Aa
Three Doses Missed of Ribavirin...with a back story
Monday, my husband had his 24-week visit with his GI doc, who told us that while his viral load was technically undetectable it was still detected. The lab sheet showed <43 detected. Oh, he is/was on triple therapy with Incevik for the first 12 weeks. There was never a more faithful taker of medication in all the history of the world. But, the doc said to stop the treatment and said he needed to go to a hepatologist and perhaps the hepatologist would go with Victrelis next time.
In the meantime, we have chatted with a research facility in the metroplex and she seemed to think perhaps the treatment shouldn't have been stopped, or paused at all. My question is whether or not he could continue to take the ribavirin, as God knows we have plenty of it in stock, while we try and figure out what is next. It was my understanding that treatment experienced patients go for the 48 weeks, so I was puzzled at the stoppage myself. We are just frantic and everything I read only addresses one missed dose. ANY, and I do mean any information would be greatly appreciated.
thanks!
In the meantime, we have chatted with a research facility in the metroplex and she seemed to think perhaps the treatment shouldn't have been stopped, or paused at all. My question is whether or not he could continue to take the ribavirin, as God knows we have plenty of it in stock, while we try and figure out what is next. It was my understanding that treatment experienced patients go for the 48 weeks, so I was puzzled at the stoppage myself. We are just frantic and everything I read only addresses one missed dose. ANY, and I do mean any information would be greatly appreciated.
thanks!
um, yeah. so was I. but then again, not really. we should have found a hepatologist instead of going with a GI whose main positive was that he was here in town. live and learn.
I agree he should have stopped if not UND at 24. Pretty basic stuff. However, I'm not sure if since he took one PI he can then take the other. Isn't there some question of resistence and mutation and stuff? Like Susan trialed with the Inc and now cannot take the Boce?
Taking more riba will not accomplish anything.
I think he has to find a trial of the all orals if anything, I dont believe taking another PI would do anything for him and I'm surprised a doctor would even suggest that really.
Taking more riba will not accomplish anything.
I think he has to find a trial of the all orals if anything, I dont believe taking another PI would do anything for him and I'm surprised a doctor would even suggest that really.
Great. We will be leaving for Dallas about 1:00 today (I am in W Texas) so I won't be checking my emails much after that so if you have anything specific, let me know and I will akd my doc. I will check this thread before I go. Having that low viral load for such a long time like your husband did is distressing. There was another member here who looked back at his first treatment old records and determined he "flat-lined" at about 400vl for several months and that was a indicator that he would relapse. He just cleared a year ago -- he started on SOC but when the PIs became available he added Victrelis to the end of his 48 weeks. He is SVR now.
Personally when I first treated I had a viral load of 40 at week 12. (I used the QuantaSure testing which is detectable to 2 and that is the test I recommend unless you use Quest and then the Heptimax (sensitive to 5). Even though I did 56 weeks I did not clear. So I am in tune with carrying these low loads of Virus and how damaging that is.
bean
Personally when I first treated I had a viral load of 40 at week 12. (I used the QuantaSure testing which is detectable to 2 and that is the test I recommend unless you use Quest and then the Heptimax (sensitive to 5). Even though I did 56 weeks I did not clear. So I am in tune with carrying these low loads of Virus and how damaging that is.
bean
Hi! Thank you! I am going to send this to Rob (my husband) and let him get in this loop. This is by far the most intelligent, information-filled forum I have found in all of my searching of the internets :-) Thanks so much for your information and your hard work helping to inform other folks!
Chris
Chris
Chrisy
The cold hard fact is that if you are detectable at week 24, you are probably not going to clear by 48 week. So I don't think the doctors did you a disservice by pulling your husband. It just means he has some time to recover and figure out what to do.
I treat in the metroplex. In fact, I have an appointment with my hepatologist this Friday. I will ask him if there are any trials coming up and let you know. If you are interested, his name is Dr. Mubarak and he is with The Liver Institute at Methodist Hospital. You can google them. They are a transplant center, and I am very impressed with my doctor's knowledge of Hep C and the new treatments. He gives seminars to GIs in the Dallas/Ft Worth area about treating with the PIs. His main office is in Dallas but I think he has a clinic maybe in Arlington once a week too. Not sure.
