A long time since I have been on here. Long story short...62 yrs old...35 years Hep C. Cirrhotic. Tried Interferon/Boceprovir, massive allergic reaction damaging left temporal lobe of brain. Cognitive, memory, organizational conceptulization, psychosis ( Hello !)
Battled back....train 7 days a week. Lift weights heavy. cardio. swim, more blah blah.
Geno type 1...Have recently been told by case nurse that Sofosbuvir is at least three years away from being on the market for geno 1s. I was taken aback to say the least. Was hoping for another kick at the can. If anybody is up to speed on Geno 1 trials and possible market dates I would greatly appreciate it. hector..if you are out there bro...I think of you often...hope all is good...and if not good at least better. Thanks in advance to all .
"massive allergic reaction damaging left temporal lobe of brain. Cognitive, memory, organizational conceptulization, psychosis?"
From peg-interferon, boceprovir or ribavirin?
"Lift weights heavy. cardio. swim, more blah blah."
So you have no portal hypertension? Lifting heavy weights lead to variceal bleeds in people with portal hypertension.
On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection.
The data submitted in the NDA support the use of sofosbuvir and RBV as an all-oral therapy for patients with genotype 2 and 3 HCV infection,
and for sofosbuvir in combination with RBV and peg-IFN for TREATMENT-NAIVE patients with genotype 1, 4, 5 and 6 HCV infection.
Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013.
My trial was the first trial for the treatment of cirrhotics. I am now starting week 36 of treatment. Minimal side effects. Fatigue is about it. There is also one other trial that is active for treating cirrhosis patients with and without portal hypertension. Data may not be available until 2014 at the earliest. So we don't know if Sofosbuvir and Ribavirin will work in cirrhotics.
You could try the actively recruiting trial ...
"GS-7977 and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation"
This is a multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 weeks in Patients Infected with Chronic HCV with Cirrhosis and Portal Hypertension with or without Liver Decompensation. Approximately 50 subjects (25 per group) will be randomized (1:1) to either receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.
Contact: Jonathan Kong 334-***@****
Aurora, Colorado, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
It could be some time before other treatment is available if you can't do peg-interferon. I would recommend talking to a hepatologist who has fully evaluated you to decide if and what treatment you should try.
Waiting around with cirrhosis is NOT a good idea ever and as you get older liver disease tends to speeds up. Also being a male with hep C has an increased risk of liver cancer (HCC).
HI...I am same old story too but with different side effects from earlier treatments than you. Wow...you got hit hard. Hector is a blessing and always gives the best advice, information and knowledge.
because this is a subject so close to him.
I have a question though...I am stage 4/geno 1 ESLD cirrhosis with decompensated liver. What stage are you and is your liver compensated or decompensated?
It took the last two years that even tho I was accepted for triple therapy and gilead that he was going to take me off of them because my liver was decompensated and the side effects that I would have at this stage with my liver in the stage it is would be awful based on what side effects and experiences I had had with all the other trials I had gotten into.
Plus, it took him a very serious talk to get through to me that since my liver was decompensated that even if I survived another trial of drugs, I would still have to have my liver transplanted. Why did I want to put myself through this drug phase which could actually kill me at this stage if not make me radically sick when I still had to have my liver transplanted any way because of the decompensation.
So is your liver compensated or decompensated?
What is your Meld?
What stage is your cirrhosis?
This info helps people like Hector guide you better. My doctor has stated to me that by the time I have my transplant there will be a pill, (no riba, no interferon, no shots,) that I will qualify for to get rid of the Hep C. He told me to get my liver healthy first at this point....get rid of the HE complications and then let's get rid of the HCV. So that is what I am doing.
65 and female...athletic and active. You can read my past posts and you will see that I not sedentary. I don't have the medical knowledge of this like Hector and a few others do but I do have the life experiences of 10 people...and of this stupid disease. Thank God I am the preverbal optimist since right now I am still dealing with acceptance and denial of this whole thing. I've always been the strong, fearless one able to overcome any obstacle.
Hector asked you a good question too...what does your doctor have planned for? And he is right, on this you can not wait. Hector and some of the other posters on here have been very helpful in walking me down the path to sensibility and knowledge. Good luck to you...keep us posted.
Thanks so much Hector. Seems like my case nurse was right. It might be a while for Geno 1 etc before a non Peg/Interferon drug hits the market.
I am getting ultrasound every 4 months to check for portal hypertension and liver cancer. So far so good. Next test is June 5th. I hope things are improving for you. How can they not...so many people keeping you in their thoughts and prayers.
Thank you for your reply. I am stage 4 cirrhosis/fibrosis compensated. Frankly if I did not know i was sick...I would not know lol. My doctor has nothing planned as far as I know. There is nothing to plan. I am allergic to Interferon. Period.
My plan is to stay informed ( hence this inquiry ) meditate, train and go as hard and as long as I can. Devil take the hindmost. Thank you again. Take care.
How are you. What a treat to hear from you. I very much hope you are well. I checked your profile.....You Won! Yaaaay. Thrilled beyond words for you. Very cool. Thanks so much for the contact info. I will get back to you soon...probably with a private message. take care.
If they were of the notion it was the INT. and not the protease then waitng until there is an INT-FREE therapy avail . or possibly being able to enter one of the trials for such as suggested would be an option.
However the reason I mention this ...if possibly it was moreso the protease you took the reaction to then I know you are in Montreal and the next generation"protease " that "may" be avail and approved by "Health Canada" might be something to warrant a discussion with your doctor.(as it seems in PH2 and 3 trails ) there were far fewer sides.
Maybe look over this thread(below) I posted a few days back(As you know Health Can .is usually right on the heels of the FDA) and might be an option prior to the INF -free therapys being avail. (might being operate word 0
I was told that the trial may have closed for HCC/ pre-transplants Hector.
My trial nurse said she was running that in her clinic. I can't vouch she is correct or not.
This is also something that since the first small limited trial was successful there could be an ongoing larger something being looked at for future trials. Something could open up in larger expanded trials pre or post approval. Since this would provide a large unmet need...... I would expect further development. My next meeting I will ask, perhaps others might as well, but if the need is there.... I would expect to see it.
Don, it may be that you could be treated off label when sofosbuvir is approved for G-2's w/ riba. I would be surprise if that is more that 5-6 months. Even if it was looked at as maintenence therapy, it could keep you going.
Also off label it might be possible to treat with simeprevir, 7977 and riba. That would be a double off label. The drugs will be available and there is some data which exists from a previous collaboration....about 2 years ago. I saw a member who was close to 2 years SVR at this point, I think.
I don't believe non-IFN is in 3 years, more like 2 years and perhaps less. Gilead claims it will file late 2014 and it has a 6 month approval process. When I do the math it looks like 2 years or under.
But who really knows.....
Hey Don, glad your doing better. Courious on how your doctor decided it was the interferon and not the Riba? If it was me I would be nervous about ever even trying Riba again unless my doctor could prove it was not the cause.
Plus it seems a little confusing here as you were never on the Boceprevir or the Incivek but was just in the lead in phase... Right?
"Thanks for the clarification...if that is the case .."
Yes it can be confusing and more so when one does not understand treatment protocol for treating with Victrelis as there is a 4 week lead in before one starts the PI...... While both Incivek and Victrealis are PI's there are different treatment guidelines....
"I did my third injection and my body exploded. Shoulders to ankles huge crazy rash."
Correct. As such I am considered
treatment naive" I have an appointment on the 5th June. One question I will be asking is if there is a test to determine exactly what I was allergic to...the interferon, or the Riba. Although I saw an Dermatologist at the time the report was that I had "an allergic reaction without specifying the cause. Dumb...I should have pinned them down. Was just to shattered. Thank you for your reply
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