Quantitative PCRs for Tx Performance and Planning

Hi All,

Just starting my 7th of 48 weeks and finally got my 4 week PCR results back...more on this later.
Since I’m naive to treatment and never had any viral load tests during tx, I can only presume that given my stats of Geno 1a, Fx 3/4, 33+ years of contamination, high pre-tx VL 10 million eq and age 52 I would be on the ‘bad’ side of the 50% SVR probability scale. But one thing I do know is that there is so much variety of tx response that I will never know where I stand in the pool of statistical unless I got an early PCR. The SOC only calls for the one 12 week PCR.

Doctors tend to watch the sx and blood counts (and rightfully so), but seem to avoid tx performance tests. Fortunately, my blood counts so far have shown a good drop in reds and white counts (which indicates the meds are working), but they are still within limits and my platelets are good. My sx yo-yo and are fairly light weight compared to the many stories I’ve read on the forum. But if my counts were way down and my sx (anaemia) were bad, knowing the 4 week VL drop would help is deciding to use recovery drugs or lower the dosages. Fortunately, it doesn’t look like I will have to deal with that scenario, but others might. This is just one good reason for an early quant PCR.

My specialist, gastro come hep doctor, was not supportive in getting any PCR outside of the SOC. Thanks to support I got from this form I went back to my local doctor and he had no problem writing the VL Rx and of course I had to pay the cost which I was happy to do. The cost was less than $200 here in Australia (most likely $100 in the USA).

Went back to my specialist for my 5 week appointment and said maybe we had a mis-understanding and that I was would to pay privately the cost of the PCR and was there any medical reason for having/not having the test. He gave me another ‘cock and bull’ storey and in short said that the 12 week was the only one that was required while any earlier ones would be useless. I hadn’t gotten the VL results from my local Dr so I didn’t tell my specialist.

Now my wife once me to dump the specialist, she doesn’t think he has enough experience in HCV tx and I tend to agree. I’m seriously considering changing, but to be fair need a reason. I need to consider all the possible scenarios in order to plan the best tx outcome, SVR.

As mentioned above, if my sx and blood counts were bad then I would have to look for an experienced hep Dr to consider recovery drugs or modify Tx dosage. This is not the case, so points to keep specialist.

If my PCR comes back with a very good response of UND (RVR), then I’ll be doing the kind of dance that embarrasses the children. Still 44 weeks of Tx to go, but all those meds would be seeking out the little bugger in all its hideaways for a good long time. Chances for SVR surges to 90+%, keep specialist.

If PCR results show a good response that would indicate UND or > 2 log10 drop at 12 weeks (EVR) then I know I’m on the SOC path to success, though my SVR probability drop dramatically to somewhere in the 40% area. An 8 week PCR will give me a trend line and the 12 week PCR would confirm what I already knew. If I only had the one 12 week PCR result and it was bad, then how would I know it wasn’t just a one off anomaly and that I was really on track? I could have been bumped off Tx for an irregular result. Keep specialist only because I’m doing the PCRs. But if at 8 weeks I’m not close to a 2 log drop then would start to look for an experienced hep Dr. Not looking good for current specialist.

If the 4 week PCR result is not looking good 0 to 1 log decrease, then I have to do some serious thinking and start the long-long term planning process. Now all the readings I’ve covered indicate that I will either be a responder or not. In the first 72 hour to 1 week phase is the time that the VL falls the most and the fastest, the second phase 1 week to 1 month the slope is less steep and the third phase it starts to flatten out. Yes I would still get the 8 and 12 week PCRs but by having early PCR this would give me time to locate an experienced hep Dr who might know my real Tx options. Dump current specialist, though he did give me three good biopsies and look for the most experienced hep Dr I can find. And change my research to the hard and long fight.

The above was written in advance of getting my 4 week VL results. Well here are my results...

Pre-Tx:  10,583,150 eq/ml
4 Wk:      1,867,644 eq/ml
Log Drop: 0.75

Very disappointing, but at least I knew where I stand. Yes you might say this is only one PCR, but that’s the very point of having more than just the 12 week PCR. So, unless further PCRs indicate otherwise I have now officially become one of the desperate txers. From this result, I’d be hard pressed to make the 12 wk 2 log drop tx cut off level. My mind starts to review all the ticks to getting the VL down for the 12 wk PCR, like upping riba, taking PCR test after the Peg instead of before, etc. For this I need a hep specialist with long term experience with ‘hard-to-treat’ patients. Experience with tx modification or customisation to individual situations.
Experience with long term tx funding via pharmaceutical companies or ?.

