Aa
Study P05685 - anyone else doing this study? (boceprevir + riba/peg for non-responders)
I haven't started the drugs yet; so far, several tubes were drawn for labs and I was biopsied last Fri. From what I've been reading about pi and listening to a lot of you at this site that ARE doing boceprevir or telaprevir, things are sounding pretty positive!!!! This study just started in Feb so hopefully there will be others that find this post and we can begin this delightful journey together. During my other rounds of tx, I worked full time but it seems like the older I get the harder it is to put on that happy face! But I'm still going to give it my all!!!!
I tried to weasle an answer out of the np for my specific start date, but she said they will contact me "soon" with biopsy results and lab work, then I will go in and start. I know the biopsy results only take about a week, so I'm thinking that I should start within in the next two weeks. Sorry to hear you've already gotten to cirrosis, I could be too....I know I've been retaining water like crazy! and not too happy about it either. Then my regular doctor realized my thyroid meds needed to be increased. What were your first signs of cirrosis? I've always wanted to know that but never had anyone to talk to about it.
Well good luck to your friend, hope she gets into a study and has great success! They are doing amazing things these days. Oh, I just re-read your post, so it sounds like maybe you're treating too? Good luck to you both, if that's the case.
Yes, I asked about both of them since I had problems with low WBC count last time. When do you think that you will start? Oh, I was sent for eye exam because I have high blood pressure and diabetes. Also, I didn't have to have another liver biopsy since I have cirrhosis they just requested the slides.
Ejoli - Do you you know if we get both of the rescue drugs? It was my understanding that we should receive both if needed, but after reading about newleaf and her study, I'm second guessing myself. Now I'm not sure the study coordinator understood that I was asking about both, procrit and neupogen.
This past Friday I took a female friend with me to my doc visit. We told them she has hep-c also and has never treated. They put her on a list for consideration for a study for treatment naive patients that they plan to begin prior to the summer with Becepravir/Rib/Interferon. My hepatologist is in Houston, Texas at St Lukes.
Joey
Joey
Yeah the study does sound like a good bet, I had been waiting for them to open the study of these new drugs to non-resp for quite awhile. I thought I would get in the vertex trial but was excluded, due to being a breakthough case. Don't feel guilty about anything, I doubt if anyone here would want anything but the best for you! You just made the decision to treat sooner than later!! (low VL) Mine is 2,805,530, still not too high. Good luck to you on results and the fairy!! and thank you for the well wishes.
Having access to the rescue drugs is a big deal in my opinion. Without them the reaction to low hgb is reduce the riba and reaction to low neutrophils and platelets is reduce the interferon. Trust me, no matter how bad you crash, they are unlikely to reduce the study drug. If you've responded well, you can get by with some interferon reduction (only thing to allow platelets to come back up) but not riba reduction. It's the drug that makes the interferon GO. Why would anybody even risk a reduction if the rescue drugs can fix the problem and keep you on full dosage?
I wonder if the new trial is providing the neulasta now because so many of us in the earlier trial are crashing without it. I've seen some really pale zombie ghosts in the clinic waiting room, just like me. It does not help gather data on the study drug if you have to take people off of treatment to recover from it. I feel really bad for the people who don't have insurance to cover the rescue drugs.
I wonder if the new trial is providing the neulasta now because so many of us in the earlier trial are crashing without it. I've seen some really pale zombie ghosts in the clinic waiting room, just like me. It does not help gather data on the study drug if you have to take people off of treatment to recover from it. I feel really bad for the people who don't have insurance to cover the rescue drugs.
I don't know whether they supply neulasta or neupogen since my WBC numbers are still okay so the question hasn't come up yet.
They've been giving me the Procrit while I'm in the low 10s. I did a big drop once I started the boceprevir so I guess that's the rationale.
They've been giving me the Procrit while I'm in the low 10s. I did a big drop once I started the boceprevir so I guess that's the rationale.
Yes, this trial does allow and provide the rescue drugs. This one is for 48 weeks only. With or without boceprevir.( 2 arms) You have 2 out of 3 chance of getting the good stuff though. I'm pretty happy about getting in! I relapsed once and am cirrhotic now so I really needed this.
I guess we're in the same study for naives, but mine only supplies the Procrit and then only if hgb below 10. Greatbird, can you get neulasta or Neupogen, the WBC stimulators? I was told that it was provided in a previous boceprevir study and my doc was annoyed that it is not with this one since he thinks boceprevir crashes neutrophils.
I got the neulasta approved by my insurance and crashed so bad once that the doc insisted I purchase the neulasta and keep it on hand. $50 co-pay for me but $1500 for my insurance co. No guilt about it since I pay $422 a month for premiums.
Chprchk, did they mention Procrit and neulasta rescue drugs provided? I understand that the Telaprevir (other effective experimentaL PI) trial running now does not want patients on rescue drugs or even anti-depressants, in order to collect cleaner data.
I got the neulasta approved by my insurance and crashed so bad once that the doc insisted I purchase the neulasta and keep it on hand. $50 co-pay for me but $1500 for my insurance co. No guilt about it since I pay $422 a month for premiums.
