Aa
ION-2 treatment status
Hello:
I had been following a thread originally started by Renee543 titled "Starting Sofosbuvir GS-5885". A lot of posts covering numerous related topics of discussion started piling onto that thread, so I thought I would start a new thread here, with the intent of letting folks post their treatment status if desired, so others in the same leaky boat might be able to get a feel for how they were doing with regard to all of us as a class. For example, I did not achieve RVR4 and was a little freaked out about that, but then a few others posted that they, too, did not achieve RVR4, but did, like me, achieve EVR6. So those were somewhat reassuring data points for me, knowing that there were others out there with similar treatment responses.
I am genotype 1b, baselined at 3.1M IU/ml, failed back-to-back non-pegylated interferon monotherapy twice, failed non-pegylated interferon plus ribavirin duotherapy once, and failed pegylated interferon plus ribavirin plus boceprevir triple-therapy once. I was biopsied at stage 3 grade 4 about 2.5 years ago.
I was admitted into the ION-2 trial and assigned to group 3, 12-week sofosbuvir plus ledipasvir without ribavirin. Side effects wer extremely minimal. As I had remarked to my hepatologist, in my case, if I didn't know that ION-2 was an open-lablel study, I would have sworn that I was assigned to the placebo group. I did, perhaps, get a slight recurrence of vertigo, for which I had prior history, and which has now subsided post-treatment, and I decided that I need new glasses but that is likely more related to old age than to sofosbuvir or ledispasvir. I did develop some colitis-like symptoms, but in retrospect, they may have been extrahepatic symptoms first beginning to develop way prior to enrollment in ION-2. I still have those, sometimes I think they are improving, sometimes not so much.
At week 1 in ION-2, I had a 4.3 log reduction in viral load count, down to 143. At weeks 2 and 4, I was less than 25 but detectable. Commencing at week 6 until end of treatment at week 12, I was undetectable. It is my understanding that the particular assay used by the lab can quantify viral load at greater than or equal to 25 IU/ml and can detect but not quantify to as low as 7.1 IU/ml. So, I was somewhere between 0 and 7.1, inclusive, at end of treatment, week 12.
One and a half weeks ago, I had my EOT+4 blood draw. As all of us in ION-2 know, the Sponsor does not share viral load data with the research clinic or us participants. But they do share the "safety panels" (ALT, AST, glucose, albumin, etc., etc.), at least they share the EOT+4wk safety panel data. Mine raised a couple of flags, but I think they are just yellow flags, not red flags, for now, anyways. My glucose, which had been pretty high prior to my attaining undetectable but fell within normal reference range limits once I had achieved undetectable at weeks 6 through 12, has re-elevated to about triple the upper limit again. AST, although still within the normal reference range, has elevated to its highest level since treatment week 6.
Latille had posted a comment in Renee543's thread that the way the informed consent document read, implied that, if applicable, the Sponsor would not request blood samples to confirm relapse until shortly after submission of EOT+12wk sample, but If the participant were undetectable at EOT+12, (s)he would be invited to schedule an appointment for EOT+24 blood sample collection. After I reviewed the informed consent document, the way it was worded, I would concur with that interpretation. My research coordinator person disagreed with that opinion, but then again, I don't think any other participants at my location have been asked to provide a confirmation sample so I don't think my research coordinator could definitively dispute that interpretation by way of example. So, not having been asked yet to provide a blood sample for confirmation testing doesn't really shed any light on the situation. Only the converse situation would. So I may explore independently obtaining a viral load test such as National Genetics Institute's "QuantaSure" test, which boasts of being able to detect viremia as low as 2 IU/ml. I understand that it ain't cheap to do test that, though.
Anyways, that's where I am at today. I invite others to post how their profile (e.g., genotype, baseline VLC, etc.) treatment status (i.e., treatment regimen -- which cohort group, your VLC data by week, clinically significant blood chem data, how far along in your treatment regimen you are), and more importantly, your post treatment status, has gone/is going, so all us ION-2 folks can, as a class, gauge how we all are coming along battling HCV. As a minimum, other participants can at least gauge their own personal progress, to some extent, in comparison to me.
