1 INDICATIONS AND USAGE
COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naive 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-naive subjects comparing rilpivirine to efavirenz [See Clinical Studies (14)].
The following points should be considered when initiating therapy with COMPLERA:
More rilpivirine-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 rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [See Clinical Studies (14)].
Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3
[See Clinical Studies (14)].
The observed virologic failure rate in rilpivirine-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 rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology (12.4)].
COMPLERA is not recommended for patients less than 18 years of age [See Use in Specific Populations (8.4)].
COMPLERA, a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and 1 non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL. (1)
This indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-nave subjects. (14)
The following points should be considered when initiating therapy with COMPLERA:
More rilpivirine-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 rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 at the start of therapy experienced virologic failure compared to subjects with CD4+ cell count greater than or equal to 200 cells/mm3.
The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.
More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz. (1, 12.4, 14)
COMPLERA is not recommended for patients less than 18 years of age. (8.4)