- Indications and Usage HIV-1 Infection: Indicated for the treatment of HIV-1 infected naive patients. Combination Requirement: It must be used in combination with nucleoside reverse transcriptase inhibitors (NRTIs) and should not be used as monotherapy.
- Dosage and Administration Recommended Dose: 150 mg (two 75 mg tablets) taken orally once daily. Administration: Must be taken on an empty stomach to avoid increased drug exposure and adverse reactions. Dosing Considerations: Dosage adjustment is required for patients with severe renal impairment (creatinine clearance <30 mL/min).
- Mechanism of Action NNRTI Activity: Ainuovirine selectively inhibits the HIV-1 reverse transcriptase enzyme. Viral Replication Block: By binding to the enzyme, it prevents the conversion of viral RNA into DNA, thereby blocking viral replication within infected cells.
- Safety and Warnings Hepatotoxicity: Liver enzyme elevations (ALT, AST, γ-GT) and severe drug-induced liver injury have been reported. Immune Reconstitution Inflammatory Syndrome (IRIS): May occur in the initial phase of treatment as the immune system recovers. Lipid Metabolism: Increases in triglycerides and cholesterol may occur during therapy. Renal Impairment: Should be discontinued in patients with severe renal impairment (CrCl <30 mL/min).
- Adverse Reactions and Clinical Research Adverse Reactions: Common adverse reactions include rash, elevated liver enzymes, diarrhea, headache, and fatigue. Clinical Research: Phase III clinical trials demonstrated that ainuovirine-based regimens achieved high rates of viral suppression and were non-inferior to standard efavirenz-based regimens.
- Drug Interactions CYP2C19 Inducers: Drugs like rifampin or carbamazepine may accelerate ainuovirine metabolism, reducing plasma concentrations. CYP2C19 Inhibitors: Drugs like omeprazole or ketoconazole may inhibit metabolism, increasing plasma concentrations and toxicity risks. Other Antiretrovirals: Concomitant use with other non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine) may lead to cross-resistance.
- Pharmaceutical Information Composition: The active ingredient is ainuovirine. Appearance: Available as film-coated tablets (75 mg). Storage: Store in a tightly sealed container, protected from light and moisture, at a temperature not exceeding 30°C.
Aibangde Ainuovirine Tablets
Brand Name: 艾邦德 ®（Aibangde®）
Generic Name: Ainuovirine
Strength: 75 mg per tablet, 60 tablets per bottle
Manufacturer: Aidea Pharma (Jiangsu Aidea Pharmaceutical Co., Ltd.)
Marketing Authorization Holder: Jiangsu Aidea Pharmaceutical Co., Ltd.
Approval Date in China: June 25, 2021
Registration Number:国药准字 H20210032
Storage: Store tightly sealed, protected from light, at a temperature not exceeding 30°C. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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