Week 26 Update-Steve's Still Hanging In There!

Wow...it's been a long time. 

Steve is still on triple therapy.  On March 13th, he had his last RNA level taken.  The result was <615 IU/mL.  He didn't get an actual count like we were used to.  Then we realized that the lab messed up and did a bDNA test instead of the usual Quantitative Real Time PCR.  With the Quantitative Real Time PCR test, you find out your actual count.  Not so for the bDNA test.  If your numbers are less than 615 IU/mL, your result says <615.  That is what the test considers clear.  So as far as the doctor was concerned, Steve is currently undetectable.

Had some problems getting the Alinia.  Humana did not want to approve more than a 20 day supply per month.  So our doctor called Humana and sent them a copy of the study that can be found on Romark's site:   "Study Showing Improved Virological Response in Chronic Hepatitis C Genotype 4 Patients Given Nitazoxanide, Peginterferon and Ribavirin."  After reading the study, Humana approved the full 30 day supply.

We also got the results of the Disability Hearing- Denied.   To paraphrase, the judge's statement said that although there is evidence that Steve is currently disabled, there was not enough documentation of Steve's depression by the doctor's prior to the date last insured.  Therefore, his illness does not meet Social Security's definition of disabled.  After seeing the records, we decided not to appeal. The doctor's truly didn't document the file properly-just mentioned the Hep- even though Steve did discuss the depression with them several times.  And since we waited such a long time to file, there was no way to document today what happened six years ago.  At least, Steve doesn't have it hanging over his head any longer.

Well, that pretty much sums up the last 3 months.  Even though he still feels pretty lousy most of the time,  Steve feels a lot better than he did without the Procrit.  As far as we are concerned, so far-so good.  Only 22 more weeks to go!!!

Week 15 Update-A Visit to the Gastroenterologist

We went to the gastroenterologist, and he had a much more positive reaction to the RNA level than we did.  He believes that the viral load is probably on its way down- not up.  The doctor said that it doesn't make sense to him that the treatment wouldn't be working now since it worked before.  So he kept Steve on the triple therapy and ordered a new blood test including viral load for week 16.

As far as Steve's hemoglobin count (10.2 at week 12), the doctor suspects Steve is probably anemic again (even though he is taking Procrit).  So he decided to lower Steve's ribavirin from 1200mg a day to 1000mg a day.  The doctor believes that the treatment will still be effective because when Steve originally started the therapy he weighed 25 more pounds than he does now.  Therefore, 1000mg is appropriate for his current weight.

On a different note, I have to give credit to the gastroenterologist.  He always takes his time with us and never minds that I come in with a dozen questions and notes from information that I have gotten off of the internet (mainly from Janis and Friends).  He appreciates the fact that I do the research and doesn't feel that I am trying to second guess him.  In addition, when I told the doctor that Steve was having a hard time getting his test results, he told me to email him if we need anything in the future, and he'll make sure that Steve gets it.

The Peaks & Valleys of the Hep C Treatments

Déjà vu! As many of you know, this is the second time Steve had responded to the treatment for Hep C. The first time was combo therapy- Pegasys and Copegus. At the six month mark, his viral load was 20. So the doctor said that the virus was considered to be cleared. However, by the end of the 48 weeks, it was back. Steve’s also tried another form of treatment. He was on Infergen for 2 weeks, and I thought it was going to kill him. So did Steve, therefore the doctor took him off of it. So, when the triple therapy (Pegasys, Ribavirin & Alinia) was able to completely clear the virus (undetectable), it was a true miracle to me. Once I saw it was back, I just couldn’t believe it. Why…why does it keep coming back?

The only way I can describe the peaks and valleys of the experiences is to compare them to being knocked down by a wave. You are in the water. The sun is shining down upon you. You are feeling great. It’s a beautiful day. Unsuspectingly, you turn around. There is a huge wave coming right at you. Before you know it, you are under water trying to stand up. You can’t. You can feel the sand pulling from beneath your feet. You wonder if you are going to make it. Will you be able to maintain your breath until you can get out from under the wave? You do. As quickly as the wave came, it disappeared. You are back on your feet. You breathe a huge sigh of relief and thank God. Suddenly another wave comes and knocks you back down.

