"BERLIN, March 31, 2011 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS™ (boceprevir) to peginterferon alfa-2b and ribavirin (PR) in adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. The new data analyses identified potential predictors for the likelihood of achieving sustained virologic response (SVR)¹ based on a patient's response during a four-week lead-in period with PR alone prior to the addition of VICTRELIS, as well as the genetic marker IL28B. The results were presented today at The International Liver Congress™ / 46th European Association for the Study of the Liver (EASL) annual meeting. "
"HCV-RNA decline after 4-week PR lead-in period helped predict likelihood of SVR
In pre-specified analyses, researchers evaluated the relationship between decline in levels of virus (HCV-RNA) after the 4-week PR lead-in period to overall SVR.
In the HCV SPRINT-2 treatment-naïve study, patients receiving VICTRELIS who had good response after the 4-week lead-in period, defined by a greater than or equal to 1.0-log10 decline in HCV-RNA , achieved SVR rates of 81 percent (203/252) in the RGT arm and 79 percent (200/254) in the 48-week treatment arm compared to 51 percent (133/260) in the PR control arm. Patients with poor response after the 4-week lead-in, defined by a less than 1.0-log10 decline in HCV-RNA, achieved SVR rates of 28 percent (27/97) in the RGT arm and 38 percent (36/95) in the 48-week treatment arm compared to 4 percent (3/83) in the PR control arm.
Similarly, in the HCV RESPOND-2 treatment-failure study, patients receiving VICTRELIS who had good response after the lead-in achieved SVR rates of 73 percent (80/110) in the RGT arm and 79 percent (90/114) in the 48-week treatment arm compared to 25 percent (17/67) in the PR control arm. Patients with poor response after the 4-week lead-in achieved SVR rates of 33 percent (15/46) in the RGT arm and 34 percent (15/44) in the 48-week treatment arm compared to 0 percent (0/12) in the PR control arm.
These analyses showed that 4-week lead-in response helped predict SVR in all three treatment groups, and the addition of VICTRELIS to the treatment regimen improved SVR rates regardless of whether patients had good or poor response during the lead-in period. "
"Data on resistance-associated variants also presented
To better understand resistance-associated variants when VICTRELIS was added to standard therapy, researchers analyzed blood samples from 343 patients who did not achieve SVR in the HCV SPRINT-2 and HCV RESPOND-2 studies. Samples were obtained at various time points of virologic failure (BREAKTHROUGH, incomplete virologic response, relapse and nonresponse), and resistance-associated variants were detected by population sequencing.
Results of this analysis [Oral presentation Parallel Session: HCV Therapy] showed that resistance-associated variants were highly associated with those patients not achieving SVR, and that the majority of patients with virologic BREAKTHROUGH or incomplete virologic response had viruses with detectable resistance-associated variants.
When analyzed as a function of poor response after the 4-week lead-in (less than 1-log10 viral load decrease) versus good response (greater than or equal to 1-log10 viral load decrease), resistance-associated variants were more frequent in patients with a poor lead-in response (68 percent) compared with patients with a good lead-in response (31 percent). Additional analyses are ongoing, with a 3.5-year long-term follow-up study underway to evaluate the persistence of resistance-associated variants over time."
Hi. I am very sorry to hear this. Of course it must have been a horrible shock. Anyone would feel terrible about this. I know it is tough to deal with. I've had my own shocks and so how muddled through. It will be up and down. Sometimes you will feel better than wham. If you have supportive people around you that you and talk to I would highly encourage you to not try to go it alone. It is worse if we keep it bottled up.
Yes, first thing is do no harm, so you can come back and fight another day IF this is a viral breakthrough.
Maybe all is not lost?
So breakthrough was after 8 weeks of Victrelis? I'm I right?
I would continue treatment if possible and see if your next viral load test still shows an increase in viral load or not. If you are having a breakthrough is will rise up fast. Maybe you can get another VL test before waiting a month? maybe from your primary doctor?
Ribavirin shouldn't be the reason so don't worry about that.
