anyone else having major tinnitus,hearing loss and phantom hearing problems SX

[purplecat]

I found out yesterday(end week 20) I am in placebo group A prove 1 trial VX-950 so I have to do regular 48 week treatment did not receive VX950.  Vertex won't tell me my PCR until week 24 so I do not know if UND or not.  My ear specialist told me to have private blood test to find out PCR to decide now if I continue or chance permanent hearing damage if I decide to continue. Had blood test yesterday.  If I come back detectable then no brainer stop treatment. I'm end stage 1 grade 1 nodel so I do have time for possible more advanced treatment.  If I'm UND I have a 70% chance at this point to clear if I continue.  Do I chance hearing damage or stop?. Dr does not know if end TX tinnitus will stop. Shot 18 I started Phantom hearing with the tinnitus. I have had regular hearing test and no further damage.  1st test showed high pitched loss. They did not do hearing test before TX so no baseline to compare. I recommend new TX starters have hearing test also! I've never heard this SX to others.  Anyone else out there?  Must decide next week if UND what to do. Do I go on if UND and chance permanent hearing damage?  Any advice will be appreciated.

[orphanedhawk]

  Hey there .I don't know if this is the right place but. . . Congratulations on completing tx !!!  
      I'm post tx 5 1/2  weeks now and my last CBC showed my blood levels improving which corresponds with my energy and attitude. Enjoy your walks on the beach.
     I'll think of you while driving by to Santa Cruz.          OH

[purplecat]

I ended treatment 09August.  Post tx 9 days now.  Tinnitus not as bad but still there. Last hearing test showed improvement.  Go back again 24August.  Audiologist continues to monitor me on monthly basis.  I was told they will follow me for the next 6 months post TX. I'm still wearing my ear plugs when I go out to protect my ears from the hurtful sounds. I hope it improves once interferon is out of my system but it is still a wait see situation.  If not improved in 6 months then I will follow up with ENT for further therapy.  I find water sounds help me.  I live in Pacifica which is a coastal community and walking on the beach and the sounds of the waves relieves the intensity and makes me unaware of the ringing. It's a place I can go for relief and relaxing mediation. My friend has a fountain in her yard and I get a similar effect when relaxing in her garden.  I'll keep in tough on progress.



        

[caseymack]

Did you hearing loss and tinnitus ever get better. I have the same symtoms as you. Ended tx about 4
months ago but hearing loss and tinnitus are still with me. I'm afraid they are permanent in my case.

Thanks,
Caseymack

[purplecat]

I'd be nowhere if it weren't for this forum.  Right again guys-Vertex came back with VL today.
I'm 1B VL 6,250,000 predose Ishak stage 2 grade 1
Day 29 72,800
Day 57  658
Day 71  78
Day 85 UND-WEEK 12
I had lower dose of 135mcg 7,8 AND 9-I had weeks wrong earlier post

DR said 70% chance to SVR if I go on.  I see ENT about my ears on Monday.  Going to find out about Vascular or Neuro question. I will also check out the new post info and SVR chances. What more data on that percentage if I'm going to risk my hearing. Shall I chance the hearing thing? Is my leg vascular IFN thing related to my ear problem?  I got the Docs really doing their homework because of all your help.  Thanks so much.  Takes the weight off this decision to be armed with information!  

[pln]

Apk said "And BTW, Vertex confirmed that the PCR assay stops the down steps at 30IU/ml if no viral RNA is detected in the qualitative test at that sensitivity. Your read on this was correct.      So does that mean it only goes to 30iu, and if something is detected they test to 10? maybe I will catch on one day. Pam

[pln]

Hello, I also wanted to ask you on your two week post, did yoy take on monday also? and did you know the results by friday. Thanks Pam

[jmjm530]

All the best with your upcoming test. While only a "study" of 1, hopefully APK's negative test will allay some of the waiting anxiety.

Be well,

-- Jim

[jmjm530]

Of course, way to early to pop the cork, but being non-detectible at week 2 is certainly very positive considering the habit of the virus to frequently relapse within the first couple of weeks after stopping the drugs. The results of your Feb 5th draw will be even more telling, but if you're like me, you'll still be holding your breath until the 12-week post treatment draw and not pop any corks until 24 weeks post. Still, the 4-week post tx draw correlates around 90% with SVR, and the 12-week draw around 98%, at least with SOC, and see no reason why it wouldn't with VX-950.

Thanks for the info and if you get a chance try and ask your study nurse how the other 24-weekers are doing as well as any 12 weekers, if your center has them enrolled. The 12 week arm should have their 4 week results in by now, possibly even later test results.

