Aa
Check this Out
This protese inhibitor trial i am signed up for is not the Vertex one..its the Boceprevir Phase II Study ....anyone out there know anything on this.,,,here s a liink to some news on it...looks really good
http://findarticles.com/p/articles/mi_m4PRN/is_2008_August_4/ai_n27967944
http://findarticles.com/p/articles/mi_m4PRN/is_2008_August_4/ai_n27967944
Ok sue, your a slow responder who is also a relapser.
can
can
Well...i know im not a RVR...So what the hell am i..im not a nul responder...im not a non responder....i became UD some where between week 12 and 24...at week 12 my load was 475....call me a slow responder i guess...but what ever ya do...do not call me sue
Found these for you:
RAPID VIROLOGICAL RESPONSE (RVR): the probability of achieving a sustained virological response early in treatment based on a decline in HCV RNA (viral load). The generally accepted timeframe is 4 weeks after starting treatment.
RVR: Rapid Virological Response (4 Week PCR – UND)
UNDETECTABLE (UNQUANTIFIABLE): a viral load (amount of viral RNA) that is below the level of detection of the test being used.
A RVR, meaning HCV RNA levels <15 IU/ml
Division of Infectious Diseases, Department of Medicine, and Division of Virology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. 8/05/08
RAPID VIROLOGICAL RESPONSE (RVR): the probability of achieving a sustained virological response early in treatment based on a decline in HCV RNA (viral load). The generally accepted timeframe is 4 weeks after starting treatment.
RVR: Rapid Virological Response (4 Week PCR – UND)
UNDETECTABLE (UNQUANTIFIABLE): a viral load (amount of viral RNA) that is below the level of detection of the test being used.
A RVR, meaning HCV RNA levels <15 IU/ml
Division of Infectious Diseases, Department of Medicine, and Division of Virology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. 8/05/08
Yeah, I had posted the same thing to you....look at post #50.
Non-responders didn't do well no matter what dose of Boceprevir they used or whether they rolled them over to a different arm of the study that used a higher dose....or whether they extended the treatment. The highest SVR was 14%.
This comes from Schering's site.....
Boceprevir in "Null" Nonresponder HCV Patients
Schering-Plough also reported top line results from a completed Phase II study evaluating boceprevir dose response and the need for ribavirin in patients chronically infected with HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy (i.e., patients who did not have undetectable HCV-RNA or who did not achieve a 2 log decline in viral load with a minimum of 12 weeks of peginterferon and ribavirin combination therapy). These "null" nonresponders to peginterferon and ribavirin combination therapy represent the most difficult-to-treat patient population. Patients who relapsed following previous HCV therapy (relapsers) were not included in this study.
This study was complex, involving seven different treatment arms. Patients were initially randomized to low doses of boceprevir (100, 200, 400 mg TID) before initiating an 800 mg TID boceprevir arm. Under the study protocol, patients received these boceprevir doses in combination with PEGINTRON (1.5 mcg/kg weekly) with or without REBETOL (800-1400 mg daily) for 24 or 48 weeks, or received PEGINTRON and REBETOL alone as a control. During the ongoing review of the study by the Data Safety Monitoring Board (DSMB), it was recommended that patients in the lower-dose boceprevir arms who demonstrated a substantial antiviral response during treatment cross over to boceprevir 800 mg TID in combination with PEGINTRON and REBETOL for an additional 24 weeks. Patients who did not demonstrate a substantial antiviral response during treatment were discontinued from the study. In addition, patients in the control arm who did not respond to PEGINTRON and REBETOL alone were allowed to cross over to boceprevir 800 mg TID in combination with PEGINTRON and REBETOL. Patients received a maximum of 24 weeks of the optimized regimen (boceprevir 800 mg TID in combination with PEGINTRON and REBETOL). In all, 357 patients were enrolled at centers in the United States and Europe, including 348 patients who received boceprevir at some point in the study.
In this study of well-documented null nonresponders, some patients achieved a sustained virologic response (SVR). Overall, 7-14 percent of patients in the boceprevir crossover arms achieved SVR compared to 2 percent in the control arm. SVR was associated with early virologic response and a longer course of therapy (more than 36 weeks). While potent antiviral activity with boceprevir was seen in the study, with viral loads in some patients decreasing below the limit of detection, viral loads for other patients decreased and then rebounded to baseline levels while on therapy and some patients relapsed following the end of treatment. Several resistant variants were observed in these patients. These HCV variants are similar to those reported after treatment with other HCV protease inhibitors and those previously observed in boceprevir in vitro studies. Whether the results of this study would have been different had all patients been started with the optimized regimen of boceprevir 800 mg TID in combination with PEGINTRON and REBETOL -- and with treatment extending to 48 weeks -- is not known.
