Reducing riba dose

I've had 9 shots of Inf. now and 4 of Procrit to deal with anemia.  My hgb was 15.6 at start of tx. and 11.5 by the fourth week, when I commenced the Procrit.  Now, 4 weeks later, it's 11.0.  I'm feeling a tad better, but suspect it's because I'm getting used to being anemic.  I'm certainly not feeling very good.  Today the doctor called and said I should drop one of the riba pills.  I'm presently taking 1000 mg. daily of riba plus Peg-Intron (I don't know how to quantify the dose - I use the 120 redipen and set it at 4).  I weighed 147 when I began, now am 139, so my weight is right on the cusp between 800 and 1000 mg. of riba.  Do you think it's safe to omit one daily pill.  I've been UND since week 4 (genotype 2).

BTW, regarding weight, how do medical people determine weight?  Most women weigh naked in the AM before they've eaten and after they've gone to the bathroom, whereas most guys I know will leave their shoes on and their pockets full when they step on the scale after breakfast.  I think this may be one of the major differences between men and women - how they calculate their weight.

[painterlady13]

Hi they did that to me about the same weeks (procrit and riba reduction) but they reduced my riba from 1200 to 600 and then by week 12 back to 800. I weighed about the same as you then although I don't know the difference in weighing men and women.  I am a woman 5'7.  Now at week 30 I have gained 15 more pounds and 4 weeks ago they upped me back to 1000 riba. (I've only been asking since oct)
BTW  I was UND at week 6 and 20. I don't suppose that it did too much (to me) by reducing BUT EVERYONE IS DIFFERENT!!!! I am just telling you what happened with me.  Good luck. Oh and hgb was 11.0 today, so, not bad.

[jmjm530]

Yes, your body does adjust to lower levels of hemoglobin over time. Early on in treatment I was in the ER at hemoglobin 11.4. Later in treatment I functioned very well at the number.

Given that you're a geno 2, you probably will be OK with the lower dose but unless you're in some sort of trouble with the side effects, I don't see why they want to reduce now, especially when your body seems to be adjusting.  FWIW my NP also wanted to reduce my ribavirin around 14 weeks into treatment but I declined. It's really a decision between you and the doctor but hopefully you will have some input.

All the best,

-- Jim

[Maui lover]

At week 5 my husband was taken off of Riba (1000mg) for 21 days due to anemia.  His hgb had dipped into the 7's at that point.  He was started on Procrit and went back on 800mg Riba after 3 weeks.  He stayed on Procrit for the remainder of his treatment.  His hgb started to drop again about a month after he went back on the Riba, so they upped his Procrit to twice weekly and reduced his Riba from 800 to 600mg.   He finished his treatment on 600mg of Riba.  He's Geno 3, was UND from week 4 on and finished treating just about a month ago and his first post-tx PCR was UND.  His hgb is now at almost 14, so he's feeling pretty good these days.  

Hang in there, I'm sure you're not feeling so hot but as others have said, I do think your body adjusts to the anemia.  That doesn't make it any easier, I'm sure, but know that you aren't alone and you will make it through this!  =)

[Cindy10]

You do get used to the anemia, just pace yourself.
I have had it on and off for 25 years, it becomes part of life. If you stay around 11, you should be ok. Mine is 11.4 and its doable. Not sure about reducing unless really needed. Good luck!

[mremeet]

Here's a recent study that investigated the effects of reduced ribavirin on SVR. In a nutshell it found that those who experienced an RVR (UND by 4 wks) could get away with lower riba dosing with minimal impact on SVR. Not suggesting this study should be taken as gospel, but something to think about. It also has a classic quote I really like: "Minor ribavirin dose reductions to manage adverse events do not appear to affect SVR adversely, unless cumulative exposure is less than 60%. Prospective studies, however, are required to establish the impact of ribavirin dose reduction on SVR."

Here's the study:

http://www.hivandhepatitis.com/hep_c/news/2007/012607_a.html

"Ribavirin Dose Reductions Due to Adverse Events Do Not Compromise Sustained Response in Some Patients"

Research has shown that adequate doses of ribavirin play an important role in reducing the risk of relapse in hepatitis C patients treated with interferon-based therapy, especially those with genotype 1.

The current standard of care for chronic hepatitis C is pegylated interferon plus ribavirin, given for 24 week to patients with HCV genotypes 2 or 3 and for 48 weeks to those with hard-to-treat genotypes 1 or 4.

In the present study, reported in the January 2007 issue of Clinical Gastroenterology & Hepatology, University of Pennsylvania researchers evaluated the effect of ribavirin and pegylated interferon alfa-2a (Pegasys) dose reductions on sustained virological response (SVR) in patients with genotype 1 HCV.

Data were pooled from 569 participants enrolled in 2 Phase III trials of 48 weeks of treatment with Pegasys plus ribavirin. All patients were evaluated for the effect of cumulative drug exposure on 4- and 12-week responses. The 427 patients who completed treatment were evaluated for effect of drug exposure on SVR.

Results

Among patients who completed therapy, more had reductions (</= 97% of  the originally prescribed cumulative dose) of ribavirin than Pegasys (43% vs 27%).

