Aa
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 *****......
Best Answer
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.
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
Dee
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
Dee
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 :)
Of course, I'm believing it won't be needed. But we gotta know the truth even if it's ugly. ;P
Thanks, Karen :)
there are a number of misunderstandings and outright wrong conclusions being repeated in the posts.
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Hector...I am so glad someone else noticed.
Will
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Hector...I am so glad someone else noticed.
Will
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...
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf
"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)].
Hope this helps.
Hector
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...
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf
"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)].
Hope this helps.
Hector
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..
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..
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