Is a SVR12 the new SVR24?

[Mike]

The term sustained virological response (SVR) is used in determining the effectiveness of HVC treatment. A sustained response simply mean that, after treatment has ended, does the patient remain virus free?

A sustained virological response, 24 weeks after treatment has ended - reported as SVR24 - has long been used as the point when a patient is deemed "cured."

With the introduction of more effective treatments, however, this end point appears to be changing.

Specifically, research comparing the predictive value of a sustained virological response 12 (SVR12) and a sustained virological response 24 (SVR24), found no statistical difference between these to end points in patients treated with a Sovaldi (Sofosbuvir) based regime.

In fact, "a SVR12 has a 99.8% positive predictive value, demonstrating the reliability of this time point for assessing a durable response."

In other words, if a SVR12 is acheived, 99.8% of these patients will remain virus free 24 weeks after treat has ended (SVR24).

This suggests that an SVR12 is the new SVR24 in patients treated with a Sovaldi-based treatment regime.

Thus:

"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."

www.journal-of-hepatology.eu/article/S0168-8278(13)60850-8/pdf


Best wishes for an SVR12, Mike

[lporterrn]

Thanks for posting this Mike

[willie g]

thx mike, I will have to read that a few more times  how do you keep up with all of this? it is appreciated   willie g

[Bucky]

Mike & Lucinda,  Since this information is on Sovaldi based treatment regime then I am hoping that it includes Olysio since I did not see it mentioned, only Interferion or Ribavirin.
Bucky

[Mike]

Hi Bucky,

That's a great question. I would assume that Sovaldi/Olysio combo would have similar stats. However, Sovaldi/Olysio is prescribed off-label, and there is very limited research regarding this combo and SVR. This will change shortly as data from the first large group of individuals completing this combo begins to be studied.

Since I completed SOL+INTF+RIBV, this was a topic I researched.

I discussed this (SVR12 cf. SVR24) with my GI, and he did not feel that an EOT 24 week VL was necessary, given the research. He updated my medical records to reflect cured. He did tell me, however, if, for peace of mind I wanted a 24 week EOT VL, he would order it.

Best wishes, Mike

[rikkyde]

My doc has told me SVR4 is the new SVR12, and I'm UDT at SVR4, about a month ago. I'm still going to be tested anyway at 12 weeks.

[Mike]

Hi Rick,

That was one of the interesting things about the research - it indicates that a SVR4 has a 98.5% predictive value, that individuals who achieve an SVR4 will achieve an SVR12 and SVR24!

I'm with you. I would do the 12 week blood work and confirm an SVR12.

Best wishes, Mike