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new hiv meds 4 drugs in one pill taken once a day..
Jan 22, 2009

Hi Dr Ben,

could you please tell me about this new 4 drugs in one pill, once a day... it sounds great.. when will it be out for general use ???

thank you so much for your time.. tim

Gilead aims to start trials in 2009 of a new four-drugs-in-one-pill product, combining all its anti-HIV drugs, the company told Bloomberg news service yesterday.

The `Quad` pill will combine tenofovir and emtricitabine (already marketed as a two-drug pill called Truvada) with a new antireretroviral drug now in phase III studies, called elvitegravir. This drug belongs to a new class of antiretroviral drugs called integrase inhibitors, and will be combined with another new drug, called GS9350, which boosts levels of elvitegravir.

Gilead hopes that if pre-licensing studies are successful, elvitegravir could receive a license for use in treatment-experienced patients in 2010.

However Gilead has its eye on the market for patients new to treatment, currently dominated by another of its combination pills Atripla (co-marketed with Bristol-Myers Squibb) which contains tenofovir, emtricitabine and efavirenz (Sustiva).

Efavirenz may be less suitable for African-American patients, said Gilead president John Milligan, because it is metabolised more slowly by people of African descent, leading to a higher risk of central nervous system side-effects.

Although elvitegravirs long-term side-effect profile is unknown, another integrase inhibitor called raltegravir has shown that it is well-tolerated in comparison to efavirenz, and just as effective at suppressing viral load. Raltegravir (Isentress), manufactured by Merck, is likely to receive US approval for first-line use during 2009.

Gileads hope is that a four-in-one combination pill, taken once a day, could have an edge over raltegravir, which must be dosed twice daily.

Response from Dr. Young

hi Tim and thanks for your post.

The so-called quad pill is indeed in development by Gilead-- it is a combination of the potential new boosting drug (ie, the long awaited replacement for Norvir) with Gilead's new integrase inhibitor and the parts of Truvada.

There's quite a bit of clinical science and good outcomes that will be required before FDA approval-- at least 2-3 years in my back-of-the-envelope calculation. To what extent the new combination meets or exceeds the characteristics of current first-line options remains to be seen, but suffice to say that there is a lot of interest.

BY



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