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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-naïve 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:
*Complera is not recommended for use in patients under age 18.
*Virologic failure was more common in subjects in the rilpivirine arm who had a baseline HIV-1 RNA of greater than 100,000 copies/mL.
*Compared to those in the efavirenz arm, virologic failure rate in rilpivirine-treated subjects conferred a higher overall rate of treatment resistance and cross-resistance to the non-nucleoside reverse transcriptase inhibitor class.
*More subjects treated with rilpivirine developed lamivudine/emtricitabine-associated resistance compared to efavirenz.
Further, Complera has boxed warnings concerning lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.
For more information, visit http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm.
The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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