valcyte

[nelle]

what a beautiful group this is. thanks for all the responses & the warm welcome. & of course, the hope. i love hearing when any of us with this brutal disease finds improvement - so glad that you are also in that group, jeff.

thanks for letting me know your experiences with valcyte & how you have approached it. after talking with all of you, i have no issues with cutting the pills. i made an appointment to see lerner on wednesday & will see what he says.

i'm still having the bad auditory inflammation & thus really severe tinnitus, though i developed severe tinnitus probably 8 years ago. which is when the disease really picked up speed on me. i lost the physical capabilities last - it was 8 years ago that i lost things like reading, etc.. more of the neuro stuff. though my cognitive issues date back to my late teens.

i am really hoping that the too high of a dose didn't too permanent damage to the brain tissue in the auditory area. i would have started cutting pills & trying lower dose today, but will let the next few days play out.

ginger - vistide infusions are antiviral infusions given for the herpes viruses. only lerner & peterson have been doing them because it is a complicated procedure that requires short stay at hospital of several hours. labs day before & day after infusions to make sure they aren't blowing out your kidneys. it is referred to as "the hammer" for obvious reasons. lerner is now putting most of his patients with multiple viral reactivation on vistide. supposedly better tolerated & more effective than valcyte. i think it is at least 6 infusions every 2 weeks. definitely landing higher functioning people than i am in bed. but then they seem to rise up. what i don't know is how well it is working with high cmv levels. most of the people i know who have done it have high hhv6. & all of them have been higher functioning than i am. the one person whose viral profile most matched mine & was far higher functioning couldn't even complete all 6. but she had vast improvement after stopping.

hard to get stats on any of these things. i can't see how i could contemplate vistide while alone - i would need a caregiver & i have no money for that.

 

[Sushi]

vistide infusions are antiviral infusions given for the herpes viruses. only lerner & peterson have been doing them because it is a complicated procedure that requires short stay at hospital of several hours. labs day before & day after infusions to make sure they aren't blowing out your kidneys. it is referred to as "the hammer" for obvious reasons.

Vistide will be available in a much easier and safer oral forum soon. The "before approval" name was CMX001. It now has a name but I forget what it is--you can google it to find out. I also forget where it is in the approval process, but close I think. I will, no doubt, cost the earth!

Tip: when replying to someone, either quote them by selecting the text you are responding to and clicking on reply under the selection or typing @nelle (their user name.) This way they will be notified that you have replied to them.

Sushi

 

[Ema]

Brincidofovir, @Sushi!

 

[Gingergrrl]

@Ema Is brincidofovir and vistide the same thing (except pill form vs. IV?)

 

[Ema]

@Ema Is brincidofovir and vistide the same thing (except pill form vs. IV?)

Vistide is the brand name of cidofovir which is given IV.

Brincidofovir is the name of the new oral form of cidofovir.

 

[Sushi]

@Ema Is brincidofovir and vistide the same thing (except pill form vs. IV?)

It also has a much lower risk.
Sushi

 

[nelle]

@Sushi - thanks for the tip... @Ema- thanks for the name.. i had heard that it was on fast track back in 2013. i thought the ebola situation would push things further. how do we really get a sense of where it is. they won't push without a market, i imagine.

 

[nelle]

I am so suffering still with very severe tinnitus. Like a freight train in my head. That is the only symptom that hasn't eased since stopping Valcyte (last dose Friday). Though my head does seem to inflame more easily. Is it possible i could have done permanent damage or does it just take time for things to ease off?

 

[SOC]

I am so suffering still with very severe tinnitus. Like a freight train in my head. That is the only symptom that hasn't eased since stopping Valcyte (last dose Friday). Though my head does seem to inflame more easily. Is it possible i could have done permanent damage or does it just take time for things to ease off?

I wouldn't worry about permanent damage at this early date. There's really no way to know, so thinking about it won't help anything.

If there was permanent damage (which seems the less likely option) nothing you do now (including worrying) is going to change that. If it is temporary, then it will clear fairly soon -- you just need to wait a little longer.

 

[nelle]

@SOC - thanks . That was just what I had been telling myself about 20 minutes ago. But it is always reassuring to have the encouragement. & klonopin....

I so love u guys. Xoxo

 

[SOC]

@SOC - thanks . That was just what I had been telling myself about 20 minutes ago. But it is always reassuring to have the encouragement. & klonopin....

I so love u guys. Xoxo

PR is a great place, innit?

 

[nelle]

absolutely. i should have joined a year ago. but glad to be here now.

 

[OnlyInDreams]

Brincidofovir (CMX001) is an experimental antiviral drug being developed by Chimerix of Durham, NC, for the treatment of cytomegalovirus, adenovirus, smallpox, and ebolavirus infections.[1] Brincidofovir is a prodrug of cidofovir.[2] Conjugated to a lipid, the compound is designed to release cidofovir intracellularly, allowing for higher intracellular and lower plasma concentrations of cidofovir, effectively increasing its activity against dsDNA viruses, as well as oral bioavailability.[3]

Brincidofovir is currently in Phase III clinical trials for use in humans against cytomegalovirus and adenovirus, after testing for safety in over 1000 human subjects,[6] and has received FDA Fast Track Designation for treatment of cytomegalovirus, adenovirus, and smallpox.[7] On October 6, 2014, Chimerix received an FDA authorization for emergency investigational new drug applications of brincidofovir for the treatment of Ebola virus disease.

In October 2014, Chimerix reported it had been given approval by the FDA to start Phase 2 trials in patients infected with ebolaviruses for brincidofovir's safety, tolerability, and efficacy.[12] A trial commenced during January 2015 in Liberia,[13] but was subsequently discontinued. Because of a lack of suitable subjects in Liberia, Oxford University and Médecins Sans Frontières planned to extend the trial to Sierra Leone, where there were still Ebola cases; but on the 30th of January 2015, the manufacturer decided to withdraw support for the trial and end discussion of future trials.[14][15]


So, they are going to focus on CMV and adenovirus testing instead of Ebola. It will remain fast tracked. I would suspect it to be commercially available first quarter 2017.

 

[nelle]

@OnlyInDreams - thanks for providing that information. 2017 seems worlds away. but glad to know that this possibility will become an option. i get the impression that both peterson & lerner are putting their patients through vistide infusions rather than using valcyte whenever possible. the way i got hammered briefly by valcyte really scares me about vistide. anecdotally i hear good things, though some patients are having to go back onto infusions several months later.

any sense if ampligen will ever get approval? or if we will ever have access to more doctors who will be able to treat us? with lerner in his 80s, he will be retiring sooner rather than later. i think he is only still practicing out of commitment to all of us who are so ill. but i sense it is still considered career suicide. as far as i know, no one wants to take over his practice. i bet the malpractice insurance cost of using drugs off label has to huge...

 

[OnlyInDreams]

@nelle - You're welcome.

Why do you have that impression? I am a former patient of Dr. Lerner. He said that my only treatment option was Valcyte.

I have no idea about ampligen. As for CFS doctors, they are a rare breed for sure. Try finding an open-minded local doctor that isn't concerned about malpractice.

The thing about Brincidofovir is that it has absolutely no side effects whatsoever. So I think most doctors would be much more willing to perscribe this vs valcyte.

Just pray that your insurance covers it though. You can bet the farm that this drug will be very expensive when it is released.

 

[nelle]

@OnlyInDreams - he changed his protocol in the last year & seems to be running majority of his patients with multiple herpes reactivation through the vistide infusions.

I see him this afternoon. Hoping to survive leaving the house.

 

[Gingergrrl]

I see him this afternoon. Hoping to survive leaving the house.

@nelle Best wishes for your appt (all of it- the travel, the discussion, the recovery, etc) and keep us posted what you learn and how you are doing.

 

[nelle]

@Gingergrrl - thanks. Dr Lerner does not consider Valcyte safe for me. It is no longer a treatment option. He seemed most concerned about my already severe tinnitus being pushed into extremely severe. (Seemed to abate a bitt today but being out has it amped bad again). When I asked of he thought side effect or too high of dose to tolerate/too much inflammation he only stated that I was on the proper dose.

I am to continue valtrex at 4 grams/day. End of treatment road

Tired & sad. & head is inflamed. Though I did expect this response. Can't think straight. So will rest. Appreciate all the responses regarding this.

He did a complete turnaround when I pointedly asked him if my prognosis was poor then. He said he never said that. That I have been sick a long time & it would take a long time to see any improvement. In prior appointments he has stressed the need for a different antiviral to go after hhv6 & cmv.

 

[SOC]

@Gingergrrl
I am to continue valtrex at 4 grams/day. End of treatment road

So what happened to the possibility of vistide? If that's your only option at this point for hhv6/cmv, wouldn't it be worth the effort to get the infusions? Or does he now think that's not safe for you, either?

 

[Butydoc]

@Gingergrrl - thanks. Dr Lerner does not consider Valcyte safe for me. It is no longer a treatment option. He seemed most concerned about my already severe tinnitus being pushed into extremely severe. (Seemed to abate a bitt today but being out has it amped bad again). When I asked of he thought side effect or too high of dose to tolerate/too much inflammation he only stated that I was on the proper dose.

I am to continue valtrex at 4 grams/day. End of treatment road

Tired & sad. & head is inflamed. Though I did expect this response. Can't think straight. So will rest. Appreciate all the responses regarding this.

He did a complete turnaround when I pointedly asked him if my prognosis was poor then. He said he never said that. That I have been sick a long time & it would take a long time to see any improvement. In prior appointments he has stressed the need for a different antiviral to go after hhv6 & cmv.

Hi Nelle,

I don't know your doctor, but he seems somewhat unapproachable. Your doctor is suppose to be working for you. He is suppose to explain to you what he is planning to do and why. You shouldn't leave his office before you have all of your questions answered. I suggest you write him a letter or e-mail and have him explain fully his recommendations.

Best,
Gary