"Although interferon nonresponders appear to respond to HCV protease inhibition, it seems that some significant element of interferon response is needed to achieve a sustained virologic response in the majority of these patients," said Eugene R. Schiff, M.D., chief, division of hepatology and director, Center for Liver Disease, University of Miami Miller School of Medicine, and the lead investigator of the study.
Schering-Plough said that in patients with little to no interferon response, alternative treatment strategies are required, and the company will continue to explore regimens containing boceprevir, PEGINTRON and REBETOL in the Phase II setting, using the insights gained in this initial study.
http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=1064540
Non-responders didn't do well no matter what dose of Boceprevir they used or whether they rolled them over to a different arm of the study that used a higher dose....or whether they extended the treatment. The highest SVR was 14%.
This comes from Schering's site.....
Boceprevir in "Null" Nonresponder HCV Patients
Schering-Plough also reported top line results from a completed Phase II study evaluating boceprevir dose response and the need for ribavirin in patients chronically infected with HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy (i.e., patients who did not have undetectable HCV-RNA or who did not achieve a 2 log decline in viral load with a minimum of 12 weeks of peginterferon and ribavirin combination therapy). These "null" nonresponders to peginterferon and ribavirin combination therapy represent the most difficult-to-treat patient population. Patients who relapsed following previous HCV therapy (relapsers) were not included in this study.
This study was complex, involving seven different treatment arms. Patients were initially randomized to low doses of boceprevir (100, 200, 400 mg TID) before initiating an 800 mg TID boceprevir arm. Under the study protocol, patients received these boceprevir doses in combination with PEGINTRON (1.5 mcg/kg weekly) with or without REBETOL (800-1400 mg daily) for 24 or 48 weeks, or received PEGINTRON and REBETOL alone as a control. During the ongoing review of the study by the Data Safety Monitoring Board (DSMB), it was recommended that patients in the lower-dose boceprevir arms who demonstrated a substantial antiviral response during treatment cross over to boceprevir 800 mg TID in combination with PEGINTRON and REBETOL for an additional 24 weeks. Patients who did not demonstrate a substantial antiviral response during treatment were discontinued from the study. In addition, patients in the control arm who did not respond to PEGINTRON and REBETOL alone were allowed to cross over to boceprevir 800 mg TID in combination with PEGINTRON and REBETOL. Patients received a maximum of 24 weeks of the optimized regimen (boceprevir 800 mg TID in combination with PEGINTRON and REBETOL). In all, 357 patients were enrolled at centers in the United States and Europe, including 348 patients who received boceprevir at some point in the study.
In this study of well-documented null nonresponders, some patients achieved a sustained virologic response (SVR). Overall, 7-14 percent of patients in the boceprevir crossover arms achieved SVR compared to 2 percent in the control arm. SVR was associated with early virologic response and a longer course of therapy (more than 36 weeks). While potent antiviral activity with boceprevir was seen in the study, with viral loads in some patients decreasing below the limit of detection, viral loads for other patients decreased and then rebounded to baseline levels while on therapy and some patients relapsed following the end of treatment. Several resistant variants were observed in these patients. These HCV variants are similar to those reported after treatment with other HCV protease inhibitors and those previously observed in boceprevir in vitro studies. Whether the results of this study would have been different had all patients been started with the optimized regimen of boceprevir 800 mg TID in combination with PEGINTRON and REBETOL -- and with treatment extending to 48 weeks -- is not known.
"Although interferon nonresponders appear to respond to HCV protease inhibition, it seems that some significant element of interferon response is needed to achieve a sustained virologic response in the majority of these patients," said Eugene R. Schiff, M.D., chief, division of hepatology and director, Center for Liver Disease, University of Miami Miller School of Medicine, and the lead investigator of the study.
Schering-Plough said that in patients with little to no interferon response, alternative treatment strategies are required, and the company will continue to explore regimens containing boceprevir, PEGINTRON and REBETOL in the Phase II setting, using the insights gained in this initial study.
http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=1064540
BTW...i think my vl is only 2 million as of last month...thats a good sign
i did have a 2 log drop by week 4...i guess this is still noy considered a RVR?...MY BASELINE was 20 million...what is the real definition of a RVR ..is it expressed in numbers or log results???
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