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

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
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Avatar universal
thanks for this hawk!

Pete
Helpful - 0
446474 tn?1446347682
"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
Helpful - 0
163305 tn?1333668571
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.
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Avatar universal
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
Helpful - 0
446474 tn?1446347682
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
Helpful - 0
3242225 tn?1348336521
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.  
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