Treatment response and decision making - Genotype 1

[Odin999]

Prior to starting treatment I was very healthy, few HCV symptoms to complain of. My ALT/AST levels had been mildly elevated for years but roughly doubled within the last two years. I am female, age 51, caucasian, ultrasound indicated no problems other than "mild fatty infiltration", no other illnesses. Don't drink alcohol. All my blood work was within normal ranges except:
ALT 148 U/L
AST  87 U/L
GGT 50 U/L

Treatment brought all my LFT levels back within normal range by week 4. I have not yet seen my 12-week blood test results. Week 8 showed moderate neutropenia, RBC decreasing but still within normal ranges.

Viral load:
Pre-treatment: "very high"  >750,000 I/U using COBAS AMPLICOR 2.0
4 weeks: 103,000 I/U using COBAS AMPLICOR 2.0 (The test was conducted right at end of week 4 within 30-40 minutes of having shot #5)
12 weeks: Currently awaiting the results

Questions:
1. What is your opinion about this response rate for Genotype 1?
2. If the virus is still detected at week 12 would you recommend waiting for more effective treatments?
3. What effect does vigorous exercise have on treatment? I was told that if I could cycle 100Km prior to treatment I would be able to ride 50Km during treatment. I was able to ride about 35Km for the first couple of months but have now had to stop due to weakness, chest pain, shortness of breath. I want to start again even if it is only for short distances, however I don't want to risk overdoing it.

Treatment is severely disrupting my life so these decisions are very hard for me. I have no family and have to support myself. Given information about Telepravir I would certainly have waited for it given my low original starting odds and the lengthy treatment duration of SOC. I am tempted to cut my losses, get my health back before some permanent damage is done, then try again with more favorable odds in a couple of years.

Thank you so much for giving your time to help people here in this forum.

[Odin999]

Thanks for your kind thoughts. I will correspond with you about it in one of the other forums. I would like to try and focus on getting Dr. D's medical advice here.

[Odin999]

Thanks very much for posting. First, I am truly sorry to hear about your husband. I empathise deeply. I hope that in time he continues to improve, even if only a little at a time. It strikes me that doing the treatment at his age, after a liver transplant, would have been a Herculean effort. I haven't delved too deeply into post-transplant TX issues, but I am aware that it is a complex situation from an immune system point of view.

From the core of my heart, I wish the best for him. I certainly know what it is like to agonize over these issues and feel betrayed by a lack of quality information. My gut feeling is that someone like your husband, who has already displayed such power and dedication to life, will be drawn forward to the best outcome possible in the circumstances. I hope that each and every little broom stroke in that back yard of yours gives him strength and health. Keep him moving, even if it is rather slowly. I wouldn't let him give up on getting some improvement yet.

I have spent the last three months looking into the medical, psychosocial, and epidemiological issues surrounding the disease and current treatments. I looked from my own perspective as suffering individual, and from that of the commercial and government interests involved. I have now read countless diaries, forum posts, and scientific studies. Er... it wasn't easy during the first 12-weeks of treatment!

Prior to starting, I was most certainly not given good information about the disease, the treatment process and risks, or the odds of success despite specifically asking for it on more than one occasion. I am appalled by the quality of the treatment I received. Fortunately, some of the things my first GI said caused me concern, so I went looking for further information almost right away. When I asked my GP to refer me for a second opinion she wasted no time in getting me out of the situation. I am very grateful for that. Nonetheless, the move was a bit too late at week #11. I have made a fair number of posts during my discovery process on the medhelp forums over the past weeks. Some of it in a state of distress.

Needless to say that I have found a great deal of variation in treatment experience. Some people are given the best information available, they have brilliant specialists who keep themselves up-to-date and who should be commended for doing the best they can in a difficult situation. On the other end of the scale it is my impression that there are instances of treatment which do far more harm than good. To be fair, you sometimes can't know until you try it. At least we should be given the full story beforehand so that we can make the best decisions given our life circumstances.

When we start out as patients, we are rarely in a position to judge the quality of a specialist or fully understand the ramifications of their recommendations. SOC should protect us, but goodness me... take a look at it from country to country. As soon as I regain some strength I will be campaigning for more research, full disclosure, and a much more compassionate and educated approach from the health authorities here.