Initially, that’s the way it feels. But on that note, they say when you are knocked down by a wave you shouldn’t try to fight it. You should remain calm. Conserve your energy and let it pass.

This too shall pass.

At the End of This Journey, What Lies Ahead Is a Big Maybe

When I read my husband's notes for the blog ( A Punch in the Stomach ), I felt terrible.  I realized that his words were a direct reflection of my reaction to seeing that the virus was back.  I also realized that I didn't handle it well.

I don't know why but, when Steve was looking through the results, all I could think about was the RNA level.  I think I was looking for ( and expecting ) confirmation that the virus was still gone.  When I saw it had come back, even though the RNA level was only 280, I blurted out "It's 280."  He said, "What are you talking about?"  I said, "Your viral load is 280."  Then he looked back down at the results, then back up at me, and instantly I felt like I wanted to cry, so I turned away.  Steve knew it.  He told me that it was okay.  Everything was going to be okay.  ( How pathetic that he had to console me. )

But it doesn't end there, I was silent through most of the ride home.  Still couldn't look at him.  I felt so sad and so angry.  Not angry at Steve but at the virus- if that makes any sense.  I couldn't understand why it came back, and I started to think to myself, "What did we do differently?   Must be some reason why it's coming back."  So I thought about how stressed out we've been, and I said to Steve that it must be the stress that's stopping him from fighting the virus; and when we get home, I'm looking for a psychologist.  And that's exactly what I did, I went straight to the computer.

In hind sight, I realize that looking for reasons was my way of trying to get some control over the situation. But there is no controlling this virus.  There is no instruction booklet that we can follow to guarantee results.  And at the end of this journey, what lies ahead is a big maybe.  Maybe the virus will be gone.  Maybe he'll still have the virus.  Maybe the virus will go away and come back.  The only control I have is to accept what happens, be there for my husband and move forward.

So Babe, since I know you read the blog, I want to tell you that I am so sorry for not being there for you!  And you don't ever have to feel bad for me.  Even though having the Hep can be hard on both of us, sick or well, there is no one else that I would rather spend the rest of my life with.  I only wish you felt better, for you, not for me.

RX Drugs are Expensive Even with Insurance!

We filled his prescriptions with the new insurance (Humana Select HMO) for the first time.  The Pegasys alone was $504, and the RibaPak cost $345.  That's for a one month supply.  As for the Alinia, that was only $50, but Humana only approved a 20 day supply.  So Steve is going to have to call the doctor, and the doctor's assistant will have to straighten that out (hopefully).

I have to say that the doctor and his assistant have both been great.  Anytime Steve needs anything they take care of it without any problem.  Thank goodness for them!

Tomorrow I am going to call Roche Patient Assistance Foundation to see if we qualify for help with the cost of the drugs.  In case anyone else needs help, the number is 1-877-757-6243.  In addition, there are other pharmaceutical industry-sponsored patient assistance programs.  For more information on those, the website is called Partnership for Prescription Assistance.

To those of you who celebrate it, we wish you a Happy Thanksgiving!

All the best to you and yours,

Lisa

Steve's Back on the Treatment!

Steve went to the cardiologist on Tuesday.  All the tests came back normal, and he was given the go ahead to go back on treatment. 

The gastroenterologist says that he wants Steve to start from square one- which means he'll be on Triple Therapy for another 48 weeks.  He'll have his first blood test in two weeks and every two weeks thereafter:  just a standard CBC.  At the 6 week point, he will have his viral load checked (which will be the first time since he's been off treatment.)

Steve's taking 1200mg of Ribavirin daily, 0.5ml of Pegasys once a week, and 1000mg of Alinia daily.  On Saturday, he is going to start taking the Procrit again (40,000 units weekly), and he will remain on the Procrit throughout the Triple Therapy.