Chprchk, did they mention Procrit and neulasta rescue drugs provided? I understand that the Telaprevir (other effective experimentaL PI) trial running now does not want patients on rescue drugs or even anti-depressants, in order to collect cleaner data.
The boceprevir trial that I'm in allows (and provides) rescue drugs. Is that the case with this new trial? It's a good thing to know ahead of time.
Good luck with that EOT fairy. She will pass me by because I wasn't UND at 8. Close (<25 but detectable at 7ish), but not close enough. Went UND at 10 (which was 9ish). They were taking my blood 5 days early because of the anemia.
Digestive issues are documented for the boceprevir, which is IMHO the most amazing stuff because there wasn't much change in my VL until I started it and then I had a 4 log drop just about immediately.
I'm actually having more trouble with the procrit (for the anemia) than the SOC or boceprevir.
So, to choprchk and ejoli--good luck with this trial! Here's hoping you both get the trial drug and go UND fast, fast, fast!!
Digestive issues are documented for the boceprevir, which is IMHO the most amazing stuff because there wasn't much change in my VL until I started it and then I had a 4 log drop just about immediately.
I'm actually having more trouble with the procrit (for the anemia) than the SOC or boceprevir.
So, to choprchk and ejoli--good luck with this trial! Here's hoping you both get the trial drug and go UND fast, fast, fast!!
I know we were randomized into 3 groups. I think I am just holding out hope that the EOT fairy will pass her wand over me. I've got a 50/50 chance of stopping at 28 wks (arm 2) or continuing to 48 wks (arm 3). I don't mind the boceprevir burps, got used to that long ago, but I do mind the repeated crashing of my blood because the riba reduces hgb, interferon reduces neutrophils and platelets, and the study drug reduces all 3. I think my blood may have finally stabilized but am not looking forward to 20 more weeks of diarrhea...not to give bad news of side effects to new trial people. Side effects from the drug are just as variable for patients as the side effects for individuals on peg/riba tx.
My understanding of the study we are on (tx naive) is that we are already randomized, which is how we either did or did not get the boceprevir. It's arm 2 that has the option of stopping at 28 weeks if RVR.
I'm sure I'm on the boceprevir as well mainly from the incredibly disgustingly awful taste of them. Plus, my VL dropped very dramatically (over 4 logs) after I started them.
I'm sure I'm on the boceprevir as well mainly from the incredibly disgustingly awful taste of them. Plus, my VL dropped very dramatically (over 4 logs) after I started them.
Thanks for link; looks pretty straight forward, looking for RVR data.
The description sounds familiar for the arms. I thought "If they switch you to the study drug if you get placebo, how can you lose?" Of course some folks will but I thought the study was a good bet.
I'm almost embarrassed to write this in this forum but I started with a low VL (81,000) and cleared in the lead-in. The 1 week PCR was done after I had had 2 peg shots, so I don't know how ridiculously early I cleared but 10 days was impressive enough for me. I really needed the good news as I started tx pretty quickly after diagnosis and a bad-news biopsy and was really anxious. Have stayed UD. I am on the Boceprevir (they always say you can't tell but you can; through the bloodwork changes if nothing else) and felt guilty since others who needed it more got randomized to the placebo group.
I did my 24 wk. PCR on Monday and am now anxiuosly waiting to see if they will let me know soon if I am in the 28 wk group or make me wait until 28 wks. With my response and the addition of Boceprevir I'm unnaturally confident that I will get SVR.
My question about my study is this: Are we really randomized to the 3 arms or do the 24 week PCR results plus RVR cause Schering to regroup us, allowing RVR's to end treatment at 28 wks.? It would save them money to reduce the treatment time, but are they more interested in having a diverse group, including RVR's, for data on 48 wks. of Boceprevir? When I find out in the next few weeks, I'll let you know.
The description sounds familiar for the arms. I thought "If they switch you to the study drug if you get placebo, how can you lose?" Of course some folks will but I thought the study was a good bet.
I'm almost embarrassed to write this in this forum but I started with a low VL (81,000) and cleared in the lead-in. The 1 week PCR was done after I had had 2 peg shots, so I don't know how ridiculously early I cleared but 10 days was impressive enough for me. I really needed the good news as I started tx pretty quickly after diagnosis and a bad-news biopsy and was really anxious. Have stayed UD. I am on the Boceprevir (they always say you can't tell but you can; through the bloodwork changes if nothing else) and felt guilty since others who needed it more got randomized to the placebo group.
I did my 24 wk. PCR on Monday and am now anxiuosly waiting to see if they will let me know soon if I am in the 28 wk group or make me wait until 28 wks. With my response and the addition of Boceprevir I'm unnaturally confident that I will get SVR.
My question about my study is this: Are we really randomized to the 3 arms or do the 24 week PCR results plus RVR cause Schering to regroup us, allowing RVR's to end treatment at 28 wks.? It would save them money to reduce the treatment time, but are they more interested in having a diverse group, including RVR's, for data on 48 wks. of Boceprevir? When I find out in the next few weeks, I'll let you know.
