Tenofovir / Dolutegravir Disoproxil Fumarate / Lamivudine

What it is and how it works

Dolutegravir inhibits HIV integrase strand transfer, preventing integration of viral DNA into the host genome; lamivudine and tenofovir disoproxil fumarate are converted intracellularly to active forms that inhibit HIV reverse transcriptase and terminate viral DNA chain elongation. Lamivudine and tenofovir are also active against hepatitis B virus.

Indications

Treatment of HIV-1 infection in adults and adolescents (weighing at least 30 kg in WHO guidance), as the WHO-preferred first-line regimen.

Dosage and administration (summary)

One tablet (dolutegravir 50 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg) orally once daily; an additional dolutegravir 50 mg dose 12 hours later is required with rifampicin.

Contraindications

Co-administration with dofetilide; hypersensitivity to any component; not suitable where creatinine clearance is below 50 mL/minute because of the fixed tenofovir and lamivudine doses.

Warnings and precautions

Tenofovir can cause renal impairment and reduced bone mineral density; monitor renal function. Discontinuation in hepatitis B co-infection may cause severe hepatitis flares. Dolutegravir absorption is reduced by polyvalent cations (antacids, iron, calcium), and hypersensitivity, immune reconstitution syndrome and weight gain may occur.

Pregnancy

Recommended by WHO for use in pregnancy, including at conception, after a balanced discussion of the small possible risk of neural tube defects; folic acid supplementation is advised.

Storage and supply

Store below 30 °C in the original container, protected from moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.