Week 9 - Tuesday - Implications of Week 12

So what are the implications for Week 12 (which I recently referred to in Week 8 Tuesday too)?

The National Institute for Clinical Excellence, NICE, “make recommendations on treatments and care using the best available evidence” to the Department of Health on a wide variety of medical diseases and conditions.

The NHS have accepted their recommendations in Technology Appraisal 75, Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C which outlines the treatment criteria, technology, need for research and other medical matters. This policy for treatment has been accepted and adopted as the standard of treatment that HCV+ people have the right to expect from the NHS.

Amongst the many things outlined in this document is the protocol for what happens at Week 12:

For people infected with HCV of genotype 1, 4, 5 or 6, initial treatment should be for12 weeks. Only people showing, at 12 weeks, a reduction in viral load to less than 1% of its level at the start of treatment (at least a 2-log reduction) should continue treatment until 48 weeks. For people in whom viral load at 12 weeks exceeds 1% of its level at the start of treatment, treatment should be discontinued.

In other words, if my viral load has not dropped sufficiently at Week 12 my treatment could be discontinued.

The document also talks about SVR (Sustained Viral Reduction) and how the results of Week 12 indicate the outcome of the treatment:

4.1.2.5 After 12 weeks of treatment, the viral load in people who eventually have an SVR after 24 or 48 weeks - treatment is generally reduced by a factor of 100 or more. That is, for every 1000 copies of the virus in the bif lood at the beginning of treatment, there would be 10 or fewer copies at the end of 12 weeks of treatment. This is known as a 2-log reduction.

4.1.2.6 For genotypes 1, 4, 5 and 6 (together called G1+), only 70-80% have a 2-log reduction at 12 weeks and, of these, about 60% (40-50% of the total group) have an SVR. Of the 20-30% that are non-responders at 12 weeks, few (perhaps 0.5% of those originally treated) go on to have an SVR.

So, as I understand this, 20-30% of patients do not show sufficient reduction in viral load at the Week 12 stage to continue treatment.

Will I be in the 70-80% group or the 20-30% group? This is the significance of Week 12!!

I have to say I am not so worried because I remain optimistic I will be in the group who are responding to the treatment. After all, my Liver Function blood test results show that my liver functions have returned to normal - after having high ALT’s for the past two and half years (probably longer but they weren’t being monitored before that!). So there is evidence that the medications have kicked in sufficiently to stop the attack on my liver and its functions have returned to normal.

But I as I write this I am aware of how much, like other HepC+ people, I have become an ‘amateur expert’ on Hepatitis C.

I support this notion in one respect. Knowledge is power. Understanding the medical information “empowers” me to take responsibility for my health and my treatment. I believe it is important to take “ownership” of my situation as I have said previously.

On the other hand, there reaches a point where I think I want to keep it simple. I don’t understand much about viral loads. I do know there are several ways of measuring them - the Americans have a different standard than the UK. I don’t understand about “changes to log2″. Nor do I really want to.

It reminds me of my days in secondary school Algebra classes when I used to think - what on earth am I learning about logarithms for - what will have to do with the real world? I can honestly say this is the first time since school I have needed to consider logs!

So while I track my other blood test results with interest I think I will adopt a more ‘laissez-faire’ attitude about viral load test results. I also know that the hospital I attend will first test me with a PCR test - the initial test to see if people have the virus. If that is negative, then the viral load blood test - much more expensive to carry out, will not be thought necessary.

I think my ‘laissez-faire’ attitude would disappear if the question of me not continuing treatment arose - but as I said already I am optimistic that the medications are doing their job. They ought to be - I am doing everything I can to support their work!

2 Responses to “Week 9 - Tuesday - Implications of Week 12”

  1. Jonathan Colam Says:

    Hi there Ron,

    The thing about numbers and statistics is that they are just that and it is perhaps more important how you feel. The expection to this is the viral load measurements as that it the one number that you have to drive down, for me the viral load is the most important of the blood work numbers. At the end of the treatment all your other bllod numbers should normalise, however once you have killed the virus your viral load will stay undetectable.

    Don’t forget that you increase your chances of a 2 log drop by sticking with the full dose of your treatment. I regularly drop in and read your blog and I don’t think you have missed shot nor a pill so just by sticking with it you stand a better chance of success.

    Well done on the normal level ALT’s, mine dropped massively before treatment but have slowed to a crwal over the last two weeks. The normal ALTs show that the treatment is working for you.

    How you feeling at the moment, has the Bells Palsy cleared up yet?

    Injection night for me - number 3, still got the bruises from 1&2.

    Cheers
    Jonathan

    Ron writes: I too decided that my viral load was going to be THE important blood test - I wanted to establish a ‘baseline’ viral load some time ago and start tracking it - until I discovered that the hospital I attend seem to have to justify doing them - and couldn’t before I started treatment. Now I realise they will avoid carrying viral load tests out, if they can, by testing my PCR first - if that’s ‘no sign of the virus’ they won’t do the viral load blood tests! (Purely my opinion, but it may be that this approach saves a significant amount of money over a year!) So I suppose their lack of emphasis on viral load testing has influenced my view on this - it isn’t as if they are testing my viral load frequently to track it - like my LFT’s - then I would delve into understanding it more clearly.

  2. Martin Bolton Says:

    Hi Ron,
    Just for info, when they say ‘Log 2 drop’ what this means is a drop by a factor of 100. Log 3 is 1000, Log 4 is 10000, and so on. Its the medical types trying to sound clever!
    Regards
    Martin

    Ron writes: You may be right, Martin, about the medical types trying to sound clever - and it may be my version of ‘clever’ to not bother!! I can see what you are saying about the level of drop and thank you for that! Talk again soon, Ron

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