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].

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].
• 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].
• 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].
• More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology].

COMPLERA is not recommended for patients less than 18 years of age [See Use In Specific Populations].

Adults: The recommended dose of COMPLERA is one tablet taken orally once daily with a meal [See CLINICAL PHARMACOLOGY].

Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL per minute).

Dosage Forms And Strengths

COMPLERA is available as tablets. Each tablet contains 200 mg of emtricitabine (FTC), 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of rilpivirine) and 300 mg of tenofovir disoproxil fumarate (tenofovir DF or TDF, equivalent to 245 mg of tenofovir disoproxil).

The tablets are purplish-pink, capsule-shaped, film-coated, debossed with “GSI” on one side and plain-faced on the other side.

Storage And Handling

COMPLERA Tablets are purplish-pink, capsule-shaped, film-coated, debossed with “GSI” on one side and plain-faced on the other side. Each bottle contains 30 tablets (NDC 61958-1101-1), a silica gel desiccant, polyester fiber coil, and is closed with a child-resistant closure.

Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).

• Keep container tightly closed
• Dispense only in original container
• Do not use if seal over bottle opening is broken or missing.

Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404. Revised: January 2013

Last reviewed on RxList: 2/19/2013
This monograph has been modified to include the generic and brand name in many instances.