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clinical trial hum genome side effects

i am in week 9 of albumin interferon alfa-2b and ribasphere which i think is ribovarin.  is anyone feeling as bad as me - fatigue sweats palpitations insomnia breathlessness
diorreha cant spell it sorry and weight loss about 2 pounds a week that doesnt bother me so much as ive done so many diets in the past that never worked & now im losing it so easy no effort whatsoever. I had anemia after 3 weeks of treatment and my tablets were reduced to half 1200 to 600 but most of the symptons persist - still knackered cant breath everything except the yellow diorreah are these symptoms permanent or a result of the interferon  every inj i take seems to have no effect so keep putting it down to ribo do these things go away after treatment i cant live like this
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250084 tn?1303307435

A : Interferon messes w/ neutrophil counts (red blood cell related).

Q:)  here’s how little I know right now…. Is riba an ‘interferon” type also”? I've  limited my reading as already drug phobic and if I read all that ‘fine print’, will scare me more! My immune is pretty good as of now, assume that will help.
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A:  I'm no doc but it sounds logical that the less dosage the less effect upon the body chemistry.  
I do believe there are alot of other factors. Mainly the personal makeup of each individual.

Agree.  Other health problems, over all general health of the person, mental/mind problems and each persons body handling the drugs differently of course.
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A: Vitamin supps were the idea of my trial nurse. She told me about them off the record because trial sponsors would frown upon it. I'd say 1000-2000 mg of each daily.

Q: Is there a list of which to take? Better yet, which not to take? Know some are ‘nots’.
(and know to hush about doing them:)
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A: Especially stay away from supps like Milk Thistle etc during treatment as there is possibility they may affect efficacy of Meds.

Did before, they made me stop it 30 days before tx.
Note: My VL was 812,000 on 1st draw (doing milk thistle)
30 days later-without- it was over 4 million!?
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A: You are fortunate to be doing 24 weeks. I'm 1a and all 1a's do 48 weeks

Believe me, counting my blessings there. I cried-bawled- on bx table when he told me 2b! (hadn’t seen him after 1st draw.)
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You: Well I guess I''l watch movie and hope that the insomnia does not torment me all night

Q: Does anything help to sleep? I have been told I COULD do xanax or valium thru out this?
This is with no history of addiction tho and I take very small dose’s, if/whenever.
How have you done as for sides, other than mentioned already?
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PS- I also wanted to mention while it's only natural to have tons of questions and reservations prior to treatment if possible do not let them consume your every thought.
I think Jesus had some good advice when he said "why do you worry about tomorrow for sufficient is today's trouble" Easier said than done but great advice
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Thank you for that! As it does at times consume me, and your right, as I have 1st shot terror going on, only 3 days to go. One of my favorites I use “ I sought the lord and he heard me and delivered me from all my fears’.
And on that note, I'll quit asking so many questions and get my mind busy:)
Don't mean to be a P.I.A. and Thank you so much for all your help.
                                                                    LL
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Avatar universal
The study protocol dictates that you will not receive your PCR until week 12 as they are blinded to the patient.  On Thurday they took blood work for wk 16.  I will receive the results as soon as they have them.
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Avatar universal
Lauri,

Q:So if we develop anemia, just the Riba is stopped?

A: May not be entirely stopped just adjusted.

Interferon messes w/ neutrophil counts (red blood cell related). I developed low neuts and have been dose reduced 2 x's. Problem w/ low neuts  is  the immune system can be compromised to the point of making you succeptible to infection. Have everybody do a lot of hand washing and stay away from crowds if this happens.
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I will be on 800 Riba (weight I guess) but believe that’s the lower dose. Could that reduce risk of anemia?

I'm no doc but it sounds logical that the less dosage the less effect upon the body chemistry.I do
believe there are alot of other factors. Mainly the personal makeup of each individual. I started on 1200 riba. There are no doubt those who stay at this dosage and never develop anemia. I have been on half that dosage since late June to prevent the hemoglobin levels from plummeting and hopefully getting higher. I got up over 10 but dipped back to 9.7 recently. 8.5 is ground zero in this trial and should I get that low riba would be suspended

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Vitamin supps were the idea of  my trial nurse. She told me about them off the record because trial sponsors would frown upon it.  I'd say 1000-2000 mg of each daily. I am so tired of swallowing pils that I stopped taking them but I did notice that hg was going up when I could stomach the vitamins.

