Aa
A viral breakthrough :o(
Haven't been posting recently because I was trying to wrap my head around some disappointing tx news. I was hesisitant to post at all but....as always.....if it can help someone else in similar circumstances.......
Triple therapy w/Victrelis; Week 8 UND; I previously happily posted that I was also UND at week 12. I was misinformed (long story). At the 12 week mark, I was actually <43, which indicates a small viral breakthrough. I do have a copy of the labs now.
I just did Pegasys shot #15 last night, and shot #1 of Procrit. For several factors that pertain to my medical history, I was placed on a long term RIBA reduction. Wait....I can hear some of you sighing. You'll just have to trust me when I say......as much as I hated the idea of a dose reduction, I did feel better. Unfortunately, my HGB has other challenges so my docs were not rushing to bring the dose back up.
My tx nurse (over 20 years in Hepatology and has been involved in clinical trials), who is also African American, is confident in my course of treatment but also reminded me of the risks and difficulty in treating African American patients. Clearing the virus is harder. Still, she said I am doing excellent in terms of the reduction in my VL from the original pre-tx of 10,700,000. The head doc of the department has also weighed in on my case, so it is more than the opinion of my doc and tx nurse. Took me a lonnnnng time to trust their care but I do. Not happy about this development at all but they feel........the first goal is to keep me alive/safe (first, do no harm?). They are looking at this as temporary and doing their best to get me to clear the virus. My outcome is uncertain at this point (in the sense that, we are all monitored each month to check we are still UND), so we will take it one week at a time. Could mean longer treatment time, among other things.
Question --- If anyone has information on viral breakthroughs and SVR, please post the link. I am curious as to data for 1 time breakthroughs of <43. Please be gentle. The mental aspects of Anemia and possibly depression are getting to me and my AD was just increased. Thanks.
Triple therapy w/Victrelis; Week 8 UND; I previously happily posted that I was also UND at week 12. I was misinformed (long story). At the 12 week mark, I was actually <43, which indicates a small viral breakthrough. I do have a copy of the labs now.
I just did Pegasys shot #15 last night, and shot #1 of Procrit. For several factors that pertain to my medical history, I was placed on a long term RIBA reduction. Wait....I can hear some of you sighing. You'll just have to trust me when I say......as much as I hated the idea of a dose reduction, I did feel better. Unfortunately, my HGB has other challenges so my docs were not rushing to bring the dose back up.
My tx nurse (over 20 years in Hepatology and has been involved in clinical trials), who is also African American, is confident in my course of treatment but also reminded me of the risks and difficulty in treating African American patients. Clearing the virus is harder. Still, she said I am doing excellent in terms of the reduction in my VL from the original pre-tx of 10,700,000. The head doc of the department has also weighed in on my case, so it is more than the opinion of my doc and tx nurse. Took me a lonnnnng time to trust their care but I do. Not happy about this development at all but they feel........the first goal is to keep me alive/safe (first, do no harm?). They are looking at this as temporary and doing their best to get me to clear the virus. My outcome is uncertain at this point (in the sense that, we are all monitored each month to check we are still UND), so we will take it one week at a time. Could mean longer treatment time, among other things.
Question --- If anyone has information on viral breakthroughs and SVR, please post the link. I am curious as to data for 1 time breakthroughs of <43. Please be gentle. The mental aspects of Anemia and possibly depression are getting to me and my AD was just increased. Thanks.
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.
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.
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
spectda
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.
Robert-
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!
Bree-
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,
Dave
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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...........
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
spectda
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.
Robert-
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!
Bree-
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,
Dave
-------------------------------------------------------------------------------------------
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...........
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.
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.
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.
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.
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"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."
Hector