Early, frequent and sensitive pcrs are essential to tx management. The main reason you stated, making adjustments. Another aspect could be a person who wants to evaluate tx response and make an early decision to continue or not. A person might choose to 'size up' current treatment methods or wait for the next generation. This person may want to have a very recent pre-tx pcr and then others at 2 and 4 weeks and make a stop-go decision. In addition, early and frequent cbc are needed to evaluate effects on those values as well. I understand that some of these options might not be available to everyone, depending on insurance coverage or, in your case, customary treatment protocols in Canada. By the way, one of the top hepatologist is in the group where you treat - Jenny Heathcote. I think she has a book on the subject, on liver care and treatment. Google her name. I have read only some excerpts or summaries.
Should add, at least for the sizing up tx option, that some Clinical Trial criteria may exclude people who have any interferon/riba treatment. So, if the possibility of a trial is a potential option, keep an eye on the criteria.
Yes, you should have your viral load tested minimally at week 4 and week 12. An additional week 8 test would be even better. Best yet would be weekly viral load tests starting at week 1. Some here, including myself, were tested that way, but we are in the minority. Ideally you want as sensitive a test as possible. 50 IU/ml is OK, but better would be a test like "Heptimax" from Quest Diagnostics that goes down to 5 IU/ml. Blood should be drawn for the viral loads the day before your injection. So, for example, the blood for your week 4 viral load test should be drawn the day before your fifth injection. The blood could also be drawn the day of your fifth injection, but it should be drawn before the injection.
Trish: I want to know my exact VL count at 4 weeks and 8 weeks if I fail, as in I'm above <50IU/ml. Is this reasonable or am I getting uptight for nothing? I'm thinking if I know at 4 weeks that I'm not doing so well, I can ask the doctor to alter my treatment to increase my odds. Then I can measure again at 8 weeks how it's going. A pass/fail doesn't give me enough information, I'm thinking. Am I off-base there?
No, in general, you are not off base, however there are a number of things to factor in such as your genotype, prior tx history if any, the amount of liver damage you have, your race, weight, height, age, doses of riba and peg, pre-tx hemoglobin and hemoglobin response during tx, etc. You might want to include some of all of this in your profile.
I'm familiar with Dr. Jenny Heathcote...my first appointment was to be with her and I got passed over to Dr. Lui instead as she wasn't in the day my appointment arrived. So now I am with Dr. Lui ongoing but being treated in the clinic that is under her direction. So .. considering that.. if this is Dr. Jenny Heathcote's clinic and this is how things are done, how does that bode for SOC for HCV patients in Ontario? Nothing against Dr. Heathcote in particular....if they are bound by the government's regulations and forced to deliver the care the government mandates...well...I am still processing all this information.
As for drug trial, I'm treatment naive at the moment. I have big decisions to make the next while. I wish he would have told me which trial but he didn't want to. He was in a big rush and brushed off any question that wasn't relevant in HIS eyes. I'm frustrated with myself because if I'd controlled my emotions better, maybe I could have spoken up for myself better but it threw me off finding out I won't get to know my exact VL going in and his response to me pressing the issue on that. He was hungry, thirsty, abrupt...and I lost my grip on pressing for the info that was so important to me. Really, I was afraid he would tell me to find a different doctor. I did get alot of my questions answered by the NP...but in the end, I left without the copy of the blood test even....I really found it distressing to get the kind of answers I got....no exact measurement of my VL going into tx, no exact measurements until 12 weeks, no extension of treatment to 72 if I'm a slow responder.
I don't know, FlGuy...alot of emotions on this one and I'm trying to sift through to find clarity of thought without the distortion that emotion can bring to it.
I've edited my profile as per your suggestion, thanks.
I'm curious. What happens to people in the U.S. if someone wants a PCR at 4, 8 and 12 and to certain sensitivities? Is this at the mercy of your particular insurance company and also whether your doctor will do this?
It will be very interesting to see what sort of response I get if I ask for a PCR with lower sensitivity. The NP seemed to be saying I should be very pleased with the one they're using as it's a low sensitivity. Imagine if I come along and say I want an even better one at the 12 week mark. If it's covered under healthcare, there should be no issue. If it's not, then I will, in the meantime, be exploring what options are available to me.
Having said that...any idea what it costs to get this test done in the U.S.? I am not that far from the American border.
Thank you for your input, Jim.
I had 4 week, 8 week, and soon 12 week VL. My sensitivity is >10.
I believe you have until 24 weeks to see how you respond, thats what I was advised.
Good luck-They didint want to give me the 8 week I had to beg and complain alot.
And Jim.. anyone... just how important IS it to know your EXACT viral load as you enter treatment? When I'm at 1.3mil+ .....could be thousands higher or millions higher and the thought of not knowing and the implications is causing me a bit of distress....that I will likely try to address by getting a test done another way.
fretting over the frequency and accuracy of vl tests is one of the favorite pastimes around here, but before becoming distressed over what might be perceived as poor medical care on the part of drs or ins. cos. it's worth taking a minute to think about *WHY* many drs currently only order baseline, w12 and w24 for 1s and baseline and w4 for g2/g3s.
We tend to assume that vl measures the actual amount of virus in the body, that when you geto und it's gone, or nearly so, and thus that it's important to make those measurements as accurate as possible. Unfortunately this view bears little resemblance to reality. Viruses are viruses because they cannot reproduce outside of cells, thus the amount of "free" virus circulating in blood is a very approximate indicator of the number of infected cells, and the copies of virus they contain. An analogy I posted a while back is that a vl measurement is like trying to estimate the population of a city by taking a snapshot photograph of a section of freeway.
Every relapse as well as all the publications on occult hcv underscore the discrepancy between vl and actual infection. However, measuring infected cells is hard/impossible, drawing blood is easy so we've go to work with the tools available. So what does a VL measuement tell you?
By itself, very little. We know VL does not correlate with liver damage and can bounce around 1-2 log units (10 to 100 fold) in a static, chronic infection. The principal value is that the decline in successive measurements, while there's still enough virus to observe in blood, indicates a trend. Comparison of one' vl decline with that collected for others allows one to gauge response to the meds and thereby estimate svr outcome.
If you don't have anything to compare against, the information from a vl test is of very limited value. For example, if you can find a study, any study, that found a significant effect in being UND<10 vs UND<50 at say week 4 or 8 then, and only then, would be reason to fret over missing that test. A key example is that there is now quite a bit of data showing that at w12, significantly different relapse rates were observed in 48week 1s that were UND<600, UND<50 and UND<10 so clearly that test has high predictive value.
If you can get frequent tests, by all means do so. As Jim likes to point out, even if the comparison data is not available now it may be in the future (though my obsevation has been that old test results seem to be of limited value). However if you can't get your Dr. to order tests that won't make any difference in his/her tx decisions (which essentially are stop/extend), it's not worth getting upset about. Possibly the worst consequence of infrequent testing is the failure to detect breakthrough, thus continuing a pointless tx, though even there the data is a bit sketchy.
That made enormous sense to me! Thank you! Was easy to read and well and clearly said,
Hello Trish, my stats were very close to yours and concidered a low priority, meaning we have lots of time to wait for better alternatives. So tight monitoring is not as essential as stage 3's. In Canada it is customary to have the first test at week 12 for people like us, and they are looking for the 2 LOG DROP, if you meet that then treatment is concidered to be working if not at this time adjustments are made. My first test at 12 weeks was <600 and because of the 2 log drop they called it undetectable.
The viral test that is the most sensitive here is the real time PCR, good to <50 and concidered as accurate as needed, eg, what percent is <50 of 1.3mil, do you really need to be more accurate than that?
Knowing where you stand at the begining is important, so you can look for that 2 LOG DROP, this is the most important number to look for. So you started at 1.3 mil, treatment will be concidered to be worth continuing if at 12 weeks your level drops to 130,000.
We need to find Doctors that we TRUST so we don't second guess them. Trust is earned by credentials, respect and explanations, weighed against what we can gather on our own. Your Doc and team is well respected out there so get them to explain their decissions. It will help to calm you and that will make treatment simpler to take and the less stress you have the better your chances are.Let us know what they say...please.
Harry, thank you for your good words...I'm on my way out the door so a quick reply to some of what you've said.
I can think of plenty of reasons why they should treat us well right from the start, from both a health and healthcare cost perspective. If treatment fails, for example, we have to keep trying until it's successful. All of that costs money to the system and stress because there are only so many doctors to go around who specialize in HCV. It's also stress on the patient and disruption to their life. The treatment is not a walk in the park, right? So...to me...it makes perfect sense to do as much as possible to make the first go-around as successful as can be. As well, to treat earlier when you're in better shape seems to offer the best chance of success. If I'm able and willing to treat earlier, why not support that? When an HCV person chooses to treat, it's a carefully considered decision and they're doing it at the time that makes the most sense to them having considered many different variables. To me, that too ensures a better chance of success. I think it's short-sighted and counter-productive in so many ways to put up roadblocks for those of us in early stage liver damage from treating if we find we are of the capacity to do so.
