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Clinical Data & Efficacy

Dolutegravir - Clinical Trial Results and Pharmacological Properties

Mechanism of Action

Dolutegravir is an HIV integrase strand transfer inhibitor (INSTI) that inhibits HIV integrase, blocking DNA integration into the host genome.

  • High barrier to resistance
  • Potent activity against wild-type and resistant strains
  • Minimal drug-drug interactions
Pharmacokinetics

Absorption & Distribution

  • Peak plasma: 0.5-3 hours
  • Bioavailability: ~70% with food
  • Protein binding: >99%
  • CSF penetration: Good

Metabolism & Elimination

  • Metabolism: UGT1A1 glucuronidation
  • Half-life: 13-14 hours
  • Fecal elimination: ~53%
  • Renal elimination: ~31%

Special Populations

  • Hepatic: No adjustment (mild-moderate)
  • Renal: No adjustment (mild-moderate)
  • Pediatric: Weight-adjusted dosing
  • Pregnancy: May need adjustment
Efficacy & Clinical Data

Antiviral Activity & Resistance

  • Potent activity against HIV-1 (EC50 nanomolar range)
  • Effective against wild-type and drug-resistant strains
  • High genetic barrier to resistance
  • Rapid viral load reduction (2-4 weeks)

Clinical Trial Results

Treatment-Naive:

  • 88% viral suppression at 48 weeks
  • Superior to efavirenz
  • Better tolerability

Treatment-Experienced:

  • 76% viral suppression
  • Effective vs resistant strains
  • Well-tolerated

Special Populations

  • Pregnancy: Safe, effective viral suppression
  • Pediatric: Efficacy in patients ≥3 kg
  • Co-infections: Effective in HBV/HCV/TB co-infection
Comparative Efficacy & Outcomes

vs. Other INSTIs

  • Superior to raltegravir in treatment-naive patients
  • Highest genetic barrier to resistance
  • Fewer drug interactions

Long-term Outcomes

  • Sustained viral suppression >5 years
  • Durable CD4+ recovery
  • Reduced opportunistic infections
  • Excellent tolerability profile
For Doctors Resources
SMPC PIL (Patient Information) Clinical Data & Efficacy Dosage & Administration Interactions & Contraindications
Key Clinical Data
  • Efficacy (48 weeks): 88% viral suppression
  • Half-life: 13-14 hours
  • Cmax: 0.5-3 hours
  • Protein binding: >99%
  • Metabolism: UGT1A1 glucuronidation
  • Resistance barrier: High
Medical Information

For detailed clinical information or medical inquiries, contact our medical team.

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