Aa
ribavarin dose with Teleprevir
I just received my med and saw the doc orders 600mg of rbavarin. When I treated last time I used 1000. I called the office he's out of town. Did he make a mistake? If so now I worry about his being sloppy . If I hadn't treated before I would be in trouble. Not a great way to start off with a new doc.
I don"t think anyone .(.at least I didn"t read so.)...was advising elapsolady of taking excessive amounts of RIBA.. the guideline for her at 143 lb is 1000.. ..I believe the general advice here was to take that vs. the 800 mg her pharmacist suggested to err on the side of best chance for enough vs. possibly too little.
Will
funny thing about anemia and hypothyroid conditions - they are associated with better svr results - these are also reasons for dose reduction and even discontinuation - many svr with dose reductions - so more ribavirin does not always = better - always better to follow established guidelines - overdose of ribavirin although rare can be fatal esp if other conditions are present - i remember talking to someone who high dosed ( very high ) and she was a mess during and many years post tx - ribavirin is known to increase interferons efficacy so it will always be included with every option involving inf - someone posted take all you can handle - not a good idea - maybe take all you can handle within recommended guidelines - also most of what is known about ribavirin comes from studies of people with minimal liver damage
http://pi.vrtx.com/files/uspi_telaprevir.pdf
----------------------DOSAGE AND ADMINISTRATION-----------------------
• 750 mg taken 3 times a day (7-9 hours apart) with food (not low fat). (2,
12.3, 17.4)
• INCIVEK must be administered with both peginterferon alfa and
ribavirin for all patients for 12 weeks, followed by a response-guided
regimen of either 12 or 36 additional weeks of peginterferon alfa and
ribavirin depending on viral response and prior response status. (2)
• For specific dosage instructions for peginterferon alfa and ribavirin,
refer to their respective prescribing information. (2) (my emphasis-willy)
=======================================================
http://www.gene.com/gene/products/information/pegasys/pdf/pi.pdf
COPEGUS should be taken with food.
Table 1 PEGASYS and COPEGUS Dosing Recommendations
Hepatitis C virus
Genotype
PEGASYS Dose COPEGUS Dose Duration
Genotypes 1, 4 180 mcg <75 kg = 1000 mg
75 kg = 1200 mg
48 weeks
48 weeks
Genotypes 2, 3 180 mcg 800 mg 24 weeks
Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks
=================================
You can take a look. This is what I *think* I see.
You can confer w/ Vertex/Incivek, your doctor and/or pharmacist. None of us are in a position to recommend anything. I surely don't know the answer but am interested in hearing the correct answer. Obviously, we are all interested in making sure people get the proper dosing.......
willy
----------------------DOSAGE AND ADMINISTRATION-----------------------
• 750 mg taken 3 times a day (7-9 hours apart) with food (not low fat). (2,
12.3, 17.4)
• INCIVEK must be administered with both peginterferon alfa and
ribavirin for all patients for 12 weeks, followed by a response-guided
regimen of either 12 or 36 additional weeks of peginterferon alfa and
ribavirin depending on viral response and prior response status. (2)
• For specific dosage instructions for peginterferon alfa and ribavirin,
refer to their respective prescribing information. (2) (my emphasis-willy)
=======================================================
http://www.gene.com/gene/products/information/pegasys/pdf/pi.pdf
COPEGUS should be taken with food.
Table 1 PEGASYS and COPEGUS Dosing Recommendations
Hepatitis C virus
Genotype
PEGASYS Dose COPEGUS Dose Duration
Genotypes 1, 4 180 mcg <75 kg = 1000 mg
75 kg = 1200 mg
48 weeks
48 weeks
Genotypes 2, 3 180 mcg 800 mg 24 weeks
Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks
=================================
You can take a look. This is what I *think* I see.
You can confer w/ Vertex/Incivek, your doctor and/or pharmacist. None of us are in a position to recommend anything. I surely don't know the answer but am interested in hearing the correct answer. Obviously, we are all interested in making sure people get the proper dosing.......
willy
This almost begs for a new and separate thread, but..... I'm not sure that I've seen a discussion of the differences between treating a PI with Pegasys vrs Pegintron.
The issue is (forgive me if i am misstating this) each drug will have it's own treating instructions for the use of ribaviren.
I believe that the current state of affairs is that without regard to which form of TX you are taking, you simply follow the SOC treating instructions for that drugs regimen (whether Pegintron or Pegaysys with the allied riba dosing) and then add the PI according to the dosing instructions of that drug. I don't believe that Telaprevir for instance recommends dosing for either IFN or riba. That is left to the doctor to prescribe on or off label since they are familiar w/ your case and medical history.
So far as Telaprevir trials go..... I was under the impression that they used almost exclusively Pegasys.
Elpaso...... I *think* the riba dosing will be based upon which drug you or your doctor chooses; Pegasys or Pegintron.
I also think that most of the performance stats for Telaprevir are primarily based upon the use of Pegasys.
There was a study in which they were compared when dosed with Telaprevir;
http://www.natap.org/2009/AASLD/AASLD_43.htm
(visit the link for the full article)
The 2 drugs provided similar outcomes but the Pegasys seemed to provide a higher SVR rate in both BID and TID telaprevir dosing.
