|New drugs for treatment naive
Nov 27, 2007
I'm confused about what doctors can prescribe for treatment naive patients.
I thought drugs like Isentress and Prezista can be prescribed to treatment naive if the patient and doctor decide it's best. but I keep hearing conflicting information. Don't doctor's have a lot of wiggle room to decide "off-label" even with HIV drugs that were approved for salvage?
| Response from Dr. Young
Thanks for your post.
The new HIV medications raltegravir (Isentress) and darunavir (Prezista) are very promising; certainly for use in treatment experienced, drug resistant patients. It is indeed because of initial clinical trials data that the two medications received FDA approval for this patient population (the "on-label" indication).
Recent studies with both medications support the notion of using both in first-line therapy- showing aspects of superiority to currently recommended first-line drugs. For example, in therapy naive persons, both drugs (in combination) appear to be as- or more potent that currently recommended medications with improvement in short-term side effect profiles.
FDA approval does not restrict healthcare providers from using the drug in other settings (such as first-line patients), but rather rightly places restrictions on the ability of drug companies to promote such use until scientific studies and agency review support this use.
I'm exciting that new drugs may actually change (read: improve) current treatment options and guidelines. This conclusion is based on a very limited number of patients in just two clinical studies. On the other hand, we have years and years of successful patient experience with our current regimens- I'd need a pretty high burden of proof before discarding wholesale what we currently use.
I hope this helps, BY
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