All the best,

-- Jim

[pln]

Jim, I was reading the vertex site, and all groups (a,b,c,d) were started by mid sept. so group d (12 weeks) are aleast a month post. I asked my study nurse yesterday if she could find out any thing, she said she would try. I went monday for my 2 weeks post, will have Results friday, this is my second pcr since stoping tx. This is very very hard waiting . I hope we get some info soon. Pam

[APKhaos]

Jan 8 & Jan 22 PCRs were both UND.

[jmjm530]

Thanks. Do let us know when you get the results of your Jan 8, 22 and upcoming February 5th draw. Also, if you have a chance, maybe you could ask your study doctor if he's learned of any results coming in from the 12-week arm. I assume someone is in that arm but apparently no one here.

Be well,

-- Jim

[lab-rat]

You're right!  I'm so glad I didn't get a rash, or anemia or any of those GI problems (or tinnitus!).  The study nurse told me that my numbers look the best out of their group anyway...however she's referring to the numbers minus the VL (which we stll don't have).  That just means my LFT's look good (ALT 13/AST 24), and all the other numbers like hgb, wbc, anc, platelets etc. pretty much match my pre-screening numbers which were all fine.  The doc said he'd be very surprised if I were not responding, and frankly the treatment and clinical trial experience have been very positive for me, so I'm not complaining.  There was just that slight glimmer of hope before the actual unblinding that I may have a shortened treatment time.  Its no big deal for me to keep going on with treatment, I just hope it works!  

My starting vl jumped around a bit - I don't have the exact nbumbers in front of me, but in June 2006 it was 8 million, then for my first screen (7/28/06) it was around 3 million, then my second screen a week later, it was 6 million.  I was sort of surprised at how much it varied pre-treatment.  Anyhow, I'll post the results when I get them just for comparison sake.  I hope you're doing well and surviving your vx-less treatment!  

[jmjm530]

Now that I think about, with all the time and money invested, I can see why all the blood draws. Makes sense they want to know as close to real time as possible both the sustained response rate as well as the relapse rate, plus who knows how many other things they are examining in the blood.

-- Jim

[jmjm530]

Just to be clear, so your blood was drawn for viral load on Jan 8 (EOT),
Jan 22 (2 week post treatment) and next draw will be Feb  5th (4 week post treatment). Then viral loads will be drawn every two weeks thereafter for one year?

Very impressive that they will draw every two weeks post treatment for up to a year. And I thought I was neurotic post treatment drawing blood for viral loads at weeks 3, 6, 24, 36 and 48 (upcoming).

Do you know when you will be given the results on your Jan 8 and Jan 22 draw?

All the best luck with the tests.

-- Jim

[APKhaos]

Jim said, "So, what I'm assuming then is that the 1/22 draw is your first draw since finishing treatment with the exception of perhaps an EOT draw sometime close to 1/07?"

Thats right, Jim. The first post tx draw was 8 Jan, and the next one is next Monday [and every two weeks for the rest of the year]. So far, so good.

[jmjm530]

Yes, I now see that follow-up tests are every 2 weeks per the first post in this thread: http://medhelp.org/forums/hepatitis/messages/44524.html

So, what I'm assuming then is that the 1/22 draw is your first draw since finishing treatment with the exception of perhaps an EOT draw sometime close to 1/07?

-- Jim

[jmjm530]

Assuming the previously posted dates are correct, then the 1/22 date would be a 2-week post treatment draw, not a 4 week. The 4-week blood draw would then probably be on February 5th.

I'm then assuming that the VX trials draw blood both at the 2 and 4 week post treatment junctures and no doubt at close intervals after?

This all does get confusing, especially when even doctors start counting at different junctures, but I'm counting from the last shot (1/7), not the last riba dose on the 15th.

In any event, while the 4-week post treatment draw would probably offer more information, the post 2-week draw is also important since so many relapses happen very shortly after the treatment drugs are stopped. Maybe that's why we haven't seen any press releases yet because I'm pretty sure they aren't going to draw conclusions based on just a 2-week draw. I do wonder however when they will post the 4-week post treatment data for the 12-week dosing arm. Maybe someone in the Vertex trial can find out from their coordinator, or maybe indeed the coordinator knows people in that ARM and how they fared.

-- Jim

[APKhaos]

Yes, we are getting full lab panels and PCR every two weeks, along with periodic full physical exam, EKG, urinalysis, et al. I agree that its probably a nominal incremental cost to get the most timely data they can.