Hang in there. I know the anemia and other sides from treatment can really be trying mentally too.
If I come across data on Victrelis breakthroughs early in treatment I will post them.
Keep us in the loop.
I hope you feel better soon.
Q&A on Hepatitis C and African Americans With Jonathan McCone, M.D., Victrelis Researcher
By Kellee Terrell
From The Body
July 6, 2011
"Recently, the U.S. Food and Drug Administration announced the approval of two drugs for hepatitis C virus (HCV) treatment, Incivek (telaprevir) and Victrelis (boceprevir) -- the first new HCV therapies in 10 years. This news is exciting for many people living with HCV, but especially so for African Americans.
HCV, a blood-borne disease that damages the liver, affects almost 4 million Americans (many of whom are also living with HIV), and African Americans account for almost 22 percent of those cases. Historically, with older HCV therapies, African Americans haven't had much success. But these new drugs appear to significantly increase the odds that treatment will work. For instance, when Victrelis was studied specifically in African Americans, researchers found that the African Americans who took the drug along with standard HCV treatment showed a significant increase in the odds that their HCV infection would be treated and cured...."
"....The most important thing to know is that HCV can be cured. Before Victrelis, we were seeing overall cure rates of just 40 percent in Caucasian Americans and only 23 percent cure rates in African Americans. But when we added Victrelis, African Americans who didn't have cirrhosis of the liver improved two-fold."
Sorry to hear this, BUT a true viral breakthur is almost always much much larger then that....... Myself i would have wanted to see if they had any blood left at the lab from the 12 week test and have them redo it.
When i was in the boceprevir trial i was und at week 6, at week 8 my labs showed a smal amount, Kwo had them rerun the 8 week results and it came back und...... There was others here that also happened to.
Hang in there.
Also should add that from 10 weeks on all tests showed UND, and i am now SVR.
I am still wrapping myself around your news, bee. I, like can do, would want the sample rerun to determine if you had virus. You just don't hear of viral breakthroughs under 43. Or get a new test. Since there was some confusion in the doctor's office - at first they told you you were UND - and later that you were detectable - are they not willing to do that?
I can only imagine how you feel. All I can say is hang in there. You started with 10 million and were at 329,000 at the lead in so you are still in the group that should clear -- if we can get this pesky BT resolved.
Reported Report SpamAbuseDuplicateGreatBird
Dec 21, 2010 .To: RobertBeWell.Being on a trial has nothing to do with it, although being blinded for VL adds to the uncertainty. My trial wasn't blinded for VL so I had them all as I was going along and had tested UND from week 12 until I got the blip. Since that blip I've tested UND--up to and including the most recent 1 year post PCR.
Hang in there. . Reply . Reported Report SpamAbuseDuplicate
Dec 21, 2010 ..If they are using the taqman 2 as many clinical trials seem to these days and a person was und, the report from roche will merely sate "HCV RNA not detected" without parameters.
This test was only recently approved by the fda but has been used in the clinical trials for a while. I don't have my printout before me but I believe that when I was under 25 it read: detected <25
If it is indeed the taqman 2 they either are unable to quantify or not approved to report a quantifiable number under 25 iu/ml. The lower limit of detection of the test is 10 iu/ml so <25 would mean RNA somewhere between 10-25 iu/ml. If it is above 25 iu/ml of course it will quantify it.
There are at least a few people here who have SVRd and reported a blip at or after week 12 and you have no way of knowing if this is one or not. As you said it can't hurt to go another 4 weeks since you aren't feeling poorly. Good luck my friend!
They used less sensitive test for you and it is reported differently. You can always ask for a more sensitive test if it would make you more comfortable.
All the odds are in your favor as everyone has mentioned. It's not over till it's over of course, and it's only natural to worry a bit, but I would be shocked if you are not und for real and if you don't svr.
Happy Holidays Everyone,
As you can see, this does happen.... I might be wrong but i really don't think this is a breakthough........ Keeping our fingers crossed...........
BTW, greatbird, robertbewell, Dave (spectda) and myself are all SVR now.
