August 11, 2011
The Food and Drug Administration (FDA) on Wednesday approved the once-daily pill Complera for patients not previously treated for HIV.
Complera, made by Gilead Sciences Inc., combines tenofovir/emtricitabine (Truvada) with rilpivirine (Edurant), a Johnson & Johnson drug that received FDA approval in May. The combination treatment will cost approximately $1,705 a month.
A statement by Gilead said the approval of Complera was supported by data from two 48-week, Phase III studies -- ECHO and THRIVE -- that compared rilpivirine to efavirenz (Sustiva), made by Bristol-Myers Squibb Co., in treatment-naive adults with HIV-1 infection. Most patients in the rilpivirine study arm received Truvada as well.
Gilead stressed consideration of the following before starting patients on Complera:
Further, Complera has boxed warnings concerning lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.
For more information, visit www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm.