Emtricitabine/rilpivirine/tenofovir

This article is about the combination medication emtricitabine/rilpivirine/tenofovir disoproxil. For the combination medication emtricitabine/rilpivirine/tenofovir alafenamide, see Tenofovir alafenamide § combinations.

Emtricitabine/rilpivirine/tenofovir, sold under the brand name Complera among others, is a fixed-dose combination of antiretroviral drugs for the treatment of HIV/AIDS.^[4] The drug was co-developed by Gilead Sciences and Johnson & Johnson's Tibotec division and was approved by the US Food and Drug Administration (FDA) in August 2011, and by the European Medicines Agency in November 2011,^[3][5] for patients who have not previously been treated for HIV.^[6] It is available as a once-a-day single tablet.

Emtricitabine/rilpivirine/tenofovir

Combination of
Emtricitabine	Nucleoside analog reverse-transcriptase inhibitor
Rilpivirine	Non-nucleoside reverse transcriptase inhibitor
Tenofovir disoproxil	Nucleotide analog reverse-transcriptase inhibitor
Clinical data
Trade names	Complera, Eviplera
AHFS/Drugs.com	Multum Consumer Information
MedlinePlus	a616021
License data	US DailyMed: Emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil
Pregnancy category	AU: B3
Routes of administration	By mouth
ATC code	J05AR08 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) US: ℞-only[1][2] EU: Rx-only[3] In general: ℞ (Prescription only)
Identifiers
CAS Number	1436864-99-1
ChemSpider	none
KEGG	D10571
(verify)

In the European Union it is marketed as Eviplera and in the US as Complera.^[7]

Medical uses

Emtricitabine/rilpivirine/tenofovir is indicated for treatment of HIV-1 in adults naïve to HIV-1 medications (where the virus has not developed resistance to these anti-HIV medications) and who have no more than 100,000 copies per mL of HIV-1 RNA in their blood (“viral load”).^[8][9]

Side effects

Common^[8][10]

• Diarrhea
• Nausea
• Vomiting
• Insomnia
• Abnormal dreams
• Dizziness
• Headache
• Rash
• Weakness
• Decreased appetite

Serious^[8][10]

• Lactic acidosis (excess lactic acid in blood) is a rare and potentially fatal side effect. It is characterized by the following symptoms: deep and rapid breathing, tiredness or weakness, nausea, vomiting, abnormal muscle pain, dizziness or drowsiness
• Serious liver problems, such as hepatomegaly (enlarged liver) and steatosis (fatty liver). Presentation typically includes: skin or the white part of the eyes turning yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements, loss of appetite, nausea, stomach pain
• Worsening of hepatitis B (HBV) infection. Patients also diagnosed with HBV who stop taking Emtricitabine/rilpivirine/tenofovir may suddenly exacerbate their hepatitis.
• New or worsening kidney problems, including kidney failure
• Onset of depressive disorders or mood changes
• Changes in bone such as osteonecrosis (breakdown and death of bone)
• Increases or redistribution of body fat
• Immune system changes (e.g. Immune Reconstitution Syndrome)

Interactions

Contraindications

Use of emtricitabine/rilpivirine/tenofovir with the following medicines is contraindicated, as they lead to reduced blood levels of rilpivirine and in turn reduce the effectiveness of emtricitabine/rilpivirine/tenofovir:^[8][11]

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• rifampicin, rifapentine
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole
• systemic dexamethasone (more than a single dose)
• St John's wort