Aa
Me & Debio-025..New viral load just in Day 8
I just got Day 8's number in.
Remember starting day pre-dosing was over 5 million (don't know how much over)
Day 3 was 424,000
Day 8 was 261,000
Now, the above was after week 1 on the twice a day Debio-025 dose + Riba + Pegasys.
After the first 7 days is over, and this loading dose on the Debio-025 is over, on Day 8, I went down to once a day dosing on the Debio, as per the protocol. I'm hoping and praying that the downward trend will continue and that it won't rebound. Everybody who prays...PRAY please. I had Day 15 drawn on Wed. June 18th. So, that will tell us on those results if the downward trend will continue. I stay on the 3 drugs until Day 29 and then, the Debio-025 Part 1 ends. By the time, I have to have a 2 log drop on that day, Day 29, in order to continue on with SOC.
Susan400
Remember starting day pre-dosing was over 5 million (don't know how much over)
Day 3 was 424,000
Day 8 was 261,000
Now, the above was after week 1 on the twice a day Debio-025 dose + Riba + Pegasys.
After the first 7 days is over, and this loading dose on the Debio-025 is over, on Day 8, I went down to once a day dosing on the Debio, as per the protocol. I'm hoping and praying that the downward trend will continue and that it won't rebound. Everybody who prays...PRAY please. I had Day 15 drawn on Wed. June 18th. So, that will tell us on those results if the downward trend will continue. I stay on the 3 drugs until Day 29 and then, the Debio-025 Part 1 ends. By the time, I have to have a 2 log drop on that day, Day 29, in order to continue on with SOC.
Susan400
OH I was right it was debio after all but it wasn't an PI just an I!
I'm not nuts after all Rexx you see, I was close. :)
I'm not nuts after all Rexx you see, I was close. :)
di you know if all protease inhibitor failure poeple have a crossover pi resistance?
my question is,if someone in a pi trial who cant clear,will have resistance, or if he later can try again with other pi s.
my question is,if someone in a pi trial who cant clear,will have resistance, or if he later can try again with other pi s.
All I know is that a reputable doctor told this to me about the inhibitor trials and my chances at being accepted by any of the protease or polymerase inhibit. trials was all be non-existant and that I had the best chance at being accepted into the Debio trial. Maybe trial sites pick and choose their patients, you know? Maybe that's what he was referring to.
Right now, I have no more PCR's scheduled until my Day 29 on July 2nd. After that, I believe that the trial is only having me get one once a month. I don't know if they'll allow me to pay for any PCR's out of pocket separate from the trial site. But, I can tell that Medicare will not pay for more than 1 PCR a month, if even that and since Medicare is my primary for insurance, if they turn it down, then my secondary won't pick it up either. I can't afford to pay for PCR's out of my own pocket so, no, I don't believe that I'll be able to have weekly PCR's. The best I can hope for is possibly getting one in between the one's the trial site pays for once a month - if there are no restrictions on my doing that. I won't do anything that will get me into trouble with the trial.
Susan400
Right now, I have no more PCR's scheduled until my Day 29 on July 2nd. After that, I believe that the trial is only having me get one once a month. I don't know if they'll allow me to pay for any PCR's out of pocket separate from the trial site. But, I can tell that Medicare will not pay for more than 1 PCR a month, if even that and since Medicare is my primary for insurance, if they turn it down, then my secondary won't pick it up either. I can't afford to pay for PCR's out of my own pocket so, no, I don't believe that I'll be able to have weekly PCR's. The best I can hope for is possibly getting one in between the one's the trial site pays for once a month - if there are no restrictions on my doing that. I won't do anything that will get me into trouble with the trial.
Susan400
"And since I had a rebound on the virus, they say I have resistance to the protease inhib., and probably will to the polymerase inhibitors.
----------------------------------------------------------------------------------------
Like dointime I'm also very interested in this. You've had a good response so far but the response rate is flattening. It's also fair to say that many people who treated, responded ansd SVR'ed had a flattening or stall right before clearing. Are you going to keep getting frequent PCR's as weeks go by?
I sure hope that this time is the ticket.
Willy
----------------------------------------------------------------------------------------
Like dointime I'm also very interested in this. You've had a good response so far but the response rate is flattening. It's also fair to say that many people who treated, responded ansd SVR'ed had a flattening or stall right before clearing. Are you going to keep getting frequent PCR's as weeks go by?
I sure hope that this time is the ticket.
Willy
"Right now, I have hope and I don't want to think any type of negative thoughts about my chances,"
You have probably thought of this already but will you be able to add alinia to your tx once the 8 week trial duration is up?
"And since I had a rebound on the virus, they say I have resistance to the protease inhib., and probably will to the polymerase inhibitors."
As you know, I am in the same boat having done the Vertex no-riba trial arm. I know about the resistance to the protease inhibitors but this is the first I have heard mention that this resistance will also apply to the polymerase inhibitors. It does not make sense to me because VX950 targets the NS3 protease but I think the polymerase inhibitors target the NS5 protease. I don't suppose you have any more info on that?
thanks,
dointime
You have probably thought of this already but will you be able to add alinia to your tx once the 8 week trial duration is up?
"And since I had a rebound on the virus, they say I have resistance to the protease inhib., and probably will to the polymerase inhibitors."
