Aa
I find this all so hard to understand
After reading this I understand it to say that 12/24 has proved to be better then 12/48 in the latest data.
http://hepatitiscnewdrugs.blogspot.com/search/label/telaprevir-incivek
http://hepatitiscnewdrugs.blogspot.com/search/label/telaprevir-incivek
Not much data on relaspers w/cirrhosis and 24 wk treatment duration but from what I read it looks like the SVR rate is higher for those who have compensated cirrhosis and do 48 wks. Also, your doctor is correct about the 60% success rate for patient naives w/cirrhosis who treat for 48 wks.
Even though eRVR is a predictor of treatment success, there are other variables such as advanced liver disease or cirrhosis that enter into the equation. Being a CC, you should have a very good response to Peg.
Tough call, if it were me I would opt for the full 48 weeks.
Study 111: A Randomized Study of Stopping Treatment at 24 Weeks or
Continuing Treatment to 48 Weeks in Treatment-Naive Subjects with
Genotype 1 CHC who Achieve an Extended Rapid Viral Response While
Receiving Telaprevir, Peg-interferon alfa 2a (Pegasys®), and Ribavirin
(Copegus®)
Subgroup Analysis
SVR24 rates were higher in subjects with lower baseline HCV RNA levels than in subjects with higher baseline HCV RNA levels (Table 19). This was not the case in the T12/PR48/eRVR+ group, but the number of subjects with baseline levels < 800,000 IU/mL is small. The SVR24 rate for subjects with cirrhosis was 61.1% (11 subjects) in the T12/PR24/eRVR+ group, and 91.7% (11 subjects) in the T12/PR48/eRVR+ group. Any differences should be interpreted with caution due to the small group sizes. For subjects with advanced fibrosis (bridging fibrosis and cirrhosis) the SVR rates were 78.9% and 87.9% respectively.
Even though eRVR is a predictor of treatment success, there are other variables such as advanced liver disease or cirrhosis that enter into the equation. Being a CC, you should have a very good response to Peg.
Tough call, if it were me I would opt for the full 48 weeks.
Study 111: A Randomized Study of Stopping Treatment at 24 Weeks or
Continuing Treatment to 48 Weeks in Treatment-Naive Subjects with
Genotype 1 CHC who Achieve an Extended Rapid Viral Response While
Receiving Telaprevir, Peg-interferon alfa 2a (Pegasys®), and Ribavirin
(Copegus®)
Subgroup Analysis
SVR24 rates were higher in subjects with lower baseline HCV RNA levels than in subjects with higher baseline HCV RNA levels (Table 19). This was not the case in the T12/PR48/eRVR+ group, but the number of subjects with baseline levels < 800,000 IU/mL is small. The SVR24 rate for subjects with cirrhosis was 61.1% (11 subjects) in the T12/PR24/eRVR+ group, and 91.7% (11 subjects) in the T12/PR48/eRVR+ group. Any differences should be interpreted with caution due to the small group sizes. For subjects with advanced fibrosis (bridging fibrosis and cirrhosis) the SVR rates were 78.9% and 87.9% respectively.
I'm trying to figure out exactly what my odds are of stopping at 24 weeks. Early cirrhosis but treatment naive with an ILb28 CC gene. Week one didn't have VL but alt normal and ast 40. At 4 week undetectable, 8 week undetectable, waiting on 12 week now, but sure that will be undetectable. My doctor says 60% but he just seem to be putting odds out there. He started giving me extra odds for being a cc and early responder and treatment naive. He really didn't know. It was kind of funny listen to him...
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
The vertex Phase III trials included no relapser response guided data but phase II did. Relapsers who eRVR, the Phase II study 106 (Prove-3) yielded 89.3 SVR with T12/PR24 and phase III study C216 (REALIZE) yielded 95.8 with T12/PR 48. The eRVR group in Prove-3 was only 42 pts. A relapser with an eRVR the odds of SVR are very good doing 24 wks.
Page 45
The model predicted that the difference in SVR rates between T12/PR regimens with and without response-guided PR duration (T12/PR24 for subjects with eRVR and T12/PR48 for subjects without eRVR, versus T12/PR48 for all subjects) was 1% to 2% in both treatment-naive and in prior relapser populations. The predictions were also consistent with the observed SVR rates by PR duration in Phase 2/3 studies.
