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Labeling updates for Edurant (rilpivirine)
On December 7, 2012, FDA approved changes to the Edurant (rilpivirine) package insert. The major changes include restricting the indication to treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL, updating the package insert with the 96 week results from the Phase 3 trials and adding a new Warning and Precaution for hepatotoxicity. Below is a summary of the recent changes.
- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥ 50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL
- Regardless of HIV-1 RNA at the start of therapy, more EDURANT treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to EDURANT treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3
- The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz
- More subjects treated with EDURANT developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz
Table 10: Virologic Outcome of Randomized Treatment of Studies TMC278-C209 and TMC278-C215 (Pooled Data) at Week 96
EDURANT + BR
Efavirenz + BR
HIV-1 RNA < 50 copies/mL*
HIV-1 RNA ≥ 50 copies/mL†
No virologic data at Week 96 window
Discontinued study due to adverse event or death‡
Discontinued study for other reasons and last available HIV-1 RNA < 50 copies/mL (or missing)§
Missing data during window but on study
HIV-1 RNA < 50 copies/mL by Baseline HIV-1 RNA (copies/mL)
HIV-1 RNA ≥ 50 copies/mL† by Baseline HIV-1 RNA (copies/mL)
HIV-1 RNA < 50 copies/mL by CD4+ cell count (cells/mm3)
HIV-1 RNA ≥ 50 copies/mL† by CD4+ cell count (cells/mm3)
N = total number of subjects per treatment group; BR = background regimen.
* CI = Predicted difference (95% CI) of response rate is â€‘0.2 (â€‘4.7; 4.3) at Week 96.
† Includes subjects who had ≥ 50 copies/mL in the Week 96 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL, and subjects who had a switch in background regimen that was not permitted by the protocol.
‡ Includes subjects who discontinued due to an adverse event or death if this resulted in no on-treatment virologic data in the Week 96 window.
Includes subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
96 window (Week 90-103), respectively.
Office of Special Health Issues
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration