why not in US?
Nov 5, 2001
Triomune is the world's first fixed-dose formulation containing a combination of 2 widely used nucleoside reverse transcriptase inhibitors (stavudine and lamivudine), with 1 potent non-nucleoside reverse transcriptase inhibitor (nevirapine). Triomune can be taken twice daily, irrespective of food.
Is there anything like this in US drug market?
Response from Dr. Boyle
No, there is nothing like this in the US. Combining drugs in that fashion can be problematic in many respects, especially regarding the formuation and binding agents involved which may affect absorption and drug levels significantly. I am unaware of any data to support putting those 3 medications in one tablet and, even if the 3 drug companies involved were interested in doing that, the FDA would require extensive pharamcokinetic data prior to approving it. Also, how is the appropriate lead in dose of nevirapine given (which decreases the rate of rash and other toxicities) if that formulation is used? What about side effects and problems with one component? As you can probably guess, I am not a fan of this approach absent strong data to support it and show that it is safe and effective.
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