Emtricitabine/efavirenz/tenofovir disoproxil is an oral antiretroviral medication for the treatment of HIV-1 alone or in combination with other antiretroviral medications. This three-drug combination contains the non-nucleoside reverse transcriptase inhibitor efavirenz (200mg), and the two HIV-1 nucleoside analog reverse transcriptase inhibitors emtricitabine (600mg) and tenofovir disoproxil fumarate (300mg).
Dosing & Administration
Emtricitabine/efavirenz/tenofovir is indicated for the treatment of HIV infection in adults and children weighing 40 kg or more. The dose is one tablet once a day at bedtime on an empty stomach. It should not be used in patients with a creatinine clearance below 50 mL/min. It should be used with caution in patients with mild hepatic impairment, and not at all in patients with moderate to severe hepatic impairment.
Emtricitabine/efavirenz/tenofovir is contraindicated in patients with hypersensitivity to any of its components, patients with severe hepatic impairment, patients with QTc prolongation or a personal or family history of various cardiac abnormalities, or in conjunction with a number of medications and herbals. Details are given in the product monograph.
Emtricitabine/efavirenz/tenofovir is associated with serious psychiatric side effects, as well as dizziness, impaired concentration, insomnia, abnormal dreaming, seizures, headache, rash, reduced bone density, immune reactivation syndrome, and osteonecrosis. A complete list of potential adverse effects is provided in the product monograph.
Emtricitabine/efavirenz/tenofovir is associated with serious hepatotoxicity, as well as with lactic acidosis and hepatomegaly with steatosis, including fatal cases. Recommendations for screening and monitoring are outlined in the product monograph.
Efavirenz, a component of this medication, may cause a serious rash. It also commonly causes a feeling of being “high,” so patients should use caution when driving or performing other activities requiring concentration. Efavirenz should be used with caution in patients with a history of seizures.
All patients who test positive for HIV infection should be screened for comorbid Hepatitis B virus (HBV) and Hepatitis C virus (HCV) infection. Co-infected patients should be started on an antiretroviral regimen targeting co-infected viruses, regardless of CD4 counts or viral loads. Current HIV treatment guidelines outline drug regimens and prescribing considerations.
Emtricitabine/efavirenz/tenofovir is associated with a large number of drug-drug and herbal interactions and contraindications. These are listed in the product monograph.
Pregnancy & Lactation
Emtricitabine/efavirenz/tenofovir may cause neural tube defects, so should not be used in the first 12 weeks of pregnancy. Pregnancy testing in female patients of child-bearing age should be done to prior to initiation of treatment with emtricitabine/efavirenz/tenofovir, and effective birth control should be used during and for 12 weeks after therapy. Current guidelines should be consulted when treating women in pregnancy. Emtricitabine/efavirenz/tenofovir is excreted in breast milk. The CDC recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
There is no known antidote for tenofovir overdose, so standard supportive treatment should be used. Emtricitabine and tenofovir can be partially dialyzed, efavirenz cannot.
Alternative Brand Names
Emtricitabine/efavirenz/tenofovir is available under the brand name Atripla.
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