end of week 4 results on triple therapy with incivek
Okay here it is. I am not undetectable BUT I went from 14,900,000 to 43 so I say that's a win!!! I will be tested again at week 8 and if undetectable then I will stay on for the remainder of the 24 weeks which would be 16 more weeks. My Dr isn't keeping anyone on the therapy for the full 48 weeks if they have compensated liver cirrhosis. I did talk to incivek and they said that my chances were as good as anyone as far as a SVR. I bet it is gone today, just one day after my blood work :) So what is your thoughts with it not being undetectable...the 43 still *****......
Did your doctor tell you that you weren't und or is that your interpretation? Since the results from the RT-PCR won't indicate "undetectable", just less than 43, I'm wondering if you might really be und?? Since Quest's RT-PCR's lowest detection limit is 43, and you reported 43, this could be possible.
Well that is good news, and i agree you were most likely und before you even got these results back. Curious though why your doctor won't tx cirrhotics for 48 weeks? That was one thing my doctor thought was important for us with cirrhosis. I did the 48 and i'm svr now and had no problems........ Wishing you the best.
Well I dont know why he doesn't but I always tell him what I want to do and he will usually comply LOL I made him give me lasix one time so my feet would look good in my shoes hahaha!!!! he came in yesterday and asked me was I going to take his head off LOL I just said I dont think so but what do you have to say??? :)
Good for you.......... You might run these nubers by him and get his thoughts.
Similar to the data with boceprevir, patients with F0-F2 fibrosis had a higher SVR rate than patients with F3/F4 fibrosis (78% vs 62% in the T12PR arm). Although the SVR rate achieved by telaprevir-treated patients with more advanced disease is much better than the 33% SVR rate achieved by patients in the control group, it is still clearly lower than the SVR rate in patients with milder disease. This explains why the FDA label states that patients with cirrhosis may benefit from a longer duration of treatment, although there are no clear data on this proposed strategy since all patients in the telaprevir arms of the ADVANCE study received RGT, including those with cirrhosis.
When you mentioned your VL went to 43, it raises the possibility that the nurse reading the results might not understand how to read them. As far as I know, the results won't state "Undetectable", but will indicate less than 43, the lowest limits of detection of the Hepatitis C Viral RNA, Quantitative Real-Time PCR - Linear range: 43 to 69,000,000 IU/mL. If there is a less than < symbol before the 43, then you are und.
I'd call the nurse back and ask if there is a less than symbol prior to the 43. Hope that clarifies a little.
Hey, dixie - I think you should get a hard copy of that report. It is a little unclear to me but the week 4 test is not that critical. I am like cando man -- I thought it was important to do the 48 when you have cirrhosis. I would be afraid to do less
I agree with cando and frijole about the 24 weeks. I'd want to know what his criteria is for stopping that early. You really only want to have to do this once - and with cirrhosis, we don't always have time for "do-overs'. Not meaning to scare, but it really is important that he is familiar with cirrhosis. We're kinda in a class of our own. :-)
The week 4 PCR is very important for naives and relapsers. Under 43 but detected is not UND and so technically the shortened treatment duration would not apply even if the patient was UND at wk 8 and 12. Cirrhotics are advised they may benefit from 48 weeks so if the doctor was planning on treating the full 48 given the 4 wk PCR was not 1000 or above it's all good. However, it look like dixie's doctor never planned on using that criteria to begin with.
That is great news , and yes .it may be the sensitivity of the test that would determine if it is indeed Det or not.
I am also curious why your doctor says" I am not keeping anyone on therapy for 48 weeks with comp cirrhosis"
The word "may" is very ambiguous in the labeling when it comes to suggesting that 48 be better than 24...however it seems like your doctor has made a hard and fast rule that none of his patience will do 48?
The SVR rates were higher for patients who achieved an eRVR: 89%, 83%, and 97% in the T12/PR arm, T8/PR arm, and PR arm, respectively, vs 54%, 50%, and 39% for patients in these arms who did not achieve eRVR. Therefore, the likelihood of SVR is clearly influenced by rapid response, but even patients who still have detectable HCV RNA at Week 4 have a 54% chance of achieving SVR.
