Complera by Gilead Sciences, Inc

COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) has been available in the United States since 2011 for treatment of HIV-1 infection in adult patients.

Complera is indicated for use in patients who have not previously used antiretrovirals and who have an HIV-1 RNA level ≤100,000 copies/mL upon treatment initiation, and to replace current therapy in adult patients who are currently using antiretroviral treatment and have very low virologic levels (ie, HIV-1 RNA levels <50 copies/mL).1

Complera has a black box warning for lactic acidosis and severe hepatomegaly with steatosis, as well as posttreatment acute exacerbations of hepatitis B infection. Its use is contraindicated in patients using medications that may reduce levels of rilpivirine to a clinically significant degree, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, dexamethasone (when used as more than a single dose), and St. John’s wort.1

Mechanism of Action
Complera is composed of 2 nucleoside analog reverse transcriptase inhibitors (emtricitabine/tenofovir disoproxil fumarate) and the non-nucleoside reverse transcriptase inhibitor rilpivirine.1

Dosage and Administration
Each tablet of Complera contains 200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir disoproxil fumarate. Tablets should be taken once daily with food.1 Use of Complera is not approved in patients with a creatinine clearance <50 mL/min.

No dose adjustment is required in patients with mild to moderate hepatic impairment (ie, Child-Pugh class A or B), but treatment with Complera in severe hepatic impairment (ie, Child-Pugh class C) has not been studied.

Pharmacology and Pharmacokinetics
Emtricitabine has a half-life of 10 hours, rilpivirine has a half-life of 50 hours, and tenofovir disoproxil fumarate has a half-life of approximately 17 hours. Emtricitabine and tenofovir disoproxil fumarate are primarily excreted in the urine, while rilpivirine is primarily excreted in the feces. When Complera is taken with a meal, exposure to rilpivirine and tenofovir disoproxil fumarate are increased, while levels of emtricitabine remain unaffected.1

Clinical Studies
Treatment-naïve patients In a pooled group of treatment-naïve patients with HIV-1, patients received rilpivirine plus emtricitabine/tenofovir disoproxil fumarate (n = 550) or efavirenz plus emtricitabine/tenofovir disoproxil fumarate (n = 546) for 96 weeks.1,2

At week 96, the percentage of patients achieving an HIV-1 RNA level of <50 copies/mL was 77% in both groups. However, discontinuations due to adverse events or death were less common in patients receiving rilpivirine plus emtricitabine/tenofovir disoproxil fumarate (4% of patients) than in patients receiving efavirenz plus emtricitabine/tenofovir disoproxil fumarate (9% of patients).

The lower incidence of adverse events with Complera was primarily due to a lower incidence of neuropsychiatric side effects and rash.1,2

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