4 weeks week viral load 60 still detected worried on 8 week tx

[printze]

I am getting very scared I am still detected have 2 more weeks to do. Should I be worried I am on 8 week tx.

[printze]

Because these drugs are so new and the full data is not in as to why people may fail I have to believe that first and foremost I will get the additional 4 weeks and if not then I still have a good chance of achieving svr in 12 weeks. I still have 8 days left so there is a good chance since my 4 week viral load that those few remaining have gone. I have to be positive that one way or another I will succeed.

[JimmyMose]

Found this

http://www.aidsmap.com/When-a-short-course-of-sofosbuvirledipasvir-fails-some-people-can-be-cured-of-hepatitis-C-with-a-double-treatment-duration/page/2965963/2965963

"People initially treated for 8 rather than 12 weeks had a substantially higher SVR12 rate: 80% vs 46%, respectively. Baseline NS5A RAVs produced an even larger difference: 100% of those with and 60% of those without these RAVs achieved sustained response. People with a single RAV had a cure rate of 69%, falling to just 50% for those with two or more RAVs. Looking at specific NS5A RAVs, all participants with Q30R or M28T still achieved SVR12, but the cure rate fell to 80% for those with L31M and to only 33% for those with Y93H/N."

Looks like odds are better for retreatment 24 weeks if 8 week tx failed.  I don't understand much or how they check for RAV but this one Y93H/N seams real tough.

I treated last year GT2 cirrhosis with SOV/RBV 12 weeks. I had read that 16 weeks might be better and asked but they would only give me 12.  I pretty much stopped worrying about it, focused on my treatment, believed it would work and achived SVR.  Now the guidelines have been changed to 16 weeks.

I think you will achieve SVR.  Stay positive and believe. Who knows maybe it's posible faith or the lack of, can be a small factor in affecting the percentages of achiving SVR.

[OdinLovesLife]

Wishing you the very best outcome.

This is all still so new. Lot's of indicators that it will be OK after 8 weeks, but I sure know how you feel being still detected myself at the 4-week mark (different treatment). It's hard not to start worrying.

In a year we will all know what the right course of action would have been. By that time there will probably be even more effective drugs available. The high current cost of HCV treatment and the hang over of terror from interferon make it all seem dire. (I slip into that frequently). When I stop to think about it logically though, the future is really bright. There will be an almost 100% effective pan-genotypic cure quite soon. So getting the health insurance sorted, or being in the queue for a trial is genuinely going to be a fruitful back up strategy for anyone worried about failure this time.  

Again, wishing you the best. If it was me I would take whatever action I could to improve my odds too. If that doesn't work out though, things aren't as bad as they were even a few years ago. There is still hope.

[flyinlynn]

http://depts.washington.edu/hepstudy/presentations/uploads/122/ion3ledipasvirsofosbuvir.pdf

ION - 3 Study

Conclusions: “Ledipasvir-sofosbuvir for 8 weeks was associated with
a high rate of sustained virologic response among previously untreated
patients with HCV genotype 1 infection without cirrhosis. No additional
benefit was associated with the inclusion of ribavirin in the regimen or
with extension of the duration of treatment to 12 weeks.”

SVR 94% (202/215)

ION-3 Study: Baseline Characteristics
1a, n (%) 171 (80)
1b, n (%) 43 (20)


From the prescribing information shert breakdown of SVR 12 Harvoni fo r8 weeks GT 1a vs GT 1b

Table 6 pg 23

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

SVR by Genotype HARVONI 8 Weeks (N=215)

Genotype 1a    93% (159/171)

Genotype 1b    98% (42/43)

SVR by Genotype HARVONI 12 Weeks (N=216)

Genotype 1a     96% (165/172)

Genotype 1b     98% (43/44)

[flyinlynn]

CROI 2015: HCV Viral Load and Speed of Decline Do Not Predict Cure with Interferon-Free Therapy


http://www.hivandhepatitis.com/hcv-basic-science/5160-croi-2015-hcv-viral-load-and-speed-of-decline-do-not-predict-cure-with-interferon-free-therapy

"Contrary to past experience with interferon-containing treatments, low levels of quantifiable HCV RNA at [end of treatment] do not preclude treatment success," the study authors concluded.

[printze]

One point Gilead did not cover out of the relapses in 8 weeks how many were gt1a the hardest to cure verses gt1b so perhaps there is a difference.

