Aa
Feeling rather abandoned after stopping treatment.
I decided to stop treatment during a study - BI 20133. I hadn't achieved UND at week 12 (under 25 or 24, don't recall). I was UND at week 16, decided to stop at week 24. The doctor fully supported my decision. I chose to stop because at week 24 I was told I would have to continue for 48 weeks. It just didn't make sense to me to continue with a 50/50 chance of success given the number of better/non-interferon options coming.
I had a follow up visit on July 5. I inquired about the rollover for this study, they have changed some of the requirements. The coordinator told me I wasn't able to participate but couldn't recall why. She said she would look into it and call me the following Monday.
I've had problems getting her to call me throughout the trial. I understand these folks are busy but honestly... The only time I *ever* asked for a phone call was to tell me what my VL was after having blood drawn. Not once did she call me with that info as I'd asked, I would wait until 2 days after she said she'd call me, then I'd call her...
So this time I decided that since I still have to do a final EKG, I'd tell her when I could come do that when she called me. I didn't have my daytimer with me so I didn't know and I would have to check.
No phone call.
She didn't schedule me for another appointment while I was there, either.
The doctor I have been seeing is fantastic. He told her to find out what else they could "get me into" as soon as possible...
Anyone else been dropped like a hot potato after a study?
I had a follow up visit on July 5. I inquired about the rollover for this study, they have changed some of the requirements. The coordinator told me I wasn't able to participate but couldn't recall why. She said she would look into it and call me the following Monday.
I've had problems getting her to call me throughout the trial. I understand these folks are busy but honestly... The only time I *ever* asked for a phone call was to tell me what my VL was after having blood drawn. Not once did she call me with that info as I'd asked, I would wait until 2 days after she said she'd call me, then I'd call her...
So this time I decided that since I still have to do a final EKG, I'd tell her when I could come do that when she called me. I didn't have my daytimer with me so I didn't know and I would have to check.
No phone call.
She didn't schedule me for another appointment while I was there, either.
The doctor I have been seeing is fantastic. He told her to find out what else they could "get me into" as soon as possible...
Anyone else been dropped like a hot potato after a study?
Yeah, I'm going back and forth on that... Do it now, wait for better. I just don't know.
I really need to find a new job. My insurance now is great and I could take time off if needed. My employer was very understanding the first time around and reduced my duties while I needed. But I now have the supervisor from hell... Been doing the same thing for 10 years and haven't had a raise since 2003! Non-profit... Ugh.
I don't regret stopping. Yes, placebo. :( With a 50-50 shot at SVR after 48 weeks it didn't make sense to me to keep going. I couldn't imagine feeling like that for another 24 weeks with such low odds.
I wasn't UND at 12 weeks. I felt that was a pretty bad indicator for success...
I really need to find a new job. My insurance now is great and I could take time off if needed. My employer was very understanding the first time around and reduced my duties while I needed. But I now have the supervisor from hell... Been doing the same thing for 10 years and haven't had a raise since 2003! Non-profit... Ugh.
I don't regret stopping. Yes, placebo. :( With a 50-50 shot at SVR after 48 weeks it didn't make sense to me to keep going. I couldn't imagine feeling like that for another 24 weeks with such low odds.
I wasn't UND at 12 weeks. I felt that was a pretty bad indicator for success...
Suezee - i am sorry you quit. I gather you were on the placebo?
It might be a good idea to wait for the second round or PIs The sides are too bad with the current two. I think they should have worked those out first.
good luck finding something
It might be a good idea to wait for the second round or PIs The sides are too bad with the current two. I think they should have worked those out first.
good luck finding something
"I thought I called you that Monday and left a message."
Uhh... No... I was waiting for the call...
So yeah, I can't do the rollover because I quit early. I asked if she had found something else for me yet, as the Dr. had asked her to do.
Nope.
I have excellent insurance, it pays for 100% of everything, I don't even pay a premium. FIND ME SOMETHING. She said she would.
Wonder if I'll hear anything before I'm sitting in their office after I do that ECG??? Next Friday.
Uhh... No... I was waiting for the call...
So yeah, I can't do the rollover because I quit early. I asked if she had found something else for me yet, as the Dr. had asked her to do.
Nope.
I have excellent insurance, it pays for 100% of everything, I don't even pay a premium. FIND ME SOMETHING. She said she would.
Wonder if I'll hear anything before I'm sitting in their office after I do that ECG??? Next Friday.
Left a message for the coordinator as well as the Dr's assistant. We shall see.
