Aa
pre-dosing ribavirin advice
I have a friend who is about to start tx after relapsing the first time. This person is considering pre-dosing ribavirin and wondering how long to predose and how much to take. There are some older threads about it but nothing recent so I am hoping for some more current info, opinions and recommendations. The person is stage 3 of course determined to do everything it takes.
tx will be with telaprevir triple therapy.
1rst treatment I believe became und late, I believe week 14 but not positive.
treated 72 weeks relapsed
had minimal drop in hgb (12.1 to 11.3)
took 1000 mg riba, weight 115, 18.8 mg per kilo
Thanks so much for the help,
Dave
tx will be with telaprevir triple therapy.
1rst treatment I believe became und late, I believe week 14 but not positive.
treated 72 weeks relapsed
had minimal drop in hgb (12.1 to 11.3)
took 1000 mg riba, weight 115, 18.8 mg per kilo
Thanks so much for the help,
Dave
If a doctor does not tell you to pre-dose do not pre-dose. There is not one study out there that supports this theory an dusing words like pharmacokinetics and synergistic doesn't make it real.
When I was a new member many years ago I listened to the sage advice of the forum guru (who actually had a study to point me to unlike this) ended up losing six full points on my hemo in just over one week and almost failed treatment by playing with ribavirin. It IS A MAJOR DRUG AND SHOULD NOT BE EXPERIMENTED WITH WITH THESE NEW PIs that already have severe side effects associated with them.
Tele has the rash and riba has the anemia and BOTH of these things have always been associated with riba to begin with. It's just foolish and I hope that other people wont make the same mistake I made by listening to people who think they know more then doctors.
No disrespect meant but seriously.........who the hell do we all think we are anyways? Talking about and surmising is one thing but recommending changes to a brand new protocol = that equals NUTS.
Warning warning danger Will Robison.................................................
When I was a new member many years ago I listened to the sage advice of the forum guru (who actually had a study to point me to unlike this) ended up losing six full points on my hemo in just over one week and almost failed treatment by playing with ribavirin. It IS A MAJOR DRUG AND SHOULD NOT BE EXPERIMENTED WITH WITH THESE NEW PIs that already have severe side effects associated with them.
Tele has the rash and riba has the anemia and BOTH of these things have always been associated with riba to begin with. It's just foolish and I hope that other people wont make the same mistake I made by listening to people who think they know more then doctors.
No disrespect meant but seriously.........who the hell do we all think we are anyways? Talking about and surmising is one thing but recommending changes to a brand new protocol = that equals NUTS.
Warning warning danger Will Robison.................................................
Ribavirin is not new territory to be taking it with a PI. SOC drugs were trialled together with the PI's, these are known substances and the SOC drugs of riba and INF work together with the PI, so having them all at max effectiveness is desirable. This isn't adding a drug that has never been used with the PI's before so you're not introducing a wildcard here, you're taking something that already has an established integral relationship with a PI throughout many many trials.
Pre-dosing ribavirin is ribavirin mono-therapy for X number of weeks in the hope that when you take your first INF injection, the ribavirin is already at maximum synergistic capability. Everybody's response is individual, however this approach is based on what we know of the pharmacokinetics of ribavirin, it's steady state levels and it's synergistic relationship with INF. The risk to this is relatively low, seems to me - you've spent extra dollars for X weeks of ribavirin to have anywhere from limited to maximum effect when you take that first INF injection.
Pre-dosing ribavirin is ribavirin mono-therapy for X number of weeks in the hope that when you take your first INF injection, the ribavirin is already at maximum synergistic capability. Everybody's response is individual, however this approach is based on what we know of the pharmacokinetics of ribavirin, it's steady state levels and it's synergistic relationship with INF. The risk to this is relatively low, seems to me - you've spent extra dollars for X weeks of ribavirin to have anywhere from limited to maximum effect when you take that first INF injection.
I found this boce FDA advisory committee information regarding bone marrow suppression informative and interesting especially since my HGB, WBCs, ANC and Platelets all declined to extremely low levels during my boce trial.
The quickest hgb decline I had was during the lead-in which would make sense when red blood cells are being destroyed from ribavirin rather then suppressed from boce. I continued to have a steady decline in hgb and platelets until I was forced to stop tx at 43 of 48 weeks.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/drugs/AntiviralDrugsAdvisoryCommittee/ucm252341.pdf
"Overall, most of the adverse events reported in these trials have been well-described for pegylated interferon and ribavirin therapy. The most important safety concern during the clinical development of boceprevir has been the decrease in hemoglobin above and beyond that observed with pegylated interferon and ribavirin alone. The anemia appears to be part of an overall bone marrow suppressive effect of boceprevir as evidenced by the increased frequency of neutropenia and thrombocytopenia in boceprevir-treated subjects compared to PR-treated controls. Further details regarding anemia observed in this development program are described detail below."
