Aa
Interesting Explanation of Boceprevir (PDF)
http://www.chem.missouri.edu/GatesGroup/Boceprevir.pdf
Magnum
Magnum
tough choices, agreed. Starting triple tx seems the right call but adding whatever you can to improve response against PI-resistant virus will be beneficial. Currently available options include alinia/ntz and IV-SIL.
Carefully checking the inclusion criteria and trial structure of the upcoming phase III trials for bms790052 and r7128 may also be worthwhile. Anything that gives you a shot at two DAAs will be a win. It's not yet clear whether those trials will include arms that test the new drug+triple vs plain triple.
Carefully checking the inclusion criteria and trial structure of the upcoming phase III trials for bms790052 and r7128 may also be worthwhile. Anything that gives you a shot at two DAAs will be a win. It's not yet clear whether those trials will include arms that test the new drug+triple vs plain triple.
Understand. The thing is how long must or could I wait....10% to 30% odds not good but better than zero from doing nothing. Already had near death event 3/4 years ago with esp/varices. Today hyerportal tension, enlarged speen, watching for cancer, not getting youger-----oh well my focus for so long has been this could be last shot to kill the virus. Decision to wait and do nothing but watch for next round is not very exciting to me.
>stop at week 12 due to not have two-log drop.
which would classify you as a null-responder. Both drugs have been approved for use with nulls but only tela has phaseIII outcome data. For tela, overall odds for nulls were 30% going down to 10% for cirrhotics. Not great. Boce did not include nulls in phase III trials but there is no reason to believe their odds would be better.
Past "noteworthy rash" would seem to suggest boce. but the main point is finding an additional drug to improve those odds. Trials for two DAAs +soc are likely to be your best bet, Also check out trials for IV-SIL ongoing in Austria :
http://clinicaltrials.gov/ct2/show/NCT00684268
All the best!
which would classify you as a null-responder. Both drugs have been approved for use with nulls but only tela has phaseIII outcome data. For tela, overall odds for nulls were 30% going down to 10% for cirrhotics. Not great. Boce did not include nulls in phase III trials but there is no reason to believe their odds would be better.
Past "noteworthy rash" would seem to suggest boce. but the main point is finding an additional drug to improve those odds. Trials for two DAAs +soc are likely to be your best bet, Also check out trials for IV-SIL ongoing in Austria :
http://clinicaltrials.gov/ct2/show/NCT00684268
All the best!
WRT "How did things work out in your past tx: what was your w4/8/12 drop and did you have issues with rash or anemia? "
In 1998 I did six months interferon w/ribavirin through dosage level study with Virgina Hepatitis Study Group, but then not clear. I do recall an early reduction of 6.5m to 600k. Later in 2002 started peginterferon w/ribavirin, but stop at week 12 due to not have two-log drop.
Both times I had what I would state was noteworthy rash. However, got through it via powders, lotions, etc.....
In 1998 I did six months interferon w/ribavirin through dosage level study with Virgina Hepatitis Study Group, but then not clear. I do recall an early reduction of 6.5m to 600k. Later in 2002 started peginterferon w/ribavirin, but stop at week 12 due to not have two-log drop.
Both times I had what I would state was noteworthy rash. However, got through it via powders, lotions, etc.....
The main reason the Gastro chose Boce is for the hopeful lack of rash. As for Anemia, I never had my pletelets go low enough for Procrit through 4 attempts. This doctor has been working with me for 11 years and I also work in conjunction with Hepatologist Robert Gish. I never dropped count low enough to continue three treatments. The fourth I went from 3.2 million to 6500, but that was the dreadful, unforgiving, satanic, all encompassing, brutally vicious, heartless and insidious Infergen. A curse on that drug...
I know it's no picnic, but forward I must go, as there's nothing else at this point. I was considered mildly-Cirrhotic about two years ago. Now? I already went through three biopsies, 2 varices banding and on and on...