Even more of a reason to treat 48 weeks...........
Also and this is the second time we have seen this here.. The patient calls the drug company and in the one instance ..it seemed the patient had a breakthrough and the drug representative says :oh thats ok ..just carry on taking the P.I.. (when clearly the labeling says to stop)
And in this instance the rep says" your chances are just as good as anyone( I presume she meant doing just 24) as the doctor suggested.
It seems like everyone is making things up as they go along.... and that there labeling was just a guideline???
Dixie...this is not at all meant to scare you...you have had a great result and it looks like you will be successful.. but you surely want to do it right and for the amount of time it takes the first time.
While i know shes not on bocep, myself i don't feel theres much difference in the two. That said, they suggest you do the 48 weeks.
The prescribing information recommends that patients with cirrhosis receive the complete boceprevir treatment course: a 4-week pegIFN/RBV lead-in followed by 44 weeks of triple therapy. This recommendation is based on the finding that patients in SPRINT-2 with F3/F4 stage fibrosis had higher SVR rates if they received the fixed 48-week course of boceprevir.
I agree about getting a copy of these results for further clarification and the importance of knowing how soon you are und. Once you have the results and know the detection limits, it will help to know what the numbers mean.
It's too early in the game, only a few months into the large scale usage of the new meds, for doctors to start tweaking - in my mind anyway. There are just too many unknowns. Not that tweaking is all that bad - many of us "old school" txr's tweaked our way into an SVR, but this was with the knowing of what DIDN'T work beforehand.
okay. so I called the nurse back as suggested. She is the one who heads the hep c clinic for my Dr and teaches how to give the drug and such. So to flcyclist, thanks for the info for sure cause the number was indeed <43 . So I said, so I am undetectable? she said , No. They changed the criteria...ugh. She said it used to be <43 was undetectable but now it is detectable but less than 43. She said the number could be 1 - 42 ...its there just <43 so now what? Also, I asked about the 48 weeks and if any are doing it. She said yes, some would and I mentioned to her about cirrhotics having better SVR on 48 week protocol. She said at my 8 week test the Dr would know which way he wants to go. Well, it is my body and I dont know if I can wait for another drug to come out. I got on this but am close to advanced cirrhosis so want to kick this in the rear. Thanks everyone for such valid info and keeping me armed with the facts.
She said it used to be <43 was undetectable but now it is detectable but less than 43. She said the number could be 1 - 42 ...its there just <43 so now what?
What i'm seeing is still exactly what flcy was saying, if the test doesn't go below 43 how can they determine that you are not und. (could be 1 -42) could be und as well. could be is not a very professional answer.
I haven't seen one that goes to 2 but that by no means, means they don't have one, now the one's I have seen that go to 5 report as below 5. I would think that if they spent the money on a more precise test that they would report it for what it was, if not what would be the point, why not get the cheaper test. These are just my thought's, maybe they know something we don't.
If she used Labcorp's Quantasure test, or Quest's TMA, the lower detection limits would detect under 43. If that's the case, is this how it would be reported - as detectable <43?. It would help to know what test was used for these results to know the lower dection limits.
Maybe someone who understands this reporting can help explain.
i'm 2/2 ....i had the same 4 week report....43...they told me it was almost und...my 8 week is coming soon...we will see...my nurse practitioner said they weren't sure yet if i would do 24 or 48 or somewhere between..right now i'll be glad to get off this itchy...rashy...incivek...good luck....billy
Now I feel like DUH, I see what you are saying, my brain is still foggy as **** from yesterday, I think my body is still adjusting to the meds, if that is possible and yes it would help to have someone who;s in the know to chime in.
yeah I am confused too. All I know for sure is that she said I am detectable but <43. I will ask for them to send me the lab reports and maybe we can chew through these new criteria or whatever .... For now, I am going to say I am undetectable because I am sure I am now, 1 day later ....confusing.
