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.
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,
Dave
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,
Dave
Have you had your vitamin D levels checked?
I am with others, get a second PCR. Play it from there....
willy
I am with others, get a second PCR. Play it from there....
willy
So sorry Bee! Hang in there and hopefully like everyone else has said it will work out,,blessings to you...anne
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!
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.
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. :(
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. :(
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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