So best wishes to us all,
still_above_dirt
I had been following a thread originally started by Renee543 titled "Starting Sofosbuvir GS-5885". A lot of posts covering numerous related topics of discussion started piling onto that thread, so I thought I would start a new thread here, with the intent of letting folks post their treatment status if desired, so others in the same leaky boat might be able to get a feel for how they were doing with regard to all of us as a class. For example, I did not achieve RVR4 and was a little freaked out about that, but then a few others posted that they, too, did not achieve RVR4, but did, like me, achieve EVR6. So those were somewhat reassuring data points for me, knowing that there were others out there with similar treatment responses.
I am genotype 1b, baselined at 3.1M IU/ml, failed back-to-back non-pegylated interferon monotherapy twice, failed non-pegylated interferon plus ribavirin duotherapy once, and failed pegylated interferon plus ribavirin plus boceprevir triple-therapy once. I was biopsied at stage 3 grade 4 about 2.5 years ago.
I was admitted into the ION-2 trial and assigned to group 3, 12-week sofosbuvir plus ledipasvir without ribavirin. Side effects wer extremely minimal. As I had remarked to my hepatologist, in my case, if I didn't know that ION-2 was an open-lablel study, I would have sworn that I was assigned to the placebo group. I did, perhaps, get a slight recurrence of vertigo, for which I had prior history, and which has now subsided post-treatment, and I decided that I need new glasses but that is likely more related to old age than to sofosbuvir or ledispasvir. I did develop some colitis-like symptoms, but in retrospect, they may have been extrahepatic symptoms first beginning to develop way prior to enrollment in ION-2. I still have those, sometimes I think they are improving, sometimes not so much.
At week 1 in ION-2, I had a 4.3 log reduction in viral load count, down to 143. At weeks 2 and 4, I was less than 25 but detectable. Commencing at week 6 until end of treatment at week 12, I was undetectable. It is my understanding that the particular assay used by the lab can quantify viral load at greater than or equal to 25 IU/ml and can detect but not quantify to as low as 7.1 IU/ml. So, I was somewhere between 0 and 7.1, inclusive, at end of treatment, week 12.
One and a half weeks ago, I had my EOT+4 blood draw. As all of us in ION-2 know, the Sponsor does not share viral load data with the research clinic or us participants. But they do share the "safety panels" (ALT, AST, glucose, albumin, etc., etc.), at least they share the EOT+4wk safety panel data. Mine raised a couple of flags, but I think they are just yellow flags, not red flags, for now, anyways. My glucose, which had been pretty high prior to my attaining undetectable but fell within normal reference range limits once I had achieved undetectable at weeks 6 through 12, has re-elevated to about triple the upper limit again. AST, although still within the normal reference range, has elevated to its highest level since treatment week 6.
Latille had posted a comment in Renee543's thread that the way the informed consent document read, implied that, if applicable, the Sponsor would not request blood samples to confirm relapse until shortly after submission of EOT+12wk sample, but If the participant were undetectable at EOT+12, (s)he would be invited to schedule an appointment for EOT+24 blood sample collection. After I reviewed the informed consent document, the way it was worded, I would concur with that interpretation. My research coordinator person disagreed with that opinion, but then again, I don't think any other participants at my location have been asked to provide a confirmation sample so I don't think my research coordinator could definitively dispute that interpretation by way of example. So, not having been asked yet to provide a blood sample for confirmation testing doesn't really shed any light on the situation. Only the converse situation would. So I may explore independently obtaining a viral load test such as National Genetics Institute's "QuantaSure" test, which boasts of being able to detect viremia as low as 2 IU/ml. I understand that it ain't cheap to do test that, though.
Anyways, that's where I am at today. I invite others to post how their profile (e.g., genotype, baseline VLC, etc.) treatment status (i.e., treatment regimen -- which cohort group, your VLC data by week, clinically significant blood chem data, how far along in your treatment regimen you are), and more importantly, your post treatment status, has gone/is going, so all us ION-2 folks can, as a class, gauge how we all are coming along battling HCV. As a minimum, other participants can at least gauge their own personal progress, to some extent, in comparison to me.
So best wishes to us all,
still_above_dirt
Hi there
6.5% of stocks is not nothing, especially as Gilead's EVP also dumped stocks...I saw something else (will try and find the link) that the company is being investigated for some kind of alleged fiduciary wrongdoing...I did wonder - could be purely financial, or maybe to do with another of their drugs. But as long as their HCV drugs work, I honestly don't care.
Thanks for starting another thread - will post there too. I have my EOT+4 in ten days or so, but results are blinded in our trial here. EOT+12 are not blinded - so it will be a long wait.
I'll post on the other thread you started - it will be enlightening and hopefully encouraging to share our interim results.
best
6.5% of stocks is not nothing, especially as Gilead's EVP also dumped stocks...I saw something else (will try and find the link) that the company is being investigated for some kind of alleged fiduciary wrongdoing...I did wonder - could be purely financial, or maybe to do with another of their drugs. But as long as their HCV drugs work, I honestly don't care.
Thanks for starting another thread - will post there too. I have my EOT+4 in ten days or so, but results are blinded in our trial here. EOT+12 are not blinded - so it will be a long wait.
I'll post on the other thread you started - it will be enlightening and hopefully encouraging to share our interim results.
best
Not incivik but failed triple with victrellis (boceprevir); viral breakthrough around wk 12, I think it was. On ION2 12wk SOF/LDV without RBV, I apparently am UND at EOT+12 checkup as I was informed that I will be continuing on trial for EOT+24 followup
If anybody still following this thread, wanted to ask you to consider following http://www.medhelp.org/posts/Hepatitis-C/-ION-1---ION-2---ION-3---LONESTAR---ELECTRON-statuses/show/1991880 and maybe post an update there if you were a participant in one of those trials
Thanx
Thanx
Well, http://www.americanbankingnews.com/2013/08/06/gilead-sciences-ceo-unloads-17388929-62-in-stock-gild/ says the CEO sold 282,242 shares and still holds 4,057,121 shares so that means he only dumped 6.5% of his GILD holdings. So now I'm not worried :)
Thanks for posting. Once I hear how my EOT+12 goes, I'm going to try to post a summary sheet of people's statuses, at least those that I can find/figure out their data without too much difficulty. I'm coming up on EOT+14 so should be hearing something about my EOT+12 soon. If not, I think I'll do my own private EOT+16. The test I had run last time claims to be more sensitive than the one they use, anyways; 2IU/ml (mine) vs 7.1IU/ml (theirs)
Interesting about Gilead's CEO and EVP dumping stock. IF I were a mistrustful person, I'd be worried about that. If it is a result of their having insider knowledge of latent toxic side effects or excessive numbers of relapses, seems to me like that would qualify as insider trading which I think is illegal. I'm worried...:)
Interesting about Gilead's CEO and EVP dumping stock. IF I were a mistrustful person, I'd be worried about that. If it is a result of their having insider knowledge of latent toxic side effects or excessive numbers of relapses, seems to me like that would qualify as insider trading which I think is illegal. I'm worried...:)
Hi
I just found this thread after following other more convoluted ones.
I've just finished the ION-1 trial in the UK (not sure if there is ION-2 here yet).
12 week arm, (of 12 week or 24 week) G5885 w/Riba; treatment naive, non-cirrhotic, G1b (and previously 1a!), baseline VL 5,000,000, I'm female, BMI 20.5, HCV 30 yrs.
UND from week 4.
VL results at week 4 post TX are blinded here - will get ALT etc though.
VL results at week 12 post TX open, as are week 24 post TX.
I had sides: gastro issues, nausea, fatigue, skin rash at week 10, breathlessness, insomnia.
TX ended 29/7/13 - since then still fatigued, gastro issues less, still insomniac. Hope they improve soon.
Don't think I'll do a private PCR/RNA test at week 4 post TX so will know nothing until 12 weeks post TX test.
Follow Gilead stuff regularly - hope this all lives up to its hype - can't help thinking that they wouldn't be doing 8 week trials in the US if the 12 week arms weren't successful, but so far, there are no long-term results, obv, so people's posts here are really useful.
Gilead's CEO and EVP dumped a lot of stock yesterday so I hope this is not because of any knowledge they have re these trials.
Wishing us all SVR
RainaM
I just found this thread after following other more convoluted ones.
I've just finished the ION-1 trial in the UK (not sure if there is ION-2 here yet).
12 week arm, (of 12 week or 24 week) G5885 w/Riba; treatment naive, non-cirrhotic, G1b (and previously 1a!), baseline VL 5,000,000, I'm female, BMI 20.5, HCV 30 yrs.
UND from week 4.
VL results at week 4 post TX are blinded here - will get ALT etc though.