Neither early virological response nor SVR were adversely affected by ribavirin reduction as long as the cumulative exposure was greater than 60%.

However, the SVR rate was significantly reduced in patients with less than 60% of the intended cumulative ribavirin dose (P = 0.0006).

Reduced SVR was associated with prolonged periods of dose reduction, temporary interruptions, or premature cessation of ribavirin.

Ribavirin dose reduction had a minimal impact on SVR in patients who achieved rapid virological response, defined as undetectable HCV RNA after 4 weeks, even when they received less than a 60% cumulative ribavirin dose. In contrast, SVR was reduced markedly in patients who had ribavirin dose reductions and did not achieve rapid virological response.

Conclusion

These findings led the study authors to conclude, "Minor ribavirin dose reductions to manage adverse events do not appear to affect SVR adversely, unless cumulative exposure is less than 60%. Prospective studies, however, are required to establish the impact of ribavirin dose reduction on SVR."

[jmjm530]

The above study is one of a number of studies suggesting that varying degrees of ribavirin reduction may not hurt ones chances of SVR. In fact, I think there was one study for geno 2's where the participants did well on only 400 mg/day of ribavirin.

On the other hand, different studies such as the weight-based versus fixed rate studies seem to support the importance of adequate ribavirin dosing. Same as some of the shorter course studies that show different results between weight-based and fixed rate dosing. Probably the most dramatic study, albeit a small pilot study, was the Sweedish high dose riba protocol that produced a 90% SVR rate for its geno 1 participants. These studies can get complicated and even within my own doctors office, I got different advice regarding maintaining my 1200 mg/day of ribavirin in face of some significant side effects.

Where I came out after reviewing studies and discussing ribavirin dosing with three quite prominent hepatologists is best to keep the dose up as high as possible as long as it does not seriously compromise either health or treatment compliance. Specifically, this advice was to genotype 1 with significant (stage 3) liver damage who had a rapid viral response at week 6.

In trying to transpose all these studies, advice from liver specialists, etc -- to pigeonca's case, the question becomes to me what are the relative risks and rewards of reducing the ribavirin now.  Currently, Pigeonca seems to be doing fairly well on treatment and adjusting to what in any event isn't an unreasonable low hgb level (11) at week 8. On the other hand, she's a geno 2 where riba may be less important and as she suggests is on the cusp of 800/1000mg a day. No right answers, but if it were me, I'd err on the side of caution and stay with the present riba dose but monitor hemoglobin more frequently to see if it will stabalize. The dose can always be adjusted later.

As to how people weigh themselves. Ideally, I go for my trough :) weight which is  in the morning, before I've eaten, and after I've emptied. The doctors on the other hand, take your weight in the office -- which may be before or after a meal, usually with some amount of clothes on -- they never asked me to remove some heavy boots for example-- and may or may not make an adjustment.

Funny story talking about men weighing themselves with their pockets full. At one point very early in treatment I lost close to 30 lbs and was afraid they were going to reduce my ribavirin. I remember loading my pockets with coins at home and wearing my heaviest boots that day :)

Pigeonca, no really right or wrong decision on this as I see it.

All the best,

-- Jim

[pigeonca]

Thanks all for the excellent info and advice.  In the meantime, I was getting into my PJ's for the night when I noticed red spots all over my tummy, legs, chest and upper back.  Riba rash?  Also there seem to be a few new spots of morphea, which is cutaneous scleroderma, an autoimmune skin condition I've had for the last couple of years, so perhaps there's a message there that I should drop the riba down to 800 mg.  Doc insists it's safe, and I don't want to be rash about the rash.

[nygirl7]

I just can't see why they would consider reducing you when your hemo is still that high.  It's not even at the Procrit level yet.  Even though you geno 2 - the one thing Dr. J told me is crucial is to not dose reduce. I can't imagine why they would consider this until it was absolutely necessary.

PS My hemo even on Epo stayed at the highest 10.5 all thoughout treatment after I started on the rescue drug...and I felt pretty well. I just wouldn't take the chance on reducing after I talked to Dr. J.  It didn't seem worth it.

(But HE had me reduce at week 46 to 800 - I had asked for "extra" riba when I started and he said the "extra" was not necessary at this point when most would be finishing treatment.)

[nygirl7]

UND is not SVR and while it's great to get to UND during treatment and we all have that goal remember - sustainning virological response IS the goal in the long run and many geno 2s lately have been relapsing. According to the doctors latest thought the odds are NOT 80% SVR and some are considering upping treatment to 48 weeks.

Be careful.

[GrandOak]

I believe reducing my riba early in tx because Hgb dropped below 10 compromised me on even reaching UND.  I also struggled with Hgb between 9 and 10.5 throughout most of the 10 months of tx before I was pulled.

I can say that I did drop VL from 72 million to 2.2 million before riba reduction and after reduction VL only dropped down to 1.8 million before breaking through and climbing again.  Since riba in the tx mixture is responsible for prevent viral replication while the Peg-Ifn kills it, it seems to follow that reducing the riba level would have a corallary reduction in the replication prevention level as well.