The Quad offers another option for simplified dosing
On May 11, 2012, the Antiviral Drugs Advisory Committee of the Food and Drug Administration (FDA) voted 13 to 1 in support of approving the Quad pill. The Quad is a full-regimen pill for treating HIV in people starting therapy for the first time. If the FDA eventually approves the Quad, it will join Atripla and Complera as the third full-regimen pill on the market.
The panel’s support is based on the results from two studies — one that compared the Quad to Atripla (Study 102) and another that compared it to boosted Reyataz (atazanavir) + Truvada (Study 103). At 48 weeks, the Quad controlled HIV to undetectable levels in 88% of people compared to 84% on Atripla. The Quad similarly controlled HIV in 90% of people compared to 87% on Reyataz + Truvada.
Taken once a day, the Quad contains four drugs: the new integrase inhibitor elvitegravir, the new booster cobicistat, and the two drugs in Truvada (Viread + Emtriva). Cobicistat supports the elvitegravir to be taken once a day. (In contrast the first integrase inhibitor on the market, Isentress, must be taken twice a day.)
In these two studies, the Quad was well tolerated. Side effects were generally mild to moderate, and included headache, diarrhea, nausea and upper respiratory infections. In Study 102, fewer people stopped the Quad regimen due to side effects such as difficulty sleeping, skin rash and dizziness compared to those on Atripla.
Although it’s not active against HIV, cobicistat is being studied as a replacement for the commonly used booster Norvir (ritonavir) in regimens that contain the protease inhibitors Prezista (darunavir) or Reyataz.
The FDA’a final decision is expected by the end of August.