Restarting triple therapy

I had to stop the triple therapy for Hep C after 2 months due to an infection in my toe. My platelet count dropped to  critical levels and I had no immune system. After 6 weeks of IV antibiotics I have returned to good health. I have never had any symptons of liver disease although I am at Stage 4 Cirrohsis.
In the next few weeks I will restart the triple therapy. I am 59 and have had HEP C for 30 years. My doctor informed me there is little information on starting and stopping the therapy. My body may be able to recognize the drug therapy and prevent it from working. Any comments would be appreciated.

[Slim1969]

One other comment the virus was undectable after 1 month and I had no side effects until the platelet count started to drop,

[willbb]

Sorry to hear about your infection and having to cease HCV therapy. Your doctor is unfortunately misinformed ,telling you there is little info. stopping and starting triple therapy.
The Incivek dosing label reads:
"To prevent treatment failure the dose of Incivek must not be reduced or interrupted"  

infectiohttp://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdfn

It may be a good idea to get a second opinion about your current status as regards to resumption of therapy from a knowledgeable doctor(in the tx. of HCV ) before resuming.

Good luck..
Will

[Slim1969]

I have several opinions from different doctors including the transplant center at Tampa General.
"To prevent treatment failure the dose of Incivek must not be reduced or interrupted"  

The above statement is very general. Its only logical that if you stop taking the drugs before the 24 weeks the chances of it curing the virus become significantly reduced. My questiion refers to restarting.

Incivek and Victrelis both target the HCV protease enzyme, making it nearly impossible for the virus to replicate. Although the virus quickly becomes resistant to either drug used alone, combination therapy with interferon and ribavirin keeps HCV in check

[willbb]

You seem to have the answers you need from  all the doctors that are advising you....I was only trying to pass on the advice from the drug company on their labeling  as you seemed to ask for about starting and stopping...
Best
Will.

[hrsepwrguy]

INCIVEK efficacy has not been established for patients with a history of exposure to NS3/4A protease inhibitors.

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

The
efficacy of VICTRELIS has not been established for patients with a history of exposure to other NS3/4A
protease inhibitors.

http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

[hrsepwrguy]

If you choose to read links provided both suggest that once the use of the PI is stopped it should not be reintroduced. But as always treatment advice should be taken from a knowledgable doctor with expirience treating HCV.

[HectorSF]

Hi. Welcome.

What is different about your case it that you stopped before week 12. This is permissible in patients that don't respond to treatment and have a viral load over 1000 (assuming Telaprevir here) after week 4 or week 12. So it is not like you did 48 weeks of treatment and failed. So the amount of viral resistance substitutions should not be too great. What was your viral load at week 4? So it is a good thing that you stopped treatment early.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INCIVEK safely and effectively.

"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 or equal to 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV-RNA levels at Treatment Week 24"

"The long-term clinical impact of the emergence or persistence of detectable INCIVEK resistance-associated substitutions is unknown. No data are available regarding INCIVEK efficacy among patients who were previously exposed to INCIVEK, or who previously failed treatment with an INCIVEK containing regimen."

The best option is to retreat and monitor your viral load to see if you respond to treatment.Otherwise you will need to wait for new treatments which won't be available for a number of years or get into a phase III clinical trial of newer treatments when they allow cirrhotics which can be very difficult to do. They usually don't allow patients with low platelet counts in trials.If you should wait for new treatments to be available you will hopefully not advance to End-Stage Liver Disease by then as you may not be able to treat.

I would work with the transplant center at Tampa General.as they are the best informed about your health status and what options are the best for you.

Good luck to you. I hope you can stop the progress of your liver disease soon.
Hector

Hector

[hrsepwrguy]

We have one member hear that failed with the incivek and is now retreating with victrelis and is having success thus far, rockymoe, follow the link to her latest update on her progress.

http://www.medhelp.org/posts/Hepatitis-C/I-just-got-my-12-week-VL/show/1631720?controller=posts&action=show&id=#

[Slim1969]

after 4 weeks the viral load was undectable.

[BonnieJB]

I started the triple therapy in June. My doctor stopped last month because I had serious mental side affects that I could not control. I tested clear twice I just had a test two weeks ago and the virus is detectable again. I was on the boceprevir/pegintron/rebetol therapy. I am not sure if I will ever be able to start treatment again because of the mental implications. I was never a depressed person in my life until this medication. I originally did the dual therapy for a year it did not work. I strated on the triple and it seemed to be working until my depression took over. I am in stage  cirrohisis. There is a new drug that has been approved in Europe. It is a one pill a day therapy. It has just come out of lab trials here now will go to clinical which will take years here in the US. The sucess rate on the new drug is tremendous with very little side affects. Good luck to you. Hope your treatment works.