Viral Load Test

[texasgal]

Hi Everyone, I have 17 days left on Harvoni. PA sent me a letter I can go take blood test for VL  4 weeks after I finish treatment. I have waited long enough & want to take test 1 week after I finish Tx. By the time they get back to me it'll be June. I'm so upset about them & how they ignore me. Does anyone know why I can't just take test when I want? This will be my 1st VL test throughout Tx.
I would appreciate any comments. Thanks, Patti

[Picnic]

4 week post treatment viral load correlates with a 98.5% chance of a cure whereas a 1 week post treatment viral load does not correlate with a cure. Just wait three more weeks and if it is undetected you are almost there.!

[rainbowray]

You can get a viral load anytime you want, but you pay out of pocket.  325 to 220 dollars, and that is discount.  Reply if you want web links.

[davidsconfused]

Hi Everyone, I have 17 days left on Harvoni. PA sent me a letter I can go take blood test for VL  4 weeks after I finish treatment. I have waited long enough & want to take test 1 week after I finish Tx. By the time they get back to me it'll be June. I'm so upset about them & how they ignore me. Does anyone know why I can't just take test when I want? This will be my 1st VL test throughout Tx.
I would appreciate any comments. Thanks, Patti

It sounds like we have the same doctor and PA. It's been a long three months minus 17 days for me too, especially with the side effects I've had.  I'd like to know without waiting another month. I haven't had any VL tests, either.

[Lynn K]

Hi texasgal and welcome

Like picnic said a one week test would have no meaning really.

Even a 4 week post treatment not detected is not a guarantee you are SVR but it is a very good indication you will remain not detected at 12 weeks post treatment.

[Philadelphia]

texasgal and davidsconfused- haven't you had a viral load test at all? All the way through treatment? Or am I misinterpreting what you have written?

[texasgal]

I started Harvoni Feb 06/2015 Have not had a VL test done. Have about 2 more weeks left now to finish. I have Medicare & supplemental, Do I still have to pay some of it? After this is there 2 more lab tests? at 4 & 12 weeks? To make sure I'm cleared? I have only seen GI for exam only, other than that he's a Phantam doctor. His office also never calls me back unless I rant like hell. I just noticed that the lab ordered for VL was March 20. so the 6 weeks would put me at May 1st for VL test. I hope I'm right. Thank you all for help on this.

[Mike]

There's a lot of misconceptions regarding when and why you would get a viral load test. A lot of this has to do with the old Interferon-based treatments and,  response-guided therapy.

In those days, it was important to show progress in killing the virus. This was because the Interferon treatments were very grueling, lasting 48-72 weeks and the cure rates were rather low - especially for genotype 1a (which accounts for 75% of infections in the US).

Simply put, if the person was not experiencing a significant drop in viral load, a decision would be made to stop treatment, as there were certain VL markers that had to be met in order to continue treatment (those who have endured Interferon will know exactly what I mean). There were also ethical considerations - in that, it was not appropriate to continue a grueling treatment when these markers were not being met and statistically the person would not clear the virus at the 6 month (26 week) mark.

This all changed with the advent of short 8-24 week and well-tolerated treatments (with the majority of those lasting only 12 weeks).

It appears the protocol is shifting to a pre-treatment VL, followed by an end of treatment VL, and a 12 week post treatment VL.

Many medical professionals believe that additional VL measures only drive the cost of treatment and they offer little clinical significance.

Although there are some exceptions to this protocol, the vast majority of those treated will only need 2 or 3 VL tests.

This is based on the fact that the vast majority of those currently being treated (90%+) will clear the virus and attain an SVR12.

Knowing this, does it really make sense to complete a VL every 4 weeks, and, can the additional cost for these tests be justified when considering the 90%+ rule?

Best wishes, Mike

[Jjules224]

Viral loads confuse me a bit-- I was looking over my old results and I was at 30,000,000 in 2004-- slowly down to 11,000,000 and the day I started Harvoni ( pre- first pill) I was 8,000,000.   Still too high for eight weeks of treatment,  but it is amazing to see the value drop over the years. ?    I know the viral load means less with HepC than say, HIV, but it is still interesting .      I am hoping that 8 million is easier to clear >

[SIXFOOTFOUR]

There's a lot of misconceptions regarding when and why you would get a viral load test. A lot of this has to do with the old Interferon-based treatments and,  response-guided therapy.

In those days, it was important to show progress in killing the virus. This was because the Interferon treatments were very grueling, lasting 48-72 weeks and the cure rates were rather low - especially for genotype 1a (which accounts for 75% of infections in the US).

Simply put, if the person was not experiencing a significant drop in viral load, a decision would be made to stop treatment, as there were certain VL markers that had to be met in order to continue treatment (those who have endured Interferon will know exactly what I mean). There were also ethical considerations - in that, it was not appropriate to continue a grueling treatment when these markers were not being met and statistically the person would not clear the virus at the 6 month (26 week) mark.

This all changed with the advent of short 8-24 week and well-tolerated treatments (with the majority of those lasting only 12 weeks).

It appears the protocol is shifting to a pre-treatment VL, followed by an end of treatment VL, and a 12 week post treatment VL.

Many medical professionals believe that additional VL measures only drive the cost of treatment and they offer little clinical significance.

Although there are some exceptions to this protocol, the vast majority of those treated will only need 2 or 3 VL tests.

This is based on the fact that the vast majority of those currently being treated (90%+) will clear the virus and attain an SVR12.

Knowing this, does it really make sense to complete a VL every 4 weeks, and, can the additional cost for these tests be justified when considering the 90%+ rule?

Best wishes, Mike

Mikes response seems to be more the way most of the groups (MDs) are going with tx now to keep costs down and with the high rate of success and low amount of side effects it makes sense to me. My MD pushed for Harvoni over Vikeria due to the need for fewer labs and reduced cost as well as easier compliance with patients.

I had a pre tx lab, labs at 7-8 weeks and then Im scheduled for EOT , 12 wk EOT and 1 yr

[apache]

4 week post treatment viral load correlates with a 98.5% chance of a cure

Can you please post a link to your source for this info?  I've tried googling SRV4, but didn't come up with any links that mentioned the 98.5% predictive value.

TIA.

[Lynn K]

http://forums.hepmag.com/index.php?topic=1477.0

"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"



I googled:
"hep c svr 4 predictive"

[apache]

I googled:
"hep c svr 4 predictive"

Thanks Lynn!   

Your google kung fu is very strong!  You bring much honor to your village! 

[Lynn K]

you give me great honor sir thank you