Especially stay away from supps like Milk Thistle etc during teatment as there is possibilty they may affect efficacy of Meds.

You are fortunate to be doing 24 weeks. I'm 1a and all 1a's do 48 weeks

Well I guess I''l watch movie and hope that the insomnia does not torment me all night long

Blessings

Big Al

PS- I also wanted to mention while it's only natural to have tons of questions and reservations prior to treatment if possible do not let them consume your every thought.

I think Jesus had some good advice when he said "why do you worry about tommorow for sufficient is today's trouble" Easier said than done but great advice

Helpful - 0
250084 tn?1303307435
As you've already been to Mt. Sanai by now, did you find out about getting the results? I found out today that in my trial (Shands, Fl.) they won't tell us anything until week 12, and than my 'Trial nurse' said they now also push to see what 4 week, etc. was than also. Still confused in some, but I didn't even know I wouldn't get certain results ,etc. Learned thru you guys :)
                                                                                      LL
Helpful - 0
250084 tn?1303307435
Your post has helped me learn more about the trial we're in, thanks. And I hope you get to feeling better and hang in there.
                                                                              LL
Helpful - 0
250084 tn?1303307435

Hi, was glad to read your post as sounds like it's been very doable, tho not great! loved your comment....
" I can't really tell the difference between before treatment - (always tired and moody) and now during treatment (always tired and moody). "
It sounds like your getting (have) the depression tho and very sorry you are pretty much alone in this. I have persistent friends and family and I doubt they'll let me crawl too far in a hole. My 3 sons all live close and here a lot. We've all discussed not taking me personal in anything for the next 6 mths. :} I also had a 20 yr friend move in with me for awhile while looking for a house to buy and she is staying longer now to see how I do. (big house, don't bother each other). Have a great guy for years but he has to travel a lot, tho he's been here every app. and will be for my shot days and to hold my hand on that 1st shot. Any advise on how to not fall apart doing that 1st one? (very drug phobic here, isn't helping a bit!)
I'm so sorry for the 'empty nest' and your lack of interest in things, but give that to yourself and don't feel like a failure at all. life is hard with this, let alone with tx (I'll find out!). Give yourself a break here. maybe reach out a bit more and tell them how your feeling?? Work?? I have both jobs ready to cover if needed. You will find a job when your able. This is not a great time for a new job and as for not cutting the mustard... you are sick! Feel no guilt there either. See if that boss can handle and 'cut the mustard' walking in your shoes.
Thanks for any and all input, hope you get to feeling better where you need to.
                                                                                   LL
Helpful - 0
250084 tn?1303307435
Big Al, Thanks for making that easy for me. I am so lost in this, especially deciphering blood work, etc.

Big Al, very happy for you on being UND thus far!
Thanks for making that easy for me. I am so lost in this, especially deciphering blood work, etc. So if we develop anemia, just the Riba is stopped? I will be on 800 Riba (weight I guess) but believe that’s the lower dose. Could that reduce risk of anemia? This phase 3 is to determine what you said and from what I have read, better tolerated, etc. Although Patnug doesn't seem to be backing that up. I -think- a lot has to do with your health going into this (guessing) and other health problems. I have otherwise good health, besides the symtoms of Hep C.
*Vitamin A and E..... I have read/heard that Vit. A is to be restricted in our diet? How much to take? Anyone doing , are we allowed , to do B12 shots? my Acupuncture, Eastern med Doc suggest them.

I had several test before starting, EKG, heart ultrasound, liver ultrasound, bx AND 'fibro scan', lung test and lots of blood work.

You: *"Yes. I am in a phase 3 trial and as  far as I know all phase 3  is 48 wks.  believe you are correct "

I guess Type 1 Phase 3 is still ongoing. Thought I read it was done and now doing type 2 trial.
Anyhow, I am type 2b and doing 24 weeks. The stressing part (besides it all:) is not knowing whether I'll be Pegasys or Albumin until the day of shot. 48 weeks is a bit less than the norm with Pegacys, etc. with type 1, right? I have so much to learn here!
how are you doing with the sides so far? You don't sound so bad in your post.
Thanks for your answers, sure I'll have more for you if you don't mind :)
              Have a feel good day, LL
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Avatar universal
Lauri wrote:

have not been told about not getting 'rescue drugs' and have been told I would get meds to help side effects
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Cba replies:
You will be asked about sides during your scheduled visits and  will get all the meds you need for the majority of sx or other conditions. I have had 2 chest Xrays for upper respitory infection and an EKG when I mentioned some minor chest pains. These types of procedures are provided at no charge.You have to pay for meds though.