Dixie was not clearly UND on the the test but as she said she probably is now. Her doctors office told her she was under 43 IU/mL but HCV RNA detectable. What we do not know is the tests lowest IU/mL level of detection. Even if RNA is detected between 1 and 42 that is not undetected so her doctors office was correct. For instance, Labcorp has a PCR which can only quantify HCV RNA at 43 IU/ml or above but can detect down to 7.1 IU/mL so if RNA was detected under 43 IU/mL the results would come back HCV RNA DETECTED under 43 IU/mL. If no HCV RNA detected it would state HCV RNA UNDETECTED under 43 IU/mL.
I'm just going to go with the flow I guess.... what can I do anyway? detectable/undetectable its still working. I was almost 15,000,000 now <43 . I am going to ask my Dr a lot more questions for sure and get that lab report copy. I just am sick of being sick and I really am not up for dying anytime soon. I have no desire to have a transplant...this better work.
I'm just going to go with the flow I guess.... what can I do anyway?
You are doing just fine..actually you have had a phenomenal response. From 15 mill.to <43 in 4 weeks is great.
You may be mis-intepreting what folks are saying somewhat. It is actually BECAUSE you are having such a good response we are just suggesting that you don"t short yourself on getting the right end result(SVR) because you didn"t treat long enough
We were just a little concerned to hear your doctor say that he would not treat a chirrotic for more than 24 weeks ,when clearly the trial results showed chirrotics did better with 48 instead of 24 . And also ..if indeed your result at 4 weeks says DET.. then regardless of the number ..DET at 4 weeks means ..again(in trials ) a much better outcome was attained with 48 weeks.
This IS working for you...we just want to make sure it stays working ..in light of being chirrotic and all that was suggested here ,is a discussion with your doctor ,,about length of time to treat.
dixie - remind me again what your biopsy read was. What is your grade and stage and what else did the biopsy report say. Is the liver architecture changing? Is the spleen enlarged and do you have any ascites?
lynda - the QuantaSure is my preferred test. The problem with it is that it has to be sent to the lab in California and the turnaround time precludes a doctor from getting the results and okaying the continuance of Victrelis within the 7-day time period (if the insurance company is requiring that before approving the Victrelis). I thought I had read about a fast timed low viral load test that could be done on sight by LabCorp but I have looked all over their website and cannot find it. I realize dixie is taking INC but you seem pretty knowledgeable and I thought I would throw this iquestion in.
A nurse at incivek told me last night on one of our contact calls. That incivek protocol was 24 weeks for treatment naive patients who were undetectable at week 4 and 12 that they have nothing about cirrhotics treating for 48 weeks. So this is probably where doctor confusion could be coming in . We had a long talk about it and she said it wasn't in incivek protocol but to see how i do. You never know if you do well and drugs are causing more harm then good after 24 you may want to stop. Still a higher success rate then the original SOC. I think we just have to wait and see how our bodies respond in all ways to the medication, then make a decision with our doctors.
Find out if you did the heptimax RNA test. If you did it has two parts. the second part taking longer and more sensitive. Your doctor may not have all the results in yet. They seem to throw negatives around without giving us numbers. I got two negatives the the hepatimax two part test and I'm taking it. I will question him more when we have our next visit. Trying to get good answers over the phone is almost impossible with some doctors. They are way toooo busy.
In 2007, my Dr said he had people live 10 years with people that had similar liver condition. In Sept 2009 I had an ultrasound. I have no idea what it means lol It says:
Cirrhotic configuration of the liver including internal fibrosis and nodularity of the hepatic contour. Multiple small hyperenhancing foci throughout both lobes of the liver. These lesions do not demonstrate worrisome T2 characteristics or enhancement washout and likely represent regenerative nodules, however, atypical and early hepatic neoplasm cannot be ruled out. Clinical correlation and repeat MRI would be helpful. The portal veins and hepatic veins are patent. Mild enlargement of the spleen with recanalization of the umbilical vein and gastroepiploic collateral vessels consistent with portal venous hypertension. Prominenet porta hepatic, paraesphogeal, and retroperitoneal lymph nodes likely reactive secondary to known chronic hepatitis. 1.6cm left adrenal adenoma.
