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New Hep C Drug
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New Hep C Drug

I have hepatitis C with beginning stage cirrhosis and supposed to be starting treatment with Pegasys, Ribavirin and the new drug Sovaldi as soon as the medication gets approved.  Has anyone been on the treatment with the new drug and what are the side effects like?  
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7469840_tn?1409849436
I have been on those three meds for 8 days. Am otherwise healthy
First week has been a breeze, figure that may change as time goes on. Spaceyness from the riba for an hour or so after taking, but that is going away, as well as sun sensitivity. Some minor skin irritation from the Pegasys, groin soreness too. Taking them for 12 weeks. That is all so far. Keep me posted, hope all goes well for you.
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'The most common adverse events (≥ 20%) for SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.'

To learn more about the potential side effects of treatment read section 6 'ADVERSE REACTIONS'  in the Vivaldi label...
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

'6.1 Adverse Reactions from Clinical Trials Experience

SOVALDI should be administered with ribavirin or peginterferon alfa/ribavirin. Refer to the prescribing information of peginterferon alfa and ribavirin for a description of adverse reactions associated with their use.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety assessment of SOVALDI is based on pooled Phase 3 clinical trial data (both controlled and uncontrolled) including 650 subjects who received SOVALDI + ribavirin (RBV) combination therapy for 12 weeks, 98 subjects who received SOVALDI + ribavirin combination therapy for 16 weeks, 250 subjects who received SOVALDI + ribavirin combination therapy for 24 weeks, 327 subjects who received SOVALDI + peginterferon (Peg-IFN) alfa + ribavirin combination therapy for 12 weeks, 243 subjects who received peginterferon alfa + ribavirin for 24 weeks and 71 subjects who received placebo (PBO) for 12 weeks.

The proportion of subjects who permanently discontinued treatment due to adverse events was 4% for subjects receiving placebo, 1% for subjects receiving SOVALDI + ribavirin for 12 weeks, <1% for subjects receiving SOVALDI + ribavirin for 24 weeks, 11% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2% for subjects receiving SOVALDI + peginterferon alfa + ribavirin for 12 weeks

Treatment-emergent adverse events observed in ≥15% of subjects in clinical trials are provided in Table 3. A side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs.

The most common adverse events (≥ 20%) for SOVALDI + ribavirin combination therapy were fatigue and headache. The most common adverse events (≥ 20%) for SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.'

(See TABLE 3)

'With the exception of anemia and neutropenia, the majority of events presented in Table 3 occurred at severity of grade 1 in SOVALDI-containing regimens.'


Good luck with your treatment!
Hector
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I thought that I replied to this but wanted to thank you for this information.  Still have not started my treatment and waiting for the meds to get approved.  Hope that it does not take forever.  Have you been through the treatment and if so how are you doing?
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Hey Sandi,
It has been a few weeks of the treatment for you...how are you doing?  Still have not started as it is taking a while for the medication to be approved.  Hope that you are doing well.  I thought that I had responded before but must not know what I am doing on here.  Hope that you are well.
Tammy
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that was really helpful. I'm starting my treatment next week so your 8 days ahead me. thanks for the heads up. I will be watching your post.
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Most side effect come from Pegasys - which is interferon. These include flu-like symptoms like headaches and fever. These effects are completely natural and you don't have to worry about them - the only problem is that treatment us long (12-24 weeks) so the side effects also last long.

You can read more about Pegasys or interferon treament at http://esofosbuvir.com/hepatitis-c-treatment/interferon-treatment/
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How's your treatment going?  I'm 12 days in and not bad at all so far!
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Hi, I am on day 40 of 84 (almost half done!). Was undetectable at 28 days, next viral load test will be at 56 days.

Doctor reduced my Ribavirin to 600 mg a day (from 1,000) as my Hemoglobin levels dropped below 10 (9.7, and the 9.6), it has now stabilized at around 10. Rash is pretty much gone at the lower level, but still have the sun sensitivity, appetite is off—nothing sounds good—but am hungry, go figure. So I am feeling pretty good overall. Just get tired, so am staying in and working at home most days, and not going out more than twice a week for short errands. I find it I get overly tired I get heart palpitations, spoke with my cardiologist, but it seems to calm down after 30 seconds or so if I lay down and rest. Am achy and get headaches a little in the evening, but not too bad. Take 1 motrin and half a benadryl at night to help me sleep which seems to work. Am finding if I keep eating little meals throughout the day, and drink enough water I am generally ok. Hopefully things will stay as they are right now. The things I am feeling now may be more of the Pegasus then before. Though my shots weekends seem to be about the same. I get bruises and rashes around the injection sites that seem to last a long time, as well as a burning and welts the evening of the shot (around injection site, but calendula seems to take care of that) and get feverish and really tired for a day or so, but generally feel recovered within 2 days.

