Any triple therapy trials yet

[Bill200]

Hi Doctor, is anyone at Mount Sinai any closer to doing any triple therapy treatment with Incivek or Victrellis for transplant patients?   If not, is it the safety and liability issues that prevent it, and outweigh this treatment for patients in critical need of treatment?  Several other centers' doctors are successfully prescribing triple therapy off-label at this time.

[Thomas D Schiano, MD]

unfortunately the pt would be required to have frequent f/u in person

[Bill200]

Doctor you mentioned some potential upcoming trials.  At what distance could the patient participate in the trial.  In other words could it be done remotely with labs, etc, taken at a remote location e.g., another state?

[Thomas D Schiano, MD]

general--in blood, urine or pneumonia

[hopewife]

Thank you for answering my question.  Yes 10 years post-transplant.  Could you elaborate on where the infections occur?

[Thomas D Schiano, MD]

is this post-transplant?  PEg/RINA can definitely lead to infection and is one of the concerns with it.  unfortunately i have seen similar things happen in the past.

[hopewife]

Is there any information online of clinical trials going on now? My husband is in a trial and he did okay for 11 weeks on incevik.  He was undetectable at 4 weeks and is still clear.  But the last week he started running high fevers (103.6) and has lost 15 pounds in 3 weeks.  He was admitted to a local hospital and put on broad spectrum antibiotics.  Nothing found in blood cultures etc.  The infectious disease doc put him on steroids and he improved somewhat they released him.  Now he is very sick, the clinic seems convinced that it is the peg/int.  Have you heard similar stories?  Seems so odd to get through 11 weeks of triple therapy to have this..???  
I am very concerned and dumbfounded by the lack of action of the clinic.

[Thomas D Schiano, MD]

we will be hopefully be involved in a clinical trial soon.  We have as a group decided to wait for a clinical trial because of safety concerns.  Please let me know who you are so we can ofer you the clinical trial when it becomes available.  thanks.