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Start treatment and have surgery
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Start treatment and have surgery

My husband is seeing doc next week to hopefully start treatment with the newly approved Sofo with RBV and INF. he has issues with his shoulder and thinks he can get surgery for that while starting this treatment. I do not know yet if his doc will prescribe this regimen and even if his insurance will cover it. (Express scripts). From all I have read, for his Hep C genotype 1a, he is going to have to get the INF regardless. Sooooo.....what do you all think. I am so worried about him, when he had is liver biopsy it said he was at a 3/4 ?? Not sure what that means.he has a lot of sensitivity in the area of his liver, and to me, has also appears to have fluid buildup. He looks 8 months pregnant to me, and the way his stomach bulges, i can't believe it is just fat. If it were you would you attempt shoulder surgery while on treatment. When he had his other shoulder done a few years ago, it was a living hell....please please ....tell me what you think. I can't stand to see him in all this pain. He also has much fatigue and sleepless nights and joint pain in general, I try to watch how much Advil he takes, because I know that is not good for the liver.
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Avatar_n_tn
Yep! I should find out any day if I'm positive with Q80K.
However....I've decided to ask my hep dr to let me treat regardless. Results show a 15/20% less effectiveness with Solvadi/Olysio if positive with Q80K but as far as I can see from other (AbbVie) trials that makes them pretty much comparable. I'm dead set on not treating with RIBA much less inf.
I have appt tomorrow so will see what he says...
67 Comments Post a Comment
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Avatar_m_tn
     is your husband seeing a hepatologist?  i would think he needs expert evaluation, with the sx you have given.  internet advice would not be appropriate for possible cirrhosis
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Avatar_f_tn
I would not recommend surgery while undergoing treatment for Hep C.  Treatment drugs will lower his white count and likely cause some anemia, both of which could make surgery more risky.  Also, depending upon the exact stage of his liver damage, a surgeon may or may not be willing to do the surgery.  Surgery can cause the liver to decompensate (stop working properly), so usually a surgeon will need a hepatologist to approve the patient for surgery before agreeing to do it.  If the surgery was difficult before, it is likely to be difficult again.  Much depends on the exact stage of Cirrhosis.  When you say 3/4, I don't know if you mean F3 (Fibrosis stage 3), or if you mean some other gradated stage of advanced Cirrhosis.  If your husband were F3, he would not have any physical symptoms of Cirrhosis, e.g. his tummy wouldn't be swollen, unless he's overweight.  If your husband already has Cirrhosis, and his tummy is swollen, then it is likely that he has advanced Cirrhosis with ascites (fluid collected on the abdomen), which is a sign that the liver is not working well.  You and your husband really need to read the liver biopsy report or consult with the hepatologist to have a complete understanding of his exact stage of liver damage.
If he is F3, a hepatologist may approve the surgery and a surgeon may do the surgery, but probably not at the same time as Hep C treatment.  If he has advanced Cirrhosis, with ascites, a hepatologist will probably not approve the surgery as it may cause his liver to fail.  
Your husband should NOT be taking Advil or any other NSAIDS without approval from a hepatologist.  In fact, he should not be taking any medication or herbal supplements without approval from a hepatologist.  Until he knows for sure whether he is F3 or Cirrhosis, he should avoid red meat, limit sodium, and not take any vitamins with iron.  He should eat more veggies and fruits, preferably organic, and try to make sure he is at a good BMI.
Keep us posted and let us know what a hepatologist recommends.
Advocate1955
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Avatar_f_tn
Thank you for the responses. My husband is seeing a Gastroenterologist who has patients with Hep C. What a nightmare, he was in a car accident and had 6 surgeries and then had to have gall bladder removed a few months later. When he was in the ICU for the accident, in a coma for a month, that is when a nurse stuck himself with a needle and protocol called for my hubby to be tested...So we later found out about the Hep C. Oh it has been a wonderful year. I got his report and it was done in May and says Grade 3-4 fibrosis suggestive of early cirrhosis. I will ask his doctor for more of an explanation because that is a bit vague to me. I felt the same as you mentioned, and we should wait with surgery. What kind of painkillers can he take? He is definitely overweight and has a weakness for sugar. I have my hands full, for sure. I love to make salads and fish, but unless he hears it from the doctor, he likes to fight me on what is best. I really appreciate your help. I do research and he just wants me to do it but not tell him, it is as if he doesn't want to think about it. Thank you again, I wish you a happy holiday. I will check in again, if there is any other advice you can give, please do. It feels so good to have people here I can go to for support and strength for my husband.
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I should add I see on the biopsy report "moderate portal fibrosis including extensive bridging, suggesting early cirrhosis." So does that mean he does have cirrhosis for sure? I hope since May, it hasn't progressed.
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Avatar_f_tn
Thanks for looking that information up.  From what I'm understanding, the liver biopsy showed F3 (Fibrosis 3), which is the stage before Cirrhosis.  This is good, because the liver has the capacity to regenerate and repair itself before the stage of Cirrhosis is reached.
Your husband has a lot of health issues that can be complicated by as well as complicate treatment for Hep C.  Being overweight can be a contributing factor  to liver disease and also to treating Hep C in several different ways.  One way is that being overweight can cause one to have "fatty liver" (a higher number of fat cells in the liver) which places an extra burden on the liver.  Another way is that overweight people tend to have a lower cure rate.  A third way is that should the time come that your husband ever requires a liver transplant, his BMI must be below a certain number to qualify.  So, for all those reasons, getting to and maintaining an ideal BMI is a positive step.  Additionally diet is important in taking care of the liver.  Generally speaking, a low fat, healthy diet, high in veggies and fruit, preferably organic, is good.  Sugar can be a problem.  You didn't mention if he has been tested for diabetes, but being overweight and having a sweet tooth puts him at risk for diabetes.  Hep C treatments can be very hard on the body and diabetes can complicate treatment.  If he doesn't have diabetes, he should try very hard to prevent it with diet.  If he does have diabetes, he should try very hard to control it.
For the time being, I would try to get him to eat healthier (low fat, reduced sodium, low sugar/sugar free, more fruits and veggies), I would try to get him to walk for 20 minutes each day outside in the fresh air, and I would make sure he doesn't take any vitamins with iron supplements.  Regular vitamins are OK, but no iron.  As far as pain control, he should avoid all NSAIDS, and medications that are filtered through the liver.  I would ask his doctor which pain medications are OK for the liver and advise him to use them in moderation.  Of course, he will need to not drink alcohol or use any recreational drugs.
Also, remember, it is his body and his health.  It is important for him to take ownership in the things that will help his health.  You can't do it for him, and you aren't responsible.  You can support him and help him, but he will make his own choices.  With the number of issues that he is facing, he may be feeling depressed or hopeless as well.
Although F3 is the stage before Cirrhosis, a good gastroenterologist or hepatologist will treat him as if he has Cirrhosis, to be on the safe side.
Advocate1955
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Avatar_m_tn
        biopsy results will show grade and stage.  grade is a # given to assess the inflamation (inflammation);
      grade #1 being mild
                #2 being moderate
               #3-4 being severe

