The FDA has approved the first drug in a new class of oral antiretroviral medications for treating a specific type of HIV infection. Maraviroc (Selzentry) is approved for use with other antiretroviral drugs in adults with HIV infection who:
* have CCR5-tropic HIV-1. CCR5 is a protein on the surface of some types of immune cells.
* have been previously treated with other HIV drugs. From 50% to 60% of patients who've previously received HIV drugs have circulating CCR5-tropic HIV-1.
* have evidence of viral replication in their blood.
Unlike antiretroviral drugs that fight HIV inside white blood cells, the new drug prevents HIV from entering uninfected cells by blocking the CCR5 receptor, the predominant entry route. This drug is a significant advance for patients who haven't responded well to other treatment options.
Maraviroc was approved under the FDA's accelerated approval process, which permits faster approval for drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening conditions.
For more information, visit http://www.fda.gov.