The quickest hgb decline I had was during the lead-in which would make sense when red blood cells are being destroyed from ribavirin rather then suppressed from boce. I continued to have a steady decline in hgb and platelets until I was forced to stop tx at 43 of 48 weeks.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/drugs/AntiviralDrugsAdvisoryCommittee/ucm252341.pdf
"Overall, most of the adverse events reported in these trials have been well-described for pegylated interferon and ribavirin therapy. The most important safety concern during the clinical development of boceprevir has been the decrease in hemoglobin above and beyond that observed with pegylated interferon and ribavirin alone. The anemia appears to be part of an overall bone marrow suppressive effect of boceprevir as evidenced by the increased frequency of neutropenia and thrombocytopenia in boceprevir-treated subjects compared to PR-treated controls. Further details regarding anemia observed in this development program are described detail below."
I completely agree that we should always be careful with advice and understand that many people who read the information here might not understand that we are not physicians.
Nevertheless, a lot of people might have been saved an extra tx or two or three if they heard some of the stories here and educated themselves well and found the right doctor to treat with the first time. I know for me the advice was invaluable in my advocating for myself through tx even though I was in a trial.
As you mentioned triple therapy is new territory, especially outside the strict guidelines of the trials. As always people should educate themselves and discuss with their doctor what their approach will be.
My guess is that many of these doctors, especially the ones who have overseen these trials will get more creative with treatment before long rather then following the guideline strictly. I have already seen someone post that their doc will use a lead in regardless of whether they use tela or boce.
-Dave
Nevertheless, a lot of people might have been saved an extra tx or two or three if they heard some of the stories here and educated themselves well and found the right doctor to treat with the first time. I know for me the advice was invaluable in my advocating for myself through tx even though I was in a trial.
As you mentioned triple therapy is new territory, especially outside the strict guidelines of the trials. As always people should educate themselves and discuss with their doctor what their approach will be.
My guess is that many of these doctors, especially the ones who have overseen these trials will get more creative with treatment before long rather then following the guideline strictly. I have already seen someone post that their doc will use a lead in regardless of whether they use tela or boce.
-Dave
I'm all for reaching SVR as much as the next person,
I mean no disrespect to anyone.
I mean, what is going to happen to people when we
start giving advice on triple therapy with Boce or Tela?
There is no evidence, that I'm aware of ,of pre-dosing with riba
while using triple therapy. Boce and Tela have there own
set of rules in this game and can knock down your HGB alone.
I have a few friends starting TX also, without giving out
stats, I find this interesting, but also guarded,
I just don't know about pre-dosing...riba with triple therapy Dave.
Good luck to all
Elaine
I mean no disrespect to anyone.
I mean, what is going to happen to people when we
start giving advice on triple therapy with Boce or Tela?
There is no evidence, that I'm aware of ,of pre-dosing with riba
while using triple therapy. Boce and Tela have there own
set of rules in this game and can knock down your HGB alone.
I have a few friends starting TX also, without giving out
stats, I find this interesting, but also guarded,
I just don't know about pre-dosing...riba with triple therapy Dave.
Good luck to all
Elaine
If I were going to pre-dose ribavirin, I'd do it for 4 weeks. Many of the articles I read show steady-state concentration at 3-4 weeks. So I would go for the 4 weeks to get maximum effect. Perhaps that's why the study coeric has posted chose a 4 week lead-in? Just a pondering thought.
Definitely take the riba with fat content foods, however I have a feeling your friend knows that.
Since your friend shows a history of tolerance to ribavirin at 1000mg over 72 weeks no less, I'd increase it to 1200mg - 4 weeks of pre-dosing at that level won't take long to give an indication of how things will go. I think your friend could handle the potential fatigue of a higher-dose riba if it meant kicking viral a$$. Weight-based dosing is fine, but your friend has the benefit of "lessons learned" from past treatment. Bringing the riba dosage down after 24 weeks *if necessary* is possible when the dosage is 1200 at a weight of 115 pounds.
And I'd be willing to kick in with procrit maintenance to keep riba at higher levels.
Alinia and SAMe for good measure.....if your friend is willing to add them in.
That's my penny's worth.
Trish
Definitely take the riba with fat content foods, however I have a feeling your friend knows that.
Since your friend shows a history of tolerance to ribavirin at 1000mg over 72 weeks no less, I'd increase it to 1200mg - 4 weeks of pre-dosing at that level won't take long to give an indication of how things will go. I think your friend could handle the potential fatigue of a higher-dose riba if it meant kicking viral a$$. Weight-based dosing is fine, but your friend has the benefit of "lessons learned" from past treatment. Bringing the riba dosage down after 24 weeks *if necessary* is possible when the dosage is 1200 at a weight of 115 pounds.
And I'd be willing to kick in with procrit maintenance to keep riba at higher levels.
Alinia and SAMe for good measure.....if your friend is willing to add them in.
That's my penny's worth.
Trish
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