OK - stop or go the distance - what to do, what to do?

[motheroffour]

Oh man, H's PCR was 75 at 24 weeks.  We ran another PCR at 27 weeks and this time it is 32, tested UND <50 but a more sensitive trest showed 32.  Physician's assistant is going nuts because they got the big UND<615 at 12 weeks and she thought UND <615 meant zero - really.  I'm loosing my mind because even if he clears this week (30 weeks) he's got all the signs of a slow responding relapser.  He told the PA in no uncertain terms that he wasn't stopping (which I agree because he's a "probable cirrhosis by bx and improving liver histology is of the utmost importance.)  He's tolerating treatment, no rescue drugs, HGB hovering about 10.5 and platelets, Aboslute neuts low but OK.  AST/ALT low normal now.  Haven't tested albumin, creatine, INR, etc. since start of treatment. Endo was totally clear and "clean as a baby's butt" according to doc.  Starting Viral Load around 550,000, 4 week PCR 20,000 something, 8 week PCR 2,400, 12 week PCR UND<615, 24 week PCR 75, 27 week PCR 32.  What to do, what to do????  He totally Riba Raged with the PA (I wasn't there) and told her the only person he would listen to is me.  Half of me wants to just let him go the 48, stop and figure he'll relapse and then I can say "I told you so" to the docs, but I can't take the stress of these PAs anymore.  H hasn't seen a doc since before he started treatment.  H thinks all is well and he's getting rid of the virus slowly but surely.

[motheroffour]

I think I agree with you regarding the immune system.  H has had this virus for at least 30 years if he got it from his little itty bitty stupid tatoo which is the most likely way he got it.  In the 25 years we've been together I've only seen him get sick once or twice.  That's why it's just shocking that he's got this life threatening liver condition.  Really, really hard for me to wrap my arms around it and come to terms with  it.  He's always been larger than life to me....that's why I married him :-)  When his initial viral load came in and he had two within a couple months, the second one was 480,000, my initial reaction was that he must have been fighting this all these years. I also think from reading about everyone on these boards that length of time of disease + lower viral load + more liver damage + over 50 is not where you want to be.  Not to mention my H like many young men I think was a heavy drinker in his twenties, how bad can that be on top of Hep C?  Not to mention moderate drinking from age 30 to 50?  It's just a recipe for yuck. We were on vacation a few weeks ago with our college kid who was drinking a  4th Corona and yapping about getting a tatoo and I was just laying in my lounger loosing it and thought my H was going to have a stroke.

[GrandmaA]

The other suggestions are better than mine. Obviously, they know a lot more about all those numbers than I do.

It also depends on a person's age. This was my last chance to try treatment. I'll be 65 next month.

[willing]

it's a hard spot to be in and I'm sorry you're having to face these decisions without the benefit of expert medical advice. A couple of thoughts/suggestions:

- as Mike points out its very unlikely that even the advice of a trained hepatologist would make this decision much easier. Currently there is nothing about a Dr's training that gives any significant insight into why tx, properly followed, fails or succeeds. What little guidance is available comes not from a sophisticated understanding of mechanism, but from simple statisical compilations of patient outcomes and these are as readily available to patients as to their Drs.

- one of the key data compilations supporting the "quit if not und by 24" is Davis(03)

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12939591&query_hl=4&itool=pubmed_DocSum

which includes the observation:
"Of those who remained PCR positive at week 24, only 1 of 4 (4%) achieved SVR compared with 14 of 43 (33%) of those who lost virus between weeks 12 and 24"

This is in a group who achieved the 2-log drop by 12. Testing was done at a level not considered sensitive today:

"Serum HCV RNA levels were measured before initiation of treatment and during therapy at weeks 4, 12, 24, and 48 by a quantitative polymerase chain reaction (PCR) assay with a dynamic range from 100 to 100 million copies/mL (National Genetics Institute, Los Angeles, CA)"

which should clock in around 600 IU/ml.

The reason today's sensitive tests are not always all that helpful is that there's not yet enough accumulated data to guide the interpretation of the results (there is more for comparing 12 week results). How many among the 14 who achieved a 2 log drop, became UND by 24 and went on to SVR actually would have shown residual VL by a more sensitive test is anyone's guess. It's worth hunting around PUBMED to see if there's more recent data.

- kicking anyone off tx when they want to continue and are bearing it well seems ill advised, all the more so if stage is advanced. At a bare minimum, virus-induced damage is being slowed/stopped and there's incomplete but encouraging evidence (often reported on this board and something I experienced personally) that this pause gives the liver a chance to improve during tx. And then there's that ongoing battle between the statistics and the psychology - *someone* has to be in that 4%.

[willing]

sorry - important typo in the above quote. That should be "only 1 of 24(4%) achieved SVR"

[motheroffour]

Yeah, "willing", that's kind of where I'm at.  I can't help but think that finishing the 17 weeks isn't going to hurt his liver histology and treatment has not stopped this man.  In fact he skied more vertical feet this year than when he was in his 20s so physically it's not hurting him.  I figure the reflux in the AM is payback for the reflux I had for 9 months with the kids :-)  I have spent the last hour searching and searching.  What I find puts him at a 10% chance of SVR IF he gets to TMA Negative.  4% might be more accurate. His odds at 72 do increase for SVR but it still isn't even 80%.  

[motheroffour]

OK, so I've spent my afternoon not on work, but on trying to find the definitions so that I can interpret all this research. OK, so does "Virus Undetectable" in studies that I'm reading correlate to TMA undetectable or PCR undetectable?  They seem to be two different things.  So if "Virus Undetectable" correlates to PCR undetectable then do these studies suggest <100 or <50?  In many cases it's not specified. Seems to be the goal is TMA negative and the Halt-C findings seem to make the most sense - 82% chance of SVR with negative TMA at week 12, 44% change at week 20, 20% change at week 24, 10% anytime after week 24...and approximately 10% of patients with a single positive TMA at end of treatment still achieved SVR.  Am I reading correctly?  I think I'll let him go the 17 more weeks, take the 10% chance and give him a chance to get rid of the interferon so if/when he relapses he can start fresh.  If he relapses it will be interesting to see if the viral load "soars".  Well...I'll keep you all posted what happens to him at the end.  If he hits TMA negative somewhere along the line I'll let you all know,. No biopsy for him according to docs for 5 years, so I'll sure I'll be pitching questions about fibrosure and fribroscan in the months to come.  I'd be estatic if his bx of probable chirrosis turned into a 3 Fibrosis!