Aa
any questions?
Hi guys. Hope all had a Merry Christmas. I am being considered for boceprevir trial for treatment niave. I am 1a with high alt and ast. Fibrosure shows no fibrosis but increasing on the imflamation score. Normal mri for the last 2 years. The viral load is what worries me it has gone up to 42million. in a very short period of time. I am tired more than normal and I have gotten flat red spots on my legs twice. I just got result back for cryo and it was neg. They are calling in the morn to ask questions, I wanted to know if there is something I should ask. Is there anything?
I SAID 85%...i meant 82%
for patients who received the PEGINTRON and REBETOL lead in and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR (ITT) was 82 percent in the 28-week regimen and 92 percent in the 48 week regimen.
http://www.medicalnewstoday.com/articles/117189.php
for patients who received the PEGINTRON and REBETOL lead in and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR (ITT) was 82 percent in the 28-week regimen and 92 percent in the 48 week regimen.
http://www.medicalnewstoday.com/articles/117189.php
Patients in any arm of the study with detectable virus at week 12 will be considered treatment failures and will discontinue treatment
THIS IS FOR MY TRIAL...the non responder group...12 weeks for us 24 for the navie
THIS IS FOR MY TRIAL...the non responder group...12 weeks for us 24 for the navie
Patients in any arm of this study with detectable virus at week 24 will be considered treatment failures and will discontinue treatment.....I SAID BY WEEK 12...i meant week 24...sorry
here you go....
Pivotal Study in Previously Untreated (Naive) Patients
The primary objective of this pivotal study, known as HCV SPRINT-2 (HCV Serine Protease Inhibitor Therapy-2), is to evaluate the efficacy of 28- and 48-week regimens of boceprevir (800 mg TID) in combination with PEGINTRON (1.5 mcg/kg/week) and REBETOL (600-1400 mg/day) compared to a control of PEGINTRON and REBETOL alone for 48 weeks in previously untreated (naive) adult patients with chronic HCV genotype 1. The study is projected to enroll a total of more than 1,000 patients, including a minimum of 150 African-American/Black patients.
In this study, in the 28-week treatment arm, rapid viral response (RVR) criteria at 4 weeks of boceprevir treatment (treatment week 8) will be used to determine which boceprevir patients can stop all treatment at 28 weeks. Patients in the 28-week boceprevir arm who achieve RVR, defined as undetectable virus (HCV-RNA) in plasma at week 4 of boceprevir treatment, will stop all treatment at week 28. Patients who do not meet the RVR criteria will stop boceprevir treatment at week 28 and continue PEGINTRON and REBETOL alone for an additional 20 weeks, for a total treatment duration of 48 weeks. In the 48-week treatment arm, patients will receive PEGINTRON and REBETOL plus boceprevir for a total treatment duration of 48 weeks. Patients in any arm of this study with detectable virus at week 24 will be considered treatment failures and will discontinue treatment.
The primary efficacy endpoint of the study is sustained virologic response (SVR).(1) Secondary efficacy endpoints include early virologic response in patients who achieve SVR. The study will be stratified by HCV genotype 1 subtype 1a versus 1b, and baseline viral load.
http://www.natap.org/2008/HCV/052108_01.htm
Pivotal Study in Previously Untreated (Naive) Patients
The primary objective of this pivotal study, known as HCV SPRINT-2 (HCV Serine Protease Inhibitor Therapy-2), is to evaluate the efficacy of 28- and 48-week regimens of boceprevir (800 mg TID) in combination with PEGINTRON (1.5 mcg/kg/week) and REBETOL (600-1400 mg/day) compared to a control of PEGINTRON and REBETOL alone for 48 weeks in previously untreated (naive) adult patients with chronic HCV genotype 1. The study is projected to enroll a total of more than 1,000 patients, including a minimum of 150 African-American/Black patients.
In this study, in the 28-week treatment arm, rapid viral response (RVR) criteria at 4 weeks of boceprevir treatment (treatment week 8) will be used to determine which boceprevir patients can stop all treatment at 28 weeks. Patients in the 28-week boceprevir arm who achieve RVR, defined as undetectable virus (HCV-RNA) in plasma at week 4 of boceprevir treatment, will stop all treatment at week 28. Patients who do not meet the RVR criteria will stop boceprevir treatment at week 28 and continue PEGINTRON and REBETOL alone for an additional 20 weeks, for a total treatment duration of 48 weeks. In the 48-week treatment arm, patients will receive PEGINTRON and REBETOL plus boceprevir for a total treatment duration of 48 weeks. Patients in any arm of this study with detectable virus at week 24 will be considered treatment failures and will discontinue treatment.
The primary efficacy endpoint of the study is sustained virologic response (SVR).(1) Secondary efficacy endpoints include early virologic response in patients who achieve SVR. The study will be stratified by HCV genotype 1 subtype 1a versus 1b, and baseline viral load.
http://www.natap.org/2008/HCV/052108_01.htm
For me i have no side effects...this is my secound round of tx and my first time treating with Bosceprevir i have had no sides,just mild headaches sometimes...if you dont clear by week 12 in my trial...you are discontinued.. retinol exam?...thats just a test for excess vit A...no biggie...long term probs?...depends on how your body reacts to the drugs..but to be honest,,,MOST people on tx do fine...i hope this helps you some...the BOC trial has up to 85% cure rate for navie patients for geno 1 type virus...
http://clinicaltrials.gov/ct2/show/NCT00708500?recr=open&cond=%22Digestive+System+Diseases%22&rank=29
http://clinicaltrials.gov/ct2/show/NCT00708500?recr=open&cond=%22Digestive+System+Diseases%22&rank=29
How's treatment? I guess what I want to know is at what point should I know whether to continue on in case its not going well. I have heard different times. I am guesing at the 4 week mark if not cleared stop? Also, what are the side affects your experienced during your different treatments? I just read that they give you a retinol exam, whats that about? Any long term problems due to the interferon? I am a little scared. my webname deceives, I am a girl. I guess a sissy. ha ha ha
If its of any help...i am into week 8 of the BOC trial(non responder arm)...you ask..i may have answers
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