A what if question..

[susan400]

Has anybody heard of any treatment modifications if one was to clear later like say, on week 8 instead of week 4?  I am wondering if anybody has mentioning changing the game plan then and extending out to 24 weeks?   Or like if somebody was on the Olyssio and Sovaldi and didn't clear until week 8, adding in Riba?    Or if you clear late , like at week 8, continue on with the Sovaldi + SOC until week 12 and at that point, drop the Sovaldi and just do an extended extra 12 weeks of the SOC?  I just want to make sure that if I do clear and it's later than the 4 week blood draw I just had, that there is something in place to carry it on out?  Has anybody tried this or do that just give up?   Susan400

[HectorSF]

I understand your anxiety about not curing the virus. We all want to be done with hepatitis C once and for all. It is attacking my new liver that wasn't even infected until in was put in me 8 months ago. I am not happy about that I can tell you. After failing 48 weeks of Sovaldi + ribavirin treatment my options right now are limited. There are no trials that I am aware of that accept patients that failed Sovaldi treatment. All I can do is whatever treatment(s) is available to me and hope for the best. Besides after being told I had terminal cancer then having a liver transplant you get a perspective on things and realize that sweating the small stuff is a waste of time and energy. All we can do is what we can do and hope for the best.

Ah, thanks for mentioning your treatment. I wasn't sure what treatment you were on. We know that outcome is based on "host factors" so you can have a pretty good of what you can expect based on trial results. Since you previous treated unfortunately that lessens the effectiveness of treatment but at least you are giving it your best shot and while you are undetectable the virus won't be doing additional injury to your liver after 30+ years. Now that is an accomplishment in itself.

NEUTRINO Study genotype 1 treatment naive patient SVR rates
Genotype 1a - 92% (206/225)
Genotype 1b - 82% (54/66)

Cirrhosis
No - 92% (252/273)
Yes - 80% (43/54)
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Multiple Baseline Factors
Genotype 1, Metavir F3/F4 fibrosis, IL28B non-C/C, HCV RNA >800,000 IU/mL - 71% (37/52)
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It is estimated that the response rate in patients who previously failed pegylated interferon and ribavirin therapy will approximate the observed response rate in NEUTRINO subjects with multiple baseline factors traditionally associated with a lower response to interferon-based treatment.

In other words about a 71% SVR.

The good new is that if this current treatment should fail we know that there are much better treatments (90%+ vs 70%) coming for harder to treat folks very soon.

ION-2: Treatment-experienced
bout 45% were prior non-responders who never reached undetectable viral load on interferon-based treatment -- a harder group to treat than people who relapsed after finishing treatment. Half had failed a previous regimen that included a first-generation HCV protease inhibitor -- boceprevir (Victrelis) or telaprevir (Incivek or Incivo) -- plus pegylated interferon/ribavirin.

Again, participants were randomly assigned to receive the sofosbuvir/ledipasvir coformulation, with or without ribavirin, for either 12 or 24 weeks.

Here too, SVR12 rates were high for all treatment arms, and similar to those seen in treatment-naive patients:

94% with sofosbuvir/ledipasvir for 12 weeks;
96% with sofosbuvir/ledipasvir plus ribavirin for 12 weeks;
99% with sofosbuvir/ledipasvir for 24 weeks;
99% with sofosbuvir/ledipasvir plus ribavirin for 24 weeks.

Good luck with your treatment!!!
Hector

[susan400]

Thanks, Hector.  As you can relate,..., I am understandable anxious about my outcome with this viral load I just had drawn on Wed.   You've probably read that I'm not on the 24 week treatment and not taking the Olyssio.  I am doing the Sovaldi and SOC.   Because of my previous bad experience with the Telaprevir and the school of thought that I might have the variant problem, I decided to do the SOC + Sovaldi.  I'm just anxious about the 12 weeks being ENOUGH to get it done.  Waiting for Ledi/Sof combo was not something I wanted to do.  Basically, because I'm not totally comfortable with the rashes involved with the proteases inh.  I have a huge problem with these skin things and don't want to add that in the mix if I can avoid it.  Fortunately, I've been blessed to not have a fast progressing damage, thus far, but after 30+ years w/o viral clearance and getting older, post menopausal, etc., it does make me want to be done with this treatment business.  I don't know how you are so upbeat and positive and helpful, with all you've been through, but you are an inspiration.  Susan400

[HectorSF]

The term RVR was used with peg-interferon and ribavirin treatment and is no longer used. It is already known that when a person becomes undetectable makes no difference in outcome with at least some treatments. Also the addition of ribavirin to Sovaldi + Oyysio makes no statistical difference in outcome as was found in the COSMOS phase 1 and 2 studies. In fact those that become undetectable by week 4  were the minority, and were less likely to achieve SVR than those who become undetectable after week 4.

Final Data from the Phase 2 COSMOS Study of Janssen’s Once-Daily Simeprevir in Combination with Sofosbuvir

"...treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12).
The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks."

"Rapid virologic response (RVR, defined as undetectable HCV RNA at Week 4 of treatment) was not found to be predictive of achieving SVR. In patients receiving simeprevir and sofosbuvir alone for 12 weeks, 93 percent achieved SVR, while 57 percent achieved RVR. "

Treatment SRV rates are not based of viral load kinetics as they were with older and now obsolete peg-interferon based treatments. There are no "partial responders" with new Solvadi based treatments. Everyone who treats with these treatments becomes undetectable at some point and stays undetectable until they stop the treatment. All people that fail treatment do so by relapsing.

Treatment success (SRV) is based on the persons host factor before starting treatment not what happens during treatment. Treatment success is based on host factors such as... What genotype are you? Do you have cirrhosis? Did you fail previous treatment? etc. People need to choose the treatment, from what is available to them, that will give them, with their particular host factors, the best chance at SRV.

As new treatments become available people will have more options to chose treatments that will be geared to different subgroups of people with certain host factors. We already have this with genotypes now but it will expand to other host factors soon.

Looking back to peg-interferon or even ribavirin for help or hope curing hepatitis C is not on anyone's radar. We are are looking for newer and more effective treatments that we see now in trials.

Hector