Emtricitabine/rilpivirine/tenofovir (trade names Complera, Eviplera) is a fixed-dose combination of antiretroviral drugs for the treatment of HIV/AIDS.^[1] The drug was co-developed by Gilead Sciences and Johnson & Johnson's Tibotec division and was approved by the Food and Drug Administration in August 2011, and by the European Medicines Agency in November 2011,^[2] for patients who have not previously been treated for HIV.^[3] It is available as a once-a-day single tablet.

In the European Union it is marketed as Eviplera and in the US as Complera.^[4]

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”).^[5][6]

Side effects

Common^[5][7]

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

Serious^[5][7]

• 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:^[5][8]

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