Soooooo confused - please clarify

[scared2death780]

I found out that I was Hep C positive after receiving a letter from the blood bank after a donation. Was retested to confirm and I am genotype 1. The day I received my letter I was on the phone and got an appt with a liver specialist the following week who ordered a viral load, additional lab work and an ultra sound. I was told my liver function is excellent, liver enzymes and labs are excellent and no evidence of any liver damage or cirrohsis. I am 49 yr old, not taking any medication. My viral load came back at 140,00 and was asked if I wanted to started triple therapy treatment 24 weeks with incivik, riba and peg. I started April 12. My HGB kept dropping started at 15 and after 2 weeks went down to 9.6 the following week 8.4 and my riba has been reduced twice now. I had my 4 week viral load drawn almost 2 weeks ago and the doctor told me not to worry he was confided it would be UND. When I had my appt with the liver doctor these labs were not back yet but he said it would be OK, Well, my load came back detected <43. I still have not gotten to speak to the liver doctor yet he has been out but I have spoken to several of the Nurse practictioners in the office. I am getting conflicting stories. One says I am responding and am still consideded UND and will still only do 24weeks, the other says detectable but <43 - says test cant tell what number under 43 but still doing well-this says will be up to doctor but prob still 24weeks. I called the 800 nbr for incivik and they told me they recomment 48 but it is up to the doctor. Someone please give me some insight. I am waiting to speak to the doctor but appt not for 2 weeks. I would like to go in with some knowlege and questions, I want to be rid of this and dont want to relapse but dont want to do 48 week.  Never in my office visits to him was there EVER a mention of 48weeks, always 24. I dont understand how everyone interprets results so differently, I have looked on other forums and I see different answers. What is right! I know everyone is different. But if my doctor says only 24weeks and I relaplse can I do other treatments. Help Im so confused.

[Advocate1955]

Cgal1957, Gilead has only requested approval so far for sofosbuvir to be combined with Interferon and Ribavirin for G1s.  The next treatment available for G1s will not be Interferon free.
Advocate1955

[Cgal1957]

Hi,
I am so sorry that you not only were mislead, but have a very irresponsible doctor.
Triple therapy is treatment can work, to many variables. Sorry those drugs are straight up poison and should only be used as a last resort. I say that because if your doc was responsible he would have ordered a biopsy. That is the only true way to determine amounts of liver damage. Not an ultra sound or a fibroscan! And if all those tests he ran came back good why tell you to treat now.  I am sure someone told you liver functions tell nothing of the state of your liver nor your VL.
Now your medical professionals are talking about reduction before you even are UD.  With your Hgb levels dropping that fast there is a problem. Procrit may or may not help it is no guarantee.
I would get on the phone and demand to see that doc now do not wait the 2 weeks.  In the meantime get yourself a new hepatologist. This is your life! These drugs are very powerful, effective in many, but they are poison.
Don't be afraid or embarassed if you have to quit, or you chose to quit. There are drugs in clinical trials and some about to be approved for G1's in the next 18-24 months. Much gentler drugs with no INF. 12-24 week treatments with orals. As we speak they are testing ones w/o Ribavirin as well.
Your doc is .........sorry just sayin

[pooh55811]

Welcome to the forum.

I am sorry you were still Detectable at 4 weeks and also sorry that the nurses in your doctor's office do not seem to know the correct protocol/recommendation for treating Genotype 1 with triple medication treatment (in your case, Interferon, Ribavirin, and Incivek).

You stated, "my load came back detected <43."

<43 Detected is still Detected. <43 Detected is NOT considered Undetected. Detected is Detected.

As has been pointed out by several posters above, if a person is still DET at the end of week 4 on Triple Med. Treatment with Incivek,  the protocol/recommendation is that the person will treat for a total of 48 weeks.

People who are not UND at week 4 do not have as good of a chance for SVR as those who are UND at week 4. Doing 48 weeks (instead of only 24 weeks) gives these people a better chance for SVR. The SVR rates are still less than they would be if they had been UND at week 4, but the SVR rates are better than if they did only 24 weeks. This was confirmed in studies/trials.

The following is taken from the Clinical Care Options:
A Practical Guide for the Use of Boceprevir and Telaprevir for the Treatment of Hepatitis C. Selecting a Treatment Regimen: Response-Guided Therapy. By Drs. Ira M. Jacobson and Jean-Michel Pawlotsky.

Note the only sentence in the second paragraph and also the only sentence in the 5th(and last) paragraph:

"Telaprevir. The prescribing information for telaprevir in treatment-naive patients recommends that all patients begin with a 12-week period of triple therapy with telaprevir 750 mg 3 times daily (every 7-9 hours) plus pegIFN/RBV.[53] ..... After 12 weeks, telaprevir should be discontinued and pegIFN/RBV continued;  for individuals with an eRVR (undetectable HCV RNA at Weeks 4 and 12), pegIFN/RBV should be continued to treatment Week 24.

Conversely, for individuals without an eRVR, pegIFN/RBV should be continued through treatment Week 48 (Table 6).

As with boceprevir, it is recommended that an HCV RNA assay with a lower limit of quantification of 25 IU/mL be used for evaluating virologic milestones for response-guided therapy. .....