VL results at week 12 post TX open, as are week 24 post TX.
I had sides: gastro issues, nausea, fatigue, skin rash at week 10, breathlessness, insomnia.
TX ended 29/7/13 - since then still fatigued, gastro issues less, still insomniac. Hope they improve soon.
Don't think I'll do a private PCR/RNA test at week 4 post TX so will know nothing until 12 weeks post TX test.
Follow Gilead stuff regularly - hope this all lives up to its hype - can't help thinking that they wouldn't be doing 8 week trials in the US if the 12 week arms weren't successful, but so far, there are no long-term results, obv, so people's posts here are really useful.
Gilead's CEO and EVP dumped a lot of stock yesterday so I hope this is not because of any knowledge they have re these trials.
Wishing us all SVR
RainaM
Hi purplecat.
I was in ION-1, 12w with Riba, GT 1b, >10M vl at screening.
I was <25 at w2 and UND at w4.
I terminated TX in July. Now i'm waiting for my EOT+4 blood draw.
Little anemia (Hb at lower 11s), very little sides.
see you here
I was in ION-1, 12w with Riba, GT 1b, >10M vl at screening.
I was <25 at w2 and UND at w4.
I terminated TX in July. Now i'm waiting for my EOT+4 blood draw.
Little anemia (Hb at lower 11s), very little sides.
see you here
That is awesome to read your lab test. So happy for you. There are many of us tx failure folks reading these post daily. Thank you so much for posting. Best of luck and on to SVR
Got the results back from my independently conducted "EOT+6" VLC. I was surprised that it only took one week when I had read elsewhere on the internet (so it had to be true, right? Coz it was on the internet!) that it could take up to three weeks.
You can imagine my anticipation and anxiety when I saw the email from my family physician, time stamped 10:37PM. Was it good news? Or was it a "SUX-2-B-U" email?
I log in to the secure portal and open the message. It reads:
"still_above_dirt: I have enclosed your Hepatitis C test results. I think you'll be happy."
And I was happy...freakin' ecstatic, actually:
Summary: NGI HCV QuantaSure
Patient: xxxxxxxxxxxxxxxx
ID: xxxxxxxxxxxxxxx
Note: All result statuses are Final unless otherwise noted.
Patient Note: PATIENT NOT FASTING
Tests: (1) NGI HCV QuantaSure (140639)
Order Note: Clinical Information: 10565N QUEST LABCORP TEST #140639
! Hepatitis C Quantitation
L5COPY Copies/mL *1
Less than 5 Copies/mL.
! HCV log10 UPTCAL Log10copy/mL (X)
Unable to calculate result since non-numeric result obtained for
component test.
! HCV Quant (IU/mL) "Result Below..."
RESULT: Less than 2 IU/mL. IU/mL
! HCV IU log10 UPTCAL Log10 IU/mL (X)
Unable to calculate result since non-numeric result obtained for
component test.
! PCR Amplification + Detection
Performed *2
! Test Information See report *3
PCR assay performed using National Genetic Institute's validated,
proprietary methodology. Results greater than or equal to 5 Copies/
mL of HCV RNA indicate the presence of virus-specific nucleic acid
sequence.
Note: An exclamation mark (!) indicates a result that was not dispersed into the flowsheet.
Document Creation Date: 06/26/2013 11:15 AM
_______________________________________________________________________
(1) Order result status: Final
Collection or observation date-time: 06/18/2013 13:10
Requested date-time:
Receipt date-time: 06/18/2013 15:42
Reported date-time: 06/26/2013 13:11
Referring Physician:
Ordering Physician: xxxxxxxxxx
Specimen Source:
Source: xxxx
Filler Order Number: xxxxxxxxxx LAB
Lab site: xxxxxxxxxx
Producer ID *1:Performed At: DE, National Genetics Inst LabCorp 2440 South Sepulveda Suite 235 Los Angeles, CA 900641748
Producer ID *2:Performed At: DF, National Genetics Inst LabCorp 2311 Pontius Avenue Los Angeles, CA 900641809
Producer ID *3:Performed At: DE, National Genetics Inst LabCorp 2440 South Sepulveda Suite 235 Los Angeles, CA 900641748
-----------------
The following results were not dispersed to the flowsheet:
Hepatitis C Quantitation, L5COPY Copies/mL, (F)
HCV log10, UPTCAL Log10copy/mL, (X)
HCV log10, UPTCAL Log10copy/mL, (X)
HCV Quant (IU/mL), Less than 2 IU/mL. IU/mL, (F)
HCV IU log10, UPTCAL Log10 IU/mL, (X)
HCV IU log10, UPTCAL Log10 IU/mL, (X)
PCR Amplification + Detection, Performed, (F)
Test Information, See report, (F)
Signed by xxxxxxxxxxxxx on 6/26/2013 10:36:33 PM
--------------------------------------------------------------------
So far, so good. SVR6 milestone has been attained. Gilead Sciences just may indeed have created the silver bullet, at least for us g1b folks. And RBV not required. So keeping my fingers crossed for EOT+12, +24, +52 (on my nickel), +104, +260, +520wks. But off to a great start.
