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Status of Telaprevir
Mar 16, 2010

Thank you Dr. McGovern for your response to my previous question on this topic. Esentially, what I'm concerned about is that IFN + RBV has not been proven to be more than 50% effective (I believe) with type 1 HepC. The fact that Tibotec's current trial with Telaprevir is focusing on treatment naive patients with Type 1 HepC and that it finished enrolling this month indicates that there may be something more promising on the horizon. There were no study sites in my city, but I guess I would have missed the boat even if there had been. I'm also currently out of work, and the prospect of "surviving" for the next 42 weeks (minimimum treatment duration for Type 1) without even attempting to look for work is grim. Is the rash you talk about Steven's Johnson Syndrome (progressive necrotizing dermatitis, I think)? Is the risk of this higher than for most other medications or combinations of meds? My status wrt Hep C is OK for now. I had a biopsy last year which revealed only 1+ inflammation and no fibrosis, and the hepatic ultrasound was normal. I also don't drink much (only beer, occasionally), and my HIV status has been undetectable for ever (15 years on Rx now). So do you think it's worth waiting for a better outcome in view of the low present risk of hepatic complications? Also, in the phase III trial that Tibotec was running, one of the exclusion criteria was "any other health condition that could interfere with the treatment" or something to that effect. It's a bit of a catch-all exclusion criterion, which is then left up to the investigator to judge. Do you know if HIV+ patients were excluded even if they had a completely normal hematology profile and were on a stable treatment regimen for at least 12 months, or were they allowed to participate? If they were allowed to participate, will Tibotec be conducting a sub-group analysis. I've been told that the medication will not be available for co-infected individuals for quite some time, until the required clinical trials have been completed. However, clearly if the results of the phase II trial that is being completed indicate that there is a cohort of HIV+ patients who responded well, then it may be worth my while to wait a bit longer. Once the medication is marketed, a physician is allowed to prescibe it to patients who don't quite meet the label indications. I have read publications indicating that some hepatologists would prescribe Telaprevir to their HIV HepC patients first line, although I'm not sure where this paper came from. So, hoping you can k,ake sendse of this meandering question, I thank you in advance for your attention and response.

Response from Dr. McGovern

There are many promising drugs on the horizon but telaprevir is probably one of the closest ones to final review.

Most trials of new drugs have major exclusions to try to understand the toxicity of the drug in relatively healthy patients without other major comorbidities.

The rash associated with telaprevir is usually mild; it can be more more significant (eg, moderate) in some patients leading to drug discontinuation.

HIV infected patients will be studied now in the upcoming trial I mentioned; trials of other new drugs for HCV usually have HIV status as an exclusion. Once the drug is determined to be safe in HCV infected patients, the next step is to do a trial in HIV infected patients.

Since you have mild disease you have many many options.....Waiting is completely reasonable. You may want to have a repeat biopsy in two years or get a non-invasive marker of liver fibrosis now to see if it agrees with the biopsy results you have currently. Then in two years you can have a non-invasive marker performed again (eg, blood test).



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