The response-guided therapy strategy with telaprevir is based on the results of 2 phase III trials in treatment-naive patients. Results from the ADVANCE trial strongly suggested that 24 weeks of therapy is sufficient for patients with eRVR.[29] In the T12PR48 arm of this trial, patients with an eRVR (UND at weeks 4 and 12) received 12 weeks of triple therapy followed by 12 weeks of pegIFN/RBV, whereas patients without an eRVR received 12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV. Among patients who achieved an eRVR and received 24 total weeks of therapy, the SVR rate was 89%, ..... ILLUMINATE trial, in which treatment-naive patients with genotype 1 HCV who achieved eRVR after 12 weeks of telaprevir ..... among patients with eRVR, 92% achieved SVR with 24 total weeks of therapy ......

Patients who did not achieve eRVR all continued pegIFN/RBV through Week 48, and 64% attained SVR (Figure 12). "


I am not including a link because I am having difficulty getting it to link without it going to my own personal page (one has to register for this site although it is free).

Just for the record, I also was Detectable at week 4. Mine read the same as yours, <43 Detectable. I did 48 weeks total treatment, finished on Aug. 25, 2011, and attained SVR in February 2013. I am cured. Several of us were in the same boat as you are, Detectable at week 4, did 48 weeks and are now UND/SVR.

To have the best chance at SVR you need to do 48 weeks of treatment. If I was you, I sure would not take a chance and do only 24 weeks.

I agree with Can-do that "dose reducing before one is confirmed UND is not a good idea."

Also, it appears that you never had a liver biopsy. You really cannot tell from the liver enzymes and an ultrasound exactly how well your liver is functioning and how much fibrosis you have. You can have normal liver enzymes and still have a lot of liver fibrosis. Also, the ultrasound can pick up cirrhosis but not lower stages of fibrosis. My liver ultrasound was perfect but I was at Stage 2 fibrosis and Grade 2 inflammation. When I started treatment my AST was normal and my ALT was a little elevated but not bad. A person can have normal liver enzymes even with advanced liver fibrosis.

Hopefully your hepatologist knows the correct protocol for treatment. If he does not, then you may want to find a new Hepatologist.

Also, if I was you, I would ask my doctor to order Procrit for the low hemoglobin. If you can get your hemoglobin up with Procrit hopefully you can increase your Riba dose. I would call and ask to speak with him. I would not wait for 2 weeks until I see him. I wold call and get the ball rolling on the Procrit. It takes a while to get approval from the insurance company and then it takes a while for the Procrit to work, so every day counts.

Please come to the forum often and ask questions. There are many people here who are very knowledgeable about Hep C and treatment and people are very will to give information and support.

Best of luck.

[can-do-man]

I am sorry your doctor seemed to take way to much for granted and it backfired, dose reducing before one is confirmed UND is not a good ideal and clearly you are not UND. Heres from the mayo clinic


A "Detected" result with the comment "HCV RNA level is <43 IU/mL (<1.63 log IU/mL). This assay cannot accurately quantify HCV RNA below this level" indicates that the HCV RNA level is below the lower limit of quantification for this assay. When clinically indicated, follow-up testing by this assay is recommended in 1 to 2 months. For the purposes of assessing response-guided therapy eligibility, an "Undetected" result is required; a "Detected" result below the limit of quantification should not be considered equivalent to an "Undetected" result.

http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/83142

[Idyllic]

Since you were not UND at four weeks the SOC (standard of care) for triple with Incivek holds that you treat 48 weeks rather than 24 weeks.

I am deeply sorry you were mislead. At seems some doctors are so confident the drugs will work sooner that they lead the patient to believe they only treat 24 weeks when in most cases there is no way to predict how long we will treat until we get our four week labs.

I thought I was only treating 24 weeks and only planned for that. In my case that was never (ever) an option though. I thought I did enough research at the beginning but I messed up on that aspect.

At least you have one doctor who knows what he is doing.

[crossroadsec]

I went through the same thing when I found out the day the script was given to me that I was doing 48. Sry to ask if you've already discussed this, but do you have cirrhosis?
For cirrhotic patients, they call for 48 weeks. I was very shocked and upset at first, but am now SVR and happy to have the rest of my life back.  
Thoughts of relapse are frightening. But there is such a slight chance. Try and focus on managing the treatment. Keep posting and rely on your support here. You can do this. xoxo Karen:)

[Dee1956]

Hello I am sorry that you are so confused. Due to conflicting statement, of you are DET you are UND; if I were you I would wait to speak to my doctor.
You have received excellent information above.  Have you seen your test to see for yourself what it says?
If you are UND at 4 and 12 you do 24 weeks.  As said above, it is a response based treatment
Best wishes to you
D

[hrsepwrguy]

"Never in my office visits to him was there EVER a mention of 48weeks, always 24. I dont understand how everyone interprets results so differently, I have looked on other forums and I see different answers. What is right!"

Incivek protocol says 48 wks for anyone DET at 4 wks
---------------------------------------------------------------------------------------------
Incivek protocol/treatment duration/futility rules/PCR testing

2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 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 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.


http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf

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

Laboratory Tests
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.

http://pi.vrtx.com/files/uspi_telaprevir.pdf .

Unfortunately we see a lot of that here where patients are told 24 wks from the start, however treatment duration is based on response to the meds, I too had to do 48 wks because I was detectable at wk 4 but I was well aware of the chance I might have to do 48 wks

[cheflady]

hi and welcome to the forum it is perfectley understandable to be scared and confused you are doing very well I know over here in Britain they told my hubby that they decide after wk 8 blood tests wether or not it will be 24wk or 48wks.but it might be different where you live. Keep looking for replies to your post there is a lot of very knowlegeable people on here. I can understand you only want to do  24wk its not a pleasent journey you have to do but it is needed to give you the best chance of been cured. I wish you all the very best and please keep us posted