|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.
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