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May 22, 2012

Hi Nelson: I've read news on the new integrase inhibitor, Dolutegravir, that according to the latest clinical trials, no integrase resistance has been found. Without resistances, wouldnt this compound be ideal to suppress the virus to undetectable levels on Monotherapy? Could Monotherapy be realistic?

Thanks for your help.

Response from Mr. Vergel

Yes, this is probably the most potent integrase inhibitor to be approved in the next few months. But that does not mean that it can control HIV as a sole medication (monotherapy). It will require a backbone with Truvada or Epzicom for naive patients (two pills once a day), or a more complex background for patients with multi-drug resistance (dolutegravir will be dosed twice a day for these patients).

It seems to be effective to most (I say most, not all) raltegravir or elvitegravir integrase mutations, so people with a virus resistant to those two integrase inhibitors can hopefully get some activity from this drug. So far, it has the same very few side effects as raltegravir and same general lack of complex interactions.

It is now available via expanded access in the US and Europe for patients with raltegravir or elvitegravir resistance. But these patients have to take it with at least one active agent in their optimized background therapy. Here is the information on how to have your doctor apply for such program: ViiV Announces Expanded Access of New Integrase Inhibitor

The company is formulating it as a one pill once a day combination with Epzicom. This combo should be approved after dolutegravir enters the market.

I hope this information helps!

In health,

Nelson Vergel

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