So newleaf09, were you UND at 12wks? Here is the link to the study I'll be starting http://clinicaltrials.gov/ct2/show/NCT00845065, two different arms. Both include a 4wk lead-in of SOC then either placebo or the iron mouth!!! hahaha If in the placebo arm and still detectable at 12wk, into the PROVIDE study ya go, so I guess we're gauranteed the real deal either way. One odd thing I noticed was that if a person goes into the PROVIDE study they are no longer on Pegasys (alpha-2a), they switch to Peg-intron(alpha-2b) along with riba, of course. I wasn't satisfied with the answer I got from the practioner when I asked about the significant ways in which each interferon interacts with the virus and the body or its elimination/excretion from the body, so I'm saving it for doc when I see him for results from biopsy. Hmm - that sounds like a Jim question. I've read some of his posts and I think he's a doc incognito!! haha
Hi Libby!
Great!!! a fellow tx partner, I love it! OMG! Looking at your profile, I see you're from the land of OZ; that makes us neighbors, I'm from MO!! I just recently found this site and find it difficult to get familiar with people, but that's just me! I've read many, many posts in the last couple weeks and it sounds like some of these people have know each other for years.....so I thought, "I'm going to start my own discussion specific to this study and see how many others I could attract." Some of their posts are so beautiful, endearing and full of compassion, makes me want to cry. What a wonderful place to be! So tell me, what tx have you been on? are you 1a or 1b? First tx was in 99, another study, interferon/riba and vitamin E. The interferon was NOT pegylated at that time so shot was 3 times a week. Man!! that stuff was bad news! Felt like I'd been run over by a mac truck ever other day. I'd barely get to feeling better and BOOM!!!! time for the next shot. The next tx was just SOC. Failed again. My third tx was SOC for 83wks and I asked for high dose, begged to stay on full dose even though my levels dropped to the point of procrit and neupogen. At least I finally responded! UND at 12wks, but it wasn't zero though and it just hung around 200 which was considred UND at that time, not the precision they have today. Anyway around 81st or 82nd week the dragon reared again, UGH!!! Soooo.....diagnosed as a non-responder, a breakthrough case, and a genotype 1a AND 3a! as my mother would say, just a regular ol' problem child!!! But then again....... being the determined, defiant, truculently, pugnacious soul that I am, (I had to look those words!!) I am treating again!!! I'll post my blood counts as soon as I here what the are along with my liver biopsy. I'm surprised though that I wasn't sent to the eye doctor as you were. I had all the other tests that you said you had. Good luck to US!!!
Great!!! a fellow tx partner, I love it! OMG! Looking at your profile, I see you're from the land of OZ; that makes us neighbors, I'm from MO!! I just recently found this site and find it difficult to get familiar with people, but that's just me! I've read many, many posts in the last couple weeks and it sounds like some of these people have know each other for years.....so I thought, "I'm going to start my own discussion specific to this study and see how many others I could attract." Some of their posts are so beautiful, endearing and full of compassion, makes me want to cry. What a wonderful place to be! So tell me, what tx have you been on? are you 1a or 1b? First tx was in 99, another study, interferon/riba and vitamin E. The interferon was NOT pegylated at that time so shot was 3 times a week. Man!! that stuff was bad news! Felt like I'd been run over by a mac truck ever other day. I'd barely get to feeling better and BOOM!!!! time for the next shot. The next tx was just SOC. Failed again. My third tx was SOC for 83wks and I asked for high dose, begged to stay on full dose even though my levels dropped to the point of procrit and neupogen. At least I finally responded! UND at 12wks, but it wasn't zero though and it just hung around 200 which was considred UND at that time, not the precision they have today. Anyway around 81st or 82nd week the dragon reared again, UGH!!! Soooo.....diagnosed as a non-responder, a breakthrough case, and a genotype 1a AND 3a! as my mother would say, just a regular ol' problem child!!! But then again....... being the determined, defiant, truculently, pugnacious soul that I am, (I had to look those words!!) I am treating again!!! I'll post my blood counts as soon as I here what the are along with my liver biopsy. I'm surprised though that I wasn't sent to the eye doctor as you were. I had all the other tests that you said you had. Good luck to US!!!
I'm 6 mos into PO5216 as are some other members I believe. My group started in mid November. Another member started in the non-responder trial a little before that. So far no one has made any negative comments that I've heard (we all gripe a little about side effects but that's what we do).
I'd like to hear what the arms of your study are once you get into it and have your copy of the protocol.
I'd like to hear what the arms of your study are once you get into it and have your copy of the protocol.
Yes, that is correct....thanks for the well wishes! And look, I've already got some company, looks like Libby is joining me...ecellent!!!
As a matter of fact I screened for this trial yesterday! I did the bloodwork, a chest x-ray, and ekg. The sonagram and eye exam I have done already. She said that I may be ready to start in a couple weeks. I'm really psyched about it. I've been trying to get in a trial since Dec. Good to hear of someone else starting it also. Yes, there are people here that have been on Boceprevir for 6 months already and it looks real promising
Good Luck and let me know when you start. -Libby
Good Luck and let me know when you start. -Libby
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
