

[tiggermidnight]

I just saw the outline of this report on the web.  They are saying 2015.
http://www.sbwire.com/press-releases/hepatitis-c-therapeutics-market-to-2018-expected-launch-of-gs-7977-in-2015-will-pave-the-way-for-an-oral-interferon-free-combination-therapy-173597.htm

[hrsepwrguy]

"Will she be able to script me 7977 with If but not Riba?"

Yes but it would be off label

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration.[1] In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication.[2] If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.

The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC).[3] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label

http://en.wikipedia.org/wiki/Off-label_use

[mythoughts]

I am a geno 3. Due to all sorts of extenuating circumstances - incl. co-infection with Hep B, my doc is recommending that I take 7977 with IF but NOT Riba.

Will she be able to script me 7977 with If but not Riba? Everyone keeps talking about 7977 with Riba getting approved. This would have to be on the open market, as I am ineligible for trials do to the Hep B.

Thanks guys!

[child24angel]

WOW!!! good for you!
Now your MELD is at 11? that is truly wonderful!!
I didn't see this before!!

My son had labs twice a week after a MELD of 20

All my best to all

Hugs
Elaine

[orphanedhawk]

We all  hope the meds are approved soon.

We  expected the triple treatment to be available  two years or so before it was approved. My hepatologist said in late 2009. It wasn't until May 2011.

My advise to anyone waiting, is to be cautious. Nobody knows how long it will take.

[Skidude]

Phase 3 trials for 7977 and 5885 w and w/o riba are starting now.  They are moving faster because the treatment and SVR phase is shorter.  Approval in 2014 is my guess.

[UKgirl55]

Oh yay.....You're a CC!!!!!!!!!!!!!

[Fmulder]

When big pharma decides people before profits!

[Doofus_jones]

Dear Hector

You're right of course. I tested TT on the iL28B test. But after hearing you were CC I'm wondering how reliable that test is. My first week has gone really OK. See the Dr on Friday.

Best to you and thanks for your valuable input.

Pete

[HectorSF]

"a MELD score has not even been discussed. "
The MELD score is used for patients with cirrhosis who are waiting for transplant to determine how ill they are and prioritize them on the waiting list. Since you only have stage 3 fibrosis, it isn't relevant to your situation.

I agree that now that you have started treatment let's see how you respond to treatment. As a genotype 2 you have a very high likelihood of success with this treatment.
Our discussion could be all a mute point if this treatment cures you.
Let's hope.

Cheers!
Hector

[BoceprevirGal]

  Yes, hang in there Pete, and lets just hope that
your virus will go undetected quickly, on the Interferon/Ribaviran; good luck~

[Doofus_jones]

hmmmm - food for thought Hector. In my case, to my knowledge, a MELD score has not even been discussed.

Now that I have started the RIBA and interferon course (I started this course as much from advice here as from the pressure from the doctor)  I think I should persevere at least till I see how well I have done after the one month check. Then it may be time for a second opinion.

I really want to thank you for sharing your knowledge with me and taking time to write such a thorough explanation. You are very kind.

Pete

[Doofus_jones]

thanks for this hawk!

Pete

[HectorSF]

"stage 3 fibrosis - My doc says I will be dead in 5 years."
What is your MELD score?

No one can predict how long someone will live.
If they could there would be no need for a MELD score which is how transplant centers decide who is the sickest at that time and need a transplant. Everyone could know when they are going to need a transplant.

Every patient has there own course of liver disease. It is individual. There are two many unknown factors to say this will happen then this. No doctor can predict when you will have bleeding varices or refractory ascites or go into a coma from hepatic encephalopathy. If they could than most of these advents could be prevented. Many End-Stage Liver Disease patients die of complications of cirrhosis not liver failure. Is that predictable? Obviously not. Variceal bleeding, infections and hepatic encephalopathy comas are common causes of death in ESLD patients.

When a person's liver is failing with a MELD score above 25 it can change quiet often. So blood test are done more often. When a person gets near liver failure it can change daily and fluctuate wildly between 20s and upper 30s. For example when one has a bleed or other complication.

MELD score uses statistics for "average" patients. Based on groups of people. What will happen to any individual is particular to that individual.

Lab Test Frequency

MELD score greater than or equal to 25; Labs needed every 7 days
MELD score 24-19; Labs needed every 30 days
MELD score 18-11; Labs needed every 90 days
MELD score less than or equal to 10; Labs needed every year

I have had cirrhosis with portal hypertension since at least 2007 if it wasn't for my liver cancer I am no where near dying of liver failure. In fact my MELD score has gone down over the last 2 years. I used to have a MELD score of 18-19. Now my MELD score is 11. And this is before I started hep C treatment so I am guessing my liver will improve even more. Who could have predicted that?