So now the next anxiety period begins. The EOT+12 test? No, the next anxiety period is waiting to see how big the invoice from Labcorp is gonna be...
You can imagine my anticipation and anxiety when I saw the email from my family physician, time stamped 10:37PM. Was it good news? Or was it a "SUX-2-B-U" email?
I log in to the secure portal and open the message. It reads:
"still_above_dirt: I have enclosed your Hepatitis C test results. I think you'll be happy."
And I was happy...freakin' ecstatic, actually:
Summary: NGI HCV QuantaSure
Patient: xxxxxxxxxxxxxxxx
ID: xxxxxxxxxxxxxxx
Note: All result statuses are Final unless otherwise noted.
Patient Note: PATIENT NOT FASTING
Tests: (1) NGI HCV QuantaSure (140639)
Order Note: Clinical Information: 10565N QUEST LABCORP TEST #140639
! Hepatitis C Quantitation
L5COPY Copies/mL *1
Less than 5 Copies/mL.
! HCV log10 UPTCAL Log10copy/mL (X)
Unable to calculate result since non-numeric result obtained for
component test.
! HCV Quant (IU/mL) "Result Below..."
RESULT: Less than 2 IU/mL. IU/mL
! HCV IU log10 UPTCAL Log10 IU/mL (X)
Unable to calculate result since non-numeric result obtained for
component test.
! PCR Amplification + Detection
Performed *2
! Test Information See report *3
PCR assay performed using National Genetic Institute's validated,
proprietary methodology. Results greater than or equal to 5 Copies/
mL of HCV RNA indicate the presence of virus-specific nucleic acid
sequence.
Note: An exclamation mark (!) indicates a result that was not dispersed into the flowsheet.
Document Creation Date: 06/26/2013 11:15 AM
_______________________________________________________________________
(1) Order result status: Final
Collection or observation date-time: 06/18/2013 13:10
Requested date-time:
Receipt date-time: 06/18/2013 15:42
Reported date-time: 06/26/2013 13:11
Referring Physician:
Ordering Physician: xxxxxxxxxx
Specimen Source:
Source: xxxx
Filler Order Number: xxxxxxxxxx LAB
Lab site: xxxxxxxxxx
Producer ID *1:Performed At: DE, National Genetics Inst LabCorp 2440 South Sepulveda Suite 235 Los Angeles, CA 900641748
Producer ID *2:Performed At: DF, National Genetics Inst LabCorp 2311 Pontius Avenue Los Angeles, CA 900641809
Producer ID *3:Performed At: DE, National Genetics Inst LabCorp 2440 South Sepulveda Suite 235 Los Angeles, CA 900641748
-----------------
The following results were not dispersed to the flowsheet:
Hepatitis C Quantitation, L5COPY Copies/mL, (F)
HCV log10, UPTCAL Log10copy/mL, (X)
HCV log10, UPTCAL Log10copy/mL, (X)
HCV Quant (IU/mL), Less than 2 IU/mL. IU/mL, (F)
HCV IU log10, UPTCAL Log10 IU/mL, (X)
HCV IU log10, UPTCAL Log10 IU/mL, (X)
PCR Amplification + Detection, Performed, (F)
Test Information, See report, (F)
Signed by xxxxxxxxxxxxx on 6/26/2013 10:36:33 PM
--------------------------------------------------------------------
So far, so good. SVR6 milestone has been attained. Gilead Sciences just may indeed have created the silver bullet, at least for us g1b folks. And RBV not required. So keeping my fingers crossed for EOT+12, +24, +52 (on my nickel), +104, +260, +520wks. But off to a great start.
