Hep C Discussion Forum

Hi Sandy,

We have commented on the lack of protocols for VL testing on the Sovaldi regimes.

The VA have a protocol that requires testing at 4 weeks, and if detected, to repeat the test in another 2 weeks. The protocol was revised on May 13, 2014.  Have a read- it's Table 14 on Page 25.

http://www.hepatitis.va.gov/pdf/2014hcv.pdf

Tig56 wrote:

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I discovered that assuming your doctor knows anything, when you hope he does, can prove disappointing.  

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The COSMOS results were presented at the 2014 London EASL conference.  Joel is being treated by a hepatology team at U of M.  If a team of university physicians, who are regularly treating hepc  patients and prescribing S/O,  haven't read the COSMOS study we are all in trouble.  

In this case I think it is safe to assume Joel's team are familiar with the S/O clinical trial results.  In general, however, I agree that there is a wide variance in what doctors know. 

Hi Sandy,

There have been several forum members remaining detectable at 4 weeks. Every one of them (including myself) were clear shortly thereafter. Impossible to pinpoint how soon after for many of us, given the different testing protocols people are encountering. The only relapse of a forum member on the S/O combo that I'm aware of was by someone who was und at 2 weeks. The RVR standards for these newer treatments are still a work in progress. There's no doubt Joel will be und in the not too distant future. And there's virtually no chance of a viral breakthrough during tx with these meds. I personally think a good idea would be VL checks at 6 weeks, then at 4 & 12 weeks post tx. The earlier tests seem rather pointless to me, since they won't affect treatment duration and can lead to disappointment and worries. The eot check seems redundant because everyone is coming back und at that point. It's what happens later that counts.

As for extending treatment, I chose to do so as a safety precaution. Insurance cooperated in my case, but I think that is more the exception than the rule. With his minimal side effects, it couldn't hurt to try. Cirrhotics are and will remain the more challenging treatment group. 

Best of luck to you,

wayne

Isiscat2011 wrote:

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In cohort 2 it shows that while 93% achieved SVR in 12 weeks, 100% did in 24 weeks.  This study is good evidence in support of extending tx (and insurance paying for it).  Your doc no doubt already knows about it.  

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I discovered that assuming your doctor knows anything, when you hope he does, can prove disappointing. When you are presented with documentation like this, you're better off by presenting it to him/her/them in the form of a question. My Hepatologist was thankful on more than one occasion (as was I), when I questioned the direction my treatment was going. Leave no stone unturned...

Tig

 

Hi again Sandy:

I don't know if you have ever read the COSMOS clinical trial results but it is directly relevant to Joel's tx.  COSMOS was the phase 2 trial study for the sovaldi/olysio combo.  About half of the participants in cohort 2 had cirrhosis; the rest were F-3.  

In cohort 2 it shows that while 93% achieved SVR in 12 weeks, 100% did in 24 weeks.  This study is good evidence in support of extending tx (and insurance paying for it).  Your doc no doubt already knows about it.  

I hope this helps put your mind at ease that this has indeed been an effective tx.  Have a look:

Cohort 2

Eric Lawitz from the University of Texas Health Science Center presented late-breaking findings from COSMOS Cohort 2. Because people with advanced fibrosis or cirrhosis are at greater risk for treatment failure, this cohort was started later after investigators saw high response rates in Cohort 1.

About two-thirds of Cohort 2 participants were men, 91% were white, 9% were black, and the median age was 58 years. (People over age 70 were excluded, but Lawitz said he would not do this again in the future.) Again, 78% had subtype 1a, 40% with the Q80K mutation. About half were prior null responders and 79% had unfavorable non-CC IL28B variants. Just over half had advanced fibrosis (stage F3) and 47% had compensated cirrhosis (stage F4).