As to the PCR results, we are literally seeing the results as soon as they are available from Covance. No more delays since the blinding was lifted.

And BTW, Vertex confirmed that the PCR assay stops the down steps at 30IU/ml if no viral RNA is detected in the qualitative test at that sensitivity. Your read on this was correct.

[APKhaos]

I'm a Prove 1 lab rat, in Group C [24 weeks] and finished with dosing five weeks ago. From a high starting VL of 28,400,000, my VL went UND around day 15 and has stayed UND since then.

The tinnitus/phantom hearing thing was one of my nuisance SX. The thing that drove me crazy was the almost constant sense of hearing a phone ringing in the background. Don't know how many times I got out of the shower to check the phone [which is what you do when you have a 20YO & 18YO driving in DC, I guess].

Its basically gone now, just five weeks after dosing ended. No sign of permanent damage in my case, but seeing an ENT is the smart thing to do just in case!

[mremeet]

Labrat sorry to hear you weren't in the VX group. But you never know, you may have been one of the one's who got a major rash if you had been on the VX (and perhaps even had to drop out because of it). Lots of us either got the rash or constant diarreah - and some both. Just think of how much *fun* you may have been spared. So try to think of it that way, because you never know it might have knocked you off treatment altogether. In the meantime lets keep our fingers crossed your VL's look good across the board, including a fairly early UND status. I don't recall your starting VL, but if it's moderate to low, your odds are good. Plus you didn't experience any dose reductions, so you're doing as well as one could hope to be doing. And I'm sorry my theory about bitter and neutral tasting pills turned out to be correct in your case. Looks like APK is the only standout in the bitter/neutral=VX/placebo experience.

And speaking of which, APK how have your VL's been coming back? Haven't seen you report all your results yet. Plus you state above "I'm a Prove 1 lab rat, in Group C [24 weeks] and finished with dosing five weeks ago...Its basically gone now, just five weeks after dosing ended." I thought you stopped on January 7? That would place you at three weeks post treatment, not five. Remember?

[lab-rat]

Hi purplecat...welcome to the club!  Sorry I don't know anything about tinnitus, but I found out last Friday that I'm also in the placebo group.  While I wasn't the least bit surprised (I'd suspected it all along) - I'd be lying if I said I wasn't disappointed.  So we didn't get the fancy new drug and now we have 28 (or so) more weeks of tx.  I've been fortunate that I haven't gotten the nasty side effects and I haven't had any dose reductions (so I drew the long straw there!). My study nurse said she would fax my vl results when she gets them; probably about 9 days.  They should give yours as well - I'd pester them until they do.  Especially since your hearing is at stake!  Good luck!!!

[mremeet]

You're right jim, Apk did state he was in week 28 (i.e. 4 weeks post treatment) in this post to you on 1/22 (C4):

http://medhelp.org/forums/hepatitis/messages/44711.html

Which of course concurs with the dates provided within this thread.

But then in the two links below he very clearly states his treatment ended on 1/7. And it's been well established all along (by apk) that his treatment has been exactly one week ahead of pln's, who stopped exactly 2 weeks ago (thereby making him on his 3rd week post treatment, not 5th week):

C17 at http://medhelp.org/forums/hepatitis/messages/44631.html

First post at http://medhelp.org/forums/hepatitis/messages/44524.html

I guess apk is still feeling the effects of treatment. That's certainly understandable, as we all know these drugs can really play with your mind.

[jmjm530]

On 1/22 you posted you did your 28-week (4 weeks post treatment) blood draw. Do you know when you will be getting the results? Hope all is well, and all the best luck still being non-detectible.

-- Jim

[purplecat]

I've never had hearing problems.  3rd shot about 2 hours later my ears started screaming.  scale 1 to 10 where 1 is sound inside your head and 10 being outside regular sounds, it got so bad as 8-2. It was horrible.  Settled down and got better as days went on. 4th shot was 5-5 sound inside my head equal to outside.  has been that way ever since.  Settles down to about 2-8 by shot day and then we go again.  Phantom sounds started week 18.  Tinnitus is like a high electrical noise for those who haven't experienced it.  Like the sound you might hear under high tension wires but higher pitched. Makes your hearing very sensitive.After shot I can't go out for a couple of days because of sound sensitivity and also feeling weak of course.  I wear ear plugs when out most of the time.  It definatley caused by TX for me.  I was always on the go before TX so no CFS symptoms. For those out there not recovering after TX and the idea of latent CFS brought out from TX?  Wow, interesting?