Or here is another option. When I relapsed the first time I was treating with a GI. I got a referral to the Liver Institute for a consult. I consulted (but did not treat) with Dr. Reem Ghalib. She left the Liver Institute and I was rolled to Mubarak. I really did like her very much and considered finding her and doing my new tx with her, but I liked Mubarak and decided to stay where I was.
However her MA called me a few months ago (not knowing I was treating) and wanted to know if I was interested in a trial. I think it was a Gilead trial without interferon. She is in Arlington and I looked her up for you. I have mixed feelings about trials, especially when cirrhosis is involved, but that would be a topic for another thread. I would highly recommend her.
http://www.healthgrades.com/physician/dr-reem-ghalib-xyxn7
I am not sure anyone would roll your hubby into VIC immediately but a consult with a good heppo will tell you a lot. I will get back with you after this weekend.
frijole (bean)
The cold hard fact is that if you are detectable at week 24, you are probably not going to clear by 48 week. So I don't think the doctors did you a disservice by pulling your husband. It just means he has some time to recover and figure out what to do.
I treat in the metroplex. In fact, I have an appointment with my hepatologist this Friday. I will ask him if there are any trials coming up and let you know. If you are interested, his name is Dr. Mubarak and he is with The Liver Institute at Methodist Hospital. You can google them. They are a transplant center, and I am very impressed with my doctor's knowledge of Hep C and the new treatments. He gives seminars to GIs in the Dallas/Ft Worth area about treating with the PIs. His main office is in Dallas but I think he has a clinic maybe in Arlington once a week too. Not sure.
Or here is another option. When I relapsed the first time I was treating with a GI. I got a referral to the Liver Institute for a consult. I consulted (but did not treat) with Dr. Reem Ghalib. She left the Liver Institute and I was rolled to Mubarak. I really did like her very much and considered finding her and doing my new tx with her, but I liked Mubarak and decided to stay where I was.
However her MA called me a few months ago (not knowing I was treating) and wanted to know if I was interested in a trial. I think it was a Gilead trial without interferon. She is in Arlington and I looked her up for you. I have mixed feelings about trials, especially when cirrhosis is involved, but that would be a topic for another thread. I would highly recommend her.
http://www.healthgrades.com/physician/dr-reem-ghalib-xyxn7
I am not sure anyone would roll your hubby into VIC immediately but a consult with a good heppo will tell you a lot. I will get back with you after this weekend.
frijole (bean)
To address your initial question continuing the Ribavarin would yield little benefit. The primary purpose of Ribavarin is to increase the effectiveness of interferon therapy.
http://archinte.jamanetwork.com/article.aspx?articleid=486762
http://www.encognitive.com/node/5376
FYI Ditto with the Interferon on its own. There was a time when it was believed Interferon maintenance therapy would slow the progression of fibrosis however the HALT-C study demonstrated this is not necessarily the case.
http://www.hepcassoc.org/news/article161.html
___________________________________________
"perhaps the hepatologist would go with Victrelis next time. "
If your husband treated with the Incivek and did not respond the Protocol would NOT be to try the Victrelis next. This has something to do with similarity in chemical composition of both drugs and/or resistance issues. I will let someone else address this in more detail if you are curious.
___________________________________
*I agree with the others if your husband was detectable at week 24 then stopping all meds is the correct procedure. However I would request a re-test as well.
Hang in there as there are sure to be other options. If you do end up seeing a Hepatologist read this or take a copy with you:
http://i-base.info/htb/16961
http://archinte.jamanetwork.com/article.aspx?articleid=486762
http://www.encognitive.com/node/5376
FYI Ditto with the Interferon on its own. There was a time when it was believed Interferon maintenance therapy would slow the progression of fibrosis however the HALT-C study demonstrated this is not necessarily the case.
http://www.hepcassoc.org/news/article161.html
___________________________________________
"perhaps the hepatologist would go with Victrelis next time. "
If your husband treated with the Incivek and did not respond the Protocol would NOT be to try the Victrelis next. This has something to do with similarity in chemical composition of both drugs and/or resistance issues. I will let someone else address this in more detail if you are curious.
___________________________________
*I agree with the others if your husband was detectable at week 24 then stopping all meds is the correct procedure. However I would request a re-test as well.
