HIV and ID Observations

Yesterday, the FDA issued a drug safety alert about severe rashes — “some fatal” — in patients treated for HCV with interferon, ribavirin, and telaprevir.

The culprit, of course, is the telaprevir. The label already contained warning information about serious skin rashes with the drug, and this alert serves to heighten our awareness of the problem, with strong wording about the importance of stopping treatment when severe rash with systemic symptoms occurs (bolding is from the FDA):

When any of these serious skin reactions occur, it is necessary for healthcare professionals to immediately stop all three components of Incivek combination treatment and the patient should receive urgent medical care. 

Anyone who has prescribed or taken this drug already knows its no picnic, and of course interferon and ribavirin are hardly a walk in the park either. (Can one mix the picnic and walking in the park metaphors? Sure, why not — a picnic in the park.)

Importantly, the FDA alert again raises the key question facing people with HCV and their providers right now: Given the rapid pace of HCV drug development, with safer and more effective regimens on the horizon, why should anyone be treated for HCV today rather than waiting a few years?

I’ve asked my ID and GI colleagues this question numerous times, and received a variety of answers, but these two are the most common responses:

• Patient has advanced liver disease and can’t wait. Who knows when the new regimens will actually be available anyway?
• Patient does not have advanced liver disease, but really REALLY REALLY wants treatment now.

I certainly can understand the former, and have treated patients in this category. But what about the second one? Is this a good enough reason to treat someone with a potentially toxic treatment that, in all likelihood, will be all but obsolete relatively soon?

Anecdotally, it seems that the GI doctors (at least those that manage HCV) are more prone to treat because the patient really wants it than the ID docs. It could be our experience with HIV treatment influencing us — we saw what happened with that first generation of HIV drugs (efficacy just barely justified the toxicity, and certainly not in early disease), and we rarely use any of those medidcations today. By contrast, the GI docs see and manage advanced liver disease all the time, and must be motivated to do anything possible to prevent it.

So what do you think?