EVIPLERA

What it is

EVIPLERA is a fixed-dose combination tablet containing tenofovir disoproxil fumarate, emtricitabine and rilpivirine. Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil), 200 mg emtricitabine, and 27.5 mg rilpivirine hydrochloride (equivalent to 25 mg rilpivirine). Each EVIPLERA tablet is capsule-shaped, film-coated and purplish-pink in colour.

Approved indications —

Treatment of HIV infection in treatment-naïve adult patients with plasma HIV-1 RNA ≤100,000 copies/mL at the start of therapy. — Treatment in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy to replace their current antiretroviral treatment regimen. Patients must not have a history of resistance to any of the components of EVIPLERA.

Dosing overview

The recommended dose of EVIPLERA is one tablet once daily taken orally with food.

Key safety warnings

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of antiretroviral nucleoside analogues including the tenofovir disoproxil fumarate component of EVIPLERA. A majority of these cases have occurred in women. Obesity and prolonged nucleoside exposure may be risk factors. More rilpivirine-treated patients with CD4+ cell count less than 200 cells/mm³ at the start of therapy experienced virologic failure compared to patients with CD4+ cell count greater than or equal to 200 cells/mm³. More rilpivirine-treated patients with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to patients with HIV-1 RNA less than 100,000 copies/mL at the start of therapy. Renal failure, renal impairment, elevated creatinine, hypophosphataemia and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate in clinical practice. EVIPLERA is not recommended for patients with moderate or severe renal impairment (creatinine clearance <50 mL/min, including patients who require haemodialysis). Patients with moderate or severe renal impairment require a dose adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet. Discontinuation of EVIPLERA therapy in patients coinfected with HIV-1 and hepatitis B virus may be associated with severe acute exacerbations of hepatitis due to the emtricitabine and tenofovir disoproxil fumarate components of EVIPLERA. Patients coinfected with HIV-1 and hepatitis B virus should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping EVIPLERA treatment.

Contraindications

EVIPLERA is contraindicated in patients with known hypersensitivity to any of the active substances or any other component of the tablets. EVIPLERA must not be administered to children or adolescents under the age of 18 years. EVIPLERA should not be administered concurrently with other medicinal products containing any of the same active components: tenofovir disoproxil fumarate, emtricitabine, or with medicinal products containing lamivudine, tenofovir alafenamide or adefovir dipivoxil. EVIPLERA should not be coadministered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin; the antimycobacterials rifampicin, rifapentine; proton pump inhibitors such as omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole; the glucocorticoid systemic dexamethasone, except as a single dose treatment; and St. John's wort (Hypericum perforatum).

Regulatory history

EVIPLERA was approved by the TGA on 2012-01-23 for the treatment of HIV infection in treatment-naïve adult patients, based on a positive risk-benefit assessment. The product was first listed on the ARTG on 2012-01-30.