I never ask what stage and grade I am because it scares me. It is easier for me to live just thinking I have more time then seeing and end...if you know what I mean. I had endoscopy in feb 2011 and no bleeding varices. I did get scared though because another study at Mayo sent me a paper stating they would like to have an extra teaspoon of blood for a study they are doing and they were contacting me because I had end stage liver disease. My Drs nurse said I don't have end stage liver disease or else I wouldn't be on this medicine. My labs from june 24th 2011 are:
I will do my best to persuade my Dr to keep me on the 48 weeks. The best I can understand with him and he is a good Dr is that because everything as far as blood work with me goes and is always normal range other than AST and ALT with no ascites or complications, that he feels like if this doesn't work the best it can for me or like he would like to see then he is afraid the meds could do more harm than good in the long run...damage. He discussed with me about waiting for a couple more years for the new drug to come out without the interferon? or the oral drugs I guess but I wanted to go ahead with this one and he said it was fine. My whole issue is that if he gave me 10 years give or take a few, 5 years ago, then maybe I should try to kill this virus before it kills me. I will just have to go into further detail with him next appt.
I just got my blood test results from my doctor and I also tested at Quest. 4 weeks ago I was at 20,000,000. The results today indicated that I was under 43. He said that I don't have 43 but that I am under 43 and that I was undetectable (I hope so!) I wish you the best!!!
My doctor told me that assuming all goes well, I will be on the Incivek for 12 weeks and Pegasys and Ribavirin for 48 weeks.
Two years ago, I was on the Pegasys and Ribavirin therapy and I was at non-detectable at 48 weeks. However, for some reason I relapsed and the Hep-C returned.
It was very stressful waiting for the Incivek to be approved! Also, my kidney blood test numbers were out of range and I had to test weekly for the last two weeks for that but now those numbers have gone down also.
I was so scared when I called for the test results today that he was going to tell me that I had to stop treatment :-( But, as I posted earlier, all is going well with me now, I am so relieved.
Good news Mike! Dixiechick - I'm loving ur fighting spirit girlio. I'm straight up w my Dr too. I asked point blank: if I were your wife, what would you do? He said 48 weeks as long as I was UND at 4 & 12. I'm def ESLD. Barely got in shape for tx. He said he'd take it to the limit for me if I could hack SE n get all the rescue drugs I needed.
Oh. And let me add... STUPID TEST VARIABLES! I know they're neccesary. But you've had to endure some needless worry IMHO. Karen :) hang in there..
Hi. I will let others comment about viral load UND.
I will concentrate my statements on liver disease and cirrhosis as there are a number of misunderstandings and outright wrong conclusions being repeated in the posts.
Before I forget. You have cirrhosis, stage 4 liver disease. "Cirrhotic configuration of the liver including internal fibrosis and nodularity of the hepatic contour." The only qualified type of doctor to treat and manage your condition is a hepatologist (specializes in liver disease). Gastroenterologists (specialize in the digestive system) are not qualified which may be the reason for so much confusion and misunderstanding of the facts of liver disease and cirrhosis.
You have stage 4/compensated cirrhosis. NOT decompensated, End-Stage Liver disease. They are two different stages, although they are both called cirrhosis. To treat your HCV in less than the best chance of SVR is taking your life into your hands. I hope you release this. Many cirrhotic patients will fail treatment and develop resistance. To have to wait from different categories of antivirals is a big risk. No doctor can tell you how long before you will decompensate and be unable to treat your hepatitis C again. That their is a "timetable" that you are on is a false belief. Each person's liver disease has its own particulars. To give someone a timetable is a sign of little understanding of liver disease. Then your only option will be a liver transplant to survive. In my opinion this is a risk nobody should take.