As I mentioned before, this will be a very interesting posting period by all on the new PI's for the next two months... So on we go... Best of luck to you. I hope to hear great news from you and all those on the PI’s...
Magnum
I know it's no picnic, but forward I must go, as there's nothing else at this point. I was considered mildly-Cirrhotic about two years ago. Now? I already went through three biopsies, 2 varices banding and on and on...
As I mentioned before, this will be a very interesting posting period by all on the new PI's for the next two months... So on we go... Best of luck to you. I hope to hear great news from you and all those on the PI’s...
Magnum
Magnum: it's Anthem and my copay for the vic was 40. Which makes no sense, because my copay for ifn is 150 for which the insco is billed about 2k and the vic should cost them twice that. I won't be surprised to see the copay go up. Forty was also my copay for alinia.
somuchmore2: I've been following this pretty closely and bottom line IMO is that sides are the only important difference between the two and one should choose based on which seem most tolerable. SOC is no picnic and each of the two PIs adds its own, different, layer of trouble. The important thing is to find something you can live, and trusting a Dr. to make the decision for you many not be the best choice: you'll have to live with the consequences.
I chose vic because the anemia seemed more manageable and predictable than a possible out of control rash and I had had skin troubles in my last tx. The main draw of the inci was the 12w duration given that I'm adding it late to an ongoing tx. In the end the risk of upsetting what has so far been a fairly stable tx didn't seem worth it.
Good luck with your decision. How did things work out in your past tx: what was your w4/8/12 drop and did you have issues with rash or anemia?
PS - an inci equivalent of the vic link Magnum posted is
http://www.ncbi.nlm.nih.gov/books/NBK1623/
at the label "A Drug Discovery Target". Comparing the links underscores how similar the two drugs are underneath all the marketing hype.
somuchmore2: I've been following this pretty closely and bottom line IMO is that sides are the only important difference between the two and one should choose based on which seem most tolerable. SOC is no picnic and each of the two PIs adds its own, different, layer of trouble. The important thing is to find something you can live, and trusting a Dr. to make the decision for you many not be the best choice: you'll have to live with the consequences.
I chose vic because the anemia seemed more manageable and predictable than a possible out of control rash and I had had skin troubles in my last tx. The main draw of the inci was the 12w duration given that I'm adding it late to an ongoing tx. In the end the risk of upsetting what has so far been a fairly stable tx didn't seem worth it.
Good luck with your decision. How did things work out in your past tx: what was your w4/8/12 drop and did you have issues with rash or anemia?
PS - an inci equivalent of the vic link Magnum posted is
http://www.ncbi.nlm.nih.gov/books/NBK1623/
at the label "A Drug Discovery Target". Comparing the links underscores how similar the two drugs are underneath all the marketing hype.
Just curious, what insurance company okay'd the prescription and what was your co-pay? My prescription provider thinks this is an important question to expedite my supply...
thanks,
Gabriel
thanks,
Gabriel
My lean is toward BOCE on too! However, that is a switch in gears because I watch the Vertex story for a very long time. In fact even went into the stock position until everything in the world appeared to be falling apart along with the 13 bankers.
Back to the important matter BOCE or TEL. I am pretty ill and suspect this is my last shot before TP. Not getting any younger and all that. However, my HEP doc is thinking I still get treatment. Status twice failed, Geno 1A, IL28 TT, stage 4 disease. Yep not much to work with but hope and pray which I'm well versed in.
Question I have is what are the top 4 factors which got you to BOCE choice?
Thank you or any others for any input as I weigh my choices.
I should clarify the peanut butter. It is actually 3 tablespoons of peanut butter for one dosing of TEL. Therefore, if you used the PB for each dose, it would be 9 TBS for the day. Now I love PB but, yikes!
Magnum: it's got to be be close. If nothing else the speed with which this went through indicates the rx processing and pharmacy supplies are already in place. Which only leaves the Medicare coverage.
Spectda: Thanks. I was set for a knock-down drag out with my insco re off-label usage but my Dr. was wiser. He wrote the script for the stock, on-label, 36w duration for relapsers which covers him and probably made approval automatic. I have no intention of taking it for that long but will cross that bridge later. After 40 years of being married to a lawyer I should have learned that, when anticipating an argument, the less said the better.
Frijole: whoa - that's a lot of PB and bagels! I've gotten in the habit of a middle of the night fruit smoothie (grind up an apple/blueberries/protein powder) which seems to keep the rbv demons quiet until morning and will probably stick with that for the 2:30 feeding. BTW I think you're on target about the RBV; my Dr. under-prescribed on the last tx and that's likely the main reason it went bad. A story we've seen replayed many times here and part of the reason I wanted to drive on this round. If I get stuck in the weeds again, there'll be no one else to blame. Current rbv dosage (1400-1500) gave a 3-4 unit Hgb decline froom base 15. Am hoping that if back that down to 1200 (my rx amount) now that the vic is kicking in I can still keep it above 9.5
You shouldn't have any trouble adding epo to tela if you go that route.. The fact that they didn't use it in their trials shouldn't limit Drs from prescribing it as needed (along with other rescue drugs).
Spectda: Thanks. I was set for a knock-down drag out with my insco re off-label usage but my Dr. was wiser. He wrote the script for the stock, on-label, 36w duration for relapsers which covers him and probably made approval automatic. I have no intention of taking it for that long but will cross that bridge later. After 40 years of being married to a lawyer I should have learned that, when anticipating an argument, the less said the better.
Frijole: whoa - that's a lot of PB and bagels! I've gotten in the habit of a middle of the night fruit smoothie (grind up an apple/blueberries/protein powder) which seems to keep the rbv demons quiet until morning and will probably stick with that for the 2:30 feeding. BTW I think you're on target about the RBV; my Dr. under-prescribed on the last tx and that's likely the main reason it went bad. A story we've seen replayed many times here and part of the reason I wanted to drive on this round. If I get stuck in the weeds again, there'll be no one else to blame. Current rbv dosage (1400-1500) gave a 3-4 unit Hgb decline froom base 15. Am hoping that if back that down to 1200 (my rx amount) now that the vic is kicking in I can still keep it above 9.5
You shouldn't have any trouble adding epo to tela if you go that route.. The fact that they didn't use it in their trials shouldn't limit Drs from prescribing it as needed (along with other rescue drugs).
Magnum
"The way my Gastro explained it, there is no choice with Boce, as that's the protocol."
What protocol? How can there be any protocol for any of this yet? It doesn't really matter. I think BOC is a good choice no matter what. I am considering it strongly. I had forgotten about your infergen overdose but I sure remember now. I hope your body tolerates the 3fer.
Willing
Thanks for the explanation on the lead in. I am being swayed towards BOC in any event, due to the dosing requirements. With TEL the expectation for optimal results is to take 20 grams of fat with every dose. I don't need and don't want to take 60 grams of fat everyday for 12 weeks. Their examples are 9 tablespoons of peanutbutter, a bagel and creme cheese, 1/2 cup nuts, among other things. BOC, on the other hand states that you should take it with food, but says it doesn't matter if it is high fat or low fat - just don't take it on a fasting stomach. So, I guess you get a 2:30 AM midnight snack!
frijole
"The way my Gastro explained it, there is no choice with Boce, as that's the protocol."
What protocol? How can there be any protocol for any of this yet? It doesn't really matter. I think BOC is a good choice no matter what. I am considering it strongly. I had forgotten about your infergen overdose but I sure remember now. I hope your body tolerates the 3fer.
