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Avatar universal

riba pkg insert (part 1) re. riba dose

I am GT 1 and my md only wants to give me 800 mg of riba because I weigh 115 lbs.  Why ?!

•for the treatment of chronic hepatitis C infection (monoinfection) in combination with interferon alfa-2b in patients previously untreated with interferon alpha:
NOTE: Consider response prognostic factors, HCV genotype, viral load, and disease progression evidence such as hepatic inflammation and fibrosis when deciding to treat a pediatric patient. Weigh treatment benefits against potential safety risks identified in clinical trials (see Contraindications/Precautions).
NOTE: The American Association for the Study of Liver Diseases (AASLD) recommends a peginterferon alfa product in combination with ribavirin as the preferred therapy for chronic hepatitis C infection.[20505]
Oral dosage (capsules or oral solution):
Adults > 75 kg: 600 mg PO twice daily (in the morning and evening) plus interferon alfa-2b 3 million international units SC/IM 3 times per week for 24—48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. There are no safety or efficacy data on treatment longer than 48 weeks.[29161]
Adults  73 kg: 15 mg/kg/day PO or 1200 mg/day PO given in 2 divided doses (in the morning and evening) plus interferon alfa-2b 3 million international units SC/IM 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks. NOTE: The manufacturer does not provide a specific maximum dosage for pediatric patients; however, for this indication, the maximum dosage for adults weighing > 75 kg is 1200 mg/day.[29161]
Children and Adolescents 62—73 kg: 15 mg/kg/day PO or 1000 mg/day PO given in 2 divided doses (in the morning and evening) every day plus interferon alfa-2b 3 million international units SC/IM 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Children and Adolescents 60—61 kg: 15 mg/kg/day PO or 1000 mg/day PO given in 2 divided doses (in the morning and evening) every day plus interferon alfa-2b 3 million international units/m2 SC 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Children and Adolescents 47—59 kg: 15 mg/kg/day PO or 800 mg/day PO given in 2 divided doses (in the morning and evening) plus interferon alfa-2b 3 million international units/m2 SC 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Children and Adolescents >= 3 years and < 47 kg: 15 mg/kg/day PO divided twice daily plus interferon alfa-2b 3 million international units/m2 SC 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Neonates, Infants, and Children  75 kg: 600 mg PO twice daily (in the morning and evening) plus interferon alfa-2b 3 million international units SC/IM 3 times per week for 24 weeks. There are no safety or efficacy data on treatment longer than 24 weeks.[29161]
Adults  73 kg: 15 mg/kg/day PO or 1200 mg/day PO given in 2 divided doses (in the morning and evening) plus interferon alfa-2b 3 million international units SC/IM 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks. NOTE: The manufacturer does not provide a specific maximum dosage for pediatric patients; however, for this indication, the maximum dosage for adults weighing > 75 kg is 1200 mg/day.[29161]
Children and Adolescents 62—73 kg: 15 mg/kg/day PO or 1000 mg/day PO given in 2 divided doses (in the morning and evening) every day plus interferon alfa-2b 3 million international units SC/IM 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Children and Adolescents 60—61 kg: 15 mg/kg/day PO or 1000 mg/day PO given in 2 divided doses (in the morning and evening) every day plus interferon alfa-2b 3 million international units/m2 SC 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Children and Adolescents 47—59 kg: 15 mg/kg/day PO or 800 mg/day PO given in 2 divided doses (in the morning and evening) plus interferon alfa-2b 3 million international units/m2 SC 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Children and Adolescents >= 3 years and < 47 kg: 15 mg/kg/day PO divided twice daily plus interferon alfa-2b 3 million international units/m2 SC 3 times per week. The duration of treatment for genotype 1 is 48 weeks; consider treatment discontinuation if an HCV-RNA value below the level of detection has not been achieved at 24 weeks. The duration of treatment for genotype 2 or 3 is 24 weeks.[29161]
Neonates, Infants, and Children < 3 years: Safety and efficacy have not been established.
25 Responses
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Avatar universal
I met with my doctor last week.  I had prepared my argument to support my 1000 mg dose of riba  (which was based on the great information I received from this forum) and to question his decision for the 800 mg of riba he ordered for me.  
I went with the intention of getting incevik since that was what his nurse told me I would be treated with, but during my visit, the doctor said victrelis.  
Since I was prepared to start with incevik, I decided not to entertain the idea of the victrelis – especially since I was requesting the 1000 mg of riba and I think the victrelis has more anemia issues.  Doctor was ok with the incevik.
Doctor then said I should take 800 mg of riba because he thought that was all I needed, even though I pointed out to him that the pkg insert and the trials said 1000 mg for under 75 kg (I am 117.5 lbs).  Doctor then agreed that I could take 1000 mg of riba !
I had to get a stress test for my heart, and eye dilation test, and should be able to start treatment soon:
Incevik  3 x 750 mg day, pegasys 180 ug/wk, and riba 1000 mg per day.
Thanks everyone…..gingerpal
Helpful - 0
Avatar universal
I weight in at 107 when I started and I'm on 1000 dose of Riba. triple therapy with incivek.
Helpful - 0
Avatar universal
Fair enough... I increased my riba dosage to 1200 3 days ago (day 7 of treatment) anyway.