I don't know you full health condition and would not even try to guess your prognosis. In my experience no good hepatologist tells a patient you have x years to live. There are other means to influence patients to treat. Frightening them, in my opinion, is not a good approach. Educating them so they understand the risks is a better approach.

I am not basing my opinion on my own illness but the other 100 transplant patients I have met over the last number of years and heard their stories of what happened to them so that they needed a transplant. No two are alike.

In the end the choice is yours own. Based on your knowledge, values and priorities in life. This is where the relationship between patient and doctor is critical. Communication is essential. It builds trust between the two. Ultimately it is the patients decision as to what they want to do.


Cheers!
Hector

[orphanedhawk]

I know you asked Hector but I'm going to interject an experience concerning the 5 year prediction.
When I was diagnosed I already had decompensated cirrhosis with ascites.
The doctor told my husband I had about 5 years.
I did treatment and  relapsed.
My liver transplant was 4 1/2  years after the original diagnosis.
The point being, my liver disease was much further advanced than yours, and I was told 5 years, which turned out to be pretty accurate.

[Doofus_jones]

Dear Hector

What you write is very interesting. The sum of knowledge I get from here is that for my case - with stage 3 fibrosis I'm better off getting on with the interferon and riba. My doc says I will be dead in 5 years if I don't. I'm suspicious of his prognosis though as medicine is all private here in Hong kong and he is charging like a wounded bull for my treatment.

I guess my question would be, in your experience is he right?

best

Pete

[HectorSF]

Waiting for Gilead's all oral treatment is not the crisis that some people appear to believe it is. Will it be on the market in 2013 or 2014??? Does a year make any difference in the amount of liver disease someone has? Rarely. Only in those borderline patients transitioning to cirrhosis and portal hypertension and those who are close to decompensating.

Most people can wait 2-3 years without any substantial change is their liver fibrosis. And people are deciding to wait for interferon free treatment. Sales of anti-virals at Vertex and Merck have slowed after last year. Sales could slow down further due to the warehousing effect as patients postpone treatment while they await the entry of all-oral treatments.

For those with cirrhosis it appears the new all oral treatments may completely change treatment for those with advanced liver disease. We will have to see the data from the upcoming trial with compensated and decompensated cirrhotics with portal hypertension to see if these patients who are at best difficult if not impossible to treat (most decompensated patients currently) can complete treatment and achieve SVR as well as my own trial data in those awaiting transplant for liver cancer.

Time will tell as more data becomes available. As we know nothing is guaranteed in the clinical trial world.

Cheers!
Hector

[8nickers8]

I am confirming what UKGirl55 said.  The 7977 and riba for geno 2's and 3's is in Phase 3 trials now, which are the last phase before they apply for FDA approval.  7977 and 5885 for geno 1's will be beginning some Phase 2 trials shortly.  

[orphanedhawk]

Thanks for filling me in.

My knowledge is limited to a summary given to me by a geneticist relative involved with HIV.
I do know it takes time and often it's longer than we would hope. That certainly was the case with teleprivir.
We all are hoping the orals are approved sooner rather than later :)

[FrontRangeMom]

The delay in approval is not primarily with FDA as they have made commitments to give a 6 month review for priority drugs. A lot of time gets eaten up with the sponsor acquiring and auditing data, doing the statistical analysis then getting concurrence from FDA that the data analyses are done the way the Agency wants to see them. Then there is the Agency review and LOTS of negotiation on the labeling. That doesn't even include the manufacturing and analytical portion of the application. It's a very labor intensive process, one that I've lived through a number of times.

[UKgirl55]

Gilead are going to apply for approval in 2013. It will be used for geno 2's with Riba and with IFN for geno 1's. In 2014 they hope to have FDA approval for their 7977+5885 (all orals) for geno 1's.
Well....that's the hope and I don't see why that can't happen.

[orphanedhawk]

No offense but the truth is nobody knows because the FDA has to approve the meds. My hepatologist is up on research and goes to the liver conventions.
He guessed that the triple treatment would be available a good two years before it was.
It really isn't up to the doctors.
First there are the various stages of clinical trials then, it is up to the FDA.
And we all know how long things can take with government agencies.
The earliest projection I've heard is 2014.

[penn1023]

I have a hepatologist appointment Nov 20 something so I will get the scoop of probably of availability then.

[Doofus_jones]

Hector

Very best wishes to you. And thanks to the fabulous life-giving researchers and scientists who created the new drug.

I'll post my results here as I go on.

Good luck to you, and me.

Pete