Page 86
While response-guided durations were not included in Phase 3 Study C216, the totality of evidence from the telaprevir development program suggests that prior relapsers with eRVR will achieve high SVR rates when treated for a total of 24 weeks. The SVR rate in prior relapsers with eRVR treated with T12/PR48 in Study C216 (95.6%) was comparable or higher than the SVR rate in treatment-naive subjects with eRVR treated with T12/PR24 in Study 108 (89.2%). In Study 106, SVR rates in prior relapsers with eRVR were equally high when they were treated with a 24-week or a 48-week regimen. These data suggest that both treatment-naive and prior relapser subjects with eRVR can shorten treatment duration with Peg-IFN/RBV by 6 months without loss of efficacy, which provides a significant safety and treatment burden benefit. For these reasons, response-guided therapy is recommended for both treatment-naive subjects and prior relapsers.
The FDA did approve the Vertex agrement: "SVR rate in prior relapsers with eRVR treated with T12/PR48 in Study C216 (95.6%) was comparable or higher than the SVR rate in treatment-naive subjects with eRVR treated with T12/PR24 in Study 108 (89.2%)."
However, IMO, I don't see the comparison as truly accurate because relapsers got 95.6 % but they also did an extra 24 weeks. All things considered from that Prove 3 vs REALIZE comparison it seems 24 weeks will be enough.
The vertex Phase III trials included no relapser response guided data but phase II did. Relapsers who eRVR, the Phase II study 106 (Prove-3) yielded 89.3 SVR with T12/PR24 and phase III study C216 (REALIZE) yielded 95.8 with T12/PR 48. The eRVR group in Prove-3 was only 42 pts. A relapser with an eRVR the odds of SVR are very good doing 24 wks.
Page 45
The model predicted that the difference in SVR rates between T12/PR regimens with and without response-guided PR duration (T12/PR24 for subjects with eRVR and T12/PR48 for subjects without eRVR, versus T12/PR48 for all subjects) was 1% to 2% in both treatment-naive and in prior relapser populations. The predictions were also consistent with the observed SVR rates by PR duration in Phase 2/3 studies.
Page 86
While response-guided durations were not included in Phase 3 Study C216, the totality of evidence from the telaprevir development program suggests that prior relapsers with eRVR will achieve high SVR rates when treated for a total of 24 weeks. The SVR rate in prior relapsers with eRVR treated with T12/PR48 in Study C216 (95.6%) was comparable or higher than the SVR rate in treatment-naive subjects with eRVR treated with T12/PR24 in Study 108 (89.2%). In Study 106, SVR rates in prior relapsers with eRVR were equally high when they were treated with a 24-week or a 48-week regimen. These data suggest that both treatment-naive and prior relapser subjects with eRVR can shorten treatment duration with Peg-IFN/RBV by 6 months without loss of efficacy, which provides a significant safety and treatment burden benefit. For these reasons, response-guided therapy is recommended for both treatment-naive subjects and prior relapsers.
The FDA did approve the Vertex agrement: "SVR rate in prior relapsers with eRVR treated with T12/PR48 in Study C216 (95.6%) was comparable or higher than the SVR rate in treatment-naive subjects with eRVR treated with T12/PR24 in Study 108 (89.2%)."
However, IMO, I don't see the comparison as truly accurate because relapsers got 95.6 % but they also did an extra 24 weeks. All things considered from that Prove 3 vs REALIZE comparison it seems 24 weeks will be enough.
But isn't this saying people who failed in the past which would qualify them for 48 weeks they are finding out that 24 is just as good. Am I not reading this correctly. That was my point. I'm trying to keep up with the latest data to see if the 24 weeks will be best for everyone before I have to make my decision on how many weeks to treat 24 or 48.
The 24 week treatment is only for those who are UND at 4 wks AND 12 wks - Of course all of us want to clear at 4 wks and stay that way. As far as "better" clearing sooner than later would be better by my defination.
Unfortunately - many will be UND at 4 weeks and be in for 48 weeks treatment.
Unfortunately - many will be UND at 4 weeks and be in for 48 weeks treatment.
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