If I could get past "Nurse No" and speak with my doctor I'm pretty sure he'd increase it.
Helpful - 0
Avatar universal
"I just wanted to add to this that I have been advised by a healthcare professional who treats HCV patients not to stress out over a 200mg difference in the riba dosage.

She says that riba is mainly used to suppress the virus and works on the relapse side and isn't responsible for VL reduction.

So.... the gist is that I shouldn't freak out about being 200 mg under the dosing guidelines because it's not going to matter when it comes to my VL at week 4, 12, etc. "

That's not true that ribavirin has no role to play in viral reduction, only relapse.  Truth is, it plays a role in both.  The amount of ribavirin you take is an integral part of the effectiveness of treatment drugs.  There are a number of studies that show the detriment or benefit of having adequate ribavirin dosage and show better results with appropriate and higher ribavirin dosages.

t's really important to treatment outcomes to eradicate the virus earlier than later.  Adequate ribavirin dosage in the earlier stages of treatment is critical.  Later in treatment, dosage reductions of ribavirin are not as impacting if necessary, however earlier in treatment full adherence has been shown to be vitally important.

Here is a link to the AASLD Treatment Guidelines:

http://www.aasld.org/practiceguidelines/Documents/Hepatitis%20C%20UPDATE.pdf

A couple of excerpts:

"The Optimal Treatment of Chronic HCV:  Peginterferon Alfa and Ribavirin

The currently recommended therapy of chronic HCV infection is the combination of a pegylated interferon alfa and ribavirin. The choice of this regimen was based upon
the results of three pivotal, randomized, clinical trials that demonstrated the superiority of this combination treatment over standard interferon alfa and ribavirin.71-73
While not directly comparable, these three trials defined several key components of therapy, namely the appropriate dose of the drugs, the optimal duration of therapy and
the need for a different regimen for patients with genotype 1 and genotype 2 and 3 infections."

"The optimal dose of peginterferon alfa-2b, based on the original registration trial, is 1.5 g/kg/week dosed according to body weight (Fig. 2). Although the dose of
ribavirin used in the original registration trial was fixed at 800 mg daily, a subsequent community-based study of patients with genotype 1 infection demonstrated that
weight-based ribavirin (800 mg for patients 65 kg; 1,000 mg for patients weighing 65 to 85 kg; 1,200 mg for patients weighing 85 to 105 kg; and 1,400 mg for patients weighing105 kg but125 kg) was more effective.71,109 Peginterferon alfa-2a is administered at a fixed dose of 180 g/week given subcutaneously together with ribavirin 1,000 to 1,200 mg daily, 1,000 mg for those who weigh75 kg and 1,200 mg for those who weigh75 kg (Fig. 2).72 The registration trial highlighted the two beneficial effects of ribavirin, an improvement in the ETR but, more importantly, a significant decrease in the relapse rate as compared to peginterferon monotherapy treatment."

Clearly, adequate dosage of ribavirin helps with both...early treatment response - which IS reduction of viral load - and relapse rate.  In addition, it's EARLY adequate ribavirin dosge.

As for triple therapy, it shows somewhat higher SVR rates for those who are adherent to dosages early in treatment compared to those who are not, so an adequate amount of INF and Riba is important in triple therapy as well, despite the extra firepower.

There are also studies that clearly show the difference in SVR rates when Ribavirin amounts are lower or higher.  So for your doc to be underdosing or minimally dosing ribavirin, especially early in treatment, is somewhat concerning.  That's my penny's worth.

Trish
Helpful - 0
Avatar universal
I just wanted to add to this that I have been advised by a healthcare professional who treats HCV patients not to stress out over a 200mg difference in the riba dosage.

She says that riba is mainly used to suppress the virus and works on the relapse side and isn't responsible for VL reduction.

So.... the gist is that I shouldn't freak out about being 200 mg under the dosing guidelines because it's not going to matter when it comes to my VL at week 4, 12, etc.
Helpful - 0
Avatar universal
Big issue for me as well.    I'm 80kg and on 1000 mg.

My doctor's nurse says that is correct.   I say she is wrong.

I upped mine to 1200 on day 7 of triple therapy and am calling the doctor in the morning.
Helpful - 0
317787 tn?1473358451
Hi I am having the same question as you are, I am 140 lbs 5' 5" and my prescription is for riba 800 mg and 120 for pegintron, I am worried it is too little so am calling the doc on Monday
In 2008 I also took 1000 Riba and 180 Pegasys maybe with the third drug it is not as important but I want to check.  I want to get to SVR this time
Thanks for the question
Dee
Helpful - 0
Avatar universal
Hi everyone, went to see the doctor this morning. I weigh 74kg as of this morning. The doctor agree to  up my dosage another 200 mg to 1200 mg. I am in my 16 week. She  also agree that i should do my best to get the virus cleared on this treatment. I will be seeing her again next week to check the blood count.Thanks again everyone.
Helpful - 0
Avatar universal
thanks all.  I started to worry about this.  I called the NP and got upset on the phone - and I haven't even started tx yet.  They probably will want to put me on anti-depressants ;)
Well...my doctor was involved with incevik trials and he says that my riba dose should be 800 mg per day.   I will try to gather info to support the 1000 mg dose.  And as a last resort,  I am still thinking about  taking an extra 200 mg ( my left -over riba pills from 2008) until i at least reach und.
Helpful - 0
Avatar universal
"200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg "

Good find spectda, sense this is the dose they used in the trials to get the svr results, i would want nothing less.
Helpful - 0
Avatar universal
"A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 HCV
http://clinicaltrials.gov/ct2/show/NCT00627926?term=telaprevir&rank=17

Biological: peginterferon alfa-2a
subcutaneous injection, 180 micrograms once per week
Other Name: Pegasys, Peg-IFN
Drug: telaprevir
375 mg tablets administered orally every 8 hours at a dose of 750 mg
Other Name: TVR, VX-950
Drug: ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg
Other Name: Copegus, RBV"
Helpful - 0
Avatar universal
yeah but you are way tougher than most ....  hi bud
Helpful - 0
1420486 tn?1384793153
I weigh 109 lbs and I take 1000 mg of riba a day. hum
Helpful - 0
Avatar universal
Thanks everyone, this forum is a goldmine.
Helpful - 0
Avatar universal
You should wear really heavy clothing when you get weighed :)
Helpful - 0
1654058 tn?1407159066
Here's my dose. I weighted 123lbs - 5'5",  and fought Hard to get up to it prior to tx.
RIBA - 200 mg 5 xs = 1000 mg d
Telaprevir 375 mg 6 = 2250 mg d
Pegasys 0.5 1 weekly
I was told if I lost down to 105 they would discontinue. I go to my 4 week tomorrow. I came home from work early n slept so I could make the 2 hr drive tonight. Staying w a friend for early appt.  I'm curious what they're gonna do w my dose. I'm so nauseated. Eatn my fat w inhibbies. Just woke up. Sry to ramble. This post is relevant to me because I'm thinking they wanted to hit hard? Sledge hammer? Cuz I'm gr4/s4. I won't be so afraid if they drop me back a lil now. Thanks guys for all ur info.. You're brilliant . And BFF's. With work, it's hard to think n research on my own some days past 3:00. Crying grateful tears, Karen :) Go Ginger! Thanks all...
Helpful - 0
Avatar universal
The recommended dosage for pegintron (peg interferon alpha 2b) and Ribavirin are different then the weight based dosing for pegasys (peg interferon alpha 2a) and ribavirin (copegus), Maybe that's one of the reasons Incivek had higher svr rates then Victrelis, although more riba with victrelis might be asking for trouble.

If you are using pegasys, ribavirin (copegus) and Incivek (the combination and dosing vertex used in the Incivek trials), the dosing is 1000mg for you. You can go clinicaltrials.gov site and look up telaprevir all trials recruiting and closed and you will see what Vertex used and are using currently. I know three woman at your weight or below that are currently treating, two of them are taking 1000 mgs and one is taking 1200 mg.

http://www.gene.com/gene/products/information/pegasys/pdf/Copegus_pi.pdf
Table 1 PEGASYS and COPEGUS Dosing Recommendations
PEGASYS Dose*
COPEGUS Dose
Duration
Genotypes 1, 4
PEGASYS Dose-180 mcg
COPEGUS Dose75 kg = 1200 mg
Helpful - 0
Avatar universal
Should have an exp. date on them, that said if anything they would have just lost some of their strenght.
Helpful - 0
Avatar universal
i have riba left over from my first treatment in 2008 - do you think these pills are still ok ?
i agree with the sledge hammer approach - i am almost tempted to take an extra pill a day for the first 4 wks.   I am GT 1, Phenotype TT.
thanks.
Helpful - 0
Avatar universal
Dosage chart.
http://www.drugs.com/dosage/ribavirin.html

Pounds to kg conversion.
http://www.metric-conversions.org/weight/pounds-to-kilograms.htm

Myself i would want a 1000 mg for at least the first 4 weeks going by your last tx. results....... But i'm one to take a sledge hammer approach.......Wishing you the best.

Helpful - 0
Avatar universal
i guess i am afraid not to take the 1000 mg which is what I took the first time.
dave spectra sent this to me which corresponds to the 1000 mg:
http://www.drugs.com/dosage/copegus.html

Helpful - 0
Avatar universal

It would seem that at 1000 your lst treament you were somewhat over prescribed...however you mentioned your HGB. stayed in safe territory...so possibly discuss this with your doctor ..with his views...however don"t forget..this time with the P.I  your HGB.. may take more of a hit..
Will
Helpful - 0
96938 tn?1189799858
You weigh 52 kg.  52 x 15/mg per kg is 780 mg riba per day.  That seems about right
Helpful - 0
Avatar universal
I weighed 120 pounds during my treatment and my riba dose was also 800.  My treatment was successful.
Helpful - 0
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