I am currently inclined consider my treatment to have been a brutal waste of time, and that my trust in the first specialist was a very costly mistake. I think I would have treated at some point, but really, given my very low initial odds of success and the likelihood of better treatments on the horizon I would have waited, and prepared more thoroughly.

[mumnmgr]

Would like to tell you about my husbands experience.  Presently 69, started 48 week therapy March 2006, liver transplant in 2000.  Before treatment, very healthy guy, could split wood, we work together in our own very challenging small business.  He was not overweight and eats very well.  Being a very committed guy, he stuck out the whole 48 weeks.  He lost 45 lbs.  Our life was **** and I thought the business would go under.  His viral load was undetectable, but 3 months after the treatment, it began coming back.  Now, a year after the treatment, he is not the man he used to be.  He's gained some of the weight back, but he can't even do regular yardwork without getting really tired.  He can't recuperate from exercise like he used to.  he falls asleep in front of the tv at dinnertime.  We both completely agree that had we known about the awful affects of the treatment during and especially after, we never EVER would have done it.  We do not feel we were informed of the severity of sideeffects, and particularly the state he would be in after the full treatment.

I think something is already being used in Europe successfully that is a much easier treatment with few side effects.  Our liver people said there are promising treatments a few years away.  

Hep C progresses very slowly, and progresses faster post transplant.  For us, there was very little affect on the liver 8 years after transplant.  But I believe that treatment probably adversely affected his overall health, his immunity, and his lifespan has been shortened.  He looks about 10 years older than he did before the treatment.  I'm sure you being much younger and healthier, the longterm side effects won't be as bad.    i'd talk to as many people that have been thru it as you can about the after effects and ignore whatever the physicians say about side effects--they only see it on paper and visit with patients briefly.  Good luck.

[Odin999]

Thank you very much.

My new specialist is recommending that we discuss treatment options if the virus is UND at week 12, but to stop otherwise. Rationale being that more effective drugs will be available in the near future, and that treatment past 48-weeks is not government subsidised.

This makes sense, but leaves me with questions about disease progression. May I ask one last quick question?
-- If I stop, what happens to VL and liver enzymes and over roughly what period of time?

[Douglas Dieterich, MD]

Ans 1. hard to know if this is 2 logs if we don't know where you started from. All HCV RNA should be quantified not > something
2.Depends. If it is down to 1000 IU i.e. another 2 logs and headed South would continue, but doing monthly Quantitative PCR's. If you get truly negative by week 24 (<5 IU) then you would need to continue to 72 weeks of treatment or about 1 year after your first < 5 IU test.
3. Exercise is good for your body and soul. Do as much as you can and maybe you can avoid antidepressants. If you get anemic ask your doc for Procrit. Should have no negative effects on your treatment. Good luck!

[Kristina538]

I think I took the time off because of symptoms....  I've been in the same job for 10 years and the last couple have been hard.  It is quite high pressure (pity the $ don't reflect :-) job.  I do get some liver pain, but have for years had intermittant trouble with constipation.  I go radically naturopathic every few years which seems to fix it - so for the last 6 months have been low fat, no red meat, heaps of water fruit & veges juices and supplements.  My GP told me not to stop work; my specialist said that full-time workers on Peg struggle and to get back to part-time if possible.  I was getting so stressed with the whole thing that I just wasn't stepping up in my job, so managed to get the 3 months off, and, if I cope with the meds, will go back but not in the high pressure area that I was in.  Luckily my boss hasn't asked me too much;  I did say it was a 'type of chemotherapy' and that I had digestion problems and I wasn't going to share the whole story with anyone until I'd discussed it with my boy.  (My son thinks I've got a pre-cancerous condition).  All these half truths will more likely be the death of me!!!!   And, I am so sorry, I did say that, like you, I had no family.  I did mean no blood family and for some strange reason I don't count my partner as family;  he is more like a good boarder but isn't very engaged and while he gets on well with my son, it's more like having 2 sons than a hubby and child and we live in my house.  My parents are dead and I have a brother who lives some distance away.  I felt so guilty after I sent my post - I guess I was thinking along the lines that being alone could quite easily be preferable, and I do feel alone  - doh - bad bad bad - it's not that bad.   However, you sound as dynamic as I am when I am on my own and I must admit that my partner has stood in the way, like a big brick wall, from me conquering the world - and being an 'olic' (achievaholic, workaholic, prove-myselfolic etc) I suppose that him being the absolute opposite, while frustrating, may actually tone me down a bit.  So I do apologise and I feel a real idiot when I type here that I don't really consider my partner as family, but it is true, and he would understand my saying this;  I hope you understand where I'm coming from.  Also, when I mentioned about coming back from the effects of Interferon, I note that I was on the monotherapy without the ribaviron.  It took some months for me to get my old spark back, but I renovated a house, and got a new job within the year afters, bushwalked and cycled and swum
At the moment, I'm just thinking that it's all okay and I'll sell my house if I can't manage to go back to work.  In reality, I'll probably be a neurotic wreck if I can't manage work and the finances go squiffy.  I can get Government assistance but not while I'm in a long-term relationship.... Ah well, as long as I get through this horrible winter we're having in NZ - the sun really does wonderful things to my state of mind.  Right now I'm just glad I don't have to get up in the morning and look after Company stuff - I can just look after my stuff.

