Most Sovaldi Relapses have happened within the four week time frame so that is why the +4 test, after that i think it is the state health dept that makes the policy be it +12 or +1year.
-- Edited by Huey on Friday 10th of October 2014 02:21:06 AM
patiently_waiting said
Oct 9, 2014
Tig56 wrote:
Hi PW,
You're right and it is desirable just for the sake of knowing if you are still undetectable at EOT+4. The interferon based protocols recommended a +4 week VL test and I know the majority of us pursued that course of testing. The wait until EOT+12 for anyone is a very long period of time. I think they have concluded that the 12th week test is going to provide the most accurate and consistent results, comparatively speaking. The fact that most will witness an undetectable result by EOT on the new DAA's seems clear, but in order to reduce costs for these RNA tests, while assuring it's accurate of a true SVR, they decided upon this time frame. It's all about saving money, while assuring accurate results. As these protocols improve and SVR rates increase to perfection, I think you'll continue to see changes to the testing procedures. If you haven't seen the latest and greatest of lab testing programs (of the near future) check out the new Theranos testing program being introduced. The prices are going to be quite inexpensive and almost immediate results. Our member Matt discussed this last week.
Understood Tig. The financial circumstances aren't always the same so if that's a factor I can see the wait. When I said above the tests weren't that expensive I was mistaken on how much they cost. I just went and checked and it was much more than I was thinking. The lady at Quest earlier this week took $40 from me and said I was paying up front in case my insurance didn't pay. I thought "wow that was cheap"...but she was mistaken...that was already factoring in my insurance payment. Anyway, good to hear they're coming out with cheaper tests now. Till then the 4 week test will be a luxury I suppose.
skewedButNotBroken said
Oct 9, 2014
Thanks I appreciate the info.
Tig said
Oct 9, 2014
Hi PW,
You're right and it is desirable just for the sake of knowing if you are still undetectable at EOT+4. The interferon based protocols recommended a +4 week VL test and I know the majority of us pursued that course of testing. The wait until EOT+12 for anyone is a very long period of time. I think they have concluded that the 12th week test is going to provide the most accurate and consistent results, comparatively speaking. The fact that most will witness an undetectable result by EOT on the new DAA's seems clear, but in order to reduce costs for these RNA tests, while assuring it's accurate of a true SVR, they decided upon this time frame. It's all about saving money, while assuring accurate results. As these protocols improve and SVR rates increase to perfection, I think you'll continue to see changes to the testing procedures. If you haven't seen the latest and greatest of lab testing programs (of the near future) check out the new Theranos testing program being introduced. The prices are going to be quite inexpensive and almost immediate results. Our member Matt discussed this last week.
Not sure if this is news to anyone here, but I thought it was very interesting in light of my recent SVR4 achievement. :) The short of it is, if you're undetected at 4 weeks after a Sovaldi based treatment regime, you're very likely to be SVR at 12, and especially 24 weeks. In fact there was no real difference between 12 and 24 and only a very slight difference between SVR4 and 12. For this reason, if it were me, I'd demand a 4 week post treatment PCR from my doctor. Waiting 12 weeks when you could be pretty sure at 4 doesn't make much sense to me. I think another at 12 makes sense as well just to be sure. These tests aren't that expensive.
HIGH CONCORDANCE OF SVR4, SVR12, AND SVR24 IN PATIENTS
WITH HCV INFECTION WHO HAVE RECEIVED TREATMENT WITH SOFOSBUVIR
Background and Aims: Sofosbuvir (SOF, formerly GS-7977), a potent uridine nucleotide analog now in Phase 3 development, has demonstrated >90% end-of-therapy (EOT) response and SVR12 in interferon-containing and interferon-free regimens, and across HCV genotypes. We evaluated concordance of SVR4 with SVR12 and SVR24 in the Phase 2 program.
Methods: Sofosbuvir has been explored in more than 500 patients, with and without ribavirin (RBV), or with peginterferon (PEG)+RBV in the phase 2 studies PROTON, ELECTRON, ATOMIC, and QUANTUM. In these studies, HCV RNA was measured at least at 4, 12, and 24 weeks following the end of treatment. We assessed the concordance of sustained virologic response (SVR) at these time points.
Results: 590 patients had HCV RNA measured at 4 and 12 weeks post-treatment, 538 at 4 and 24 weeks post-treatment, and 547 at both 12 and 24 weeks post-treatment. Relapse after having achieved SVR4 was uncommon; 8 patients who had achieved SVR4 subsequently relapsed by 12 weeks post-treatment and one patient who had achieved SVR12 relapsed at 24 weeks post-treatment. In two cases, patients with reported relapse at SVR4 were later found to have achieved SVR. Positive and negative predictive values are tabulated.