So now the next anxiety period begins. The EOT+12 test? No, the next anxiety period is waiting to see how big the invoice from Labcorp is gonna be...
Is anyone on this regimen of drugs or have been on it that have failed triple with incivek?
Got my independently conducted "EOT+6" VLC drawn yesterday. I grt the impression from reading other heppers' posts on this and other forums that the test I had done (LabCorp Quantasure test #140639) can take two to three weeks to get results back. So we'll see...
(why LabCorp Quantasure over Quest's Heptimax? Coz' there's a LabCorp within minutes of my workplace)
(why LabCorp Quantasure over Quest's Heptimax? Coz' there's a LabCorp within minutes of my workplace)
So you are same cohort as me but two weeks ahead of me. And a somewhat more enviable VLC history on this trial than is mine. Were you treatment-experienced? PI-experienced? Per my original post, I was treatment-experienced -- null responder at less than 2-log reduction on the mono and duo therapies and breakthrough somewhere between weeks 8 and 12, I think, on the triple therapy. And I had made it all the way down to 25IU with the boceprevir at its week 8. Talk about having the wind taken out of your sails...
If you have decent health insurance, you might consider asking your friendly family physician who is no doubt totally divorced from this trial to cut you a set of routine blood chem test orders, and maybe a really sensitive HCV while (s)he's at it. I did, but the HCV test that was ordered by my family doctor was far from being the best selection (fairly high threshold of detection) so I declined to submit to that test.
My Friday's independent blood chem all looked pretty good this time around. The doc threw a handful of other tests onto the list coz' I "hadn't been in for a physical exam for a while." The EOT+4 "problem children" that had sent up the yellow flags for me are behaving way better as of last Friday A.M. Glucose has returned to normal range, albeit the very high side of normal range (add three points and I'd get a "HIGH" flag again), AST and ALT are, like everything else on Friday's blood chem test results, roughly middle-of-the-road insofar as each test's reference range is concerned. So that was all very good news for the hypochondriacal Mr. still_above_dirt dude to hear, especially given the stubborn extrahepatic symptoms still hangin' around (dark urine, cracked bleeding skin, etc.). Makes me wonder whether to go ahead with the independent QuantaSure HCV test; even with insurance, I think my copay would still be about $150. But it may well be worth every penny spent for the peace of mind that it would bring if, with a threshold of detection at 2IU/ml, it would result in my reading my most "favoritist" word this year: "Undetectable"
If you have decent health insurance, you might consider asking your friendly family physician who is no doubt totally divorced from this trial to cut you a set of routine blood chem test orders, and maybe a really sensitive HCV while (s)he's at it. I did, but the HCV test that was ordered by my family doctor was far from being the best selection (fairly high threshold of detection) so I declined to submit to that test.
My Friday's independent blood chem all looked pretty good this time around. The doc threw a handful of other tests onto the list coz' I "hadn't been in for a physical exam for a while." The EOT+4 "problem children" that had sent up the yellow flags for me are behaving way better as of last Friday A.M. Glucose has returned to normal range, albeit the very high side of normal range (add three points and I'd get a "HIGH" flag again), AST and ALT are, like everything else on Friday's blood chem test results, roughly middle-of-the-road insofar as each test's reference range is concerned. So that was all very good news for the hypochondriacal Mr. still_above_dirt dude to hear, especially given the stubborn extrahepatic symptoms still hangin' around (dark urine, cracked bleeding skin, etc.). Makes me wonder whether to go ahead with the independent QuantaSure HCV test; even with insurance, I think my copay would still be about $150. But it may well be worth every penny spent for the peace of mind that it would bring if, with a threshold of detection at 2IU/ml, it would result in my reading my most "favoritist" word this year: "Undetectable"
I started 30Jan13 the 12 week ION-2 no riba. <25 detectable week 2, <25 UND week 4. My EOT was 24Apr13. My 12 week post treatment 17July13 coming up. I've gotten nothing on 22May13 post 4 week tests concerning ALT/AST etc.. My NP nurse changed just at the end of my 12 weeks, so this new one has no rapport to give me any data. Now it's just the Drama waiting game.
I'm in touch with one ION-1 participant who was told to come for their 24 week Post tests that will be end of July. So 12 week with and without Riba ION-1 post 24 Week tests are happening soon. Is there anymore ION-1 participants that can also post their status?
