ribavirin dosage late in tx

How important is it to be taking a full ribavirin dosage late in treatment?

I am male, 39yrs, 140lb, genotype 1a, in week 34 of peg-intron+riba treatment. I started tx with a viral load of 3,000,000IU/m. Viral load tests were undetectable at 12 and 24 weeks (yay!).

However, I have not been tolerating the ribavirin very well - anemia, fatigue, the usual...
My starting riba dosage was 800mg/day, but I have been at that dosage for only a total of 8 weeks (out of 34 weeks so far). To keep my HCT above 32% my doctor has been "surfing" my ribavirin dosage in the range of 400 - 600 mg/day.I'm worried that this is not a therapeutic dose and I'm vulnerable to relapse.

I have been urging my hepatologist to prescribe procrit to combat the anemia and allow me to finish treatment on a full ribavirin dose. I do not want to be a relapser! But he thinks I am doing fine and my chances of SVR are very good, and I should not worry, etc...
I even told him I would pay for the procrit myself if he would just write the prescription.

Should I aggressively pursue the procrit route, or give in and hope my doctor's low-dose approach is right?

Cheers,
Andrew

[MichaelT]

It is a "rule of thumb" to dose genotype 1s at 1 or 1.2 grams a day and do whatever it takes to get to and maintain that dosage.

A temporary reduction in dosage seems to okay, but the target range is important for GT 1's.

I would urge you to have a discussion with your doc and her/his experience in this respect, afterall you seem to be responding well and generalized "rules" may not apply to your specific situation, but your concerns are valid and deserve a well reasoned explanation as to why a lowered dosage doesn't compromise your treatment.

-Michael

[MichaelT]

http://www.hcvadvocate.org/Medical_Writers_Circle/Pockros-2.htm

[GI.PA]

Much of the data that is coming out suggests that the most important time to be on full dose Rib and peg is the first 12 weeks of treatment.  Adding Procrit now to get you to full dose at 30+ weeks may not be of an added benifit, except to make you feel better.

This is very much "art" of medicine as the data to support all this is coming out but slowly.

GI.PA

[MichaelT]

Could you point me in the direction of some of this literature? I am eager to read it. Thanks.

-Michael

[cindee]

I'm 48yr old female...I have geno type 1a. MY viral load was wayyyyyyyyy up there. DR told me I had, had it for 20-30 yrs. I did shot46/48 tonite, I do next friday @ Myrtle Beach!!!!! And then I do my last shot on halloween.  I have been undect since 12wks. I had I lot of pains and still do. I was anemic, and fatique and all the pains....well for some reason my liver dr just told me, he did not use procrit @ all. So I didn't question him. He said he uses provigil....is it used to treat people who have trouble staying  wake in the day. I have used it some, but I fell like I need to rest, rest, rest...been fighting uppper resp. for about 2 months now. Antibiotics helped some. My liver dr was kind enought to control my pain w/ lortabs. I am on a 'high' tonite...I think it's 2 reasons..hubby has 9 dys off and I only have 2 shots to go!!!!!! I started tx dec 6 last yr and my hubby @ me got married 1/2/03. We had some time off toghter. But I was too sick to go on "Honeymoon".....so Myrtle Beach @ Charleston...here we come!!!!We are lucky to spend the first part w/ his family, and they are wonderful Christian people who have  been always for "US". I am truely blessed and I will pray for you as well as all my family and their families as well. Have good week-end.   ~Cindee~

[willing]