[Odin999]

Thanks so much for your messages. It is certainly comforting to hear from people who do return to normal after treatment! Interesting to see your numbers/progression and hear how it is affecting you. Did you have to take the time off because of HCV symptoms?

It is really hard to make these decisions. I started this whole journey because I was feeling a slight change in my wellbeing. I more or less accepted the presence of the virus and what it meant for me socially etc. What I wanted out of treatment was to secure more healthy years - an ultimate improvement in quality of life. Since starting treatment my attitude toward living with virus has changed a bit. The treatment certainly highlights what a terrible illness it can be.

I cannot find one single completed scientific study which takes a broad view on the subject of long term effects of the treatment. Max Hopwood in Sydney is currently gathering subjects for a study on side-effect persistence but I don't suppose that will be published any time soon and it is likely to be quite small. All the studies seem to focus on one of only two key measures, arrest/reversal of liver damage, and detection of the virus. I can understand that those are the most important factors to measure in the end. However, this is such a tough treatment, and such a gamble for a GT1 with a "very high" viral load. I could be looking at 48 - 72 - or more weeks with a possible relapse at the end of it and all sorts of health problems I didn't have beforehand. It does make sense that the Pegylated Interferon treatments could have a higher risk of causing permanent damage due to the greater and more consistent exposure to the drugs. There is a point of diminishing returns, yet indentifying that point without comprehensive information is terribly difficult.

[Kristina538]

And on the comment of losing your business and house.... I have 3 months off work and, if I'm not up to going back then, have seriously thought of selling my house and spending the money.  I will really need faith in my higher power then :-(,  but it might not be so bad to downsize after all.   Once again, I hope you manage an informed decision - from your heart not your chemical-lade emotions.  Regards Kristina xx

[Kristina538]

Hi Odin999,
I'm 53 yrs old female and, like you, have had elevated alts for years with a slow but sure increase in the last 2 years which rose to Alt 205 Ast 131 and have now (naturally - I'm working hard here) reduced to ALT 128 AST 79.  GGT in the upper limits of normal.  My ultra-sound showed slight fatty change and spleen upper limites of normal (same measurement as a 1994 scan so....), but my bioby shows fibrosis heading towards early stage cirrhosis.  Like you, I really try to look after myself, don't drink etc (don't exercise like you do though but I AM all of 2 years older so walking jogging with the dog will have to make do.
I know that the Ribaviron is the killer with breathlessness (I am nervous as I already have a dormant lung condition);  I was told that exercise is really good, but also, if you're breathless, to take it easy.   Also, I noted that you're thinking of stopping treatment.  I was on the non-peg interferon in 1994 when I was very active;  it really really slowed me down and I thought I'd never recover, but i did - slowly but definitely and got back into swimming and bush walking and aced a new job etc etc.  I really think that if you are as fit as you are, you can afford to take a few months of taking it easy for the wonderful miracle of clearing this damned virus.
I have no family either, and a teenage son who very much depends on me and I so realise how difficult all of your decisions are.  Sometimes when we're alone, and it's only between us and the Universe, it can be a blessing (better than being with family or friends that aren't helpful anyway).  
The top Specialist I spoke to said that symptoms are short lived i.e. you will return to normal; in saying that I know that with some people recovery is slower, but you certainly sound in good shape.  I was told to go on tx 2 years ago and was just too busy trying to earn a living;  now, with the results of my biopsy I realise my chances of clearing are slimmer because I did this.  All the very best wishes with your difficult journey.