[printze]

I agree those with no fibrosis low viral load and tx naive could be considered for the 8 weeks I am F2 tx naive I believe that 12 weeks should be the protocol however with these direct acting drugs they work differently from the older ones and I have read those who were still detected at end of tx still went on to Svr, it is hard to know these drugs continue to work stopping replication of the virus I still want tha extra 4 weeks being a slow responder as is in my case. These drugs are so new

[hepcandme]

This must be nerve wracking for sure and it wasn't even covered in your Hep C How To Manual

I think that for those who are treatment naive and with no damage to their liver, 8 weeks might just be enough but I think you are being prudent - and your doctor should be as well - to extend treatment if you are still detected at your next labs

Sending positive thoughts your way that we were all just being worried unnecessarily and that SVR is within your grasp!

[printze]

Thanks everyone just keep me in your thoughts the next few days will be nerve wracking waiting for the answer I really think they Gilead should omit 8 weeks and just suggest 12 weeks and 24 weeks. even though 8 weeks does work for some I am the example that fitting that criteria it still is not enough. Praying I get that extra time all I can do is wait for now.

[patra_]

If the Ins Co has the nerve to deny the extension, appeal that decision immediately!  There are 2 reasons to do this:

1.  So you can get the meds without interruption of tx, paid for by the Ins Co.

2.  So, if they deny it the 2nd time, you still have time to get help from Gilead, again, so that your tx is not interrupted.

Good luck with this - here's praying the Ins Co approves the extension right away, without problems, so you can continue your tx without a break in tx!

Blessings,

Pat

[virt111]

Good luck, Printze! Hoping that it gets approved.

[printze]

Forms sent to my insurance today for additional 4 weeks praying they approve the additional. I will let you all know. Wish me luck.

[keepingOnkeepingOn]

I'd have it extended to 12 weeks and don't take no for an answer.

[Ekkiemom]

Hey P!  Don't judge your labs by other treaters labs, remember we are all diff and not all have RVR OR EVR.

You are going in the right direction and that is a great indication, so relax

Peace
Deb

[hepcandme]

Thinking about you and sending good thoughts your way for a hearty Undetected in the weeks to come!

It ain't over till it's over

[printze]

Thank you all I only have 12 more days of pills to take so you can understand my anxiety. I am waiting to hear my doctors imput on this possibly tomorrow my case nurse said some people do respond slower than others. My first viral load at 2 weeks was 108, 60 at 4 week. Fingers crossed.

[Momof286]

I finished my 8 week on April 7 I was detected at <15 on week 4 and at 8 weeks I was undetected. My starting viral load was 689,000 so I was bummed I didn't reach undetected at 4 weeks. My doctor and nurse wasn't concerned with my 4 week results but actually were happy. They said being undetected at 4 weeks didn't predict SVR outcome and that the new meds are different as far as response time etc. that being said they didn't feel extending my treatment was necessary. I have my 4 week EOT coming up on May 5 so I am hoping for undetected. I have also seen on another forum of the 8 week treatment a member was detected 29 at EOT and still cleared the virus. Also a member did 12 weeks and was detected at EOT and cleared the virus 12 weeks post! Keep up your positive thinking! Everyone responds differently and with these new drugs guidelines are different response times don't predict future outcomes!

Keep your eye on the prize! And try not to stress too much! I did and felt the same feelings you are and I am just keeping the bigger picture in my head!

[jules2551]

Hang in there Printze.  I agree with Virt.  The rules have changed with Harvoni's new treatment.  So UND doesn't mean you will not be SVR.  Just keep on taking the pills I know it's nerve wracking.  

jules

[Rbeth]

Hi printze,

I have also read the same.
I did Harvoni 12 wk results >
Wk 4 -550
Wk 7- <15 Detected
Wk 8- <15 NOT Detected
Wk 12-  Not Detected

So, I wasn't undetected until wk 8, that being said, I did do 12 wks
I do think you're good to go, but I must say, if you can get extra 4 weeks, why not~? I probably would....if I could. Can you get a VL checked at 7 wks?

Anyway, talk with your doc more about this, try not to worry ~ you'll be fine and always advocate for yourself :-)

Best blessings,
Randy

[virt111]

Here are a couple of links:

http://hepatitiscnewdrugs.blogspot.com/2015/03/hcv-rna-does-not-always-mean-treatment.html

and

http://cid.oxfordjournals.org/content/early/2015/04/02/cid.civ170

Best wishes for you.

[virt111]

I've read on another forum where a couple of people said that they were still detected at the end of treatment and went on to get SVR12.

Don't want to promote another forum here, so here's an excerpt in reply to another 8 weeker who was detected at the end of treatment:

"on the last day of my 8 wk treatment, i tested Detected 29.  That's 29 with NO more Harvoni to be taken to fight the Virus.... I just tested at 11 wks post treatment for SVR12 and came up Undetected, so stop worrying.   Low level detected even at end of treatment often resolves itself over the next several wks to a good outcome."

I would ask your doctor about it just to have a backup plan. Maybe he/she can get another 4 weeks approved, if needed.