I can put up with all this if I get SVR!

Hope everyone else is doing ok on their meds.
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thanks for sharing sandi, vintage

i will be starting soon.. i am not afraid anymore. i already suffer pain, horrible fatigue,  don't go out except every few days for errands and docs. no appetite,  for over 2 years i have not been able , can't do what i used to do, barely can do light housework…
so if i treat perhaps i will feel better..when it is all over.if i SVR
and 12 weeks! i can do it...

i think of the people doing chemo for cancer..my mom for one., the kids ...how brave.

i can't be afraid. one day i'll look back and say.. hey i feel great!
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hi I will be starting treatment in a few days I just hope and pray this new medication works this time, I cant stand the thought of another failure, Iam genotype 1b the hardest to treat,I hope everything goes good for you...
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Hi. My husband. Is going through process to get the two drugs. Did you have any hassles with your insurance company?

Thank you in advance for answering.
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We've been through the ringer with Blue Shield. My husband is on his 2nd week of Sovaldi w Riba, even thou he should be on Sovaldi & Olysio!
After much fighting & writing he has Finally been approved.
Blue Shield has seen the light.....
Just an FYI in case that's your Ins Carrier.. housewife
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Have you started your treatment and how are you doing?
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Hey Sandi,
How are you doing and maybe you are done now?  I finally am getting my medication this week and plan to start after Easter.  Nervous about this and wondering why my doctor did not recommend the Solvadi with the new Olysus (not sure of spelling) that is supposed to cure and is interferon free.  Give me an update if you get a chance.
Tammy
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How is everyone doing with their treatment?
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Hi Tammy, I have 19 days to go, will be done end of April. Don't be afraid of the Interferon if you have to take it, I have found it really isn't that bad. The Ribavirin really seems to cause more Sx. I am awaiting my viral load results from week 8 labs, so should know tomorrow. My doc raised the Riba dose to 800 mg after lowering it to 600 mg from 1,000 mg because my hemoglobin had dropped below 10. Supposedly it doesn't impact the final results. I hope not. So far Sx have been fatigue, mostly for two days after shot, appetite is off, but has been manageable. Drink lots of water, keep food intake up. Feel free to ask me any questions, good luck!
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Thanks Sandi,
I was thinking of taking my interferon in the evening, then starting the other meds the next day.  Did you have any problem with sleeping?  I do now but I know it is just being anxious about the treatment.  

The other concern I have is that my platelets are low and hoping that they don't have to lower doses etc and treatment will not be as effective.  Were you able to drive, work etc????  Sorry for all the questions but curious.  Thanks for you help with all this.  
Tammy
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You will do just fine. I am in week 8 of 12 weeks of same meds you will be on. I have been tired most of the time but able to work about 30 hours a week. Some days are better than others. My emotions run high but I have learned to manage that. Just drink, eat, and rest all you can. Our bodies can handle this as we need the cure!
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Hi Tammy, I have a hard time sleeping, but find if I take half a Benadryl at night I can sleep. I try to not drive for an hour or so after taking the Ribavirin, as it gives my head a buzz. I take my shot on Friday night about 7:30. I usually have to go to bed within an hour or so after. My nurse told me to take two Motrin an hour before and one extra strength tylenol half an hour after. I keep a tube of calendula by my bed, as I usually get an injection reaction of itching and welts in the middle of the night. Low platelets are common, I am sure your doctor will monitor you closely. These are common things, and really minor. One day at a time!
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I just finished my treatment of Solv/Ribv a week ago today.      12 weeks.   UND at 2 weeks.      F4.    Wrote a lot on different posts about my experience but noticed some thoughts and question so thought to share.   Hmg levels were my biggest concern as my #s were all over.     Started at 14.2 and my lowest was 10.4.     It's funny but they became the lowest after treatment ended.     Generally a steady decline but spiked up a few times.    Had my post blood work done Fri and still UND.     Docs say levels start to rise 7-14 days after treatment stops.     Sandi you are almost there so hang in there.    Tammy hope you get approval and start treatment soon.    Also will say its a powerful drug combo but not having the virus is so worth the treatment.    Before treatment had so many aches and pains, fatigue, you name it.     Since finishing treatment didn't realize how the virus had made me feel miserable.    Everyday now I feel better and better.    Am here if you guys need help with side effects as the people prior to me starting helped me to get thru it.    Looking back its the best treatment I have ever taken with such positive results.     All of my liver tests are now normal.    So very grateful and hoping all of us finally beat this disease.        Kim
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I love your spirit. I think that what you have reported will be encouraging to those who are beginning to treat, hope to treat soon, or in the midst of treatment.