Hang in there as there are sure to be other options. If you do end up seeing a Hepatologist read this or take a copy with you:
http://i-base.info/htb/16961
Your doctor is correct to stop treatment. The protocol is I'd Hep C virus is DET at week 24 of triple tx w Inc treatment must be stopped. It means that treatment isn't working and isn't going to work, so there's no point in continuing. Additionally, by continuing, your husband is developing resistant virus, which may create difficulties for future treatment. I guess it's fine to ask for another PCR, if your doctor is willing, but it is probably futile. I'm sorry to sound so discouraging, but this treatment didn't work for your husband. It's best to follow your doctor's orders and stop treatment, recoup his strength, and move forward with a hepatologist. I don't believe he'll be able to treat with Victrellis, because the two are so similar. Sorry this didn't work for him.
Advocate1955
Advocate1955
Hmm...I see part of my post was cut out (accidentally).
The following part:
"As far as viral load goes, he is either Detectable or Undetectable. There is no "technically undetected" status. If his VL showed 1000 IU/mL at Wk 4 or 12: stop all 3 drugs
2. HCV RNA detectable at Wk 24: stop all treatment "
should read:
As far as viral load goes, he is either Detectable or Undetectable. There is no "technically undetected" status. If his VL showed any virus as Detectable then the virus is present. The test just cannot be numerically counted below 43, but it can be detected.
Futility Rules (Stopping Rules):
1. HCV RNA > 1000 IU/mL at Wk 4 or 12: stop all 3 drugs
2. HCV RNA detectable at Wk 24: stop all treatment
I guess I should reread my posts to be sure they are intact before posting them.
Anyway, hrsepwguy explained it better.
The following part:
"As far as viral load goes, he is either Detectable or Undetectable. There is no "technically undetected" status. If his VL showed 1000 IU/mL at Wk 4 or 12: stop all 3 drugs
2. HCV RNA detectable at Wk 24: stop all treatment "
should read:
As far as viral load goes, he is either Detectable or Undetectable. There is no "technically undetected" status. If his VL showed any virus as Detectable then the virus is present. The test just cannot be numerically counted below 43, but it can be detected.
Futility Rules (Stopping Rules):
1. HCV RNA > 1000 IU/mL at Wk 4 or 12: stop all 3 drugs
2. HCV RNA detectable at Wk 24: stop all treatment
I guess I should reread my posts to be sure they are intact before posting them.
Anyway, hrsepwguy explained it better.
I wishyou and your husband all the best moving forward
The test results can get a little confusing, here are the details of your husbands test
Hepatitis C Viral RNA, Quantitative Real-Time PCR 35645
Linear range: 43 - 69,000,000 IU/mL 1.63 - 7.84 log IU/mL
Reference Range(s)
HCV RNA, PCR, Quant <43 IU/mL
HCV RNA, PCR, Quant <1.63 LogIU/mL
Please note: the guidelines for the use of new anti- HCV therapies (boceprevir and telaprevir) recommend using a test method that detects plasma viral nucleic acid levels as low as 10 IU/ml. This assay has a lower Limit of Detection of 7.1 IU/ml for genotype 1 and conforms to the recommendation. Quantitation of plasma HCV nucleic acid levels below 43 IU/ml (the Lower Limit of Quantitation for this test) may not be linear, and in this circumstance are reported as "<43 IU/mL HCV RNA Detected".
http://www.questdiagnostics.com/testcenter/OrderInfo.action?fn=35645.html&labCode=SJC&orderInfoLabName=null
The test actually test down to 7.1 IU/ml but is unable to put a number on from 7.1 to 43 IU/ml it is only able to tell you if it is detectable or not, that is why you get the <43 detectable
Once again wishing you and your husband all the best
The test results can get a little confusing, here are the details of your husbands test
Hepatitis C Viral RNA, Quantitative Real-Time PCR 35645
Linear range: 43 - 69,000,000 IU/mL 1.63 - 7.84 log IU/mL
Reference Range(s)
HCV RNA, PCR, Quant <43 IU/mL
HCV RNA, PCR, Quant <1.63 LogIU/mL
Please note: the guidelines for the use of new anti- HCV therapies (boceprevir and telaprevir) recommend using a test method that detects plasma viral nucleic acid levels as low as 10 IU/ml. This assay has a lower Limit of Detection of 7.1 IU/ml for genotype 1 and conforms to the recommendation. Quantitation of plasma HCV nucleic acid levels below 43 IU/ml (the Lower Limit of Quantitation for this test) may not be linear, and in this circumstance are reported as "<43 IU/mL HCV RNA Detected".