So sorry to hear this news, but I wonder if this goes back to the interpretation of "<43". It seems to me that lack of consistency in the way the labs report the results leads to confusion, not only for us, but for the doctors.
Do the 8 and 12 week PCR's state "<43" only, or does include the words "Detected" or "Undetected". If it states "<43, Detected", then indeed it seems clear there is virus below the LOQ.
I'd want to run a more sensitive test now to eliminate this confusion. If you're using Quest you can do the Heptimax, or just do the second part of it (TMA) to save a little time. I hope things get sorted out quickly and you can continue on trt. Best wishes to you.
I'm sorry, I don't have the information you need but I just wanted to say that I'm with you - fighting on.
It is definitely shattering news. I was still DET under 25 at week 12. It was a 5 log drop, I'm told, although I still don't fully understand what that means.
Hang tough. We'll get there. Unfortunately I can't find any information about treating Aboriginal people and the success rates and I wonder if I might have the same 'issues' you do. :(
Psalm 131-..."And I will rest in God's arms the way a child is cradled by it's mother"- my prayers and thoughts are wrapping around you as well.
Bee! So sorry to hear this.. but don't despair... if I were you, as the others said, I would have my primary order a heptimax or quantasure asap to put your mind at ease. I am sure it is just a blip!
So sorry Bee! Hang in there and hopefully like everyone else has said it will work out,,blessings to you...anne
Have you had your vitamin D levels checked?
I am with others, get a second PCR. Play it from there....
I wish you could tolerate more ribavirin. In my trial for victrelis I was und at week 10, DET <25 at week 10, und from then on until 6 month SVR. I treated for 43 weeks total.My trial doctor did not consider that a breakthrough. He said a real break through would mean that my VL had climbed several hundred or more.
Which test is your doctor using? I would expect that they would use something that is detectable to at least 25 as they did in the trials. the taqman 2 which was used in the trials and has a quantifiable limit of 25 and a lower sensitivity of 7.2 is available. Why not use that one so they know precisely where you are?
Best of luck, you know we are all rooting for you,
bee...everybody here loves you...good luck moving forward....billy
I just want to let you know that I am sending you a big big hug and praying for you that you will be clear next tests that they do. I hope you are able to get a second PCR! Here routing for you..dear friend!
May God heal your body and soul.
May your pain cease,
May your strength increase,
May your fears be released,
May blessings, love, and joy surround you.
Biggg Huggggggggggs anita
Am wondering though, did your doctor not know that you tested det. at week 12?..... I see you just now started procrit, just so you know it takes a few weeks to help. It would be great if you can get back up to speed on the riba.
You have gotten some great info above, nothing I could add, you will be in my thoughts and wishing you all the best moving foward.
bee, just wanted to let you know you're in my thoughts and prayers. hang in there. best of luck to you my friend. belle
Hi Bee...sorry to hear this ,however I would agree that this very well might not be a breakthrough at all.
There was a member here recently (however not here now) who was <43 UND. at week4 and then at week 8 showed <43 DET. At the time it was considered just a blip and she re-tested at week 10 and again was <43 UND. as she was at week 12 and 16 and right thru to week 24.
I would agree to possibly get the same sample teted if possible ,and if that is not do-able then get another PCR right away to confirm and if they could do the test with a lower level ofs sensitivity it may be beneficial.
Good luck Bee..
This is the labcorp test used in the Victrelis trials. I don't understand why your doctor is not using something more sensitive quantifiable to 43. Hopefully the procrit will allow you to take more ribavirin when it kicks in.
Hepatitis C Virus (HCV), Quantitative, Real-time PCR (Graphical)
HCV RNA Quantitation, TaqMan®
Test Number: 550070
"The limit of detection of this assay is 7.1 IU/mL for HCV genotype 1, and the quantifiable range of the assay is 25 IU/mL to 69,000,000 IU/mL."
I agree that you should retest and hopefully it was a glitch. It all sounds too iffy to me. Best of luck and we'll all cross our fingers for you.
I hope your doctor will re-run the test or use a more sensitive test. Best wishes for UND.