Vitagechix, almostsixty - Good luck...
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Thanks everyone, these are positive answers and very helpful.  I am still waiting to get all the paperwork faxed to get my Solvati, but when I get it I am hoping to start Monday evening.  Thanks Kim. Sandi, almost sixty (I will be 60 in June:).  
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I will be 64 this month! So we are all about the same age. Are you starting your injection on Monday night? So you are not working the next 2 days? I have mine on Friday night, so that I am ok to work by Monday morning. You just want to make sure your timing is right for your schedule.
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58 here.      Baby Boomer disease!!!!!      Never to late to clear.       We still have a lot of livn to do.           Kim
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Kim—This is true, I need to see my daughter get married, and grandkids some day! Thank goodness my daughter tested negative for the disease.
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We do have a lot of living to do, I have 3 grandkids and one on the way and they keep me full of life:)  Sandi what is calendula....never heard of this.  I am guessing some kind of ointment.  

Crazy baby boomer era...I was part of that crazy drug, free love scene...who would of thought after all these years that the hep would do this much damage.  What stage liver disease are you all in.  I am early cirrhosis but they say it can improve a bit after treatment.  I have been trying to eat real healthy, I have been a vegetarian but started no sugar (except for the few jelly beans I have been eating:) and white flour etc. and eating smaller meals throughout the day.  I don't have an appetite but do eat and have not even started the treatment.  

If you have any food tips let me know.

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Calendula is an herbal cream for rash and skin irritations, I got mine at the health food store. I get welts in the middle of the night at the injection site on shot night, it isn't bad and doesn't last long, it wakes me up though, but the cream calms the skin right down, smells good too. Don't use anything with arnica, as it has St. John's Wort in it (contraindicated for Sovaldi)

Yep, I was in love with a widely talented painter, moved up to the bay area for a short time. He was always careful with his drugs, but of course hepc wasn't identified then. Sex and drugs and rock n' roll. Thought I had dodged the consequences of that. I did natural childbirth in 1989, and have had a good diet since then.

After I found out about the hepc last fall, I really cleaned my diet up more, started walking and lost 20 pounds in 3 months. My weight has stayed the same throughout Tx.

My doc didn't do a biopsy, so no definite stage, my doctor didn't seem to think I had cirrhosis, as all my liver blood markers were really good, well within normal ranges, and my ultrasound didn't show anything.

I hear a lot of advise on this forum about diet, but while you are on the meds my opinion is eat whatever you can or want to eat. I have had a really healthy diet, but am finding I have to add fat and oil to my diet while on these meds, also crave red meat and salt too, probably because of all the water I am drinking, and I have been anemic most of the time (not badly so though—13.3 (start), 10.3, 9.7, 9.6 (at which point my doc reduced the ribavirin for a few weeks, but has since raised it at my request for the last month), 10.1, 11.1). Had a real craving at the beginning for hamburgers and tacos. Eat light on shot night, I usually have thai food with tofu. Interestingly red meat and raisins really don't help with the anemia as it is the ribavirin that is destroying them along with the virus, but I figure it can't hurt.

I try to have healthy snacks to grab and eat, have no energy to fix anything: cheese sticks,
nut and dried fruit packets from Trader Joe's,
frozen tamales from Trader Joe's
organic dried cereal,
have been using 2% organic milk on my cereal too for the fat factor,
also have been eating mandarin oranges, apples
celery and peanut butter or laughing cow cream cheese,
also have instant breakfast too for a midmorning snack,
organic apple sauce is handy too,
ginger snaps, candied ginger (I made my own)

Breakfast is usually instant oatmeal with dates and walnuts, and I add a teaspoon of coconut oil (again for the fat factor). I take my meds at 8:15 morning and night, and it seems to work for me.

Try to stock up before you start. It is funny, everyone gave me soup, and it is not what I want to eat.

My doctor and nurse had no restrictions on eating, but also we do want to give our livers as much of a break as possible so they can do their healing.

I drink 70-90 oz of distilled water a day, I find it is easier to drink then spring water.