He's already feeling the effects of the meds.  Couldn't sleep last night.  Had several charlie horses in his legs.  Today he has had a bad headache all day, and he is freezing again.  

But as I've said before, if it works, it's all worth it.  I am speaking for both my husband and myself when I say that!

Blood Test Results Are In - The Procrit is Working!!

Steve has been feeling a lot better  The Procrit is working his RBC count (3.52), WBC count (3.8) and Hemoglobin (12) have all increased. And we've been getting along just like we did before the treatment.  No more fighting over nothing.  I am so happy.  I feel like I have my husband back.

He feels bad about how irritable he was, but we both realize that is quite common and a side effect of the treatment.  He was reading some blogs on Janis and Friends that he could really relate to.  He told me that a lot of bloggers on treatment were talking about how they were fighting with their spouses over nothing but couldn't stop themselves.

Steve is going for his stress test (and echocardiagram) on Wednesday.  If all goes well, he will be resuming the Triple Therapy with the addition of Procrit. 

It has been a long hard road for him, but he definitely wants to continue the treatment (which makes me very happy)!

Finally Stopped the Itching!!

Steve was going out of his mind from the itching.  He said he felt like something was crawling all over him.  It got so bad that he wasn't sleeping at all. He just wanted to jump out of his skin.  The medication that our primary care physician prescribed ( Hydroxyzine HCL 25mg and Triamcinolone 0.1% Cream FOU) wasn't working at all. 

So Monday I called a dermatologist, and they were nice enough to get Steve in the same day.  The dermatologist prescribed Clobetasol Propionate Foam, 0.05%.  The first night he used it my husband was able to sleep, and it has been working ever since.  He itched a little here and there the first few days but nothing like before.  He isn't itching at all anymore.  He uses the foam twice a day (in the morning and before he goes to sleep).

Day 2 - Off Treatment (Temporarily?)

I can't even begin to tell you how I feel right now.  The whole idea of my husband not being on treatment is surreal.  I feel like I dreamt that we went to the doctor, and I'm waiting to wake up. 

Quite honestly, I know that right now my husband dreads the mere thought of going back on the treatment.  It took everything out of him.  I only hope that these feelings will pass.  I know he had a really hard time.  Words can't even describe how he felt.  At times, he literally thought he might be dying.  And still I can't help but feel it might be the only hope for us to have a future together.

Which is why I cried today when I saw the comment that Sheba left for me.  She understands my hope and my fear.  I read it to my husband.  I just hope her words run through his mind if he gets the option to go back on treatment.

Thank you Sheba.

Wk 12 Results Are In ... The Virus is Undetectable!

Good news.  For the first time, the virus is totally undetectable!!

Although, we have hit a small bump in the road.  The doctor is very concerned that my husband is experiencing such severe shortness of breath.  The blood test did reveal that Steve is anemic (RBC 9.4), and the anemia could be the cause. However, since Steve's father had a history of heart disease, the doctor doesn't want to take any chances.  He is ordering Procrit to increase his red blood cell count and temporarily taking Steve off the treatment.

The doctor wants Steve to see a cardiologist and have a stress test before he continues any further.  If everything goes well with the stress test, he is going to go back on the treatment but this time with the addition of the Procrit.

I didn't know how Steve was going to react, but he was actuallly relieved.  I think the doctor gave him the ok to do what he knew needed to be done.  When we were leaving the building, he sat down on a bench in the doorway and started crying (sobbing).  He then said, "At least we know it works, but I just couldn't take it anymore."

Right now he is looking forward to getting his strength back.  A few minutes ago, he was talking about how he is going to prepare himself both mentally and physically to restart the treatment.  At least now, he knows what to expect and hopefully with the addition of the procrit he'll have a better experience.

Most important is the fact that the triple therapy worked...at least up to this point.  So there is hope, not only for my husband, but for others with genotype 4 (and studies are currently being conducted on genotype 1 as well). 