      staging is the level of fibrosis
      stage #0 being no scarring
                #1 minimal fibrosis
               #2 fibrosis outside of blood vessels
               #3 bridging fibrosis
              #4  being cirrhosis

      be careful and ask ??s.   a full evaluation by a hepatologist for a biopsy with grade3 and stage 4.
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Thank you, I wii ask his doctor about testing for pre-diabetes. He does have. increased urination, increased thirst, fatigue,  increased hunger. He dies not drink alcohol so I think sugar is his vice. He definitely has to get his BMI down. After his accident he had so many surgeries with issues from broken bones, bleeding on brain, ( thank goodness no brain damage) collapsed lungs, fractured vertebrae, broken ribs, radius and fractured leg...I could go on.....I had to wait a few months before I could give him the hep C news.i hope he doesn't have diabetes too.  I have Muktiple Sclerosis, so I am supposed to reduce stress... Lol....there are days I don't want to get out of bed, but knowing we are a team, I keep moving. I need to start exercising again too.
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Thank you for this info. It shows me more details that I will question the doctor. ;)
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Typo.....multiple sclerosis....need more coffee...
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Avatar_f_tn
You have a lot on your plate.  Be sure to take care of yourself too.  Coffee is a good start!
Your hubby needs a good hepatologist, in order to determine which is the top priority right now:  the surgery on the shoulder or treating the Hep C to prevent further damage to the liver, and also to monitor the state of his liver so that he doesn't have untreated symptoms of decompensated liver (e.g. varices, ascites, or hepatic encephalopathy).
Advocate1955
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Avatar_m_tn
       I also have MS with my liver disease.  i am in a similar situation, with my wife battling cancer. i take care of her.  take care of yourself, and best of luck  to the two of you
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Thank you for your response and telling me about your MS. I am hoping your liver disease is under control? Did you go through treatment? I hope your wife is doing well and the doctors have the cancer under care. Oh boy, I am so sorry. Please take care of yourself too. I have started to take time out for meditation, despite working full time as well. I do my best when I am on a exercise regime and I have 2 days to get moving because I promised my doc and myself to get my butt moving on a routine in Jan. With MS, if we don't have a good muscle base and an exacerbation hits, it is not good. God bless you my friend. I was diagnosed in 1996 and have been on the injectable Copaxone since 1999. I also am on a plethora of vitamins and supplements in addition to a few Prescription drugs. I lost 25 pounds after my husbands accident running non stop and felt the best I have felt since I can remember. My neurologist also helped me with some other tests and holistic approaches that I know are helping. Losing the extra weight is surely a plus. I also stopped eating all bread and cookies, cakes and try to avoid gluten and am amazed at how much better I feel, plus it helps keep the weight off. I decided to try it on my own ( not tested for celiac) and since I feel better, more energy, lost weight and my skin is flawless! So I tested it by eating sugar laden pies and cakes and cookies, and my face broke out, I was irritable, and felt sluggish...connection? I think so!!
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Hello, thank you for this information, it made me do some more era each and I found this! http://www.hivandhepatitis.com/hep_c/news/2011/0125_2010_b.html
Have you ever seen this correlation between BMI and amount of RBV and treatment success. Since I am now really worried about his BMI, and there is no way he is going to loose weight prior to treatment, I have to hit his gastroenterologist with every angle. So besides success rate of treatment, the other thing you mentioned about him not being able to get on a transplant list with a high BMI, I am really freaking. I don't want to mention it to him now but will in the doc office tomorrow. When that doctor sees me coming with my little notebook, he must think....oh boy I am never getting out of here, the question woman is here. I just can't wait until tomorrow is over and we can just take the next step towards treatment. My hubby already thinks he is going to be laid up from day one. I hope we can get on the Sof/RBI/Inf for 12 weeks, that would be good. I am praying that since he got through that horrific accident, God has plans for him here and that staying as positive and upbeat as I can will help him through it.
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Avatar_m_tn
       i did clear the hep c virus, and it has been a god send for my ms. i couldnt agree with you more, movement and ressistance exercise, along with a good diet has done more for me than drugs.  i am ppms thus my forum name, and DMDs do nothing for me.  Enjoy the holidays!!
barry
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Avatar_f_tn
Hi Faithdove,
Here are some questions that I have posted in my journal.  I combined some questions that HectorSF and Orphanedhawk, two other forum members had posted in past threads, and you are welcome to use them, modify them to suit your purpose when you and your husband see his doctor next:

http://www.medhelp.org/user_journals/show/615811/Preparing-for-first-appointment-with-hepatologist

It may vary from state to state, but here in Washington, I believe one's BMI needs to be under 40 in order to be considered for a transplant.  There are many other qualifying criteria as well.  My guess is that your hubby can only handle one thing at a time, so it may be good to start with one or two changes at a time.  For example, start incorporating a healthy, liver friendly diet first.  Reduce or eliminate sugar next.  Restrict red meat and iron supplements next.  Lower sodium next.  And so on....

Be aware that Interferon and Ribavirin both have significant mental health side effect possibilities.  Both can cause depression and anxiety, and it sounds like your hubby may be having some struggles with one or both already.  Some doctors will start a patient on a low dose of an anti depressant or an anti anxiety before starting treatment for this reason, to help with the negative psychological side effects.

Really, it will take a good hepatologist to guide the process of which health issues to address first.

Keep us posted.

Advocate1955
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I'm a little late to this party, but wanted to add my two cents anyway. You've gotten a lot of great advise and I just wanted to add a little emphasis to some of it. Your husband's gastroenterologist may be adequate, but that level of training is not optimal. My own excellent gastroenterologist immediately referred me on to a really good hepatologist just as soon as he was sure I had Hepatitis C (back around 1990). I liked my gastroenterologist and was sorry to move on, but ever since I have been very grateful that he did move me on up the line. If your husband has cirrhosis or if any complications arise during tx it can be dangerous to proceed without the extra level of education and experience that a hepatologist has. Please consider again whether you really want to start tx under the care of a gastro instead of a hepatologist. The more damaged the liver is when going into tx, the greater the risk of complications arising during tx, and if that happens you will surely be safer if you are in the hands of one who has a higher level training and more specific experience.

As to the shoulder surgery, I also want to urge your husband to consider it very carefully. I've been through a horrible time with both of my hands, with osteoarthritis in the basal thumb joints causing really significant pain and loss of functioning in both hands. I basically de-evolved into a mammal without one of our greatest advancements: opposable thumbs. This problem reached a crisis point three years ago but I was also about to begin my third attempt at tx to eradicate the virus. Having done tx twice before, I knew better than to try joint replacement surgery while on tx. Believe me, there is only so much a mere mortal can bear at once. I treated for 48 weeks, finishing tx in Sept. 2012, and achieved SVR as of March 2013. It took a full year to get most of the way recovered from tx. I still suffer excessive fatigue and some digestive issues, but I think those are from the cirrhosis, which can't be cured. In the summer of 2013 I finally felt well enough to tackle some of the other big issues. In mid-August 2013 I had joint replacement surgery on my right thumb and by November it was functioning far better  than before surgery. On Dec 2 I had the same done on my left hand. I'm quite sure I could not have handled this surgery while on tx or even immediately after. I hope your husband can be persuaded to spread these things out, or I'm afraid he may be setting himself up for failure in one or both counts. These things are so hard, and take so much out of you, that its a horrible waste to not give them the best odds you possibly can.

For the pain meds issue, it really depends on exactly what kind of pain and it does require a good doctor's advice. The ground rules however, are no NSAIDs (no aspirin, ibuprofen, naproxen, none of those meds, whether Rx or OTC. Most patients can take Tylenol, but within limits. At doses less than 2000 mg/day, Tylenol is the safest pain med for patients with liver disease, however, at higher doses it can be one of the most dangerous. It can cause even a healthy liver to fail completely and irretrievably when an overdose is taken, so you must read labels carefully. Do not take the full 2000 mg in Tylenol tablets and then add on some other mixed medicine that contains Tylenol in its list of multiple ingredients! If the pain is severe enough to warrant, most liver patient can take narcotics if care is taken about the Tylenol frequently added to these drugs. It also has to be carefully tallied into the daily total.

For arthritis-type pain there are a few other non-NSAID meds that can slowly help to relieve inflammation. I get some relief from both Plaquenil and Limbrel, and a good rheumatologist would be able to advise on this subject. Good luck! Breaking the sugar habit is also a really hard thing to do. I confess to being a sugar addict myself, in a fairly classic sense, with occasional periods of being clean of sugar, sometimes as long as a year, but with frequent relapses back into addiction and resultant weight gain. I'm on one of those binges right now and hoping to get clean again soon. Its hard!!!
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Thank you everyone! I am armed with my questions and the apt is at 1:45 tomorrow . Will post to let you know what happens. I mentioned to my husband about going to a hepatologist, but he wants to stay with this doctor, so I won't rock the boat. I researched each of the three drugs and listed what I hope to hear from this doctor, if not, the questions shall come in. I will definitely start off with asking him how much time he has to answer my questions, so I know which ones to make priority. Stay tuned!!!!
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Avatar_f_tn
Best of luck with the appt.
Keep us posted.
Advocate1955
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We went to the apt and it went really well. Almost every question I was going to ask, the doctor answered as he spoke to us. I did ask him what Stage we are at and he said 3-4 and we don't have time to wait for the next set of drugs. He really was excited about Sovaldi and said he is going to a big conference on Jan 9 so he may learn more info from peers. He was concerned about the price and said at $1000 a pill for 12 weeks, we have to be sure we can afford it and check insurance coverage. He wrote out the scripts for three drugs and told us to check the insurance. I asked him about getting him on an antidepressant now, and he said that Zoloft is a good one but to clear it with his primary when we go to see him to get his BP meds refilled. So my hubby asked him, how sick will I get, I can go into work right? The doc said, oh you will get sick, so it will not be easy and once you start, you have to stick to it as prescribed. I told the doc that I told him he would feel sick, but I was too much of a chicken to give him details. The doctor said, that other people have gone through the older treatments for up to a year (or more) and that 12 weeks is so much better, but still you will feel sick. Then my hubby asked about the surgery and the doc gave him a one word answer..."No". Again the doc mentioned the price of the drug and was hoping the insurance would work out, he was worried we might end up with a Hugh out of pocket say, $20,000. So we got home and looked up his insurance, and I couldn't believe it, they will cover Solvaldi and his copayment for 90 day is $50! We have to get on phone tomorrow and let him know we are covered and so next he can go in for the baseline bloodwork, get on that antidepressant, and when all the meds come in, start treatment. I will keep posting and let's hope that nothing changes with the cost in 2014, or you will hear me screaming...I swear I hope that wasn't a typo...but it said, your copayment is $50 and what we will pay is $999,980!
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Avatar_m_tn
       great news!!!  i started zoloft when i treated last time.  it took 16 days to kick in, but when it did i did settle down.  it caused a little anxiety while waiting for it to work, but was worth it. your copays sound right to me.  
barry
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If you don't mind my asking, what insurance do you have? I hope it's Blue Cross and they'll cover my treatment, too.
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Avatar_f_tn
You will probably have a co-pay for both the Interferon and the Ribavirin as well, but it will probably be similar if the co-pay for Sovaldi is $50 per month. I'm glad to hear that your hepa said no to surgery while on treatment and I'm also glad he's willing to recommend starting an anti depressant ahead of time.
Good luck and keep us posted.
Advocate1955
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I am very impressed. It sounds like your gastroenterologist is both smart and caring, really far more on the ball than most are. He's handling things pretty much perfectly so far and that means a great deal when it comes to your husband's odds of success. Just make sure your husband follows all the rules of treatment. The treatments are rough but effective if done right, and its a massive waste of energy and money to do them half-heartedly. My personal best guess for the timing of the shoulder surgery would be to wait six months after treatment, but maybe this short 12 week tx will have him recovered enough to do it a month or two later if all goes well. The HCV is life-threatening, so give it top priority in tx. Best wishes!
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For his prescription plan, my husband has Express Scripts, I think they were Medco and now Express Scripts. His copayment will be $50 for a 90 day supply. The prescription plan is not the same as his health insurance, that is United Healthcare. What prescription plan do you have? You can call them to be sure it is covered.
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Hello, I already have a pill container for him that gets filled up once for the week. We used it when he was on 7 medications after his accident. Lol, I would fill it up for him: Morning, Noon, Dinner time and Bedtime and he was a compliant patient. I myself am on so many meds, plus a daily subcutaneous injection for my MS, that his regimen for 12 weeks will be manageable. Thank you for your support ;)
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Dear Barry and Advocate, it appears the Zoloft may have the highest of all the copayments at $80 for 90 day supply. I couldn't get a price for the Interferon yet, but it is covered, and the RBV will be $10 for 90 days if I did the calculations right. I couldn't get an apt with his primary care doc, until Jan 14, so that is not good considering it takes a few weeks for a SSRI to kick in as you mentioned, Barry. I begged the nurse to see if she could get him in sooner if anyone cancels telling her the situation. I can be a real persistent pain in the arse when need be. Must be all my own experience with my own doctors ;p. I want to thank you both for your support. Also I want to wish everyone a happy New Year's Eve and 2014. We will be hunkered down at home tonight, nice and warm as it is freezing here in NJ. I will continue to update as we move into this journey and really appreciate you taking it with me. It is so comforting to know you are all here.
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Thanks for answering my question, FaithDove. I did call my insurance company and the person I talked to said Sovaldi is not on their formulary, and she couldn't tell me if it would be covered or not.
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Dear WyoSue, this is the same thing I had read an article about a few weeks ago for ExpressScripts, as they too were saying they were not going to add it to their formulary so when I checked, I was so excited! Keep checking as it may be added in 2014. I can't imagine that Gilead can get away with keeping the price so high with all the new competition coming soon. Also, call the company as they do have a patient assistance program, but you will still have to pay along with whatever your insurance won't cover. Also see if your doctor can work with them, sometimes that can push things. Maybe others on this thread can give other ideas from their experience. If you have time to wait, I bet the price will be driven down by competition. I know that the pharm companies have to price drugs to make up for all the money spent in the years and years of research, but in this situation, competition will force the price down eventually or people just won't be able to buy it and then basic economics kicks in as well. ...supply verses demand. Let me know what happens with your situation, ok? I will pray that it works out for you.
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        my copay for zoloft is about the same.  sertraline, the generic equivalent is $10 for 90 days.  
barry
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I saw my gastro doc today. BlueCross Federal has added Sovaldi to it's formulary, so it's covered. As near as I can tell, my copay will be 30% of the AWP (average wholesale price). That means I have a copay of $25,200 for 12 wks of Sovaldi. I don't qualify for the Patient Assistance Program because my income is more than 500% of the federal poverty level ($11,490 for a single person, so 500% equals $57,450 per annum). That's OK, I wasn't expecting to live long enough to use my retirement nest egg anyway and it's a lot better than paying the entire $84,000 out-of-pocket. Unfortunately, I still have to wait to start treatment because of other health issues that need to be resolved (broken tooth, digestive problems). But, now knowing that my insurance will cover some of the cost has given me much more hope.
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Wow, $25,200.00?
Advocate1955
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Is that including this???

