To treat or not to treat? That is not the question.

[fretboard]

I've been a member of this forum for a few months now and what I have learned is all good and I couldn't have learned it from anywhere else.  As far as HepC goes, this is the only forum of which I participate in, most of the posts on this site are pro-treatment and I think that's what initially attracted me to this forum.  Even though it's a pro-tx forum there are some posters who say to treat, however wait until you are having some symptoms.  I wish I had their exact words, but it's really not that important as I think it's obvious.  I am waiting for a clinical trial but I'm having to wait as I have mitigating circumstances concerning prescription meds, so I will be seeing my GI in early July and getting my bloods and an ultrasound done, minimum.  I am also pro-treatment, with all these issues associated with the HepC tx, I am geno 1, so it seems like the genotype with the extra aggressive tx, if there is such a thing.  HepC is such an enigma of a virus and tx often affects, teeth, skin, nerve damage, arthritis, fibro, riba rash, anger the list goes on and I don't want to continue about the bad things that may or may not happen to anyone if they go through tx.  No doubt that HepC is a tenacious bugger and the tx sometimes very difficult, but dang it seems even worse for geno 1's being the longest to tx.  Here's my question, If you choose treatment, is there any indicators that can tell you in advance to get off of treatment as it may cause you a myriad of other ailments and/ or permanent disabilities?  I've read of some heppers who have gone through tx and a couple who even wish they wouldn't have, that's why I ask this question.  I guess it really goes out to the ppl who have had major complications with their tx and have even gotten worse as a result of tx, but of course anyone with an opinion can answer.  Be kind as I'm just looking for an answer, I don't care how good the doctor is he can't feel what you're feeling during tx so my feeling is you really have to stay focused and don't just think your doctor is some God as some of them think they are, they're only human.  I don't know, that's why I'm asking.  I want to have a clue prior to treating as I feel that if I go through anything adverse, I would get off of treatment, but at the same time I don't want to be overly cautious.  God Bless  

[mikesimon]

Viewpoint: What Is the Risk of Developing Hepatotoxicity From Statin Therapy in
Patients With Hepatitis C

Incidence of Statin Hepatotoxicity in Patients With Hepatitis C

Khorashadi S, Hasson NK, Cheung RC
Clin Gastroenterol Hepatol. 2006;4:902-907
Summary

Drug-related hepatotoxicity refers to an injury associated with impairment of liver function caused by exposure to a medication. Overall, drug-related hepatotoxicity is relatively uncommon, with an incidence ranging between 1/10,000 and 1/100,000.[1]

The statin class of medications — drugs used to treat hyperlipidemia — has been associated with a spectrum of liver injury, ranging from increased aminotransferase levels (0.2% to 2.7%) to rare reports of fatal hepatic failure. Usually, the hepatic enzyme elevation occurs early in the course of therapy — typically within the first 3-12 months of initiation of the medication. Most of these elevations are asymptomatic and associated with higher doses of drug.

This well-recognized association between statins and liver injury, albeit relatively rare, has led to recommendations by the pharmaceutical manufacturers as well as expert physician advisory panels for routine monitoring of liver enzyme levels in patients receiving statin medication and avoidance of statins in patients with active or chronic liver disease. However, there has been recent challenge to these recommendations, given data suggesting that at least in normal-risk patients, there was no difference in statin- and placebo-related hepatic enzyme elevation.[2] Indeed, the most recent clinical guidelines on the use of statins in patients with diabetes mellitus did not even recommend hepatic enzyme monitoring unless the baseline values were elevated.[3]

However, the clinical assessment of statin use in patients with chronic liver disease is less clear. The aim of this study by Khorashadi and colleagues was to assess the use of this class of medication in 3 cohorts: 166 patients with hepatitis C on statin therapy, 332 patients with hepatitis C not on statin therapy, and 332 patients on statin therapy but without hepatitis C.

The 3 study cohorts were appropriately matched for age, sex, and body mass index. For patients in the first cohort (hepatitis C, statin therapy), they found a higher incidence of mild-to-moderate elevations in aminotransferase levels compared with those not on statin therapy (22.9% vs 13.3%; P = .009), but a lower incidence of severe increases in liver biochemistry (1.2% vs 6.6%; P = .015). Overall, for patients on statin therapy there were no significant differences between the hepatitis C-positive or -negative cohorts, with regard to mild-to-moderate aminotransferase increases, severe increases in aminotransferases, or the need to discontinue statins as a result of hepatotoxicity. Therefore, statin therapy was not associated with a higher risk for severe hepatotoxicity.

