Jibeian Azvudine Tablets

1. Indications and Usage
HIV-1 Infection: Indicated for use in combination with nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) for the treatment of adult patients with HIV-1 infection with high viral loads (HIV-1 RNA ≥100,000 copies/mL).
Novel Coronavirus Pneumonia (COVID-19): Indicated for the treatment of adult patients with moderate (Ordinary type) COVID-19 (for 1 mg specification only).
2. Dosage and Administration
Administration: The tablets must be taken orally under fasting conditions. To ensure accurate dosing, the tablets should be swallowed whole and must not be crushed.
HIV-1 Infection: The recommended dose for adult patients is 3 mg once daily, taken orally before bedtime.
COVID-19: The recommended dose for adult patients is 5 mg once daily. The treatment course for COVID-19 should not exceed 14 days.
3. Mechanism of Action
Reverse Transcriptase Inhibition: Azvudine is a first-in-class, orally active nucleoside reverse transcriptase inhibitor (NRTI).
Viral Replication Blockade: It is converted intracellularly into its active triphosphate form, which competitively inhibits viral reverse transcriptase and terminates viral DNA chain elongation, thereby effectively inhibiting the replication of HIV-1 and SARS-CoV-2.
4. Safety and Warnings
Pregnancy and Lactation: Based on non-clinical reproductive toxicity studies, azvudine may cause fetal harm. It is not recommended for use during pregnancy or lactation. Effective contraception should be adopted during and for 4 days after the last dose.
Hepatic and Renal Impairment: Caution is advised for patients with hepatic or renal impairment, as it has not been fully studied in these populations.
Pediatric Use: Safety and efficacy in pediatric patients have not yet been established.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include dizziness, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased γ-glutamyl transferase (GGT), nausea, and diarrhea.
Clinical Research: Clinical trials have demonstrated that azvudine effectively suppresses viral loads and improves clinical symptoms in patients with HIV-1 infection and COVID-19.
6. Drug Interactions
Antiretroviral Agents: Concomitant use with other antiretroviral agents (e.g., Tenofovir disoproxil fumarate, Efavirenz) may significantly increase the systemic exposure (AUC) of azvudine, though this does not affect clinical efficacy at the recommended dose.
Nephrotoxic or Hepatotoxic Drugs: Caution is required when co-administering with drugs that may cause liver or kidney toxicity, as they may increase the risk of adverse reactions.
7. Pharmaceutical Information
Composition: The active ingredient is azvudine. Excipients include microcrystalline cellulose, lactose, croscarmellose sodium, polyvinylpyrrolidone K30, and magnesium stearate.
Appearance: White or off-white tablets.
Storage: Store in tightly closed containers at controlled room temperature.