http://www.questdiagnostics.com/testcenter/OrderInfo.action?fn=35645.html&labCode=SJC&orderInfoLabName=null
The test actually test down to 7.1 IU/ml but is unable to put a number on from 7.1 to 43 IU/ml it is only able to tell you if it is detectable or not, that is why you get the <43 detectable
Once again wishing you and your husband all the best
More back story. The first time he was treated, and this time as well, he achieved <43 IU/mL status by week 4 and remained there for the entire treatment. He does have cirrhosis, but his last liver biopsy was in 2009 and, frankly, we can't remember what the exact level was, just know they wouldn't have started treatment at all if it was a more severe stage. We have labs done at Quest and the HCV RNA are only expressed in <43 IU/mL and <1.63 Log IU/mL.
I'm sure that the doc was correct but it is, so to speak, a hard pill to swallow after going through the triple therapy and looking at that 80% plus SVR rate....
I'm sure that the doc was correct but it is, so to speak, a hard pill to swallow after going through the triple therapy and looking at that 80% plus SVR rate....
PS: I would agree that it would be most advantageous to see an actual Hepatologist in the future. A Hepatologist is an expert and he/she should know more about Hepatitis C and should be knowledgeable about upcoming treatments and management.
I guess it was the undetectable but detectable thing that threw me and then when this research person questioned it, it just had me a little frantic. Thanks for the input!
Welcome to the forum.
I am very sorry that your husband is still Detectable at week 24. I know it must be devastating to have to stop treatment.
However, if I was you, I would request another VL test to be certain there was no lab error and I would continue treatment until the results of that lab test are known (with your doctor's knowledge and okay, of course).
You do not state what happened the last time your husband treated. Did he ever clear the virus? Did he Relapse? Or did he not respond well (either a non-responder or a partial responder? His response to his last treatment would be a factor in determining how long he treated. If he relapsed, he would treat for 24 weeks. If he was a partial responder or a non-responder then he would do 48 weeks. Also, if he has cirrhosis he would do 48 weeks.
Also, was he ever Undetectable while on this 24 week treatment?
As far as viral load goes, he is either Detectable or Undetectable. There is no "technically undetected" status. If his VL showed 1000 IU/mL at Wk 4 or 12: stop all 3 drugs
2. HCV RNA detectable at Wk 24: stop all treatment
http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Supporting%20Assets.aspx
I am very sorry that your husband is still Detectable at week 24. I know it must be devastating to have to stop treatment.
However, if I was you, I would request another VL test to be certain there was no lab error and I would continue treatment until the results of that lab test are known (with your doctor's knowledge and okay, of course).
You do not state what happened the last time your husband treated. Did he ever clear the virus? Did he Relapse? Or did he not respond well (either a non-responder or a partial responder? His response to his last treatment would be a factor in determining how long he treated. If he relapsed, he would treat for 24 weeks. If he was a partial responder or a non-responder then he would do 48 weeks. Also, if he has cirrhosis he would do 48 weeks.
Also, was he ever Undetectable while on this 24 week treatment?
As far as viral load goes, he is either Detectable or Undetectable. There is no "technically undetected" status. If his VL showed 1000 IU/mL at Wk 4 or 12: stop all 3 drugs
2. HCV RNA detectable at Wk 24: stop all treatment
http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Supporting%20Assets.aspx
First I would request a retest then go from there, if indeed he is detectable even <43 IU/ml he is technically detectable and the doc is following proper protocol stopping all treatment
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)]. Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).
Table 2: Treatment Futility Rules: All Patients
HCV RNA - Week 24: Detectable
Action - Discontinue peginterferon alfa and ribavirin
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
http://www.drugs.com/pro/ribavirin.html
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)]. Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).
Table 2: Treatment Futility Rules: All Patients
HCV RNA - Week 24: Detectable
Action - Discontinue peginterferon alfa and ribavirin
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
http://www.drugs.com/pro/ribavirin.html
Well I agree treatment should not of been stopped as 48 weeks is whats called for if not und at week 4, missing only 3 doses should not be a huge deal... If you still have the riba and interferon I would get back on it and get into a hepa asap......... Good luck
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