The importance of  higher ribavirin dosage as a significant SVR factor for 1s has been clearly established within the last couple of years. See for example <a href="http://hepatology2.aasldjournals.org/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=fullfree&id=ajhep036s121#head3">Table 3</a> in a summary of the Fried Pegasys data. Also two recent studies of extented tx, <a href="http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={99753635-F7E5-49BB-BB9A-63350891B720}&MKey={201E3AB1-B366-4CFC-879B-196DF41D3A21}&AKey={704CF973-D8A8-4909-A16B-9F7D9FB76BC7}&SKey={B95B7700-4CCE-45A4-8AB0-70F91E33D429}">teravic</a> and the <a href="http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={59C5D3F8-7761-41F4-8C09-0158C9152B37}&MKey={201E3AB1-B366-4CFC-879B-196DF41D3A21}&AKey={704CF973-D8A8-4909-A16B-9F7D9FB76BC7}&SKey={B95B7700-4CCE-45A4-8AB0-70F91E33D429}">Berg et al</a> study  mention that the 800mg dosage used in their studies has been recognized to be sub-optimal in the time elapsed since  the studies were started.

A recent study by <a href="http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={36E90257-8816-41F3-870A-664EE3F924AF}&MKey={201E3AB1-B366-4CFC-879B-196DF41D3A21}&AKey={704CF973-D8A8-4909-A16B-9F7D9FB76BC7}&SKey={B95B7700-4CCE-45A4-8AB0-70F91E33D429}">Herrman et al</a> worked on refining the rough 1000/1200 cutoff for riba dosage and found 13.75mg/Kg to have the best predictive value. This is 6.25mg/lb so at 140 you shoukd be doing about 900 a day. The mechanism of riba action is still under investigation but evidence is accumulating that it works by (1) promoting excessive mutation in the virus (2) inhibiting hcv polymerases's ability to make copies of the viral genome (<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12950173&dopt=Abstract">see</a>) These are both important factors in clearing the virus from infected "reservoir" cells -an effect that continues through the end tx.

After seeing the Herrman study I increased my riba dose against my Dr's recommendation (I'm at 37): if you're on tx you don't really have the time to wait for the standard-of-care to catch up with the research..

[raheem]

As a 1b guy, my understanding is that it is very important to maintain a full dose(1000mg or 1200mg) of ribavirin if possible. Any reduction will decrease your chances of having a SVR. My HCT got down to 26 before my doc gave my procrit at $450 per shot! If you are in an HMO, he may have wanted to keep costs down and cut back on the riba instead of getting you the procrit. At 34 weeks, I don't know if it makes any difference if you increase the riba and get on procrit at this point.  The good news is that you have been undetectable from the start. I've found you have to challenge these doctors and have them explain exactly why they don't want to follow the manufacturer's product guidelines.

[TESSTUBE]

Adavisirl - my own doc would not drop the riba pills below 800.  As a 2b we always kept the dosage at 800 but my doc dropped the pegasys to 75% the last 10 weeks out of 24 (after 2 undectable tests at 6 weeks and 13) to combat some of the fatigue.  Strictly our own decision - but we wanted to try dropping the dosage a bit before adding any additional meds to the equation.  I'm all for science but I have to agree with GIPA that there is a need for a bit of the artist in these treatments.

Almost Done 2 - have a great time in South Carolina.  I spent two weeks down in South Carolina after tx and I bounced back really fast from the treatments and my blood tests came back in good shape 3 weeks post tx. That clean air and southern cooking really did it for me.  I'm praying you do just as well.

[doll face]

My doctor has so far refused to put me on procrit too even though my blood counts are so low. As long as he doesn't decrease  my dose of riba. I have relapsed once and am not taking any chances by cuttting down my dosage.(did that the first time around) I too am a 1a 39 year old (female 135 lbs)and have been on 1000mg of pegasys for 16 weeks now even though I am starting to have more and more problems with sides I will insist on procrit before cutting down. Just my opinion though I don't know your whole circumstances. Good luck.

[kk7788]

when i started tx, i weighed 167 pounds, so my doctor prescribed 1200mg of ribavirin. now i have lost weight down to 142 pounds. should i dose reduce? i have been really sick from the ribavirin. i only have 7 more shots to go out of 48 (genotype 1a, high viral load, had it 18 years). should i just suck it up and finish at 1200 or reduce? the anemia has gotten pretty bad, and i've been miserable.
kat