'Rescue drugs' are in a different category. They are for when you develop a side ( in my case anemia)
that if it gets too low would require you to be taken off treatment. These drugs are super expensive so perhaps that's why they don't prescribe them. I tend to think that this trial is to determine both efficacy and Safety of the Albumin Interferon. If they were to start putting people with low hemoglobin on Procrit then it would pehraps cloud the final data of just how safe it is. So it's kinda like 'how low can you go? If you get below 8.5 they take you off riba until hemoglobin levels increase.

FYI Vitamin A and E are good for briging the hemoglobin levels up.
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CBA, your doing 48 weeks? Your in Type 1 trials? I thought type 1 trial was over?
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CBAreplies: Yes. I am in a phase 3 trial and as  far as I know all phase 3  is 48 wks.  believe you are correct . Phase 1 and probably 2 are history because you cannot proceed to phase 3 until the data comes in an earlier phases

Let me know if I can provide any other info

Big Al
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Avatar universal
I am taking 1200 mg of albuferion and 1200 riba..  My sides are the following disturb sleep, mild riba rashes(white itchy pimples, riba  rage (mostly in a bad mood and quick to snap at my wife)  Thank God I have no body pain and I am able to jog at least 4 times per week

Tomorrow I am schedule to Mt Sinai, NYC for my 16th week  blood work  Does any one know the study protocol. Will the give my viral load results?  I was at 900ml at week 12, down from 23mil from the start of treament, more than a 4 log drop
Helpful - 0
Avatar universal
Sorry about the mis-type above - fingers won't listen to brain - brain won't listen to brain.  I just did shot # 5 last Friday.  I am Genotype 1b doing the albuferon (900) every two weeks and riba (1000) daily.  The first shot was like a two week flu jammed into one miserable night.  That has been the worst of it for sides.  I can't really tell the difference between before treatment - (always tired and moody) and now during treatment (always tired and moody).  It all sucks but atleast I feel progressive fighting back.  I had originally tried to enter a clinical trial with NIH but was rejected because I didn't have enough liver damage.  I am greatful to be part of the Human Genome Sciences study with shots every two weeks - what a deal.  I didn't realize at the time that one door closed so another better one could open.  I have little faith but this turn around makes me humble.  

I too have lost weight (116 now).  I have lost my buttocks.  I feel unattractive and pathetic.  My attitude is whimpy or I am sleeping.  I have isolated myself from my family.  I am so very lonely but feel so unworthy of anyone's attention.  My daughter is getting married this Saturday and I don't care.  Yikes.  I do feel like a failure in so many ways.  I need weed to make me hungry and help with my disposition.  Sorry to ramble - anyway - the study here in Fairfax, VA is blind until week 12 which will be October 13.  

It isn't easy.  I wish I had help.  Empty nest means no witness to ones needs.  I  was released from my last job.  My former boss said: "I could'nt cut the mustard, I couldn't keep up".  He didn't know my pre-existing condition - Hep.  Last Monday I had an interview for a new job.  I just sat in the parking lot hearing my old bosses words over and over - can't keep up, can't cut mustard, ketchup or relish.  I drove away after a couple hours never leaving the car.   Two more boohoos - my hotwater heater and oil tank are both leaking and it's getting cold.  