I'm in touch with one ION-1 participant who was told to come for their 24 week Post tests that will be end of July. So 12 week with and without Riba ION-1 post 24 Week tests are happening soon. Is there anymore ION-1 participants that can also post their status?
WOW - that's awesome. Thank you very much for sharing that with us.
wishing you the very best - please please keep us posted!
wishing you the very best - please please keep us posted!
Following you to this thread. I finished ION-2 12 week course of treatment with riba at the end of April. UND at week 6. As of this week I have finally regained my pre-treatment energy level - multiplied by about 3! Riba kicks my butt with serious anemia. Now I'm feeling unstoppable. Maybe this is what SVR feels like! Had physical on 14th, will be interesting to see if lab results correlate with trial lab results. Will post if anything interesting. Otherwise just waiting until late July for verdict!
BTW - thanks for starting this new thread, the other was getting too tangential.
BTW - thanks for starting this new thread, the other was getting too tangential.
I entered the trial at UM in Miami on April 17. I am genotype 1a naive
I was randomized to 24 weeks of GS 5885 with Ribavirin for 24 weeks
Baseline viral load 4m
Week two 25 or less but detectable
Week four UDL
As of tow weeks ago I was UDL
Hemoglobin baseline was 16 it has progressively dropped and now at 12
I am told unless it drops below 10 now changes will be recommended
Low end of normal range for enzymes
So far so good
I have been swinging at ghosts trying to determine what side effects are psychosomatic and what are real
Here is what I have determined are real for me
I rarely if ever sleep all night - usually up about two hours after I go to sleep and I entertain my self for an hour or so - sleep very lightly at the edge of consciousness - try and nap for an hour in the late afternoon
Eyes are a little runny
Minor skin rashes
Aerobic capacity greatly reduced but manageable
I am upbeat and positive as 8 have no data on relapses from GS 5885
I hope you all find this helpful and will give my data from this weeks draw when I get the results next Thursday
I was randomized to 24 weeks of GS 5885 with Ribavirin for 24 weeks
Baseline viral load 4m
Week two 25 or less but detectable
Week four UDL
As of tow weeks ago I was UDL
Hemoglobin baseline was 16 it has progressively dropped and now at 12
I am told unless it drops below 10 now changes will be recommended
Low end of normal range for enzymes
So far so good
I have been swinging at ghosts trying to determine what side effects are psychosomatic and what are real
Here is what I have determined are real for me
I rarely if ever sleep all night - usually up about two hours after I go to sleep and I entertain my self for an hour or so - sleep very lightly at the edge of consciousness - try and nap for an hour in the late afternoon
Eyes are a little runny
Minor skin rashes
Aerobic capacity greatly reduced but manageable
I am upbeat and positive as 8 have no data on relapses from GS 5885
I hope you all find this helpful and will give my data from this weeks draw when I get the results next Thursday
I have been on ION 2 study now going on 9 weeks with RBV scheduled for total of 24 weeks...definitely doable so far. Let's see how many respond so we can all follow especially after they are done!!
I have been following the thread you mentioned with great interest ~ and you are right in that there are numerous topics and it often gets confusing. I can only think of a few people who have posted about ION-2, ironically it is because they both have cat in their user names (hepcat & purplecat)
http://www.medhelp.org/posts/Hepatitis-Social/7985-Gilead-trail-stopping-at-12-weeks-no-riba-ION-2/show/1933105#post_9082880
http://www.medhelp.org/posts/Hepatitis-C/any-relapsers-sofosbuvir-GS-5885--riba-12-wks/show/1931926
I hope this works out and you post your results for your next EOT labs or the result if you pursue this on your own (I would be tempted as well) but you still may hear from these folks. I can imagine the anxiety is unreal so hang in there :)
http://www.medhelp.org/posts/Hepatitis-Social/7985-Gilead-trail-stopping-at-12-weeks-no-riba-ION-2/show/1933105#post_9082880
http://www.medhelp.org/posts/Hepatitis-C/any-relapsers-sofosbuvir-GS-5885--riba-12-wks/show/1931926
I hope this works out and you post your results for your next EOT labs or the result if you pursue this on your own (I would be tempted as well) but you still may hear from these folks. I can imagine the anxiety is unreal so hang in there :)
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