Thanks for all that, Will. You are always so helpful. :D
Will and I have the same Dr. I don't doubt for a second that he knows what's what.
I'm ready to try again but not today. Or tomorrow. ;) I'm waiting to see what happens in the next little while and when I say "now" I really mean within the next year or two. Things seem to move so slowly that now doesn't mean now anymore, to me. Haha.
I think that when I do try again, it will be timed to start in the fall so I can enjoy the sunshine I missed last summer! Hellloooo Wasaga on Saturday! I spent 12 hours in the sunshine last Sunday without a worry. I like that.
What I don't like is a diseased liver!
Thanks for all that, Will. You are always so helpful. :D
Will and I have the same Dr. I don't doubt for a second that he knows what's what.
I'm ready to try again but not today. Or tomorrow. ;) I'm waiting to see what happens in the next little while and when I say "now" I really mean within the next year or two. Things seem to move so slowly that now doesn't mean now anymore, to me. Haha.
I think that when I do try again, it will be timed to start in the fall so I can enjoy the sunshine I missed last summer! Hellloooo Wasaga on Saturday! I spent 12 hours in the sunshine last Sunday without a worry. I like that.
What I don't like is a diseased liver!
See above - The doctor I have been seeing is fantastic. He told her to find out what else they could "get me into" as soon as possible... .
I absolutely read that and I hope your doctor is aware of all the criteria involved with accepting someone into a trial. Most do not know because they don't have to know. They have staff that goes through all that for them. The fact that you were only on SOC may definetely help you because you haven't really had any trial drugs. Personally I would go to your trial site for answers, telephone calls can be easily neglected but a patient in the office can not. good luck, I hope things work out for you.
I absolutely read that and I hope your doctor is aware of all the criteria involved with accepting someone into a trial. Most do not know because they don't have to know. They have staff that goes through all that for them. The fact that you were only on SOC may definetely help you because you haven't really had any trial drugs. Personally I would go to your trial site for answers, telephone calls can be easily neglected but a patient in the office can not. good luck, I hope things work out for you.
You may also want to give some thought on waiting until possibly the "second generation" protease"s hit the street....
This is just my opinion mind you but I follow all the newest reasearch and development very closely as you know . That,along with input from Wong.
it seems likely there may be a new drug or two on the market within in a year or so( JMHO)
Albeit these will still involve INF. however the studies show( some great efficay less dosing difficulty with fewer sides then the two on the market currently
I particularly like TMC 435 ( I think they have actually given it a name now ,however I can't recall off hand )
This is a post of mine recently if you are interested.. maybe a chat with Wowing on this ..
Best ..
Will
By willbb
| Jun 29, 2012
22 Comments
Report
..
.
I have followd the data on this particular drug since it's inception and I feel it may be the next 'Protease" to hit the market ..before the all orals
Same type drug as Vic & Inci (taken with INF. /Riba) ,however data shows in PH 2 trial to be effective with 1) "only once a day dosing" 2)no fat requiements and 3)very few side effects.
Just some info as a tag on to hectors excellent linked Info below.
Will
Agents Undergoing Clinical Trials
Second-wave, First-generation Protease Inhibitors
The second wave of PIs for HCV includes agents with improved potency and dosing, but with resistance profiles that are similar to telaprevir and boceprevir. It is proposed that the term 'second-generation' PI be used for agents that have an improved resistance profile, such as several that are currently in development.
TMC435
TMC435 (Tibotec, Medivir Pharmaceuticals, Janssen, Raritan, NJ, USA) is a potent, noncovalent HCV NS3/4A protease inhibitor. In a phase IIa, double-blind, placebo-controlled trial of a treatment-naïve and treatment-experienced genotype 1 population, patients were randomized to two groups with a total of seven arms. The first group received TMC435 (25, 75 or 200 mg QD) or placebo (PBO) as a loading dose for a week followed by another 3 weeks of the PI and 24–48 weeks of PR. The second group received 4 weeks of the PI (25, 75 or 200 mg QD) or PBO in combination with PR for either 24 or 48 weeks. Viral load reduction in subjects in the second group who received the PI at 25, 75 or 200 mg QD with concurrent PR were −4.74, −5.52 and −5.44 log10 units, respectively. Grade 3/4 AEs were reported in 10–11% of subjects who received the 200-mg daily dose. The most common AEs were fatigue, nausea, influenza-like symptoms and headache. At 12 weeks, all patients who received the PI (75 or 200 mg) for 4 weeks + concurrent PR had HCV RNA <10 IU/mL.