Atleast my children are well and beginning new hopeful lives.  I can still try to do better with less and less.  What a banquet?!  L  
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264121 tn?1313029456
"still knackered"  I love that term! You must be British.  Actually, I am willing to be it is the interferon causing your issues because... you are having classic interferon side effects which will hopefully get better somewhat as your treatment goes along.

http://www.cancerhelp.org.uk/help/default.asp?page=4009

Go down to side effects, all of yours are mentioned.  I am so sorry sweetie!  Keep writing, I am going to be your nauseated, vomiting diarhea buddy starting next week.  We can do the good fight together ok?

p.s. ask if they can put you on procrit or epogen to increase your hematocrit.  You'll feel much stronger.
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Avatar universal
I am receiving 1200mg of albuferon and 1200mg of ribavarin. I am scheduled to have a pcr this Thursday.  Will the give me the results or is week 16 blinded?
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250084 tn?1303307435
Obviously we all stay up late!
Okay, I am confused. Albumin Interferon (Human genome Science's, right?) Phase 3 trial....(just saw the 2b in your post patnug).....I start it sept. 25th. I have not been told about not getting 'rescue drugs' and have been told I would get meds to help side effects. In fact, my study nurse said she is concerned I won't ask for or do drugs for sides. Until I walk in on that day I do not know if I'll do Pegacys or the Albuferon, but do know I am getting 800mg Riba (I weigh 126). CBA, your doing 48 weeks? Your in Type 1 trials? I thought type 1 trial was over? Sorry, still learning here and I am really tired to be following well right now, but would like to hear more on both of you. I'll get back on here tomorrow.                                              LL
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Avatar universal
The second paragrap in my post should read:

It sounds as if your trial nurse(s) are closely monitoring your condition evidenced by the dose reduction of riba.  In this trial they do not use rescue drugs. If they did  your hemoglobin levels which are causing  the anemia and the dizziness / breathlessness/fatigue could be treated
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Avatar universal
Hello,

I am in week 27 of 48 of the same clinical trial. Your sx are very common with most hep treatments.
I can empathize with what you are going through.

It sounds as if your trial nurse(s) are closely monitoring your condition evidenced by the dose reduction of riba.  In this trial they do not use rescue drugs. If they did  your hemoglobin levels which are causing  the anemia and the dizziness / breathlessness/fatigue.

I was dosed reduced at about 13 weeks for the same reasons as you in fact from 1200 to 600. My hemoglobin slowlly got up over 10 and I almost made it to where they could add another 200mg to the dosage.

My recent blood work has seen the levels dip back into the 9's

Fortunately I was on full dosage for the first 12 weeks which is considered to be the most critical in terms of becoming undetectable. Praise God I was UND (undetectable at my 12 week pcr test (viral load test) and have remained UND even though the dsage of both riba and interferon have been reduced.

You only have 3 weeks until your first PCR. Don't become discouraged as the 12 week mark is the first major crossroad. The sx are present because the riba/interferon are doing the job.

All the people in my trial group were UND at 12 weeks. You will be too so press on and get to that 12 wk PCR. and that UND ( or at least a 2-load drop)

All the best.

Big Al
cba51
Nashville, TN


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250084 tn?1303307435
Hi, you are the 1st I have read here on the albumin interferon ( AKA- albuferon )trial, which I start in one week! I have researched /read many good things about it. I start at Shands in Gainesville, Fl. I am type 2b, stage 2-3 fibrosis and have carried this virus over 30 years before dx in May this year.  What type are you? What about a bx?  and where are you doing this? How long is your tx time? Do you have other health issues? Can I ask your age and are you thin or heavy because standard Riba in this trial is 800 mg., so confused on your dose there. All other studies have shown that it is better tolerated than the norm. Also, not sure the difference in ribasphere and ribavirin, but the trial is with that latter,  So very curious to hear more info. from you and very sorry your doing so poorly with it.

You said “every inj i take seems to have no effect so keep putting it down to ribo do these things” ….. do you mean "riba doING these things? you think the riba is causing the worst? You are not putting down the shots, right? ( not doing?) Do you have a hepatologist or UND? Please add more info. and hopefully we can help each other in this and truly hope you get past all that. Are you new to this forum? It's a wonderful, caring, educating place and has helped me tremendously. Many here say that often the worst is at the start, of course than some say later. To my understanding of albuferon it is about the same as the 'norm' interferon we all do but it is moleculed to albumin, which is already in our bodies, but that makes it last longer, etc. and less shots. (short summation there). Have you researched it much? Sorry to hit you with so many questions when your feeling so bad, but a bit confused with what you posted and all the info. I have on the study.
Anyhow, i'll be watching for your post and maybe others here can help with more answers.
                                                                                LL
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