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Looks like I'm being invited to the dance - Phase 2 Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C
Yesterday I heard from my doctor that they are trying to enroll me in the Phase 2 VX-950 trial, which is great news and something I've been asking for.
My dilema is that I'm absolutely swamped with commitments from work, church and family...more than usual. I'd like to hear from the VX-950 people here on the board just how crappy they feel and if they are working effectively. I own a business with a high profile role that require much travel.
On my last tx with Peg-Intron and RBV I felt pretty worn down after 8 months. I'm certain that I could take 3-6 months of this but would only do a year again if my health forced it.
My background is 49 year old male, contracted HCV about 25 years ago; geno 1b; Stage 1/Grade 0; started tx with 3M VL; no EVR but did get a 4log drop at week 2; eventually dropped to 9,600 but started to rise around month 8; game over. Other that HCV and some newly found arthritis I'm in great shape and run 15-20 miles per week.
So, I really have a few questions that you guys could help me with:
1.) VX-950 people...how crappy do you feel?
2.) Who's done both Pegasys and Peg-Intron. Which made you feel crappier?
3.) Given my stats, would you jump on the wagon now or wait to see if they can dial this tx down to 3 months, which I could do standing on my head.
Thanks,
Mike
My dilema is that I'm absolutely swamped with commitments from work, church and family...more than usual. I'd like to hear from the VX-950 people here on the board just how crappy they feel and if they are working effectively. I own a business with a high profile role that require much travel.
On my last tx with Peg-Intron and RBV I felt pretty worn down after 8 months. I'm certain that I could take 3-6 months of this but would only do a year again if my health forced it.
My background is 49 year old male, contracted HCV about 25 years ago; geno 1b; Stage 1/Grade 0; started tx with 3M VL; no EVR but did get a 4log drop at week 2; eventually dropped to 9,600 but started to rise around month 8; game over. Other that HCV and some newly found arthritis I'm in great shape and run 15-20 miles per week.
So, I really have a few questions that you guys could help me with:
1.) VX-950 people...how crappy do you feel?
2.) Who's done both Pegasys and Peg-Intron. Which made you feel crappier?
3.) Given my stats, would you jump on the wagon now or wait to see if they can dial this tx down to 3 months, which I could do standing on my head.
Thanks,
Mike
That's a VERY good point!
My trial clinic is maybe 15 minutes away, but many people travel considerable distances to a trail center. In either case, the visits are many, and non-negotiable. For most of the visits, the window is just 24 hours either side of the scheduled date.
My trial clinic is maybe 15 minutes away, but many people travel considerable distances to a trail center. In either case, the visits are many, and non-negotiable. For most of the visits, the window is just 24 hours either side of the scheduled date.
jim - Yeah I'm having trouble believing the FDA is going to flatly allow a placebo group amongst the relapsers. That's just insane, especially when combined with denial of rescue drugs. Hopefully they'll back off on that one.
miked - I didn't fully explain in my previous post the complete implication of what happens if you are on placebo and either your neutrophils or HGB drop below 750 or 10 respectively. If your ANC's go below 750, they will cut your IFN dose in an attempt to get the ANC's back up to acceptable levels (instead of giving you Neupogen which could prevent an IFN reduction). If your hemo goes below 10, they'll cut your riba (instead of giving you Procrit which could prevent a riba reduction). As you probably know, if you're an SOC relapser and happen to end up in the placebo group and experience an IFN and/or riba reduction early on in treatment (which is when rescue drugs are prohibited), then clearly that would all but devastate your chances of SVR-ing (much less clearing early). And even in the case of someone getting the real telaprevir, a dose reduction of either IFN or riba early on could cut your odds considerably. We have a few treatment naive Prove 1 folks here who received VX950 and were not successful at clearing the virus (one without riba and the other with no dose reductions if I'm not mistaken). So even if the telaprevir is in the mix, IFN and riba reductions could still have a very adverse effect on anti-viral performance, especially in an SOC relapser.
Also, flguy brings up a great point. There ARE a lot of visitations required. If you have a requirement to travel alot for your work, you'd better check out the required trial visitation itinerary. It's pretty rigorous, especially during the first 12 weeks (if the 12 week dosing period will be retained as it was for Prove 1 and 2). Plus of course there's the hassle of transporting all the drugs everywhere you go, including the always refrigerated IFN. Not suggesting that doesn't make it worth it, but it is definitely a factor to consider. I had to put off all long term work related travel during my treatment program. For me it wasn't a big problem, but if you can't easily get out of travel committments, then it will likely be a problem for you.