All I can say to others, is that early quant PCRs (4 & 8 week) are mandatory for tx performance and planning.

Go4SVR

[CockSparrow]

Sorry about the not so good news. At least now you know.
Wish I had done what you did but.

All the best
CS

[jmjm530]

While the response wasn't what you would want at week 4 (at least a 1 log drop) you still have time to try and make 'adjustments' such as upping the riba, peg, etc.  (I figure you were joking about taking your PCR right *after* the shot as all that changes is a number.) And yes, the best person to do this is a liver specialist with lots of experience in hard to treat cases. How has your hemoglobin (hgb) been holding? Sometimes "good" is not a good answer, since hgb drop can be associated with SVR and therefore some docs might up the riba if your hgb doesn't drop enough.

As to the 4-week viral load tests, it's becoming more and more standard, but evern better is weekly (from week 1) viral load testing until non-detectible. That's how my doc did it and it gives the most flexiblity in fine tuning treatment during the first critical 12 weeks. All this is something to discuss with your doc *before* starting treatment.

-- Jim

[Go4SVR]

Thanks, life goes own... it's not the end of the world. Now the 'fun' begins on how to find out what I need to change in the overall tx. I have to be open to the many possible outcomes and hopeful I can find the best that is going to happen. And even if I fail to achieve SVR (not that I’m giving up) I could reduce modify the tx the acute level to a point that I could have a long and happy life.

Modifying the dosage and taking more frequent PCRs (weekly) to see if the tx modification works, if not take a break. Either the dosage or change of meds is either going to show sign of success in the first 4 weeks or it’s not. There is now sense in modify a tx plan and grinding through a full 48 weeks without encouraging results. I’d rather short cycle tx changes until I get the results that show promise, then go the full term.

If I never achieve UND then I’d rather consider taking a month’s treatment every 3 or 6 months to keep the VL down. The thought of grinding through 72 weeks of exactly the same treatment Rx doesn’t appeal to me, especially for only a few percentage points of hope

Go4SVR

[Go4SVR]

The first ‘adjustment’ is to change doctors. I made an appointment and hopefully he will be open to customising treatment to my individual requirements. I now know the questions to ask at interview time. But still, the range of options is not great between Peg or Riba dose changes.

No, I was serious when I suggested taking the PCR after the Peg. Maybe not right after, because I suspect that it takes a day or so to bring the VL down. This was only a one off event to pass the 2 log cut off at 12 weeks. During tx, I normally would take my VL count when the meds are at their weakest level. I want the real results.

My haemoglobin and other counts have dropped but are still within range. So I suspect that I could take a dosage increase, but only to the point that I can still work. Life must go on...

          Pre-tx    2wk     4wk    Normal
HB        16.4   13.6     13.4    (13.0-17.5)
RBC      4.94   4.14     3.99    (4.4-6.0)
WBC       9.4    6.2       5.1    (4.0-11.0)
PLT        194   262      174     (150-450)

Weekly PCRs is a lot! But if the Dr was experienced enough and he was willing to short cycle tx changes until the right response was found then that makes sense then monthly. Making a tx change and grinding for months doesn’t make sense now days.

Go4SVR

[zazza]

You seem to have a grip on your situation, although you did not receive the news at week 4 that you wished for. Keep at it! Zazza

[jmjm530]

GO: Weekly PCRs is a lot! But if the Dr was experienced enough and he was willing to short cycle tx changes until the right response was found then that makes sense then monthly.
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But that's really the key, even with the 4-week VL tests. If the doctor doesn't know what to do with the information (or won't change tx regardless) then more frequent testing has diminished effectiveness, other than more info for the patient or the next time you treat. Only when the doctor uses use info to steer treatment does it benefit the patient at that time.

GO: My haemoglobin and other counts have dropped but are still within range. So I suspect that I could take a dosage increase, but only to the point that I can still work. Life must go on..
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If I read it correctly, you're stage 3 out of four possible stages. If so, even though you've gotten a respectable drop, upping your riba should still be on the table. Yes, it could affect QOL, but then again, so can relapse or viral breakthrough. Also, there's always the helper drug, Procrit (epo).

GO: I was serious when I suggested taking the PCR after the Peg
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Of course that might get you UND but to what aim? Insurance is the only thing I can think of if they only allow you to continue with a two-log drop at week 12 and you've already decided to extend tx to 72 weeks. Unless you're legitimately (vl before shot) UND at week 12 (and UND at week 24) then 48 weeks has very poor results.