The PILLAR study (Protease Inhibitor trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen) is an ongoing, 5-arm, global phase IIb randomized, double-blind, placebo-controlled study in 386 treatment-naïve patients. TMC435 was administered in doses of 75 mg or 150 mg QD for either 12 or 24 weeks in combination with 24 weeks of PR. Patients receiving TMC435 were allowed to stop all treatment at week 24 with HCV RNA levels <25 IU/mL at week 4 and HCV RNA <25 IU/mL at weeks 12, 16 and 20. Patients who did not meet criteria for a virologic response continued with PR for the full 48 weeks. TMC435 demonstrated potent antiviral activity, at week 4 (RVR) and at week 12 (cEVR) with 92%. HCV RNA was undetectable (<25 IU/mL) for the majority of patients; 83% of them were able to stop all treatment at week 24. The viral breakthrough rate was 4.9% in those who received the PI. Interim 24-week results from the stage IIb ASPIRE trial of TMC435 100 mg QD or 150 mg QD in combination with PR have revealed similar results in treatment-experienced patients infected with HCV genotype 1 who had previously received at least 1 course of PR. At week 24, with the higher dose of TMC435, HCV RNA was undetectable (<25 IU/mL) in 94% of relapsers, 89% of partial responders and 87% of nonresponders.[48] However, it should be noted that approximately 90% of the patient population in ASPIRE was white. As previously described, decreased viral responses are observed in black populations as compared with nonblack populations, which suggests that the patient population in ASPIRE is easier to treat than is a more representative cross-section of the total HCV patient population. Phase III studies in various stages of execution will examine safety and efficacy of the PI in treatment-naïve patients, relapsers and nonresponders.
This is just my opinion mind you but I follow all the newest reasearch and development very closely as you know . That,along with input from Wong.
it seems likely there may be a new drug or two on the market within in a year or so( JMHO)
Albeit these will still involve INF. however the studies show( some great efficay less dosing difficulty with fewer sides then the two on the market currently
I particularly like TMC 435 ( I think they have actually given it a name now ,however I can't recall off hand )
This is a post of mine recently if you are interested.. maybe a chat with Wowing on this ..
Best ..
Will
By willbb
| Jun 29, 2012
22 Comments
Report
..
.
I have followd the data on this particular drug since it's inception and I feel it may be the next 'Protease" to hit the market ..before the all orals
Same type drug as Vic & Inci (taken with INF. /Riba) ,however data shows in PH 2 trial to be effective with 1) "only once a day dosing" 2)no fat requiements and 3)very few side effects.
Just some info as a tag on to hectors excellent linked Info below.
Will
Agents Undergoing Clinical Trials
Second-wave, First-generation Protease Inhibitors
The second wave of PIs for HCV includes agents with improved potency and dosing, but with resistance profiles that are similar to telaprevir and boceprevir. It is proposed that the term 'second-generation' PI be used for agents that have an improved resistance profile, such as several that are currently in development.
TMC435
TMC435 (Tibotec, Medivir Pharmaceuticals, Janssen, Raritan, NJ, USA) is a potent, noncovalent HCV NS3/4A protease inhibitor. In a phase IIa, double-blind, placebo-controlled trial of a treatment-naïve and treatment-experienced genotype 1 population, patients were randomized to two groups with a total of seven arms. The first group received TMC435 (25, 75 or 200 mg QD) or placebo (PBO) as a loading dose for a week followed by another 3 weeks of the PI and 24–48 weeks of PR. The second group received 4 weeks of the PI (25, 75 or 200 mg QD) or PBO in combination with PR for either 24 or 48 weeks. Viral load reduction in subjects in the second group who received the PI at 25, 75 or 200 mg QD with concurrent PR were −4.74, −5.52 and −5.44 log10 units, respectively. Grade 3/4 AEs were reported in 10–11% of subjects who received the 200-mg daily dose. The most common AEs were fatigue, nausea, influenza-like symptoms and headache. At 12 weeks, all patients who received the PI (75 or 200 mg) for 4 weeks + concurrent PR had HCV RNA <10 IU/mL.
