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 elvitegravir’s 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.
Gilead’s 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.