As for my viral load....it's not 1.3mil, Harry. It's above that somewhere and I don't know where. That's simply the upper limit of the assay used. If they are only going to permit one, then they should use one with a much higher upper limit. You mention what my log drop should be... but suppose I'm actually sitting at 6mil IU/ml ? Then a successful two log drop could be interpreted as slow response if they're going to assume that the upper limit of 1.3mil IS my VL...which it isn't. It could be 1.4mil, it could be 10mil. We don't know. So that frustrates me. Incidentally, the NP told me I need a drop to 1000IU/ml to have a two log drop. So I dunno...I haven't done the actual calculation myself as I don't know how to calculate it just yet, but it's another item on my "must learn" list.
I hear you on the trust issue thing. I agree with you. And if the doctor will have the patience to answer my questions...and in turn, I understand why he would rather not answer some questions yet, as in none of the more detailed tx questions because I may end up in a drug trial...if I respect his time and education and he respects my need to understand.. I can relax and trust him. I agree with you. He should feel comfortable explaining his decisions. And then...I will be able to relax and trust him. I may not like the information I've gotten but at least I'll know the reality and work with that.
Thanks for your words, Harry. Appreciated.
I don't understand what your nurse means. If getting down to 1'000 IU/ml would equal a 2 log drop, then that would mean starting at 100'000 IU/ml. A 2 log drop equals a decrease in viral load of 99%.
From personal experience and observation here, the better clinicians are now ordering both frequent and sensitive viral load tests, on at least a monthly basis -- be it Dr. "D", "A", "S" or "J". Some, like my doc, "MyOwn's" and a few others, order weekly vl tests until UND. And while I agree that it's never good to obsess over spilled milk -- or milk not available in the neighboorhood --I cannot see any reason whatsover -- insurance aside -- why one should not at least ask for both frequent and sensitive viral load tests.
In my opinion, the Why's have less to do with study data and more to do with the fact that most clinicians are a year or more behind the treatment curve. As to the "4" and "8" week example, above, it's not just future usefulness we're talking about. "Susie2007" has already mentioned that Dr. Sh has already stated that more frequent early testing can differentiate between and EVR and a null responder in certain scenations, providing valuable information to the clinician in regards to future PI treatments.
First sentence, second paragraph should have read in part:
"In my opinion, the Why's have less to do with lack of specific study data and more...
I don't understand what your nurse means. If getting down to 1'000 IU/ml would equal a 2 log drop, then that would mean starting at 100'000 IU/ml. A 2 log drop equals a decrease in viral load of 99%.
Zazza, I didn't do any math on what the NP said, I just noted it. So was relaying it. Seems Harry's math is better, eh? :) Thanks for the clarification.
I wouldn't waste to much time obsessing over this...The bottomline is you have to work within the confines of the system, whether that is the canadian medical system, or the us insurance system(or pay out of pocket). Also keep in mind that these systems are based on accepted SOC treatment...extended treatment is not soc. So if one is advised by their doc to extend treatment, or treat outside soc, coverage is up to the insurance company (can. gov) not the doc ordering the treatment (unless they can get freebie meds etc.)..Some of us are blessed with being able to see what they believe are only "the top docs",whether for consult or treatment, others aren't so blessed, insurance won't cover or individual can't afford the air fair or out of pocket $600 consult fee..
a 2 log drop from 1,300,000 would be 13000
I also think we need to keep in mind, that while this is a fantastic forum, with many knowledgable people, we are in no way a representation of the average hepc patient dealing with this..We all have gone outside the box just coming here, for info, advise etc.--questioning our docs..When you think about it, let's say there are 100 of us here, that is out of the 200-300k treated annually....we are just a small tiny smattering in the overall picture...don't know exactly why I thought I should add this, just thought I should, kinda an apple/orange thing I reckon and something to keep in mind when making decisions...........;^)
Along the lines of my previous post (we've touch on this discussion in the past)..But as I said, I don't believe we are at all a very good representative group of the overall hcv population..I would say we have a higher number of relapsers, retreaters, treatment extenders, trial participants, study participants,new drug trial awareness, released study data awareness, again, than the general population...Much of what we collectively take for granted here in our discussions, is still outside of soc and thus considered experimental...(increased riba/extended tx time etc,in a round-about way even more frequent and accurate pcr's/tma's)....We are a more hcv educated group (my opinion) than the average hepper pop....I'd go as far as saying more educated than a good percentage of the medical field when it comes to hep...