Thank You for Your Comments & Support

Sometimes I feel so isolated.  It's really hard watching someone you love deteriorating right before your eyes; and there is nothing that you can do, because the very thing that is eating them up inside is the only hope of a cure.  But when I get your comments, I know that I am not alone.  We are not alone.  And I thank you so much for being there!!  You are the best medicine ~  for my husband and for me.  So I just want to say thank you.

Study Shows Nitazoxanide Could Have the Potential to Eliminate the Need for Ribavirin in the Treatment of Hepatitis C

Found an article on Medical News Today's website that suggests that treatment with Nitazoxanide (Alinia) and peginterferon alpha-2a could have the potential to eliminate the need for ribavirin in the future. Thought it was interesting. Hope you do as well.

Romark Announces Presentation Of New Data For Nitazoxanide In Chronic Hepatitis C At AASLD 2008

Article Date: 04 Nov 2008 - 0:00 PDT

"Romark Laboratories, a privately held biopharmaceutical company, announced that data from studies of nitazoxanide in chronic hepatitis C virus (HCV) infection are being communicated in three presentations made at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting(R), and the 50th Anniversary Meeting of the International Association for the Study of the Liver (IASL) in San Francisco, October 31 - November 4, 2008."These new studies confirm earlier data suggesting synergistic activity between nitazoxanide and peginterferon in genotype 4 patients and provide a first look at sustained virologic response in a limited number of genotype 1 patients," said Jean-Francois Rossignol, M.D., Chief Science Officer of Romark Laboratories and discoverer of nitazoxanide. "These data also provide interesting insights into the mechanism of action of nitazoxanide, including a potential role for its combination with STAT-C drugs, and confirm previous findings related to its safety."The three presentations include:-- "Evaluation of a 4 Week Lead-In Phase with Nitazoxanide (NTZ) Prior to Peginterferon (PEGIFN) Plus NTZ for Treatment of Chronic Hepatitis C: Final Report," J.F. Rossignol et al., Sunday, November 2, 4:15 PM PST (Oral Session IASL #87), and Tuesday, November 4, 8:00 AM - 12:30 PM PST (AASLD Presidential Poster #1848)In this Phase II study, 44 patients (40 with HCV genotype 4; 3 with HCV genotype 1; and 1 with HCV genotype 2) received 4 weeks of nitazoxanide 500 mg twice daily followed by Pegasys(R) (peginterferon alfa-2a) and nitazoxanide for 36 weeks. Data from Romark's STEALTH C-1 trial was used as an historical control. Analysis of data was by intention-to-treat.Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of nitazoxanide followed by the addition of peginterferon for 36 weeks experienced a SVR 24 weeks after the end of treatment compared to 50% in the standard of care (SOC, peginterferon alfa-2a plus ribavirin for 48 weeks) historical control group (P = 0.006), 61% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon alfa-2a, and 79% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus SOC.Of the 44 patients in the study, 78% (n=40) of patients with HCV genotype 4, 100% (n=3) of patients with HCV genotype 1, and 100% (n=1) of HCV genotype 2, had an SVR with undetectable virus at 24 weeks following end of treatment.Adverse events reported for these 44 patients were similar to those reported in the STEALTH C-1 trial. Patients treated with nitazoxanide experienced no more side effects than patients who received the SOC therapy. Only one of the 44 patients discontinued therapy due to noncompliance. There were no serious adverse events or discontinuations due to adverse events."These data confirm findings of our STEALTH C-1 trial related to safety and efficacy of nitazoxanide in patients infected with HCV genotype 4, show that the nitazoxanide lead-in phase prior to standard of care treatment can be reduced from 12 to 4 weeks, and indicate that ribavirin may not be needed to maintain SVR," said Emmet B. Keeffe, M.D., Chief Medical Officer of Romark Laboratories.-- "Potential Role for Nitazoxanide in Combination with STAT-C Agents for the Inhibition of HCV Replication Without the Development of Resistance," Korba, et al. Sunday Nov. 2, 5:30 PM PST (Oral Session #115)This oral presentation by Brent Korba, Ph.D. of Georgetown University Medical Center, described preclinical studies demonstrating synergistic interactions between nitazoxanide and direct-acting antiviral drugs targeting NS5B (2'C methylcytidine and HCV-796) and NS3 (telaprevir and BILN-2061) in HCV replicons. Nitazoxanide was also active against telaprevir- and 2'C methylcytidine-resistant mutant replicons. The authors concluded that nitazoxanide is a good candidate for combination therapies with STAT-C agents in the absence of interferon or ribavirin.-- "Nitazoxanide (NTZ) is an Inducer of eIF2a and PKR phosphorylation," Elazar et al., Tuesday, November 4, 8:00 AM - 12:30 PM PST (Poster #1881)This poster presentation by Menashe Elazar, Ph.D. of the Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, showed that nitazoxanide increases the intracellular levels of phosphorylated eukaryotic translation initiation factor 2alpha (eIF2alpha), a key mediator of host cell antiviral defenses. Co-treatment with interferon increased nitazoxanide-induced eIF2alpha phosphorylation. . Nitazoxanide was also shown to increase the phosphorylation of protein kinase R (PKR), a key step in the activation of PKR's kinase activity towards eIF2alpha."Data presented in each of these communications has provided important information in guiding the ongoing clinical development of nitazoxanide," said Dr. Rossignol.About Hepatitis CHepatitis C is a blood-borne infectious disease that is caused by the hepatitis C virus (HCV). It is the most common cause of chronic hepatitis in the U.S. and may eventually lead to cirrhosis, liver cancer and liver failure. The disease is transmitted by contact with HCV-infected blood. A large majority of those infected do not show symptoms, but fatigue, abdominal pain and nausea can be common. The current standard treatment of care, peginterferon and ribavirin, is effective in about half of all patients treated. According to the Centers for Disease Control, HCV affects an estimated 4.1 million Americans.About Romark LaboratoriesRomark Laboratories (http://www.romark.com/news/11032008.aspx), a privately held biopharmaceutical company, has discovered and developed a new class of small molecule antivirals known as thiazolides. The Company is developing nitazoxanide, the first of the thiazolide class, for the treatment of chronic hepatitis C, and is developing other new thiazolides for treating viral diseases including chronic hepatitis B. Alinia(R) (nitazoxanide) is approved by the U.S. Food and Drug Administration and marketed by Romark for the treatment of Cryptosporidium and Giardia infection.Romark Laboratories http://www.romark.com/news/11032008.aspx