"I had endoscopy in feb 2011 and no bleeding varices. "
An endoscopy doesn't show "bleeding varies". You would be vomiting blood if you had bleeding varies. What the endoscopy does is measure the stage or your varices. How likely they are to burst. Varices are caused by hyper portal tension which cirrhotics have and showed on your ultrasound scan.
"the portal veins and hepatic veins are patent. Mild enlargement of the spleen with recanalization of the umbilical vein and gastroepiploic collateral vessels consistent with PORTAL VENOUS HYPERTENSION."
The lab results you post provide little to no information on the status of your liver disease I'm afraid.
As far as treatment time the limited data is clear for cirrhotics. If you are treatment-naive or were a relapser during previous treatment you can treat for 24 weeks. All other cirrhotic patients should treat for 48 weeks until new data proves otherwise. See Incivek label data below.
Info based on the Incivek label:
From Incivek label...
"INCIVEK must be administered with both peginterferon alfa and ribavirin for all patients for 12 weeks, followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on viral response AND PRIOR RESPONSE STATUS."
"TREATMENT-NAIVE patients with CIRRHOSIS who have undetectable HCV-RNA at weeks 4 and 12 (eEVR) of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies (14.2)]."
2 DOSAGE AND ADMINISTRATION:
"Table 1: Recommended Treatment Duration..."
"TREATMENT-NAIVE and Prior RELAPSE PATIENTS:"
HCV RNA - triple therapy - peg-interferon - Total duration
Undetectable at Weeks 4 and 12 - First 12 weeks - Additional 12 weeks - 24 weeks
Prior PARTIAL and NULL RESPONDER Patients:
- 48 weeks
"....there were small numbers of subjects enrolled in some key subgroups. In the T12/PR group:" (12 weeks of Incivek, 12 weeks of peg-inf & Ribavirin) .....Twenty-one subjects had cirrhosis at baseline and the overall SVR in these subjects was 62% (13/21). Among subjects with cirrhosis, 43% (9/21) achieved an eRVR and of those 78% (7/9) achieved SVR."
"Twenty-three percent of INCIVEK-treated subjects had cirrhosis at baseline. SVR rates among cirrhotic subjects who received INCIVEK combination treatment compared to Pbo/PR48 were: 87% (48/55) compared to 13% (2/15) for prior relapsers, 34% (11/32) compared to 20% (1/5) for prior partial responders, and 14% (7/50) compared to 10% (1/10) for prior null responders."
The following points should be considered when initiating treatment with INCIVEK:
• A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment [see Microbiology (12.4) and Clinical Studies (14.3)].
there are a number of misunderstandings and outright wrong conclusions being repeated in the posts.
Hector...I am so glad someone else noticed.
Bravo Hector. I don't like to read it, but it's basically what I was told by Dr. That is one of the reasons only a transplant team would prescribe to me for tx. They'll be the ones who will be able to facilitate a transplant in case of total liver failure. The kidney team is the floor below theirs and my sis is a match if I get into trouble there.
Of course, I'm believing it won't be needed. But we gotta know the truth even if it's ugly. ;P
Thanks, Karen :)
Sounds great to me! I also have cirrhosis and will start tx tomorrow, my doc is doing the same as yours, if I am UND at 4 and 12 weeks I will tx an additional 12 weeks, if not I guess that is it.
as the dosing instructions states, if und at 4 and 12 weeks relapser will treat additional 12 weeks
It then says "Cirrhotics may benefit from additional 36 weeks"
I am so happy for you congrats
You would think the nurse could have been more helpful though maybe she doesn't know and you need the doctor to tell you you are UND
2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
This is an older thread. Many may not look at it. It would be better if you will start a new thread and more people will respond. Post exactly what your lab report says, all of it. Don't leave anything out. Then people can interpret it for you.
To start a new thread, go towards the top to the orange bar and "Post a Question".
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