Willing
Thanks for the explanation on the lead in. I am being swayed towards BOC in any event, due to the dosing requirements. With TEL the expectation for optimal results is to take 20 grams of fat with every dose. I don't need and don't want to take 60 grams of fat everyday for 12 weeks. Their examples are 9 tablespoons of peanutbutter, a bagel and creme cheese, 1/2 cup nuts, among other things. BOC, on the other hand states that you should take it with food, but says it doesn't matter if it is high fat or low fat - just don't take it on a fasting stomach. So, I guess you get a 2:30 AM midnight snack!
frijole
http://www.hivandhepatitis.com/2008icr/aasld/docs/110408_a.html
• In a planned interim analysis, addition of boceprevir in both the 28-week and 48-week regimens markedly increased the SVR rate compared with standard therapy.
• The SVR rate was higher with a 4-week pegylated interferon + ribavirin lead-in for the 48-week regimen:
• No lead-in, 28 weeks: 55%;
• Lead-in, 28 weeks: 56%;
• No lead-in, 48 weeks: 66%;
• Lead-in, 48 weeks: 74%;
• Standard therapy: 38%.
• In a planned interim analysis, addition of boceprevir in both the 28-week and 48-week regimens markedly increased the SVR rate compared with standard therapy.
• The SVR rate was higher with a 4-week pegylated interferon + ribavirin lead-in for the 48-week regimen:
• No lead-in, 28 weeks: 55%;
• Lead-in, 28 weeks: 56%;
• No lead-in, 48 weeks: 66%;
• Lead-in, 48 weeks: 74%;
• Standard therapy: 38%.
I would guess that you will get all three meds at the same time. I don't think not having the boce from 44-48 weeks will matter, if you decide to start with all three. Of course its off label and not what the doc is recommending.
I thought the best results were with a lead in during 2b trials. I will look for the data.
I thought the best results were with a lead in during 2b trials. I will look for the data.
The way my Gastro explained it, there is no choice with Boce, as that's the protocol. If you remember, I did respond to Infergen, but with the overdose I was on, it eventually would have caused my liver to fail. So, am I considered a responder? That's the $64,000 question.
At any rate, this is another chance, and as much as I would rather lie on the beach in the Bahamas, I'm going for it. My dad died of Chirrosis because at that time there was no medicine to cure him. We have a chance and that's a cause for hope.
Magnum
At any rate, this is another chance, and as much as I would rather lie on the beach in the Bahamas, I'm going for it. My dad died of Chirrosis because at that time there was no medicine to cure him. We have a chance and that's a cause for hope.
Magnum
Congrats on getting the pills so quickly Willing, I am truly amazed. Hopefully Magnum and the other's waiting for them will find the experience of obtaining them as painless as you. I am pretty shocked that it happened so quickly.
-Good luck everyone,
Dave
-Good luck everyone,
Dave
magnum: good point about approvals possibly being more likely before the accountants see what it's costing. I was (happily) surprised it was so easy.
frijole: triple tx only works when the PI acts together with an "adequate" ifn response. The lead-in allows you to measure ifn response without the PI - and a tipping point in the SVR odds is less than a log drop at 4w. For someone with known strong past response, like yours, it's a waste of time - might as well start all three together regardless of which you choose. However for someone with an unknown or questionable past response, the lead-in can provide valuable information about whether triple tx is worth the investment.
Pretty red/yellow pills now taking up more room in the fridge. And an excess of throw-away plastic packaging (one mini bottle per day). I suppose the point is to make sure one stays on top of the every-8 hr dosing. I opted for 10:30am, 6:30pm and 2:30 am (since the insomnia usually hits around then). First dose down, no fangs yet but I'll keep checking.
Not sure trading the LoneStar for hot sauce is a good move, but at this stage either one seems about as accessible as one of those fabled Swedish coeds..
frijole: triple tx only works when the PI acts together with an "adequate" ifn response. The lead-in allows you to measure ifn response without the PI - and a tipping point in the SVR odds is less than a log drop at 4w. For someone with known strong past response, like yours, it's a waste of time - might as well start all three together regardless of which you choose. However for someone with an unknown or questionable past response, the lead-in can provide valuable information about whether triple tx is worth the investment.