Hope that helps!
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Wonderful advice  Sandi.     I'm a personal trainer so if anyone has work out questions let me know.    Am with you both on wanting to be here for our children and grandchildren.     My daughter had Addison Grace 1 month before starting treatment. What other motivation is there!!!    My son  24  is still my baby.     Think we all had a crazy life as most in the 70s did.    BTW. Day 9 post treatment and gotta say after all these years with Hep C, do I feel great.   Live in Fla and lovin  the renewed sense of being truly healthy after being sick from this virus for so many years.   Can't wait for everyone to be free from such a horrible disease.      Now that is the reason to get thru this treatment.   (And to one day hold our new grand babies).           Kim
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Have you seen the trial results for the Turquoise II trial that came out at EASL, the European Conference that was held last week? It can be seen on the HCV Advocate site. They are the only pharma company that devoted a whole study to people with cirrhosis. The results for genotype 1b patients were 100% and for geno 1a patients they were almost as good. Even for previous null responders to interferon, the cirrhotic people who did 24 weeks, like myself, had a 93%  chance of cure. Side effects were minimal to none. I would ask my doc if that is something he would consider for you. hey should be FDA approved before the end of this year. I never thought I would be cured, but I was and it was easy.
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yes it was a hassel between the drs office and the insurance company , but I stayed on the phone with both of them till they got tired of me and went ahead and approved the three sovaldi, ribavirin, and pegasys . They hope you give up they don't want the cost. I also found copay cards on line my detutctible went from 600.00 down to 75.oo with these copay cards. started treatment last week no side effects as of yet goodluck keep fighting
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started last week doing great thanks for asking...
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Thank you so much Kim,
I am waiting for my Sol to arrive in the mail, hopefully the end of this week.  My plan is to start treatment Monday.  I want to enjoy the Easter weekend with the family, we always have a great meal together:)  Glad that you made it through.  You only had to do 2 drugs?  I have the triple, Interferon, Ribavirin an Solvadi.  So I am sure I will have lots of questions.  
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Hi,  Was reading the posts and I wanted to ask you about heart problems since you mentioned palpitations.  
I am on day 35 of Sovaldi + Ribavirin regimen.  I am Geno 2.
I suffer from atrial fibrillation not related to valve problems and I have been extremely worried about heart complications with Ribavirin.  Can you share anything your cardiologist might have told you about what to watch for?  I would be very grateful.
In case anyone reading cares, let me add that I have had some side effects.  mainly fatigue and shortness of breath when I walk a little bit.  Also some loss of appetite and a few headaches.
I started with a viral load of 6761290 on 3/14 and the most significant drop was after a week to 1110.  Later on 3/27 I was down to 220 and on 4/11 no longer detectable.
Thanks for any info.
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Hi, I also have afib not related to heart valve problems. My heart has been fine, but I have had some heart palpitations if I over do it, don't eat or drink enough. They only last about 30 seconds or so. Have found I can't exercise at all, I just get too tired. I do get afib from anxiety, and had an anxiety attack when my hemoglobin got low, and I was so worried that I went to the er and had it checked. That was when my ribavirin was reduced. My cardiologist wasn't worried about me, I have followed up with him. I have had to be very careful to avoid anxiety, but haven't taken any meds, though I do have some Xanax if I feel anxiety building. I have been taking my  Atenolol and low dose aspirin. My viral load was 192,000 at the start and has been UND since week 4 (probably since week 2). My advise would be to rest rest rest, eat lots of tiny meals, keep your blood sugar up, drink lots of water. The hemoglobin levels can be hard on your heart when they get too low, it makes your heart work harder. Anxiety is a Sx of these meds, so if you are prone to anxiety like I am, do what you can to avoid it. I am on day 70 today. Hope that answers your question.
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Avatar_m_tn
"4/11 no longer detectable."  Cheers!  
L1z1224  hepc4Sandi Best wishes to both of you and everyone else on treatment.

I have only had a couple of flutters lasting a couple of seconds.

About 23 years ago I had rapid heart beat episode and went to ER took 2 hours to return to near normal.  Contributing factor 60 hours with only a couple of hours of naps during a private poker marathon event.  The lack of sleep, consumption of lot's of coffee (20 cups) and sugar (lots of candy) was the primary cause.  It was a "wake up" scare to at least avoid extended sleep deprivation, excess caffeine. Had a few more but much less severe and shorter ones with the last one about 10 years ago. ( other than the ER time cardio test never showed any concern.

Especially now as I'm older and on treatment my only problem is my excitement being on tx finally with almost no side effects and if any nothing different than I regularly experience before treatment.  Pretreatment sleep ave 7 hours.  Now 5.5 to 6.5  hours  I'm upbeat now, but not too anxious, eating good, staying hydrated and only two cups of coffee a day.        
CAD 4 stents 1 1/2 yr ago and cleared by cardio 2 weeks prior to tx (EKG).