Help with out-of-pocket costs

There are a number of ways we can provide financial support for treatment. Our specialists will explore funding options including a:

Co-pay coupon
The SOVALDI™ (sofosbuvir) co-pay coupon program will cover the out-of-pocket costs of your SOVALDI prescriptions after you pay the first $5 per prescription fill, up to a maximum of 20% of the catalog price of a 12-week regimen of SOVALDI. The coupon can be applied to up to 6 fills
For residents of the 50 states, District of Columbia, Puerto Rico, Guam and the Virgin Islands. Prescriptions must be filled by a pharmacy in these locations
The coupon is limited to one per person and is not transferable
Coupon is not valid for prescriptions eligible to be reimbursed: in whole or part by Medicare, Medicaid, or any other federal or state-funded healthcare benefit program
by private plans or other health or pharmacy benefits programs that reimburse you for the entire cost of your prescription drugs

The SOVALDI co-pay coupon is not prescription drug coverage or insurance and is not intended to substitute for such coverage
Gilead Sciences, Inc. reserves the right to terminate or modify this coupon at any time without notice

Filling your prescription

When the time comes, you’ll want to be sure there’s a pharmacy with the medicine you need in stock. Some medicines may need to be filled at a specialty pharmacy. Support Path specialists can help you find the right pharmacy, and work to ensure your medicines reach you on time.
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I'm sorry it looks like your on a federal Insurance program
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I would contact Gilead about options to help you with that $25,200 copay estimate. Although what can-do-man cites is correct, it could be read that the co pay assistance with Sovaldi would still apply for the portion of the cost that is not covered by the federal healthcare BCBS plan. Don't assume that you need to spend that money... Though you may have to, I doubt it. Gilead does not want cost to get in the way of treatment (it would add more headaches and more screams directed at them because of their cost decisions re: Sovaldi). Don't spend your retirement savings...when you may not have to...Good Luck. Joanne
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FYI - Note that the the info for the co-pay coupon that can do man posted applies regardless of ability to pay. I obtained a coupon from their website and did not have to answer questions about my annual salary. Note also that I do not yet have a prescription either (i.e., can obtain coupon prior to obtaining prescription).
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Have you considered asking your doctor about a clinical trial? Here is one that may be recruiting right now and if I could get my hubby on it, I would but it looks like the exclusion criteria would exclude him and we don't have time to change directions at this point....
Someone on another question just provided this:
Found a Phase 3 trial that just started recruiting Dec 17, 2013
with his Stage 3/4  Non-cirrhotic or cirrhotic?

A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the Triple Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

Official title
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
ClinicalTrials Identifier: NCT01979939
This study is currently recruiting participants  

Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
Inclusion Criteria:
Subjects chronically infected with HCV genotype 1
HCV RNA ≥ 10,000 IU/mL at screening
Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
Treatment-experienced subjects are eligible

Exclusion Criteria:
Evidence of cirrhosis
Liver or any other organ transplant
Current or known history of cancer within 5 years prior to enrollment
Documented or suspected HCC
Evidence of decompensated liver
66 Study Locations including many USA states , Canada, France, Australia, and Puerto Rico Most locations have started recruiting as of this post

link
http://www.clinicaltrials.gov/ct2/show/NCT01979939?term=bms-791325&rank=5

What do you think!!!
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In regard to the coupon, this is the part that is confusing..The SOVALDI™ (sofosbuvir) co-pay coupon program will cover the out-of-pocket costs of your SOVALDI prescriptions after you pay the first $5 per prescription fill, up to a maximum of 20% of the catalog price of a 12-week regimen of SOVALDI. The coupon can be applied to up to 6 fills