In summary, it's not just educating doctors about the week 4 PCR, but in all aspects of individualized treatment of which the week 4 PCR is merely a tool. Frankly, most docs I've met do not want to be educated -- they either are or are not -- and especially by their patients. Easiest thing is to do your homework before treatment and find a doc who already is using the treatment approach you want. If that is not possible, then by all means try to "educate", "suggest", "cajole", "bully", "fanagle" -- whatever -- your doctor into doing what you believe serves your interests.

All the best,

-- Jim

[Go4SVR]

Hi Jim,

We’re on the same track regarding the use of PCRs as a feedback tool to modifying Tx. I’m willing to up my dosage, but I haven’t come to grips yet as to what level I can cope with in relation to sx vs results vs lifestyle. But at this point I expect to modify Tx until I get the required response. I’ll assess the sx and the use of recovery drugs when and if I ever get there.

Yes the 12 week test is a Tx funding concern. If I pass, then it gives me time and Rx resources to trial Tx modifications.

I’m actually not too concerned about any long term Tx without the correct response first. I would expect that I might be testing 3 or 4 Tx adjustments over the 48 weeks. It would be nice if I found the best one in the first go, but that hasn’t happen. Once I find the best results that I can sustain then I go the long run, the sooner the better.

Top of the list is to get a Dr which is open to Tx customisation and successful pre-experience would be a bonus.

Thanks for you advise,
Go4SVR

[CockSparrow]

Thought I better give some advice on Tx in Australia. Basically it sux. All you are going to get out of MediCare is SOC, no EPO, no 72 weeks and no higher doses of Peg or Riba. You can pretty much forget about retreatment too cause MediCare don’t pay for it. Affordable Health Care gotta luv it.

That’s the downside, what you can do and (allowed to) is pay for anything above SOC yourself. This wont be cheap. A 4 pack of Pegasys is $2,000 and PegIntron $2300 or there abouts. EPO costs about the same. Now you know why only 1% or so of HCV+ people in Aust do Tx every year.
With what I have seen our SVR rates are about the same as the published studies, no higher mind you.

GO - I’d rather consider taking a month’s treatment every 3 or 6 months to keep the VL down.
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I wouldn’t bother with this its kinda been tried before and doesn’t do much.
Apart from that its not VL that does the damage its our immune system.

You might want to contact a Dr Greg Dore who is involved with the Chariot  High dose Pegasys trial.
Heres his bio
Associate Professor and Head, Viral Hepatitis Clinical Research Program, National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney. Infectious Diseases Physician, St Vincent’s Hospital, Sydney.

Some things to consider would be taking Pegasys every 5 days until week 12. This is fairly easy to do as you already have the meds and you can reorder them in time. I reordered mine quite close together a couple of times. You will lose 10 days as you will go through the INF in 25 days instead of 35 but you can worry about that after you hit EVR.

Double Dosing would be harder to arrange in the 5 weeks you have left to week 12 and you would risk missing a dose or at least being late with it.
Double dosing with both pegs makes sense at least to me but both of these options are probably better left till after you EVR in an attempt to hit UND and should only be done with your Doc’s approval.

Don’t bother trying to cheat with the week 12 PCR test, it wont benefit you and wont make that much difference. Inject it straight into the vial when the nurse isn’t looking, that’ll confuse em.

No point trying to kid yourself if it aint gonna work it aint gonna work. Then its time to take stock and plan for next time. When you miss EVR the odds are pretty slim.

All the Best, I know what you are going through
CS

[meki]

Just do me a favor -- ok? Stay away from the colloidal silver.

*G*

Life isn't horrid yet --- you have plenty of time to be a "late" bloomer - and they may up your doses just enough.

Sending you tons of warm thoughts and hoping that your regimin brings you to a better lowering of the Viral Load at your next PCR.

Hugs,

Meki

[Go4SVR]

Hi CockSparrow,

There’s no doubt you are the bona-fide Australian Tx expert on this forum. I always appreciate your advice as it’s based on long hard found experience.

I’m getting the picture that I only have 48 weeks (no 41 weeks) of government support. And I am trying my best to get the most out of a difficult situation. The full price of my one month Pegasys RBV pack of 4x180mcg Peg and 168 tabs 200mg of Riba is $1927.91 AUD. I’m a bit taken back on the cost of the EPO which is a limiting factor on upping the Rx dosage option.

I see your point on the ‘maintenance’ month’s treatment every so many months. It was just an idea. I can’t see a SOC month’s dose would bring down the VL enough to be worth the cost and to the level that would unburden my immune system.

