Emtricitabine/rilpivirine/tenofovir
| Combination of | |
|---|---|
| Emtricitabine | Nucleoside analog reverse-transcriptase inhibitor |
| Rilpivirine | Non-nucleoside reverse transcriptase inhibitor |
| Tenofovir disoproxil fumarate | Nucleotide analog reverse-transcriptase inhibitor |
| Clinical data | |
| Trade names | Complera, Eviplera |
| Legal status |
|
| Routes of administration | Oral |
| Identifiers | |
| ATC code | J05AR08 |
| (verify) | |
Emtricitabine/rilpivirine/tenofovir (trade names Complera, Eviplera) is a fixed dose combination of antiretroviral drugs for the treatment of HIV.[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 Europe it is commercialized 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
- Diarrhea
- Nausea
- Vomiting
- Insomnia
- Abnormal dreams
- Dizziness
- Headache
- Rash
- Weakness
- Decreased appetite
- 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
References
- ↑ "Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination". Food and Drug Administration. August 10, 2011.
- ↑ "Eviplera; summary of the European public assessment report". European Medicines Agency. November 2011.
- ↑ "FDA approves Gilead-J&J HIV pill Complera". Business Week. August 10, 2011.
- ↑ Complera/Eviplera (Rilpivirine + emtricitabine + tenofovir), aidsinfonet.org
- 1 2 3 4 Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2014. Accessed October 28, 2014
- ↑ Eviplera [package leaflet]. County Cork, Ireland: Gilead Sciences Limited.; 2013. Accessed October 28, 2014.
- 1 2 Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services [updated May 1, 2014]. Available from: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed October 29, 2014.
- ↑ Shah, Krupa; Gleason, Lauren; Luque. "Polypharmacy in the HIV-infected older adult population". Clinical Interventions in Aging: 749. doi:10.2147/CIA.S37738.