36 month relapse?

[8nickers8]

I was just following the thread asking for everyone who is on 7977 to write a small paragraph about themselves and in it someone wrote that their hepatologist said that one of the first patients who was on 7977 trial and undetectable for at least 6 months after treatment came back as relapsed after 36 months. Has anyone heard anything about that?  I look all the time to see if anything is released and the only relapsers I know of are Genotype 1's who respond while on drug but relapse shortly thereafter.  Any one know anything?

[8nickers8]

I an so sorry.  I was so wrong about the information that I gave regarding cryoglobulins.  Interferon is not an immunosuppressant.  I had it mixed up with cyclosporine which is the med that they give to transplant patients to suppress the immune system so that the body doesn't reject the new donor organ.  Anyway, I did some checking and for myself, my hepatologist did the blood work that showed the cryoglobulins showing up at about 7 days which means they would be the type II or type III.  And I definitely have so many of the symptoms that Dawn described and that are in the wonderful article that she gave me the link for that describes the symptoms.  But the strange part is that two big indicators for cryoglobulinemia, something they call C4 and C3, are usually very low in people who have cryoglobulinemia and mine are normal.  So, I"m very confused.  I am asking my PA from my hepatologist's office to run a blood test for cryoglobulins and C4 and C3 again. I asked her to be sure it is for 7 days and not the one for 72 hours because mine doesn't show up until at least 7 days.  Anyway, I hope to have the prescription for that this week and I will let you all know what happens with that.  Again, I apologize for the misinformation that I gave.  Oh and the question as to whether or not 7977 and that class of drugs would help the cryoglobulins as they know the interferon helps them, is still an open question.

[8nickers8]

Thank you so very much for this explanation and all the information.  I am beginning to understand now.

[zako7]

Check your source of information very well may be it's 36 weeks and not 36 months.

[Idyllic]

He is saying the person would have to have treated and cleared the virus and then three years would have to have lapse for the person's account of events to make sense. If the drug did not introduced to trials until 2010 then the three year timing does not jive. Somehow there might be confusion with the dates in that post.


People who did not treat in a trial usually take (or took) a combination of drugs:

Just as an example : Hepatitis C FDA-Approved Combination Therapy


  Boceprevir + Pegylated Interferon + Ribavirin
  Telaprevir+ Pegylated Interferon + Ribavirin
  Pegasys + Copegus (peginterferon alfa-2a + ribavirin)
  PegIntron + Rebetol (peginterferon alfa-2b + ribavirin)
  Roferon A + Ribavirin (Standard interferon alfa-2a + ribavirin)
  Intron A + Rebetol (Standard Interferon alfa-2b + ribavirin)
  Infergen + Ribavirin (consensus Interferon + ribavirin)
______________

If you look to your right there is a box that has "Recent Activity" then another that has Medhelp Answers and the box under that says "Related forums"
http://www.medhelp.org/forums/Hepatitis-Social/show/76

[Advocate1955]

Copegus is a brand name of Ribavirin.
I can't answer your second question because I don't understand what you mean by "7977 the 48 months of something else".  I believe what Hector was referring to was the various description of the first trials of 7977 that included 7977 followed by various lengths and combinations.
Advocate1955

[8nickers8]

What an honor to be in a group like this with so much knowledge and understanding.  Question, someone mentioned a social arm of the hep c community and a medical arm of the hep c community.  How do I get to the different arms?

[8nickers8]

Hector I don't understand all this nor do I understand what you mean.  I think you are saying that 7977 hasn't even been in clinical trial for 36 months let alone having a failure.  Right?  Also, what the heck is Copegus?  I am stunned to see 7977 the 48 months of something else.  What is all that?

[maybe368]

Hector is absolutely correct with has answer, but I just wanted to give my opinion that anyone that relapses  36 months after svr was probably re-infected. Remember that just because you clear the virus, you are not left immune to re-infection to the same, or different geno-type...Mark

[HectorSF]

Any third hand stories should be taken with a grain of salt. I find it curious that someone supposedly relasped 36 months/3 years after treatment with 7977. Treatment with 7977 only started in 2010 (a Phase IIa study which ended in almost a year later). Treatment was for 48 weeks in combination with peg-INF and ribavirin in only treatment-naive patients.

Pharmasset Initiates Phase 2a Trial With PSI-7977, A Chirally Pure Isomer Of PSI-7851
January 2010

'Pharmasset, Inc. (Nasdaq: VRUS) announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

The Phase 2a trial is expected to enroll about 60 patients with chronic hepatitis C infection who have not been treated previously. The primary goal of the study is to determine the safety and tolerability of PSI-7977 in combination with pegylated interferon and ribavirin. The primary efficacy endpoint of the trial will be the proportion of patients who achieve a rapid virologic response (RVR), defined as undetectable levels of HCV (measured by TaqMan assay) four weeks after the initiation of treatment. Patients will continue to be followed through a Sustained Virologic Response (SVR) endpoint. Patients will be randomized to receive one of four treatments:

-- PSI-7977 100mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus

-- PSI-7977 200mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus

-- PSI-7977 400mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus

-- A control arm with Pegasys and Copegus'

http://www.medicalnewstoday.com/releases/176924.php

So comparing various current treatments with 7977 and trying to derive something useful from a different treatment regime is comparing 'apples to oranges' so to speak. The devil is in the details.


Cheers!
Hector