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.
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..
Will
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..
Will
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
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.
Keith
Keith
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.
Dearest beeblessed,
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.
Amen.
Biggg Huggggggggggs anita
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.
Amen.
Biggg Huggggggggggs anita
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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