October 20, 2006 (AIDSmeds)—Bristol-Myers Squibb announced today that it has received U.S. Food and Drug Administration (FDA) approval for a 300mg capsule version of its protease inhibitor Reyataz® (atazanavir). For HIV-positive people combining Reyataz with Norvir® (ritonavir), the 300mg Reyataz capsule can be used in place of the two 150mg capsules currently recommended when both drugs are taken together.

For HIV-positive people who have not taken HIV drugs in the past – that is, people starting HIV drug treatment for the first time – the FDA-approved dose of Reyataz is 400mg (two 200mg capsules) taken once a day. However, a frequently prescribed dose is 300mg Reyataz plus a single 100mg Norvir capsule, both taken once a day.

Norvir is used in this situation to boost Reyataz levels in the bloodstream, potentially making it more effective against HIV. In fact, the combination of Reyataz and Norvir is necessary for people who are using medications that contain tenofovir (such as Atripla™, Truvada®, or Viread®) and recommended for people using Sustiva® (efavirenz) in the same regimen. The addition of Norvir is also the FDA-approved way to use Reyataz by HIV-positive people who have used other HIV medications in the past.

Reyataz plus Norvir is listed as a “preferred” protease inhibitor option by the United States Department of Health and Human Services in its treatment guidelines for first-time treatment takers.

The approval of the 300mg Reyataz capsules will help reduce the total daily pill count for those currently using two 150mg Reyataz capsules plus Norvir. The correct dose, using the new 300mg formulation, will be one Reyataz capsule plus one Norvir capsule once a day.

According to a BMS spokesperson, the new capsules will be available within the next seven to ten days.