As you know, I am in the same boat having done the Vertex no-riba trial arm. I know about the resistance to the protease inhibitors but this is the first I have heard mention that this resistance will also apply to the polymerase inhibitors. It does not make sense to me because VX950 targets the NS3 protease but I think the polymerase inhibitors target the NS5 protease. I don't suppose you have any more info on that?
thanks,
dointime
Debio-025 is not a PI, but it is an inhibitor drug, just not a polymerase, or a protease. It's called a cyclophilin inhibitor. Yes, I am definitely getting all 3 drugs, the Debio-025, the Riba and the Pegasys. I don't know what the future will hold for me, with this, but it's a hope and that's all I have to go on, hope and prayers. I was turned down for any more Vertex trials, now or any future VX trials, since I've already been exposed to the VX-950 under Group C (the no Riba) group. And since I had a rebound on the virus, they say I have resistance to the protease inhib., and probably will to the polymerase inhibitors. Since I have the bridging process started, I didn't really want to sit around and wait for another go at taking VX, Riba and Pegasys, whenever VX is finally out on the market and available to consumers and that's if any doctor will even allow me to retreat with all 3 drugs. Most doctors look as someone like me who has treated 8-9 times (this being my 9th or 10th - if you count the maintenance I tried), and never cleared, and seem to think that it's not going to work. Right now, I have hope and I don't want to think any type of negative thoughts about my chances, you know? I can't allow myself to get into that mindset or the depression will set in and I'm trying to avoid that. Anti-D's have never agreed with my body.
Susan
Susan
Wow! I didn't know you had started again and is the Debio-025 a PI type drug? is it a study but now you're getting the real thing? I will be hoping and praying that you will be successfull on this protocol !!! Lord knows you deserve it... I just saw this as I seem to be around less than I used to but still check in quite often to check on everyone. Take care and God Bless you in your efforts to beat the beast!
Scott
Scott
I thought about responding to this post for a while. I was thrown off that trial yesterday. I only did the Debio once a day @400 mg. I hope twice a day will work for you. Like you I started at 5mil+. I am not sure about the first few days they just told me my count was going up and down. At week 4 I was at around 800,000. At week 8 I was @173,000. I was called yesterday afternoon and at week 12 I want back up to 1,300,000.
If you would like my e-mail is ***@****
Jim
If you would like my e-mail is ***@****
Jim
Got the other mail, all good. Was worrying after reading mine and the vertex restrictions and at the hosp. I thought I saw yours had that, blinded, shhh and all that.
Don't worry on the other!! This is going well thus far, keep that mind set!
Gotta rush to work, I want a few more sick days! :(
LL
Don't worry on the other!! This is going well thus far, keep that mind set!
Gotta rush to work, I want a few more sick days! :(
LL
Don't worry about it, my trial nurse told me that the Debio people have no restrictions on my posting my details on line. I specifically asked her about this and she said she didn't care if I posted all my result because the Debio people had no restrictions and it's not like the Vertex group. So, I'm in the clear. I wasn't going to post anything about it without getting that permission.
Susan
Susan
You know I'm rooting for you :)
See my e-mail ASAP, important, before you post anymore here.
LL
See my e-mail ASAP, important, before you post anymore here.
LL
Great news!! You are doing well, prayers are free for the asking and very powerful. No worries, I got your back and so does the man upstairs. God Bless
Well, a 2 log drop from 5 million is 50,000, as I am sure you already worked out. So you need to get your VL from 261,000 to 50,000 in 3 weeks with once a day debio-025.
It must be so stressful for you just waiting for those all-important results. As you can see, many people here including me are waiting with you and hoping. Hang in there,
dointime
It must be so stressful for you just waiting for those all-important results. As you can see, many people here including me are waiting with you and hoping. Hang in there,
dointime
I am on weight based Riba, but I dare not take extra because my platelets are already below normal. Can't take the risk... The platelets will probably bounce back up after I get done with Part 1 and I'm just on the SOC. I've never had the platelets problem before, but the Debio does list it as one of the side effects. I just need to make it through the next 12 days w/no dose reductions!
Susan400
Susan400
Fantastic news a huge log drop in 1 week. It sounds like you will doing a heap of CBC (blood) testing on this trial which is similar to the trial I just came off. Regular testing can be great if you continue to get the the downward trend, however, for me at about week 4 the virus waged a bit of fight back and I went from 56,000 to 107,000. At that time I believe I was underdosing with the ribaviron at 1000mg and should have been on 1200mg for my weight of 76kg (not sure pounds) which had increased from 74kg at the baseline. Protocol said I could'nt get an increase so I got stuck on that dose and the internal fight continued until week 12. I went from baseline 4,480,000 vl to 59,000 week 12. By the time I got my head around all this by about 8 weeks I began to overdose to 1200mg riba but just missed my 12 week 2 log drop at 12 weeks. I mention this just so others realise the importance of getting the riba right. Worldwide dosing is done weight based, well mostly, however individually our metabolisms are different. I guess what I'm saying is that if you witness a rebound at any stage, up your riba by 200 mg straight away, this will be against trial protocol, but don't tell and get your riba where you can. Do this only if your RBC, HGB, Plateletts etc are all okay. Sorry bout the rave here, but I want people to know how important the riba is in this fight and I don't mind seeming a little odd to do so.
Anyway susan you most likely won't need to consider any of this because you will be rvr by week 4 and remain so until EOT and beyond. Fingers crossed and again, congratulations. Emi
Anyway susan you most likely won't need to consider any of this because you will be rvr by week 4 and remain so until EOT and beyond. Fingers crossed and again, congratulations. Emi
This made me so happy to read this. I'm not much of a poster but have been reading for years, and I really want to see you freeeeeeee!!!!
My prayers are with you too,
Ev
My prayers are with you too,
Ev
Dude - you've already hit a 2 log drop from your original point... RIGHT?
Go girl --- I've got you in my thoughts!
Super hugs!
Meki
Go girl --- I've got you in my thoughts!
Super hugs!
Meki
Have an Answer?
You are reading content posted in the Hepatitis Social Community
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.