Take care...
miked - I didn't fully explain in my previous post the complete implication of what happens if you are on placebo and either your neutrophils or HGB drop below 750 or 10 respectively. If your ANC's go below 750, they will cut your IFN dose in an attempt to get the ANC's back up to acceptable levels (instead of giving you Neupogen which could prevent an IFN reduction). If your hemo goes below 10, they'll cut your riba (instead of giving you Procrit which could prevent a riba reduction). As you probably know, if you're an SOC relapser and happen to end up in the placebo group and experience an IFN and/or riba reduction early on in treatment (which is when rescue drugs are prohibited), then clearly that would all but devastate your chances of SVR-ing (much less clearing early). And even in the case of someone getting the real telaprevir, a dose reduction of either IFN or riba early on could cut your odds considerably. We have a few treatment naive Prove 1 folks here who received VX950 and were not successful at clearing the virus (one without riba and the other with no dose reductions if I'm not mistaken). So even if the telaprevir is in the mix, IFN and riba reductions could still have a very adverse effect on anti-viral performance, especially in an SOC relapser.
Also, flguy brings up a great point. There ARE a lot of visitations required. If you have a requirement to travel alot for your work, you'd better check out the required trial visitation itinerary. It's pretty rigorous, especially during the first 12 weeks (if the 12 week dosing period will be retained as it was for Prove 1 and 2). Plus of course there's the hassle of transporting all the drugs everywhere you go, including the always refrigerated IFN. Not suggesting that doesn't make it worth it, but it is definitely a factor to consider. I had to put off all long term work related travel during my treatment program. For me it wasn't a big problem, but if you can't easily get out of travel committments, then it will likely be a problem for you.
Take care...
Will a 3 month duration do the job? That is one of the current burning questions, at least for me as that is what my trial arm does. There is no data out yet on folk who only did 3 months and I haven't seen any of them report here either. So the answer to this question right now is anybody's guess. I hope that Vertex will choose to go public at the April EASDL conference in Barcelona on how the first 20 PROVE1 people who did 12 weeks are getting on.
dointime
dointime
vx950 w/ 1200 riba & pegasys 175, first time tx. started august. in 48 wk soc group. cleared at day 22. felt very crappy first 4 months. missed some work but not much due to screening, biopsy, frequent med appts to draw bloods etc. required by the study. missed 2 doses of vx & riba due to severe lower gi stuff, cramps constipation & vomiting for a day and a half. not sure how much was related to the vx, but i wound up taking miralax every day & still do, that really helps the gi stuff. since its my 1st time in tx, i cant compare it to plain soc or peg intron. my vl was around 4 mil pre tx, w/ good biopsy. chose to treat on docs rec. also, im 54 pretty healthy otherwise & didnt want to put it off, figure it would be tougher on me as i get older &/or less healthy. glad i made that decision given the results so far. overall my sx (have all the typical ones) were moderate to hi moderate for the 1st 4 months & moderate after that. they are getting better the past couple of weeks. some days are mild now. best of luck to you whatever you decide.
The part I'll respond to is PegIntron vs Pegasys. TX1 = 24 weeks PegIntron/800 Riba. TX2 Pegasys/1200 riba on 19 of 46 now. I've found Pegasys less rude. Tx's are about the same with respect to sides, junky feeling, ability to focus at work etc. Since it's more riba, I think the impacts of Pegasys are less than PegIntron. But, other may have different experiences. Take all life matters into consideration and I hope you make the right decision for you.
Twelve weeks of VX + SOC followed by 12 weeks of SOC was moderately rough. I'm fortunate to be able to control my work schedule, but being VP of a major national club created more demand that I was wanting.
Got through it OK, but since I've been off tx a surprising number of people have told me that I looked like death around the time that was the last three months of tx. A high profile front line role that required a lot of public appearances or tough negotiation would not be much fun.
As Jim say, your current stage allows the luxury of waiting a little to see the results of the VX Prove 3 non-responder trial, and other current trials. If any of these have a high SVR rate for non-responders, you are in great shape. Countering that, the trial is available now, if free [tx drugs, labs, and clinical care], and offers a higher level of monitoring than you will get from most private practitioners. Its your call, but you are in a great position to choose.
Got through it OK, but since I've been off tx a surprising number of people have told me that I looked like death around the time that was the last three months of tx. A high profile front line role that required a lot of public appearances or tough negotiation would not be much fun.
As Jim say, your current stage allows the luxury of waiting a little to see the results of the VX Prove 3 non-responder trial, and other current trials. If any of these have a high SVR rate for non-responders, you are in great shape. Countering that, the trial is available now, if free [tx drugs, labs, and clinical care], and offers a higher level of monitoring than you will get from most private practitioners. Its your call, but you are in a great position to choose.
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