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lamivudine, tenofovir disoproxil and efavirenz

J05AR11

Forms & Strengths

Fixed-dose combination tablet: Lamivudine 300 mg / Tenofovir disoproxil fumarate 300 mg / Efavirenz 600 mg

Adult Dosing

One tablet orally once daily, taken on an empty stomach, preferably at bedtime to reduce central nervous system adverse effects

Pediatric Dosing

Not recommended for pediatric patients due to fixed dose and weight-based requirements

Indications

Treatment of HIV-1 infection in adults and adolescents weighing at least 35 kg

Mechanism of Action

Lamivudine: Nucleoside reverse transcriptase inhibitor (NRTI) inhibiting HIV-1 reverse transcriptase
Tenofovir disoproxil fumarate: Nucleotide reverse transcriptase inhibitor (NtRTI) inhibiting HIV-1 reverse transcriptase
Efavirenz: Non-nucleoside reverse transcriptase inhibitor (NNRTI) binding directly to reverse transcriptase and blocking RNA- and DNA-dependent DNA polymerase activities

Contraindications

Hypersensitivity to lamivudine, tenofovir, efavirenz, or any component of the formulation
Co-administration with drugs highly dependent on CYP3A for clearance where elevated plasma levels may lead to serious events (e.g., elbasvir/grazoprevir)
Severe hepatic impairment (Child-Pugh Class C)

Adverse Reactions

Dizziness, insomnia, abnormal dreams, rash
Headache, fatigue, nausea, diarrhea, vomiting
Lactic acidosis and severe hepatomegaly with steatosis
Decreased bone mineral density, renal impairment, Fanconi syndrome

Drug Interactions

Substrate of CYP3A4 and CYP2B6 (efavirenz is an inducer and inhibitor of CYP enzymes)
Do not co-administer with other medications containing lamivudine, tenofovir, or efavirenz
Potential decreased concentrations of certain azole antifungals, methadone, and calcium channel blockers
Increased risk of nephrotoxicity when co-administered with nephrotoxic agents or NSAIDs

Curated Content: Needs Vetting Before Put to Clinical Use