In some of these poor doc's defense...they probably never trained in medical school for having to deal with educated patients, and take offense to the show of knowledge...they probably go to bed every night cursing the internet (lol)...
oh well, enough rambling....trish I did find this link (you've probably already have it)...but basically outlines CA's soc for hep c
Tirsh: just how important IS it to know your EXACT viral load as you enter treatment? When I'm at 1.3mil+ .....could be thousands higher or millions higher and the thought of not knowing and the implications is causing me a bit of distress....that I will likely try to address by getting a test done another way.
Since I believe you are pre-treatment, do you mean "exact" or "sensitive"? Yes, it could be "thousands or millions higher" due to test variance, but within the context of logs it's important to have a pre-treatment viral load done to computer log drops during treatment as well as for predictive value where low viral loads have predictive values -- higher viral loads less predictive. The more sensitive tests become important once treatment has started to confirm UND.
A few years ago when I treated, my doc did weekly tests until UND. Very early on, I got a second opinion -- hepatologist mind you -- who told me that all my viral load tests were meaningless and the only one important was the week 12 test. Even here in the discussion group there were many who derided my week 4 test.
Moving forward, the week 4 test is fast becoming a standard part of treatment. Data back then was avaliable to suggest the importance of RVR but it just didn't get filtered/assimilated into the general physician population and/or they were awaiting for larger/more confiriming studies. BTW, about the doc, who told me that all I needed was a week 12 test -- I just read a published article he wrote about the importance of the week 4 test. While I agree we should try not to obsess about anything outside of our control, if available, asking for frequent and sensitive viral load tests has no downside, only an upside -- outside of the financial issue which insurance usually picks up if the doc writes a rx. The week 4 standard is one example. Studies about frequent viral load testing during tx to pick up relapses is another. And then there's Dr. Sh's conversation with Susie2007 about how the lack of frequent early vl testing leaves clinicians with question marks for PI candidates for those who failed SOC.
The question isn't why get frequent and sensitive viral load tests, but why not?
I must not have made myself clear.....I completely agree more frequent and more sensitive tests are best, left to me they would be weekly until undi, monthly after that...but that isn't typical, aside from the more progressive doc's, and from what I've gathered certainly not the norm in Canada...
It appears early and frequent testing 4,8,12... is becoming the norm...here (again, I don't know about Ca.), for the most part the insurance co's will pay for the tests...falling under blood lab work, I've never really been able to find an exclusion clause in my policy preventing it with an r/x...and as you've said, the sqeeky wheel gets the grease...
I think trish was right on the mark with her questions and approach..but again we are limited by having to work within the system we're in , I'm afraid many don't realize what you have to go through to get extended treatment-if you can, it isn't anywhere near a given..In my experience and reading others we were all denied coverage as "experimental" and only under appeal got it to go through, if not and then only after being denied twice could one get aid from the drug companies...and all this is getting tougher everyday to get through the insurance co's....
I guess I just hope for someone who is new here(I know you're not new Trish), they understand that much of what we discuss is not the norm..
A general comment....while this may seem like I'm obsessing about something beyond my control, I don't consider it to BE beyond my control. Not yet. If I want a VL test done and the government won't pay for it, I've already started looking into alternatives. I wanted to ensure that I was thinking straight before I waste energy on this. And I'm very sure I want these tests done for my own peace of mind as well as to be able to accurately assess my status during treatment in ways that my doctors are not ABLE to provide due to regulations and to be able to advocate for myself if I feel that my treatment needs to be tweaked..
I *will* be pursuing the option of getting in independent test done. Hopefully it's as easy as getting a script from my doctor, walking into the lab and forking over the cash to pay for it. Nothing is ever THAT easy but I fully plan to test it out this coming week. I'm going to make an appointment with my family doctor and explain to him what I want and why .. if he gives me the script, I'll walk the two blocks over to the lab and test the next phase.
If that won't work, I'll see if I can get the test done in the U.S., which is an hour and a half away from me and my family lives on the border. And I'll just keep trying through various means until I either get the test done or I have to finally accept that it ain't gonna happen and I'll suck it up. It does mean that much to ME.
I appreciate all the discussion and info here, I am finding it immensely valuable.
It appears early and frequent testing 4,8,12... is becoming the norm...here (again, I don't know about Ca.),
I don't know what is the norm in Canada in general...there is SO much to learn about my own country and it potentially varies from province to province....but what is the norm at the clinic I go to is a 2, 4 and 8 week Quantitative PCR to a sensitivity of <50IU/ml and then a 12 week Qualitative PCR. Because of who they are - teaching hospital and all, I'm thinking that is not necessarily the norm persay. I don't know what they do beyond the 12 weeks...we haven't gotten that far yet.