Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate

HIV-1 infection: Oral: One tablet (efavirenz 400 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg) once daily

Store below 30°C (86°F).

False-positive urine tests for cannabinoids have been reported with some screening assays used in HIV-infected and uninfected subjects receiving efavirenz. Confirmation of screening tests for cannabinoids by a more specific method is recommended.

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.

The Health and Human Services (HHS) Perinatal HIV Guidelines consider efavirenz in combination with lamivudine and tenofovir disoproxil fumarate as an alternative initial regimen in antiretroviral-naive pregnant females; this regimen may be preferred in females who require co-administration of drugs with significant interactions with preferred agents, or in females who need the convenience of once-daily dosing and are not eligible for rilpivirine.

In general, females who become pregnant on a stable antiretroviral therapy (ART) regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated (HHS [perinatal] 2017).

The manufacturer's labeling of this combination product recommends pregnancy testing prior to therapy, and effective contraception in females of reproductive potential during treatment and for 12 weeks after therapy is discontinued.

Refer to individual monographs.

• It is used to treat HIV infection.