Conclusion: High levels of concordance between SVR4 and later time points were observed. There were few relapses in patients who achieved SVR4. Positive predictive values and sensitivity of SVR4 for SVR12 and SVR24 were >98.5%. Specificity and negative predictive values were lower, reflecting the relatively higher contribution of the few discordant patients in the much smaller number of patients who relapsed. SVR12 has a 99.8% positive predictive value, demonstrating the reliability of this time point for assessing a durable response."
-- Edited by patiently_waiting on Thursday 9th of October 2014 11:54:23 PM
-- Edited by patiently_waiting on Thursday 9th of October 2014 11:56:07 PM
My Doc is waiting EOT+24 then one year.
Most Sovaldi Relapses have happened within the four week time frame so that is why the +4 test, after that i think it is the state health dept that makes the policy be it +12 or +1year.
-- Edited by Huey on Friday 10th of October 2014 02:21:06 AM
Understood Tig. The financial circumstances aren't always the same so if that's a factor I can see the wait. When I said above the tests weren't that expensive I was mistaken on how much they cost. I just went and checked and it was much more than I was thinking. The lady at Quest earlier this week took $40 from me and said I was paying up front in case my insurance didn't pay. I thought "wow that was cheap"...but she was mistaken...that was already factoring in my insurance payment. Anyway, good to hear they're coming out with cheaper tests now. Till then the 4 week test will be a luxury I suppose.
Thanks I appreciate the info.
Hi PW,
You're right and it is desirable just for the sake of knowing if you are still undetectable at EOT+4. The interferon based protocols recommended a +4 week VL test and I know the majority of us pursued that course of testing. The wait until EOT+12 for anyone is a very long period of time. I think they have concluded that the 12th week test is going to provide the most accurate and consistent results, comparatively speaking. The fact that most will witness an undetectable result by EOT on the new DAA's seems clear, but in order to reduce costs for these RNA tests, while assuring it's accurate of a true SVR, they decided upon this time frame. It's all about saving money, while assuring accurate results. As these protocols improve and SVR rates increase to perfection, I think you'll continue to see changes to the testing procedures. If you haven't seen the latest and greatest of lab testing programs (of the near future) check out the new Theranos testing program being introduced. The prices are going to be quite inexpensive and almost immediate results. Our member Matt discussed this last week.
http://www.theranos.com/
http://www.theranos.com/test-menu?ref=footer
Tig
Not sure if this is news to anyone here, but I thought it was very interesting in light of my recent SVR4 achievement. :) The short of it is, if you're undetected at 4 weeks after a Sovaldi based treatment regime, you're very likely to be SVR at 12, and especially 24 weeks. In fact there was no real difference between 12 and 24 and only a very slight difference between SVR4 and 12. For this reason, if it were me, I'd demand a 4 week post treatment PCR from my doctor. Waiting 12 weeks when you could be pretty sure at 4 doesn't make much sense to me. I think another at 12 makes sense as well just to be sure. These tests aren't that expensive.
HIGH CONCORDANCE OF SVR4, SVR12, AND SVR24 IN PATIENTS
WITH HCV INFECTION WHO HAVE RECEIVED TREATMENT WITH
SOFOSBUVIR
Background and Aims: Sofosbuvir (SOF, formerly GS-7977), a
potent uridine nucleotide analog now in Phase 3 development,
has demonstrated >90% end-of-therapy (EOT) response and SVR12
in interferon-containing and interferon-free regimens, and across
HCV genotypes. We evaluated concordance of SVR4 with SVR12 and
SVR24 in the Phase 2 program.
Methods: Sofosbuvir has been explored in more than 500 patients,
with and without ribavirin (RBV), or with peginterferon (PEG)+RBV
in the phase 2 studies PROTON, ELECTRON, ATOMIC, and QUANTUM.
In these studies, HCV RNA was measured at least at 4, 12, and
24 weeks following the end of treatment. We assessed the
concordance of sustained virologic response (SVR) at these time
points.
Results: 590 patients had HCV RNA measured at 4 and 12 weeks
post-treatment, 538 at 4 and 24 weeks post-treatment, and 547
at both 12 and 24 weeks post-treatment. Relapse after having
achieved SVR4 was uncommon; 8 patients who had achieved SVR4
subsequently relapsed by 12 weeks post-treatment and one patient
who had achieved SVR12 relapsed at 24 weeks post-treatment. In
two cases, patients with reported relapse at SVR4 were later found
to have achieved SVR. Positive and negative predictive values are
tabulated.
Conclusion: High levels of concordance between SVR4 and later
time points were observed. There were few relapses in patients who
achieved SVR4. Positive predictive values and sensitivity of SVR4 for
SVR12 and SVR24 were >98.5%. Specificity and negative predictive
values were lower, reflecting the relatively higher contribution
of the few discordant patients in the much smaller number of
patients who relapsed. SVR12 has a 99.8% positive predictive value,
demonstrating the reliability of this time point for assessing a
durable response."
-- Edited by patiently_waiting on Thursday 9th of October 2014 11:54:23 PM
-- Edited by patiently_waiting on Thursday 9th of October 2014 11:56:07 PM