Pretty red/yellow pills now taking up more room in the fridge. And an excess of throw-away plastic packaging (one mini bottle per day). I suppose the point is to make sure one stays on top of the every-8 hr dosing. I opted for 10:30am, 6:30pm and 2:30 am (since the insomnia usually hits around then). First dose down, no fangs yet but I'll keep checking.
Not sure trading the LoneStar for hot sauce is a good move, but at this stage either one seems about as accessible as one of those fabled Swedish coeds..
Yep - I read what I could but the article was really Greek to me. I am glad there are smart researchers around who can wrap their heads around this.
What about that lead it? Is it a good thing or not? What do you think?
frijole
What about that lead it? Is it a good thing or not? What do you think?
frijole
According to my Gastro (as I posted before), the reason he wants me on Boce is the potential rash shouldn't appear, but there is still the question of Anemia with Boce. In my case, throughout 4 treatments, I've never had that problem, which I understand can be corrected wit Procrit.
Here's something else to think about. Boce has a one month lead in with standard treatment, while Tele has no lead in. Decisions, decisions...
Magnum
Here's something else to think about. Boce has a one month lead in with standard treatment, while Tele has no lead in. Decisions, decisions...
Magnum
I looked at the document but it looked like something beyond my comprehension so I didn't print it out. Do you think there is information in it that may help a person make the decision between VIC and INC (sounds like old friends and tattoos).
TODAY? YOU'RE PICKING UP YOUR VIC TODAY? HOW ABOUT A CASE OF HOT SAUCE INSTEAD OF LONESTAR?????????
frijole
TODAY? YOU'RE PICKING UP YOUR VIC TODAY? HOW ABOUT A CASE OF HOT SAUCE INSTEAD OF LONESTAR?????????
frijole
Yeah, very wordy reading to be sure. I'm awaiting approval from Medicare. Hopefully there won't be a problem, but with the dwindling Medicare funds available (due to funding wars), it's going to be iffy. Maybe not right now, but as the requests pour. It will be a very interesting two months coming up...
Magnum
Magnum
thanks Magnum, thick reading but very nice summary of the nuts and bolts of SCH 503034/boce/vic development. Sttarting with something that closely resembled the natural substrate of the NS3 protease and then slicing/dicing/modifying until they got a small molecule candidate usable as a drug. Figs. 6 and 10 really drive home what resistance mutations look like.
Good luck with your vic rx. On my end the path was much easier than I had expected. The insco faxed back that no prior authorization was required, the vic was covered, and my copay is 40. By comparison, my copay is 150 and 10 for monthly supplies of ifn/rbv. I'm going to get it from a small pharmacy associated with my clinic. They had no difficulty ordering it and I'll pick up the pills today. They need to be kept refrigerated, like ifn,
Though I won't be using them I also found that a big chain pharm, RiteAid, can oder vic from their supplier who has it in stock. Cost (with no insco coverage) would be 5808 for what I think is a month's supply - 336 200mg pills (which looks like a hefty markup relative to the 4400 Merck wholesale price).
Good luck with your vic rx. On my end the path was much easier than I had expected. The insco faxed back that no prior authorization was required, the vic was covered, and my copay is 40. By comparison, my copay is 150 and 10 for monthly supplies of ifn/rbv. I'm going to get it from a small pharmacy associated with my clinic. They had no difficulty ordering it and I'll pick up the pills today. They need to be kept refrigerated, like ifn,
Though I won't be using them I also found that a big chain pharm, RiteAid, can oder vic from their supplier who has it in stock. Cost (with no insco coverage) would be 5808 for what I think is a month's supply - 336 200mg pills (which looks like a hefty markup relative to the 4400 Merck wholesale price).
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