So if WyoSue has to pay 30% with her own insurance and if she can use this coupon, does that drop her down to 20% copayment that would now be  around $15,000? Something doesn't make sense!!! That is a far cry from the $5!! Wahhhhhhh!!!!! I do not understand this, it has to be wrong, definitely would call the company and ask them. Also ask them if there are any other patient help programs available. Why put a carrot on the string as $5 and then say up to maximum of 20% catalog price (and is that catalog price different than the average wholesale price AWP)?
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I am going to having a problem with affordability on the insurance for the Sovaldi (have to take the Infer./Riba w/it according to my doctor), because of the fact that my primary insurance is a medicare HMO and they don't add new FDA approved drugs to the formulary for at the very least 6 mon. and even then, it's not a guarantee.  The person on my insurance's cust. service explained that they don't even review newly FDA approved drugs until 6 mon. and that the review process can take some time and that not all drugs will make it to the formulary.  If it makes it to the formulary it will be at at Tier 4 or 5.  Interferon and Ribavirin would probably be on there, but again, at a Tier 4 or 5.  My husband's company has prescription drug coverage on me as well, but since I'm not ready to start my 11 or is it 12th treatment until the springtime, I haven't asked them if they plan on adding the Sovaldi. I hope that they do.  Before I do my next treatment I'm probably going to need another biopsy because by the springtime (June) I'll be at 4 yrs since the last one. While I don't particularly like Interferon and Ribavirin.., I know I can handle them because I've already done them SO MANY times.., unfortnately, so far w/o responding.  As far as a clinical trial goes, not of the trials will take me anymore because I've been exposed to Telaprevir, way on back in 2007 when it was in trials and I was in Prove-3. I was randomized into the no Riba group and even though I had a huge viral load drop in the first 10 days, it rebounded back up by like day 11-14 (most like due to lack of the Ribavirin).  Since most of the clinical trial sites won't accept someone who was exposed to a protease inhibitor w/o having all 3 drugs..., I'm left with waiting for FDA approved drugs (now that's Sovaldi, Interferon/Riba).  As far as a fatty liver (my last sono) showed that I've just not developed mild steatosis (fatty liver).  However, one does not have to be fat, does not have to be diabetic, does not have to have elevated triglycerides, or insulin resistent,.., to have a fatty liver.  I am a thin/normal weight woman, no cholesterol or blood sugar issues whatsoever.But, I have had Hep C for 30 yrs.  Susan400
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Sovaldi costs $1000 per pill. A 12-week treatment regimen is 84 pills which will cost $84,000. My co-pay for a Tier 5 non-preferred specialty drug is 30%. Unless, I'm doing the math wrong, that comes to $25,200, right?
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When the time comes for me to start treatment (hopefully in a or two), I'll certainly look into the Sovaldi coupon program. And I'm very interested in hearing from other members of the group who start treatment with Sovaldi and how much it costs them.
Thanks, FaithDove, for the clinical trial info. I don't qualify for that one because I have Genotype 2. I live about 100 miles from a hepatology center that conducts clinical trials. I'm on their list and they called me several weeks ago about a trial they were recruiting for. Unfortunately, they said I was too skinny. Just a couple years ago, my doc told me to lose weight so I got busy and lost 15 lbs. Darn it.
I sure hope all goes well with your husband's treatment and Sovaldi works for him. Keep us posted....
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Here's another clinical trial!!

Here is another Phase 3 for subjects with Subjects With Compensated Cirrhosis

A Study of an Investigational Treatment Regimen of Daclatasvir(DCV)+Asunaprevir(ASV)+BMS-791325 in a Fixed Dose Combination(the Triple Regimen)With or Without Ribavirin(RBV)for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
ClinicalTrials Identifier: NCT01973049
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
Status Recruiting
Start date 2013-12
Last follow-up date 2014-12 (Anticipated)
Primary completion date 2014-10 (Anticipated)
Criteria
Inclusion Criteria:

•  Subjects chronically infected with HCV genotype 1
•  Subjects with compensated cirrhosis
•  HCV RNA ≥ 10,000 IU/mL at screening
•  Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
•  Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the DCV/ASV/BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

Exclusion Criteria:

•  Subjects without cirrhosis
•  Liver or any other organ transplant
•  Current or known history of cancer within 5 years prior to screening
•  Documented or suspected hepatocellular carcinoma(HCC)
•  Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

http://www.clinicaltrials.gov/ct2/show/NCT01973049?term=bms-791325
scroll down link and click to Show 49 Study Locations
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I wish I could help you with the math, but it has me very confused! Too skinny! What the heck is that about, well good for you losing weight regardless, that is better for your health overall. I am still wondering if your health insurance goes through a speciality pharmacy like CVS Caremark? Genotype 2, okay, so what I just posted won't help. Are you on a general clinical trial list so they will call you for any trial with Genotype 2? That is good if that is the case, the 100 mile trip is not, but they must reimburse you for something if you participate?? I don't know, but for sure all questions you may want to ask. Thank you, I hope and pray my hubby gets through this, after his horrific accident early last year, it has been too much for him and for me! But we will all keep moving forward and get through this one road block after the other!!!!!
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I wanted to let you know I am thinking of you and tell you I really admire you! Ten times of various treatments, wow, you are a very strong person an I know you will beat this. From all of the reading I have been doing, the goal of many pharm companies is to get a drug regimen without INF and RBV. It is going to happen and you will be free of this disease. God Bless you and thank you for sharing your strength and know that you are an inspiration. Hugs.
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One more thing I just thought of, something has to give with getting these drugs to patients faster and not have insurance holding up treatment.... waiting 6 or more months to get them on their formulary. Many folks needing treatment are baby boomers, so doesn't it behoove the insurance including Medicare, to get these type of meds available instead of having people end up having to deal with further issues from lack of treatment. Boy am I learning a lot and it only makes me madder!!  
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So I am a nervous wreak over my husband's upcoming treatment. I read another post on this site about side effects during and after treatment. Neuropathy, was one of them. I am trying to remain positive but am such a worry wart. My hubby got up this morning and then went back to bed, I am sitting here thinking too much. I really hope he gets his energy back once we banish this Hep C, this fatigue is really impacting his quality of life. Thank you for listening.
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Gilead is the only one that can truly answer questions regarding their coupon coverage based on your insurance. It does appear that WyoSue will still need to pay up to 10 percent of the cost (still $$$$), but maybe not?! Good Luck with coverage WyoSue.