Willy
The issue is (forgive me if i am misstating this) each drug will have it's own treating instructions for the use of ribaviren.
I believe that the current state of affairs is that without regard to which form of TX you are taking, you simply follow the SOC treating instructions for that drugs regimen (whether Pegintron or Pegaysys with the allied riba dosing) and then add the PI according to the dosing instructions of that drug. I don't believe that Telaprevir for instance recommends dosing for either IFN or riba. That is left to the doctor to prescribe on or off label since they are familiar w/ your case and medical history.
So far as Telaprevir trials go..... I was under the impression that they used almost exclusively Pegasys.
Elpaso...... I *think* the riba dosing will be based upon which drug you or your doctor chooses; Pegasys or Pegintron.
I also think that most of the performance stats for Telaprevir are primarily based upon the use of Pegasys.
There was a study in which they were compared when dosed with Telaprevir;
http://www.natap.org/2009/AASLD/AASLD_43.htm
(visit the link for the full article)
The 2 drugs provided similar outcomes but the Pegasys seemed to provide a higher SVR rate in both BID and TID telaprevir dosing.
Willy
(full prescribing information for Incivek)
http://pi.vrtx.com/files/uspi_telaprevir.pdf
14 CLINICAL STUDIES
14.1 Description of Adult Clinical Studies
The efficacy and safety of INCIVEK in subjects with genotype 1 chronic hepatitis C were evaluated in three adequate and well-controlled clinical trials: two
in treatment-naïve subjects and one in previously treated subjects (relapsers, partial responders, and null responders). Subjects in these studies had
compensated liver disease, detectable HCV-RNA, and liver histopathology consistent with chronic hepatitis C.
((My emphasis-Willy) In all three studies, INCIVEK was
administered at a dosage of 750 mg every 8 hours; the peginterferon alfa-2a (Peg-IFN-alfa-2a) dose was 180 μg/week, and the ribavirin (RBV) dose was
1000 mg/day (subjects weighing less than 75 kg) or 1200 mg/day (subjects weighing greater than or equal to 75 kg).
Plasma HCV-RNA values were
measured during the clinical trials using the COBAS® TaqMan® HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of
quantitation of 25 IU/mL. SVR in all studies was defined as HCV-RNA less than 25 IU/mL at 24 weeks after the planned end of treatment.
---------------------------------------------------------------------------------------
Seems to me that this is the trial design upon which FDA approval was based.
You would have to ask yourself if they know more or know less than the folks who designed the trials. I personally agree w/ willing and others that a bit too much in the beginning is preferable to starting with reduced dosing. Starting with reduced dosing to make it "easier" does not factor in having to retreat because you relapse or break through. Reducing the riba dosing lower than clinical trials will almost certainly cause a lower SVR rate in groups. A second headache results when you are possibly saddled w/ PI resistance.
This same prescribing information also conveys that no trials have been done testing the effects of attempting to retreat w/ a PI.
Willy
http://pi.vrtx.com/files/uspi_telaprevir.pdf
14 CLINICAL STUDIES
14.1 Description of Adult Clinical Studies
The efficacy and safety of INCIVEK in subjects with genotype 1 chronic hepatitis C were evaluated in three adequate and well-controlled clinical trials: two
in treatment-naïve subjects and one in previously treated subjects (relapsers, partial responders, and null responders). Subjects in these studies had
compensated liver disease, detectable HCV-RNA, and liver histopathology consistent with chronic hepatitis C.
((My emphasis-Willy) In all three studies, INCIVEK was
administered at a dosage of 750 mg every 8 hours; the peginterferon alfa-2a (Peg-IFN-alfa-2a) dose was 180 μg/week, and the ribavirin (RBV) dose was
1000 mg/day (subjects weighing less than 75 kg) or 1200 mg/day (subjects weighing greater than or equal to 75 kg).
Plasma HCV-RNA values were
measured during the clinical trials using the COBAS® TaqMan® HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of
quantitation of 25 IU/mL. SVR in all studies was defined as HCV-RNA less than 25 IU/mL at 24 weeks after the planned end of treatment.
---------------------------------------------------------------------------------------
Seems to me that this is the trial design upon which FDA approval was based.
You would have to ask yourself if they know more or know less than the folks who designed the trials. I personally agree w/ willing and others that a bit too much in the beginning is preferable to starting with reduced dosing. Starting with reduced dosing to make it "easier" does not factor in having to retreat because you relapse or break through. Reducing the riba dosing lower than clinical trials will almost certainly cause a lower SVR rate in groups. A second headache results when you are possibly saddled w/ PI resistance.
This same prescribing information also conveys that no trials have been done testing the effects of attempting to retreat w/ a PI.
Willy
I just started second round of treatment with Incevik, and my Ribo dose is 800. I am 130 alb, 5'4's. The first round I started at 1000, and dropped to 88 lbs in 6 ms. The doc reduced the Ribo to 800. I was a bit surprised at the lower dose of Ribo this time, and wasn't sure if it was the new protocal for the triple treatment of based on past history. I will have to ask them about this. My now 25 year old daughter was in the Telapavir Drug trial (and is CURED) and I am fairly sure she was also only on 800 of Ribo
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