Exceptional patient status

[poorlyshodcobler]

No job, no EI, no social assistance, no insurance. About to start a trial with TMC435 but have many misgivings about the procedures that my physician expects me to be available for (15 visits) as opposed those required by the clinical trial (8). I'll spare you the details of the wrangling I've been through, but found out that both Boceprevir (Victrelis) and Telaprevir (Incivek) are currently approved in Canada for HepC mono-infected patients and the recommended treatment duration is 12 weeks with Ribavirin + one of the two HepC protease inhibitors + PegIntron weekly. The protocol that I plan to participate in involves a similar 12-week course of therapy BUT requires that patients continue PegIntron and RBV for an additional twelve weeks. I just finished grad school and hope to find work soon, but this extended treatment course would make me unable to work for at least the next 6 months, which really makes my life, and everything I've done with it, seem worthless. I believe that Victrelis is available on an “Exceptional patient” (Patient d’exception) basis, whereby the cost of treatment is covered by the RAMQ, but the entire therapy must be requested from and approved by the RAMQ for that patient alone under the supervision of the requesting physician. This would reduce the treatment duration with IFN and Ribavirin by 12 weeks (the additional 12 weeks tacked on for the protocol) would not require the same frequency of intensive visits as required by the protocol and by my physician during the first 12 weeks of therapy. Does anyone out there know of physicians who accept to treat patients on an “exceptional” basis? As Boceprevir, Teaprevir and TMC435 are all protease inhibitors, the safety profile should be similar. Boceprevir is manufactured by Merk, Telaprevir by Vertex and TMC435 is being developed by Tibotec. Boceprevir and Telaprevir are dosed 3 x day, whereas TMC435 is once-a day. This is the ONLY benefit I see in participating in the trail: once a day dosing rather than TID dosing. If anyone has additional advice regarding whether I should or should not participate in this trail, please advise.

[flcyclist]

First, congrats on finishing your graduate degree and getting this behind you.  You should be very proud to have completed and shouldn't feel these efforts are worthless in any way.  As Odin pointed out there are several things you should know before proceeding which will assist you in making the best decisions moving forward.  If no insurance and limited resources, a trial would be a very tempting route given your situation.   Good luck.

[printze]

Do you live in Quebec ? I do,,Montreal . If so what hospital are you going to ?

[OdinLovesLife]

I can't see any information about your disease stage, genotype, IL28B type  and so on, in your profile. These factors affect a decision to undergo a particular type of treatment at a particular time.

One thing most people will say though, is that there is almost never a good reason to rush into HCV treatment.

There is a lot of research activity going on at the moment including trials for treatments without Interferon. Some are better than others and availability in your area might be an issue. Each one needs to be considered on its own merits.

It might be possible to get some new shoes and treat at the same time if you get into a trial without IFN. If your health permits, why not shop around a bit?

[willbb]

Participating in a trial  can be an excellent way of receiving tx. if there is no insurance.
Are you in Quebec?

Will

[curiouslady1]

I also faced just finishing grad school, still had to write my thesis and no job when I was diagnosed.  I chose not to  treat but to wait.  That was 20 years ago and a successful, fully functional career.  I now treat in a trial and UND.