GT2 2nd week tx SOV/RBV  AST ALT dropped from  109,150  to 22, 25 PLATELETS 88 to 115,  hgb 16.7 to 15.5, NEUTROPHILS 2.3 to 3.7 and . waiting on VL results 6 day delay.  
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I have all my meds and will start the treatment on Monday evening.  Glad to have others who have walked what I will be going through.  Will be looking for your input.  I think I need a lesson on all the acronyms that you all use...no clue what you are talking about with most of them but sure that I will learn quick!  
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Happy news Vintagechix.    The sooner you get it going the sooner you will be UND.    I also am prone to the heart palp and the anemia seems to be a part of that.     Hopefully your hmg levels will stay up there and the fatigue and racing heart will be none to minimal.   Should it occur it only a short time  so try not to worry as that makes it worse.     What will compound that is caffeine in any form.    Chocolate is a real culprit.    Here's a trick to make it stop.     Lay on your back with a book on your belly.   Take deep breaths and make sure the book goes up and down.    That will level out that rapid beat.   Shallow breaths cause hyperventilation and the circle repeats itself.   Eat some sort of protein with every meal as that regulates the blood sugar and also keeps the heart quiet.   Sandi and Jimmy you guys are doing great and can't tell you how much better you will feel after treatment ends.   In the scheme of life it's just a little blip on the radar screen and before you know it the word hep c will no longer be in your vocabulary.         Kim
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1 week in with sovaldi, rib, and pegasys good so far thanks for asking love to all...
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I will pray for you. Hope you will be fine soon.i I also got my Anti HCV result weak positive.i will pray for all of you. I believe god will cure all of you soon.
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"GT2 2nd week tx SOV/RBV  AST ALT dropped from  109,150  to 22, 25 PLATELETS 88 to 115,  hgb 16.7 to 15.5, NEUTROPHILS 2.3 to 3.7 and . waiting on VL results 6 day delay. "

Hey Jimmy
Those are great week 2 results. You must be excited!

Nan
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Jimmy, looking forward to seeing your VL results.  I am UND on my last labs and probably was at 4 weeks.  I'm over halfway thru tx. :)  Hoping we all find SVR.  Nan, hope your husband is doing better.  Happy Easter
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"Nan, hope your husband is doing better."

My husband is doing better, thank you. His creatanine is at 2.21 as of Thursday from a high of 2.9. Hopefully his kidneys will continue to improve and get back to where they were before this IV antibiotic injured them (1.46).
Still can't believe that happened.  I made a formal complaint to the hospital administration. Unfortunately his doctor was out of the country when this happened or I really don't think it would have happened.

His doctor has stopped the procrit so the HE episodes he has had since stopping it have been much shorter in duration and not as severe.  So we are really grateful for that.  The good news is that although the procrit was stopped, the hgb went up from 8.8 to 9.1 on it own.  

My best wishes for all who celebrate for a Happy Easter and/or a Happy Passover.

Nan
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thank you and will take all the prayers I can get:)
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thanks Kim, will try to remember all this.  I don't drink any caffeine so that's good but these are some good points.  
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I started the meds Monday evening with my shot, and is it normal to have a low grade temperature?  It's only like 99.9 but it has been 2 day and it comes and goes.  So far just get body aches, headaches, low grade temperature so far.  Not too bad.  
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Yes, I think a fever is normal. I get a mild fever and chills for about a day and a half, especially bad on the night I get my shot. Make sure you are drinking enough water—remember half your weight in ounces, so I am 140 lbs, so I drink 70 oz. of water plus extra because I drink a cup of coffee in the morning. So I drink about 82 oz. a day. (2 and a half Nalgene bottles) the water will help with fever and headache. Avoid caffeine and sodas, as they dehydrate you. Yay! Congratulations on starting Tx!
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Thanks Sandi....
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Avatar_m_tn
Just finished week 1, a little more emotional, some fatigue, but determined to see it through.
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I am into my 4th week.  The first week I seemed to do well but after that I deal with exhaustion and no appetite.  I have been losing weight and it's so hard to make yourself eat when you don't feel like it.  I have been doing some Ensure drinks.  My platelets are blood counts are low and I am praying that they don't get too low to adjust the medicine.  But if this is the worst of it than it's worth it if the meds do the job.  

Keep me posted and I will be praying for you as I do myself each day to take the medicine:)  Hang in there!
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Tammy S, I am awaiting Insurance approval to start the 3 month program, with Friday night shots,Chronic hep c,,liver is in fibrosis state, yes I am a baby boomer to :), IV clean 31 years, figured that's how I did this, I was diagnosed 8 years ago, told to await new meds in the future the future is here. Good luck God bless all.
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How are you doing? I am the same age as you and am trying to treat. I am hoping my doc will give me the authorization this week. I am 1a and will have to use the three meds.
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