Faithdove, hang in there...we can only plan and deal with what we can plan and deal with...so...we plan...and deal with it...one day at a time...
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Thank you, ...I have to remember...."right foot, left foot, breathe"....
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I apologize if I've missed something here....I'm new to the hep world having only been diagnosed 3 months ago. I'm Gt 1a with cirrhosis(F4).  Trial results show Sovaldi(sofosbuvir) and Olysio(simeprevir) withOUT inf and even RIBA have same if not better results.

My hep dr has agreed to write 'off label' for treatment with these two drugs. I just don't know why any doctor would prescribe inf at this point...again I'm not an expert. Can only share my experience.

"In a pooled analysis of the 12-week treatment arms in cohorts 1 and 2, SVR4 was achieved among patients treated with simeprevir and sofosbuvir with or without ribavirin, in 96 percent of patients with IL28B non-CC genotype, 91 and 100 percent of patients with a METAVIR score of F4, respectively, and 95 percent of prior null responders.

All patients who completed treatment were HCV RNA undetectable at end of treatment and there were no viral breakthroughs in either cohort 1 or 2. The COSMOS study interim results show no benefit from adding ribavirin to simeprevir and sofosbuvir in this difficult to treat groups of hepatitis C patients and that 12 week treatment may confer similar clinical benefit to 24 week treatment. - See more at: http://hepatitiscnewdrugresearch.com/sofosbuvirgs7977simeprevirtmc435.html#sthash.WXRMZpK3.dpuf"
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Did your gastro test you for the presence of
virus with the NS3 Q80K polymorphism? Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.
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Yep! I should find out any day if I'm positive with Q80K.
However....I've decided to ask my hep dr to let me treat regardless. Results show a 15/20% less effectiveness with Solvadi/Olysio if positive with Q80K but as far as I can see from other (AbbVie) trials that makes them pretty much comparable. I'm dead set on not treating with RIBA much less inf.
I have appt tomorrow so will see what he says...
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Please keep us posted on how it goes! I am now thinking to ask my husband doc about this as well!!!
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One more thing, is your insurance going to cover this "off-label" combination?
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Hi, did you get your test results back for Q80K? My husband is getting tested today.
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Hi friends, need you positive energy and prayers that my latest plan works. Thanks to all of you and all the info I have gleaned from this site, here is were we are. My husband went to have the test done for Q80K. The tech had no clue on how to handle the prep of the blood for this teat and had him sit there for over an hour contacting his doctor and calling other sources. I guess it is so new! Anyway, supposedly the prep and blood must get processed within a 6 hour timeframe. (I wasn't there so this is what my husband heard them saying). I will be calling to find out the results because he forgot to ask how long it would take for results to come back...ugh...Now, if he is negative and if his insurance will pay for both Sovaldi and Olysio, let the treatment begin!!! If not, we are at Plan B and that is Sovaldi with Copegasus and Pegasus. He saw his primary care doc, and has a script for Zoloft and so in case we go to Plan B, we are ready. I can't tell you how many hours I have spent calling his gastro, talking with his nurse, writing emails providing the info on the clin trials to his doctors, and hours and hours reading and researching. The info you all have provided and the support has giving me the strength to carry on. I also just found out my mom has been having issues and is scheduled for a endometrium biopsy. She lives 4 hours away and I want to run to her but have to make sure my hubby is ok here. Please play, I have faith that Someone above is guiding us to what is His will. If my husband did not have that horrific accident, we would never have found out about this a Hep C! So I believe that everything happens for a reason but sometimes it is not easy to see it at that moment. Thank you all and I will keep you posted on our journey.
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Finally! Results show that I do have Q80K. Same here with the labs....the sample has to be frozen within a certain time. Mine were not so had to go back for a redraw. They only test this once a week and it takes 5 days for results. Then the report was confusing so I got the call I was negative and a few hours later that I was positive. Quest labs and yes it's new to them hence all the confusion.

But! After talking to my hep dr we decided to go ahead with the off label of Sovaldi/Olysio regardless. I might mention too that he consulted with the Director and got his approval as well.

I realize that my chances to clear fell from 100% to 91%.....

"When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K."

....but I am willing to go with those odds as opposed to the infer/RIBA route.
Doc actually never mentioned interferon except in the beginning that that wasn't what he supported. He did suggest that I could do Sovaldi and RIBA but it was my personal choice not to.

