Aikening Albuvirtide for Injection

1. Indications and Usage
HIV-1 Infection: Treatment of treatment-experienced adult patients with human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents.
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Injection or Intravenous Infusion ONLY.
Recommended Dosage: The recommended dosage is determined by the patient’s body weight.
Body Weight ≥ 50 kg: 300 mg administered once every 2 weeks (14 days).
Body Weight < 50 kg: 200 mg administered once every 2 weeks (14 days).
Critical Administration Instructions:
Preparation: Reconstitute the lyophilized powder with Sterile Water for Injection. Gently rotate to dissolve; do not shake vigorously. The reconstituted solution can be further diluted with 0.9% Sodium Chloride Injection for infusion.
Infusion Time: If administered as an infusion, it should typically be completed within 30 minutes.
3. Mechanism of Action
Fusion Inhibition: Albuvirtide is a novel peptide-based HIV-1 fusion inhibitor.
Target Binding: It specifically binds to the HIV-1 gp41 envelope glycoprotein.
Viral Entry Blockade: By binding to gp41, it inhibits the fusion of the viral envelope with the host cell membrane, thereby preventing the entry of the virus into the target CD4+ T lymphocytes. It acts at an early stage of the viral replication cycle.
4. Safety and Warnings
Hypersensitivity: Serious hypersensitivity reactions (e.g., rash, urticaria, angioedema) have been reported. Patients should be monitored, and the drug should be discontinued immediately if a severe reaction occurs.
Injection Site Reactions: Local reactions such as pain, erythema, swelling, and induration at the injection or infusion site are common.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: The most frequently reported adverse reactions are injection site reactions (including pain, erythema, and induration), headache, and rash.
Clinical Research Highlights: Clinical trials (e.g., the ALCYONE study) demonstrated that in treatment-experienced patients with virologic failure, the addition of albuvirtide to an optimized background regimen (OBR) resulted in significant and sustained reductions in HIV-1 viral load compared to OBR alone.
6. Drug Interactions
Antiretroviral Agents: Albuvirtide is primarily metabolized by proteolysis and is not a substrate, inhibitor, or inducer of cytochrome P450 enzymes. Therefore, clinically significant pharmacokinetic interactions with other antiretroviral agents are unlikely.
Concomitant Medications: As with all antiviral therapies, the overall regimen should be carefully managed to avoid overlapping toxicities with other antiretroviral drugs.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Albuvirtide.
Appearance: White to off-white lyophilized cake or powder.
Packaging: Single-use vial (300 mg or 200 mg calculated as albuvirtide).
Storage: Store in the original carton at 2°C to 8°C. Do not freeze. Protect from light.