I found the article in Medical News today. To access the article directly, the address is: http://www.medicalnewstoday.com/articles/127968.php.

Wk 8 of Triple Therapy: Experiencing Severe Shortness of Breath

I am really worried. Went out this evening, just to walk the dog, with my husband. (It was a short walk.)

My husband got so out of breath I thought he was going to collapse again. He said his chest felt really tight, and he could hardly breath. He also said it happens often, but he doesn't want to tell the doctor. He's afraid he'll stop the treatment. I'm afraid he is going to have a heart attack.

I don't know what to do...

Today Is My Husband's Birthday

Today is my husband's birthday. He has been in bed most of the day. He got up a few times but went right back.

I was hoping we would be able to get together with some friends for a quick dinner to celebrate, but he isn't up to it.

As I am writing, I am wondering if the idea of going out with friends was more for my benefit than his. Since he started treatment, we haven't socialized at all. He is just not up to it physically or mentally. Just the idea of having to make small talk makes him anxious right now, and I totally understand that. However at times, I do feel very isolated.

Getting the Runaround with Health Insurance

Well I started my new job last week. They gave us a brochure with all the info on health benefits. The only thing it lacked was the copay amount for level four drugs-- which includes all the drugs my husband is currently taking for the Hep C Triple Therapy. So I called the insurance company, their rep told me to ask my personnel representative. The personnel rep told me to call the insurance company.

In addition, all of the drugs (Alinia, Pegasys, and the RibaPak) require preauthorization. So I am going to have to try to get my husband's doctor involved to see if he can get Steve pre-authorized before I change insurance.