Results

• Sustained response rates in Cohort 2 were similar to those of people with less advanced liver disease in Cohort 1.
• 93% of participants assigned to simeprevir/sofosbuvir either alone or with ribavirin for 12 weeks achieved SVR12; among those treated for 24 weeks, SVR12 rates were 93% and 100%, respectively.
• Everyone treated for 24 weeks was cured regardless of HCV subtype; in the 12-week treatment arms, 2 genotype 1a patients without the Q80K baseline mutation and 1 with the mutation relapsed.
• 2 people (both in the 24-week triple therapy arm) had non-virological failure.
• People with all IL28B variants had SVR12 rates greater than 90%, with no clear pattern.
• Overall SVR12 rates were 98% for people with advanced fibrosis and 95% for those with cirrhosis.
• There were 3 relapsers, all treated for 12 weeks (2 with and 1 without ribavirin); 2 of the relapsers had cirrhosis (1 a prior null responder, the other treatment-naive).
• Treatment was generally safe and well-tolerated even for patients with advanced liver disease.
• There were 4 serious adverse events and 1 discontinuation for this reason.
• The most common side effects were fatigue, headache, and nausea.
• 13% of participants developed anemia, all but 1 in the ribavirin-containing arms.

Again, the researchers concluded that SVR12 rates were high, regardless of baseline characteristics, and that extent of liver fibrosis/cirrhosis and prior treatment history did not play a role.

The current package insert for simeprevir states that pre-treatment testing for the Q80K variant is "strongly recommended," but this may be unnecessary when using it with other direct-acting antivirals. "As we enter the world of multiple DAAs, additional DAAs should cover Q180K, so dont need to test for it," Lawitz said.

Given that ribavirin adds side effects but did not appear to improve efficacy, a pair of Phase 3 trials testing sofosbuvir/simeprevir alone -- OPTIMIST-1 for non-cirrhotics and OPIMIST-2 for people with cirrhosis -- are now recruiting. Since 12 weeks of treatment was highly effective in COSMOS, the new studies will compare 8 vs 12 weeks to see if treatment can safely be shortened to just 2 months.

4/13/14

-- Edited by Isiscat2011 on Sunday 22nd of June 2014 05:34:47 PM

Hi Sandy:

This has happened to others who went on to become UND at the next VL check at 6 or 8 weeks.  I would ask doc for another VL check in a few weeks and also ask him to give the ok for extending tx as Malcolm and others have already suggested.  

That hubby's VL has dropped by so much (almost 3 million is a large number of virus butt to kick in 4 weeks) is encouraging news.  It is also very good news that he is tolerating the tx well; that will make extending tx a bit longer very doable.  Hang in there, Sandy!  Sending some sunshine your way.

sandypsych wrote:

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oops.  I never have gotten the hang of those signature lines!

Yes he is geno 1a.  He has been in several treatment protocols, with the most recent being Incivek/riba/interferon.  Currently he is on Solvaldi/Olysio without the Riba since there is suspicion that contributed to his horrible rash last time.

The doctor had not mentioned a longer course of treatment, though it makes sense.  The side effects have been so minor (some insomnia, but that's really it) that we would rather do four/six/twelve more weeks and be done with this beast!  I may contact them this week, and ask about that.  We go back to U of M to see the doctor at the end (at the 12 week mark).  so if we are going to extent treatment we will undoubtedly need to fight with insurance .  So I might as well gear up for the fight now.  

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 Sovaldi is a good drug, It works, and your combo is only one of 3 new drugs combo for geno 1 that they are experimenting with right now. 24 weeks is the most he might have to take it, In my opinion . 

mallani wrote:

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Hi Sandy,

We know from previous posts that hubby is Geno 1a. Given he is still Detected at 4 weeks, you might like your doctor to consider extending Rx to 16 or 24 weeks. Cirrhotics should have a bit of leeway and hubby has a history of problems with the early antiproteases and Riba. Best of luck.

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 I Agree, Geno 1 will have the Peg- IN and the Extended RVR does indicate a longer treatment duration, from my understanding this is why they test at 4 weeks, to find people who may need a longer treatment duration.

Hi, Sandy,, We don't know what your genotype is, the genotype has a lot to do with the RVR or rapid viral response, They also have what they call Extended RVR, that is what it sounds like you have. This only means something if you are taking Peg-IN , since the new all oral tx this RVR " measured at four weeks as a standard " is not necessary as it only indicates response on the Peg=IN. So now it is better to test later after the drugs have had time to effect the VL in all genotypes.
Let us know what your genotype is and we can help more. you can put this info in your signature, and Welcome!