Viewpoint

Drug-related hepatotoxicity cannot be viewed as a single disease. Many different mechanisms lead to hepatotoxicity, which may be predictable or unpredictable. In the case of statin-related injury, it seems to be an idiosyncratic reaction that is not predictable. Additionally, the evidence would support that no relation exists between the type of statin used and the occurrence of liver abnormalities. On the basis of these study findings, it also appears that in patients with hepatitis C and well-compensated liver disease, these agents can be used in a manner that is comparable to that in patients without chronic liver disease.

These findings are very much supported by a recent liver expert panel recommendation to the National Lipid Association.[4] This panel that (1) asymptomatic increases in aminotransferases represent a class effect associated with statin use and do not necessarily indicate liver dysfunction; (2) fulminant liver disease associated with statins is very rare; (3) routine monitoring of liver biochemistries is not warranted for patients receiving statin therapy; (4) well-compensated chronic liver disease and Child's A cirrhosis are not contraindications to statin use; and (5) statins can be used in patients with nonalcoholic fatty liver disease and steatohepatitis.

Appropriate use of statins in an expanded population of eligible patients should hopefully lead to improvement in the cardiovascular health of appropriately selected at-risk patients. Additionally, these agents may improve the hepatic disease — especially in those patients with hyperlipidemic-related nonalcoholic steatohepatitis.

From:   http://www.medscape.com/viewarticle/542993?src=mp

Mike

[comeagain]

Something that baffles me is that many people seem a little bit to keen to participate in trials (studies) with placebo or blind amount of doses.

Ok if there is absolutly no other options I can understand, like if you know you probebly gonna die in a short time if not.

I´m in a study right now for relapsers geno 3 but i know exacly from the begining what meds and what doses I was gonna be given, otherwise I would never joined up.

What Flguy was saying about increasing the odds for svr,( I wanna underline his whole post think it was the best adwice i ever have heard in the subject) was exatly my point about getting out of the box can you get a doc or even a whole team of docs with you out, that would be perfect.

ca

[gauf]

All good suggestions. No predicting how it will go. I am currently DD every 5 days and am tolerating treatment on pegasus farrrrrrrrrrr better the I did on SD of pegintron. (perhaps the supps are helping this) Some claim the opposite. You got to get educated and rely on your labs and of course what your  body is telling you. FLGuys suggestion on a 6 week trial makes very good sense in my mind.

[FlGuy]

You may not see hepatologist in the insurance directory since hepatologists are usually sub-specialities of Internal medicine or Gastroenterology

[fretboard]

Why won't my doctor prescribe me statins, something for my cholesterol?  This is a very good question, the only reason that my current doctor has given me is to prevent any more liverr damage.  I should take my current doctor the threads that were recently on this forum on Alinia and some of the other statins.  After I read those, I was really steaming.  I think when I go see my GI in July I'm gonna talk to him about it as I think he would be more willing than my MD.  Most MD's I've run into don't know didley about HepC.  More frustration!!  Anyways, I'll see what happens when I start tx, I looked at my insurance directory and they don't even list Heptologist so the only way I'm gonna see a Heptologist is to get on a clinical trial.  I guess I'm approaching it like this, I have an appt. with my GI in July.  The clinical trial site people have said that it would take another 2 to 4 months to match me to a trial.  Whichever place puts up the tx first is getting the gig.  LOL  Anyways,  I gotta run, starting work early today.  That's gonna take some getting used to, oh well as long as my feet don't swell anymore than normal I'll be fine. LOL  thanks for all the replies, I've got plenty of more reading to do as I want to be totally armed with information for tx.   God Bless  

[FlGuy]

There are a number of different approaches to take and to know some of the various angles takes a medical team that's will to discuss and inject a little creativity with the Peg.  An option might be to 'test drive' treatment for maybe 6 weeks or so, to determine viral response, the physical side effects and the effects of the meds on any other conditions that might exist (osteo, platelets, other blood values).  Some docs may be willing to work through some 'non standard' approaches like increasing dosages, other treatment additives (like Alinia), pre-dosing, med schedule alterations. And, to be anticipatory during treatment.  An a geno 1 in your 50's trying to find or create any advantage against the no-so-great odds is worth the time and the effort.  No one wants to go through grueling treatment only to come up empty.  Nothing is assured but if you can find a doc who will use the rulebook only as a guideline and treat you as an individual, you may be able to look the devil in the eye before blinking so quickly.  Finding an astute hepatologist is a good first step.