The PILLAR study (Protease Inhibitor trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen) is an ongoing, 5-arm, global phase IIb randomized, double-blind, placebo-controlled study in 386 treatment-naïve patients. TMC435 was administered in doses of 75 mg or 150 mg QD for either 12 or 24 weeks in combination with 24 weeks of PR. Patients receiving TMC435 were allowed to stop all treatment at week 24 with HCV RNA levels <25 IU/mL at week 4 and HCV RNA <25 IU/mL at weeks 12, 16 and 20. Patients who did not meet criteria for a virologic response continued with PR for the full 48 weeks. TMC435 demonstrated potent antiviral activity, at week 4 (RVR) and at week 12 (cEVR) with 92%. HCV RNA was undetectable (<25 IU/mL) for the majority of patients; 83% of them were able to stop all treatment at week 24. The viral breakthrough rate was 4.9% in those who received the PI. Interim 24-week results from the stage IIb ASPIRE trial of TMC435 100 mg QD or 150 mg QD in combination with PR have revealed similar results in treatment-experienced patients infected with HCV genotype 1 who had previously received at least 1 course of PR. At week 24, with the higher dose of TMC435, HCV RNA was undetectable (<25 IU/mL) in 94% of relapsers, 89% of partial responders and 87% of nonresponders.[48] However, it should be noted that approximately 90% of the patient population in ASPIRE was white. As previously described, decreased viral responses are observed in black populations as compared with nonblack populations, which suggests that the patient population in ASPIRE is easier to treat than is a more representative cross-section of the total HCV patient population. Phase III studies in various stages of execution will examine safety and efficacy of the PI in treatment-naïve patients, relapsers and nonresponders.
Yeah... Thinking about it... Also thinking about calling and leaving some snark on the voicemail. ;)
Maybe some thought of treating with one of the P.Is on the market now(Inci or Vic) ??
Seeing as you only did the old SOC you have no resistance issues to be concerned with ..Just thinking out loud ...
Will
Seeing as you only did the old SOC you have no resistance issues to be concerned with ..Just thinking out loud ...
Will
Hi Will,
This from the revised inclusion criteria, which is the reason I asked if I would be able to do the rollover:
"Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures."
I've been pretty bummed out since getting the dreaded DET back... :( But I'm ready to try again.
This from the revised inclusion criteria, which is the reason I asked if I would be able to do the rollover:
"Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures."
I've been pretty bummed out since getting the dreaded DET back... :( But I'm ready to try again.
See above - The doctor I have been seeing is fantastic. He told her to find out what else they could "get me into" as soon as possible...
Hi Sue..
Nice to see you again. fret is correct in that once you leave a study of your own accord ,it is usually the drug companies policy to deny you any further studies be it rollover or otherwise.
Their feeling is by not completing the duration for their info. you in a sense burned them from usuing your boy for science once therefore they will not be burned again
.
I am not eligible for further studies for the same reason ,,adn quite frankly I personally would not enter another one as I will treat next time on my own terms
As you know I am at the same center and yes our doctor is on top of things ,however I understand where you are coming from sometimes with staff..
Best to you Sue..
Will
Nice to see you again. fret is correct in that once you leave a study of your own accord ,it is usually the drug companies policy to deny you any further studies be it rollover or otherwise.
Their feeling is by not completing the duration for their info. you in a sense burned them from usuing your boy for science once therefore they will not be burned again
.
I am not eligible for further studies for the same reason ,,adn quite frankly I personally would not enter another one as I will treat next time on my own terms
As you know I am at the same center and yes our doctor is on top of things ,however I understand where you are coming from sometimes with staff..
Best to you Sue..
Will
"The doctor fully supported my decision."
Yes, but did he say that you would be accepted into other studies or at least the rollover? That is the question you need answered. Most trials will not allow someone who has tried tx but did not complete the arm of tx they were enrolled in. I agree with you and I probably would have stopped tx as well. That said, by stopping you may have painted yourself out of being accepted into other trials or even into the rollover of the trial you were in. You need to find out. good luck!!
Yes, but did he say that you would be accepted into other studies or at least the rollover? That is the question you need answered. Most trials will not allow someone who has tried tx but did not complete the arm of tx they were enrolled in. I agree with you and I probably would have stopped tx as well. That said, by stopping you may have painted yourself out of being accepted into other trials or even into the rollover of the trial you were in. You need to find out. good luck!!
I went the traditional route for tx, not in a trial, and have seen the similar poor follow up for scheduling PCR's, sending approvals to the specialty pharmacy, returning phone calls, no follow up at eot. As with you, I liked my doctor, but the staff was awful. Unfortunately, this doesn't appear uncommon for many going through tx, whether in a trial or not. Some are lucky to have wonderful docs and a very responsive staff.
If you can't get a response via phone call, it seems the only choice would be to park yourself in their office and get the answers you're looking for. It would be hard to ignore your request for information if you're in their office.
If you can't get a response via phone call, it seems the only choice would be to park yourself in their office and get the answers you're looking for. It would be hard to ignore your request for information if you're in their office.
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