DOLUTEGRAVIR 50 mg + ABACAVIR 600 mg + LAMIVUDINE 300 mg Tablets

Fixed-Dose Combination (FDC) – Complete Once-Daily Regimen for HIV-1

ATC Code: J05AR13 | Prescription Only | WHO-Preferred First-Line Antiretroviral Therapy

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Product Description:

Dolutegravir/Abacavir/Lamivudine is a once-daily, single-tablet regimen (STR) combining three antiretroviral agents used in the treatment of HIV-1 infection:

• Dolutegravir (50 mg): Integrase inhibitor that blocks viral DNA integration into the host genome.
• Abacavir (600 mg): NRTI that inhibits reverse transcriptase and terminates viral DNA chain elongation.
• Lamivudine (300 mg): NRTI that works synergistically with abacavir to impair reverse transcription.

This co-formulated therapy provides high virologic suppression, minimal pill burden, and a high barrier to resistance. It is approved for use in adults and adolescents who are HLA-B*5701–negative.

Available Presentation:

• Strength: Dolutegravir 50 mg + Abacavir 600 mg + Lamivudine 300 mg
• Formulation: Film-coated tablet (appearance may vary by manufacturer)
• Packaging: Bottle of 30 tablets (once-daily dosing)
• Route of Administration: Oral
• Storage Conditions: Store below 30°C in a dry place; keep container tightly closed

Uses:

• First-line antiretroviral therapy (ART) per WHO, CDC, and PEPFAR guidelines
• Preferred for:
  • Patients with renal impairment (tenofovir-sparing)
  • Adolescents and adults with high adherence potential
  • Virologically suppressed patients transitioning to single-tablet regimens
• Safe for pregnant women and patients co-infected with tuberculosis (dose-adjusted)

Indications:

• HIV-1 infection in adults and adolescents ≥12 years and ≥40 kg
• Used in:
  • Treatment-naïve patients
  • Virologically suppressed patients switching from multiple-tablet regimens
• Included in national HIV programs, PEPFAR, and Global Fund protocols

Regulatory and Safety Profile:

• ATC Code: J05AR13
• Pharmacologic Class: INSTI + NRTI Fixed-Dose Combination
• Pregnancy Category: B (recommended after first trimester with counseling)
• Black Box Warnings:
  • Hypersensitivity reaction risk due to abacavir – HLA-B*5701 screening required
  • Lactic acidosis and hepatomegaly with steatosis (rare)
• Common Adverse Effects: Headache, insomnia, nausea, diarrhea, fatigue, weight gain
• Serious Risks: Hypersensitivity reaction, hepatotoxicity, immune reconstitution inflammatory syndrome (IRIS)
• Contraindications: Known HLA-B*5701 positivity, severe hepatic impairment, resistance to any component
• Monitoring Parameters: Viral load, CD4 count, liver and kidney function, HLA-B*5701 screening, adherence

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To request regulatory dossiers, supply pricing, or add this item to your HIV program formulary, contact us at info@panamfarma.com.