[Odin999]

Thanks for that. I am/was a mountain biker  

I was pushing a bit at the beginning and feeling fantastic afterwards. 30Km of what I would formerly have regarded as moderate terrain made me very tired, as though I had done a 100Km rain, mud, and mountain classic challenge. I thought it was really helping me get through treatment. I still think it will if I can nurse myself back into it. I had two shocks though. One time, I pushed a bit too hard and my temperature shot up over 38 degrees several hours afterwards. About three weeks ago I started to get symptoms that appear to be anemia. The muscle just started to fall off me at an alarming rate. I slowed right down, then last week stopped. I don't have my latest test results yet so I can't confirm the anemia. Exercise is so important to me. Even stopping for one week has made me feel like a bloated ball of blubber.

I was going to avoid the quality of practitioners issue when asking Dr. D these questions. I want to rescue my health and my life first and foremost. It's hard not to talk about it though. I was so disturbed by my first GI that I asked my GP to introduce me to someone else. I have only seen the new person once but she seems like a vast improvement. Everything she says is in line with latest research and is sensible. I have missed the opportunity to tweak and monitor during the initial 12 weeks though. I can't even know whether I have already had a 2 log drop or not. I don't know my starting viral load range. I wouldn't even have the 4-week VL information if I hadn't been exceptionally persistent in asking for it.

My introduction to this treatment was like being knocked off my feet, and then thrown straight into a vat of poison. I wasn't told of the low success rate for my genotype or about the post-treatment convalescence period required. In retrospect, I realise that he didn't even confirm that my ALT/AST levels were persistently higher than normal.

I have lost most of my income for three months and my clients are now very unsettled. At first there were practical issues like being told that I needed to be "trained" by the GI for the first 4 injections on Wednesday afternoons. After the 4th he said I needed a bit more "confidence", which I found insulting (Redipen for goodness sake!). I went for the 5th because I wanted my test results, but the way things were going it could have been more if I had not become thoroughly creeped out and refused to do it.

I have had a very large dose of fatigue and flu-like symptoms. I can tough that sort of thing out and it has settled a bit now, but I have not been coping well with the brain fog when trying to work. I am looking for ways to deal with that or I have to stop treatment. Not sure if over exercising was affecting it a bit. I certainly was incredibly stressed at the interactions with the first GI. I have calmed down now that I have a better specialist. I am at the 12-week crossroads, fearful of losing my small business and house, trying to figure out the best course of action from here on.

[Uplink]

What the doctors usually look for is at least a 2 log drop in your viral load by week 12 to justify continuing treatment. So if your VL is 1,000,000 at the start of treatment, you lop off 2 zeros giving 10,000 or less as a week 12 cutoff. Doctors who keep up with the latest in treatment (like our Dr. Dieterich here and UNLIKE my GI) test frequently at the start of treatment, and tweak your TX to try and make it happen for you.

As far as exercise during TX, I think it's really helped me, but you need to keep in mind that with the Ribavirin nuking your RBC's your body can't process as much oxygen, so you need to go slower and/or avoid hills. If you keep it aerobic and avoid going into oxygen debit, you can still do significant mileage. I find that my body can't deal with the lactic acid produced when you push too hard (during TX).

I put an electric motor on my bicycle at the start of TX, and it's worked out great. I live at the bottom of a 400 foot hill, and couldn't get up the hill with my mild anemia, With the motor assist, I ride to work most days, a 30km round trip. I love it! I am in week 51 of 52 TX, and haven't missed a day of work. If you are interested in the electric motors, google "Endless-Sphere forums".

I am sorry you don't have family to help you through... there are a lot of great folks in these forums who can provide some support!

[ellie4]

Good morning,

Sorry for your current situation, which is very similar to mine, minus taking tx. Interested to see response. One big difference is stage 2 whatever that means, because my gastro said it could be a 1 or 3, to truely know would me bx. during laproscope.