I can't ( I won't ) change insurance until I know that my husband will be able to continue treatment. It's just very frustrating going through the process. You ask all the right questions, but no one has any answers nor do they care.

Week four - Viral load went from 545,900 to 21,800

We got the results back from his second blood test today. Everything looks good. No anemia. His thyroid was ok. His HCV viral load went from 545,900 (last test was taken two years ago) to 21,800.

Since he was only on treatment for four weeks when the test was taken, we are very hopeful and happy with the results! But we are trying to keep our cool. Because the first time he was on combo therapy (without the Alinia), he cleared and then relapsed.

I have to say the side effects are much worse this time than the first time he was on treatment. They are getting worse everyday. He gets very bad stomach aches everytime he eats now. He is still getting dizzy and is very short of breath. Yet he is determined to hang in there. He knows that no matter what he is going through today, it is the end result that matters the most!!

Best to you and yours,

Lisa

Hepatitis C Triple Therapy Week 5

Sometimes it is really hard watching him go through this. He's still dizzy and short of breath a lot. On top of that, and the nausea, he is now experiencing numbness in his leg.

The hep c treatment is taking its toll on him emotionally as well. He is starting to get irritable and really frustrated. I just hope he can push himself through this. I know it is really hard for him, but I keep thinking of the possible prize at the end.

Today is the first day of week 5. He had his second blood test yesterday. The doctor ordered a CBC, CMP, Thyroid test, and HCV quantitative to get a base viral load. (I would imagine most doctor's would order the baseline prior to starting treatment. But my husband's doctor didn't expect him to get the medicine as quickly as he did, and Steve wound up starting the treatment before the doctor ordered the HCV quantitative.)

Week Four

The past week has been really hard on my husband, but he’s getting through it. After he collapsed and hit his head on the table (A Call for Help post), he was really dizzy for days. His doctor came to the conclusion that he probably had a concussion; although the emergency room doctor never said anything to us about it. In addition to that, because the side of his head hit the table, he can hardly open his mouth. It’s even an ordeal for him to chew.

But aside from that, he is definitely feeling better today. Believe it or not, we even laughed about the whole sequence of events since he started treatment. Week one was rough but tolerable. Week two, his mom winds up in the hospital. Week three he collapses. So far, week four is extremely uneventful, and we plan on keeping it that way!

Best to you and yours!

Lisa :-)

First Doctor's Visit Since Starting Hepatitis C Triple Therapy

My husband saw the gastroenterologist. It was his first visit since he started the triple therapy for hepatitis c. The doctor went over his first blood test results with us. At this point, everything looks good. Steve is not anemic. His hemoglobin, hematocrit, and RBC count are lower than normal but nothing to be alarmed about.

Because he has been experiencing extreme nausea and fatigue, the ribavirin was decreased from 1400mg a day to 1200mg. In addition, instead of taking 6 tablets totalling 1200mg of ribavirin, the doctor wrote him a prescription for 600mg tablets. So he only has to take one pill twice a day.

The doctor also recommended, that before my husband gives himself his weekly injection, he should take ibuprofen. This should lessen the flu-like symptoms he gets after the shot, i.e. body aches, chills.

As far as my husband's blood pressure is concerned, since it is only high occasionally and started before he began treatment, the doctor does not believe it is a side effect of the therapy. Therefore, he does not want him to start taking blood pressure medication. It can have negative effects on the liver, and the less medication he takes during the triple therapy the better.

Week 3 of Hepatitis C Triple Therapy

Week 3 of the triple therapy has been really hard to him: physically and emotionally. He's been extremely nauseous, weak and dizzy. He's been getting the chills a lot as well.

I don't know if the dizziness is a result of the stress from his mother being in the hospital or if it's a side effect of the treatment. However since he fell (A Call for Help), he has hardly left the house. When we did, I drove- he realized that he couldn't.

Tomorrow we are going to see his gastroenterologist. He should have the blood test results, and hopefully we'll get some answers.