Fixed-Dose Combination: This tablet contains a fixed-dose combination of two active ingredients: Tenofovir Disoproxil Fumarate (TDF) (A) 300 mg and Lamivudine (B) 300 mg.
Dual Antiviral Action: Both medications are powerful antiretroviral agents, and this combination is highly effective against both the Human Immunodeficiency Virus (HIV) and the Hepatitis B virus (HBV).
NRTI Class: Both TDF (a nucleotide reverse transcriptase inhibitor) and lamivudine (a nucleoside reverse transcriptase inhibitor) belong to the foundational class of NRTIs used for managing HIV and HBV.
Once-Daily Dosing: The formulation is designed for once-daily administration, which significantly simplifies the treatment regimen and improves patient adherence.
Advantages
Effective Against Two Viruses: This combination offers the significant advantage of treating both HIV and chronic HBV simultaneously, making it an ideal choice for patients who are co-infected.
Reduced Pill Burden: The single tablet formulation of two drugs reduces the overall pill burden for patients, which is a key factor in improving long-term adherence and treatment success.
Synergistic Antiviral Effect: The two drugs work synergistically to suppress viral replication, providing a more powerful and effective therapeutic combination than either drug alone.
Favorable Safety Profile: It has a well-established safety and tolerability profile, and is a widely used and trusted combination in global clinical practice.
Uses
HIV-1 Infection: Indicated for the treatment of HIV-1 infection in adults and adolescents, always as part of a combination antiretroviral therapy (ART) regimen.
Chronic Hepatitis B (HBV) Infection: It is also used for the treatment of chronic HBV, particularly in patients who are coinfected with HIV, where both viruses need to be treated simultaneously.
Post-Exposure Prophylaxis (PEP): This combination is a key component of regimens used for PEP to prevent HIV infection after a potential occupational or non-occupational exposure.
First-Line Therapy: It is a common component of first-line ART regimens for HIV, often combined with a third agent from a different class to form a complete and potent treatment plan.
Nature
Reverse Transcriptase Inhibitors: Both TDF and lamivudine are inhibitors of the viral enzyme reverse transcriptase, which is crucial for both HIV and HBV replication.
Mechanism of Action: After being converted to their active triphosphate forms inside the cell, both drugs competitively inhibit the viral reverse transcriptase and are incorporated into the viral DNA chain, leading to chain termination.
Inhibition of Viral Replication: By terminating viral DNA synthesis, both drugs effectively block a critical step in the replication cycle of HIV and HBV, thus suppressing viral activity.
Metabolism & Excretion: Both drugs are primarily eliminated by the kidneys. Therefore, dose adjustments or a change in therapy may be necessary for patients with significant renal impairment.
Storage
Temperature: Store the tablets at controlled room temperature, typically between 20∘C to 25∘C (68∘F to 77∘F).
Protection: Keep the tablets in their original, tightly closed container, protected from light and moisture.
Patient Warning (HBV): Patients with HBV should be educated that abruptly stopping the medication can lead to a severe flare-up of their hepatitis, so they should not discontinue it without consulting their doctor.
Child Safety: Store the medication in a secure location, out of the reach of children and pets.