I really like your idea on the short cycling of the Peg on the last month before the 12 wk PCR. I know Riba is cheap and easy to up the dosage, but I think Peg is the powerhouse of the Tx. Short cycling at 5-6 days is a more realistic option then upping the Peg dosage and much less risky on Sx. For all those reading this, I must get a Dr approval. I’m getting a referral to a new more experienced Hep Dr and I’ll also try and contact Dr Dore, and let everyone know if anything comes out of it.

I see you use the broad definition of EVR as being >2 logs at 12 wks. And yes that is my simple goal at this time is to keep the funding going. UND is the next milestone and that may take some serious Tx increases. I’ll cross that bridge when I get there. I understand the odds and with only one PCR in hand I still think there is time adjust the Tx and improve the VL in about 4-5 weeks. I can only try. I still in the game.

Thanks again for the feedback,
Go4SVR

[Go4SVR]

Hi Meki,

I'm far from giving up hope. If I don't get the results I looking for then I automatically start coming up with another bag full of options and keep trying them out. Since I'm naive to Tx I can't be too far out of Tx modification all at once. One step at a time, but I'm learning to quick step.

Thanks for all the warm thoughts.

Go4SVR

[CockSparrow]

Forget about 6 days do 5.
Its also no different than shifting injection days.
CS

[dointime]

What about pre-loading with ribavirin 8 weeks before starting the peg.  That way your blood serum levels of riba will be at full strength at week 1 of tx when the peg starts work.  

[jmjm530]

Double-dosing Peg is starting to become more and more common, especially in re-treatment scenarios. (See the Dieterich/Jensen video over at ClinicalCareOptions Website/Free reg required). Side effects aren't all that much different. I double-dosed myself between week 2-4. Don't know how much it would help at the week you're at, but If you're going to up the Peg, why not really up it by double-dosing? Of course, get your doctor on board as with any dose change.

All the best,

-- Jim

[Go4SVR]

Hi,

Someone on the forum had suggested 6 day short cycling Peg. I like a 5 day cycling for two reasons: I sense the Peg is almost gone by Thursday (I inject on Fridays) and the 5 day brings the cycle back in alignment with the seven days faster. Short cycling and double-dosing are two different approaches and I’m not ready to consider double-dosing and short cycling at the same time, yet. So getting back into my 7 day cycle give me more options.

Going back to my very important milestone target of >2 logs at 12 weeks, I intend to first get my first feedback on Tx modification by taking my 8 week PCR a day after my Peg shot. I’m going to take my Peg on Thursday and have the PCR on late Friday PM at my normal scheduled time. Also, I’m scheduled to take my Riba at 7 PM. I will take it about an hour or two before the PCR. Normally you would take a Quant PCR when the meds are at their weakest (to get the real VL). I’m going to take it when meds are at their strongest level. It seems to take a day to get through my belly fat. Saturdays seem OK until evening and then I can feel the Peg induced fatigue feeling.

This contrived 8 week PCR will hopefully give me the numbers that will support the next round of decisions. If it’s low enough, meaning close to two log drop then I can lighten up on myself and don’t have to push my new Dr into any quick decisions on short cycling. But if all I gain is the 0.5 log which I suspect may be the range of variance between the weeks’s med affected VL, then that would bring me up to only 1.25. And I start to desperately look at Tx alternative which I can get Dr support.

The easy and cheap Tx alternative of increasing Riba, which there seems to be room from my daily intake of 1200 to 1400 or 1600 (not double-dosing yet). Regarding Peg Tx modifications, for risks and costs short cycling is at the top of the list. Maybe the Peg dosage is adequate, but is too low by the end of the week and the VL has had a day or two to skyrocket for my normal PCR point.

I’ve worked it out that I have time in the last month to do my PCR test adjustment and hopefully talk my Dr into a full 4 week Peg 5 day short cycle. I determined that it would cost me only 2 extra Pegs over the 4 week period. That’s a good extra amount of about 50% over the period and significantly few periods with minimal Peg in my system.

If I obtain a Tx pass at 12 weeks then it a whole new ball game.

Cheers,
Go4SVR

[Go4SVR]

In the beginning, I hadthe same concerns that there should be a period were the Riba has time to build before the first Peg. Most people start treatment with Peg and Riba on the first day. I did. Riba is an end game med. It may or may not be a real issue at Tx start. Though if I were to do it again I'd take a week's Riba and the Peg at the end of the week. That way it's easier to count the weeks and you finish with the last shot.


Go4SVR