Rilpivirine contraindications
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Indications And Usage
EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
This indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naïve subjects [see Clinical Studies].
The following points should be considered when initiating therapy with EDURANT:
- 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 [see Clinical Studies].
- 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 [see Clinical Studies].
- 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 [see Microbiology (12.4)].
- More subjects treated with EDURANT developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see Microbiology].
EDURANT is not recommended for patients less than 18 years of age [see Use In Specific Populations].[1]
References
Adapted from the FDA Package Insert.