Soooo......pharmacy has them and confirmed my copay of $30 each. The prescription has been written. As long as Aetna doesn't throw a wrench in the works I should be starting soon. :)





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Pamelajean, thank you for all of this info. I am sorry they found the Q80K. As you said, if the results are comparable to or BETTER then RBV with or without Interferon, it has to be the best choice! I will pray that you get the meds now without any wrenches!!! I will keep posting our journey, please do the same okay?
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I will.....and know I pray for you and yours on your journey!
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Update..well, here it is mid Feb and I am still trying to help my husband get on treatment. We got really far and now all of a sudden his gastro wants him to come in next week to discuss the plan. You see, he wrote a script for Olysio and Sovaldi. We have the bottle of Sovaldi sitting here on the table. The Olysio is at his insurance company just waiting for us to call to have it shipped!!!!!!! The plan was to have him checked for Q80K and then decide. So after waiting for 4 weeks for results (and of course me calling them every few days to see if results came in) GUESS WHAT? He is negative. So what could be the problem? He is genotype 1a, has a major accident last year, over 8 surgeries and still has issues. He is in early stages of cirrhosis. Do you think he is considering going to Sovaldi, RBV and Interferon. I am so upset. I need advice and support. My husband can't understand all this science and gets very confused when I try to explain. His accident also caused two bleeds on his brain, so he has some cognitive issues. I want to cry....I can't see him going through the interferon with all he had already gone through. We have a prescription for Zoloft that he was going to fill if he was to go on the interferon and that was before we got the doc to write a script for the off label combo. However, have you ever gone on an antidepressant and then come off? The withdrawal from that stuff is horrific. Help!!!! I am at my wits end.
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It's hard to say.  It could be something so simple as they want to do updated blood work or EKG or something to get started on treatment.  Also, information in this field is changing so rapidly, it could be that your husband's gastro has changed his mind and is planning to recommend a different course.  Or maybe it's just to review how to take the medications.  So, do you have an appt for him to go back in to see the gastro?  Let us know what he/she says.
Advocate1955
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I'm so sorry that a delay arose, but I'd bet it won't mean a major change. I hope not! As for the Zoloft, I have to disagree quite strongly. Its true it is horrible to stop it abruptly - I did that by accident once when I forgot to pack my Zoloft for an extended camping trip, and it was a monstrous experience. However, if you reduce the dose very gradually it is not hard at all. I took Zoloft for about 20 years and quit last fall with no ill effects at all. I was on 150mg a day for many years, and dropped it to 100 for a week, then 75 for a week, then 50 for a week, then 25 for a week, then just for good measure I took 12.5 for a final week. It involved a lot of careful cutting of pills but I had no side effects other than a very slight increase in irritability. My husband didn't even notice it, so it clearly wasn't very bad. I didn't have any of the horrendous nightmares I got the time I did the accidental abrupt stop. I've been off it completely since Thanksgiving  and have done just fine! I think if the time in the med was shorter, the withdrawal could probably proceed more quickly too. I couldn't say whether Zoloft will help you, but if it might then it really makes no sense to hold back for fear of the horrors of quitting it. Good luck!
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We go tomorrow to see the doctor. Will let you all know the outcome.
Thank you for your support!
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Thank you, that is very good to know. ;)
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Well the decision has been made. Sovaldi plus Interferon  and Ribavarin. I was on the phone last night ordering the Interferon or Ribavarin  and they all arrive Friday afternoon. Looks like day one will be Saturday Feb 22. He picks up the Zoloft today. Finally, a plan in place!!!! I still would have preferred the off label combo, but my husband was ok with the triple. It is ultimately his choice and it is only 12 weeks, so I am hoping the side effects aren't going to get too bad.
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My hubby is now on week 2, I gave him his 2nd interferon shot on Friday, so he has been out of it all day yesterday and most likely today. I just made breakfast and made sure he took his pills at 6 am this morning.  Now he went back to bed. His side effects so far have been major fatigue, diarrhea the day after the shot, flu like symptoms, muscle aches and pains and head ache. ... He did miss 2 days of work last week from the fatigue. Hopefully, once his body gets used to the plethora of meds he is taking, things will settle down. His hemoglobin is at 17 from his blood results on Tuesday, so at least he is starting out high.   Onward we March!

I keep telling him to think positive, healing thoughts to help his body stand up to this monster. I am committed to watch over him these next 11 weeks, to make sure he is eating and drinking lots of water.
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I am excited to report my husband is undetectable!!! He will be at week 6 on Friday, but has been undetectable after the 4th week. We got the results yesterday. We still have a way to go and keeping close eye on his hemoglobin and platelets, so far he is still on the highest dose of RBV at 1200 mg a day along with the weekly Pegasus shot and daily Sovaldi. I continue to give him the meds exactly 12 hours apart at 6 am and 6 pm with food. He eats plenty during the day including snacks. Drinking water has now become habit. I am so grateful to have found this forum.
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Faith
Undetectable - the definition is "not able to be detected". What a wonderful word to hear in relation to this insidious virus - Hep C. Your husband's virus is "not able to be detected"...let us all take in the power of that and how it can turn someone's entire future around.

Here's to hearing and reading  that word more and more as those with Hep C move forward with these new treatments.

Nan
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Thank you Nan. His doctor described the Sovaldi as taking a "hammer to a cockroach"!!! It is 5:30 am and I am making his breakfast. Almost time for his 6 am meds!!  The past week was rough for him and for me, as my mom is very ill and he insisted on going with me to see her 4 hours away by car. Daily activities knock him out and that trip was way too much.
I am thinking of you and your husband and hope things are improving. You both have been through so much. Hugs.
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