What is the recommended dose of Raltegravir (Integrase inhibitor) for the treatment of HIV infection?

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Raltegravir Dosing for HIV Treatment

The recommended dose of raltegravir for the treatment of HIV infection in adults is 400 mg administered orally twice daily. 1

Standard Dosing Recommendations

  • Adults: 400 mg film-coated tablet twice daily 1
  • Pediatric patients:
    • If ≥25 kg: 400 mg film-coated tablet twice daily
    • If <25 kg: Weight-based dosing (approximately 6 mg/kg/dose twice daily)
    • Alternative options for those who cannot swallow tablets include chewable tablets or oral suspension 1

Special Dosing Considerations

Tuberculosis Co-infection

When coadministered with rifampin for tuberculosis treatment:

  • Adults: Increase raltegravir dose to 800 mg twice daily 1
  • Pediatric patients <18 years: No data available to guide dosing with rifampin 1

For patients with HIV and active tuberculosis receiving rifamycin-based treatment:

  • Raltegravir 400 mg twice daily (in combination with 2 NRTIs) is recommended 2
  • Integrase strand transfer inhibitor (InSTI)-based regimens are preferred over protease inhibitor-based regimens for tuberculosis co-infection 2

Maximum Dosing

  • Maximum dose for chewable tablets: 300 mg twice daily
  • Maximum dose for oral suspension: 100 mg twice daily 1

Administration Considerations

  • Raltegravir can be administered with or without food 1
  • Film-coated tablets must be swallowed whole
  • Chewable tablets may be chewed or swallowed whole
  • Oral suspension requires preparation (100 mg packet suspended in 5 mL water) 1

Formulation Considerations

Different formulations of raltegravir are not bioequivalent:

  • Do not substitute chewable tablets or oral suspension for the 400 mg film-coated tablet 1
  • Each formulation has specific dosing requirements

Drug Interactions

  • No cytochrome P450-related drug interactions are expected as raltegravir is not a CYP substrate, inducer, or inhibitor 3
  • Important caution: Raltegravir should not be coadministered with rifampin to prevent treatment failure 3
  • When used with rifapentine for latent tuberculosis infection, raltegravir exposure may be increased but the regimen is generally well tolerated 2

Once-Daily Dosing Option

While the standard dosing is twice daily, research has explored once-daily dosing:

  • A 1200 mg (two 600 mg tablets) once-daily formulation (Isentress HD) is available for treatment-naïve adults 4
  • Once-daily dosing simplifies treatment regimens and may improve convenience 4
  • In some studies, raltegravir 800 mg once daily plus 2 NRTIs has shown efficacy, particularly in virologically suppressed patients 5

Clinical Efficacy

Raltegravir has demonstrated high efficacy in both treatment-naïve and treatment-experienced patients:

  • In treatment-naïve patients, raltegravir shows similar efficacy to standard initial therapies 3
  • In treatment-experienced patients with drug-resistant HIV, adding raltegravir to an optimized background regimen significantly lowered HIV RNA compared to optimized background treatment alone (62.1% vs 32.9%) 3
  • Raltegravir treatment is associated with a lower impact on serum lipid levels compared to efavirenz 6

Safety Profile

Raltegravir is generally well tolerated. Common adverse effects include:

  • Diarrhea (16.6%)
  • Nausea (9.9%)
  • Headache (9.7%) 3

Summary

For standard HIV treatment in adults, raltegravir 400 mg twice daily is the recommended dose. Special dosing considerations apply for tuberculosis co-infection, pediatric patients, and those unable to swallow tablets. A once-daily formulation (1200 mg) is also available for treatment-naïve adults.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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