Emtricitabine/tenofovir disoproxil is a two-drug combination of a Nucleotide and Nucleoside Reverse Transcriptase Inhibitor (NRTI), used for the treatment of HIV infection in combination with other antiretroviral drugs.
Dosing & Administration
Emtricitabine/tenofovir is indicated for the treatment of HIV infection in adults and children weighing 17 Kg or more. Emtricitabine/tenofovir also has the indication for pre-exposure HIV prophylaxis for sexual contact, and the following off-label indications post-exposure HIV prophylaxis in the occupational and non-occupational settings, including after sexual assault, and for pre-exposure HIV prophylaxis for injection drug users. Dosage adjustments are required in some patients with renal impairment. Safety and efficacy in patients with hepatic dysfunction has not been established. Dosages depend on indication and patient weight, and are detailed in the product monograph.
Emtricitabine/tenofovir is contraindicated in patients with allergies to adenosine analogues, and patients with certain medical conditions (see list in product monograph).
The most common adverse effects are nausea, diarrhea, headache, fatigue, rash, abnormal dreams, depression, dizziness, insomnia, weight loss, and abdominal pain. A complete list of potential adverse effects is provided in the product monograph.
Lactic acidosis and hepatomegaly, including fatal cases, have been reported with the use of emtricitabine/tenofovir.
Discontinuation of emtricitabine/tenofovir in patients co-infected with HIV and Hepatitis B virus (HBV) may lead to serious acute HBV exacerbation. Monitoring recommendations for co-infected patients who discontinue emtricitabine/tenofovir are listed in the product monograph.
All patients who test positive for HIV infection should be screened for comorbid HBV infection. Co-infected patients should be started on an antiretroviral regimen targeting both viruses, regardless of CD4 counts or HBV viral loads. Current HIV treatment guidelines outline drug regimens and prescribing considerations.
Current HIV treatment guidelines recommend testing HIV-positive patients for Hepatitis C virus (HCV), and regular ongoing testing for those deemed to be at high risk. If HIV/HCV co-infection is identified, consideration should be given to treating both infections concurrently.
Using emtricitabine/tenofovir for HIV pre-exposure prophylaxis may lead to drug resistance in people with undiagnosed HIV infection or who acquire HIV infection during use. Emtricitabine/tenofovir should only be used for this indication in patients confirmed to be HIV-negative immediately prior to starting emtricitabine/tenofovir, and periodically during use.
Emtricitabine/tenofovir is associated with a large number of drug-drug interactions, as listed in the product monograph.
Pregnancy & Lactation
Highly active retroviral combination treatment should be used in all pregnant women, regardless of viral load and CD4 count. Data from the Antiretroviral Pregnancy Registry do not show that either of the components of emtricitabine/tenofovir causes major birth defects above baseline. Components of emtricitabine/tenofovir are 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 treatment that is specific for emtricitabine/tenofovir overdose. Patients should be closely monitored and provided with supportive care. Both components of emtricitabine/tenofovir are partially removed by hemodialysis.
Alternative Brand Names
Emtricitabine/tenofovir is also available under the brand name Truvada.
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