raltegravir

Brand: Isentress, Isentress HD

Prototype: dolutegravir
Drug Class: HIV integrase strand transfer inhibitor (INSTI)
Drug Family: antiretroviral
Subclass: first-generation integrase inhibitor
Organ Systems: infectious-disease

Mechanism of Action

First-in-class INSTI; binds the active site of HIV integrase with a divalent metal chelation mechanism, blocking the strand transfer of HIV DNA into the host chromosome; does not inhibit CYP3A4, making it the INSTI with the fewest metabolic drug interactions.

HIV integrase (strand transfer step)

Indications

  • HIV-1 infection (treatment-naïve and experienced)
  • HIV-1 infection in pregnant women near delivery (rapid ART initiation)

Contraindications

  • raltegravir hypersensitivity

Adverse Effects

Common

  • nausea
  • headache
  • diarrhea
  • fatigue

Serious

  • severe skin reactions (SJS, TEN — rare)
  • elevated CPK, rhabdomyolysis
  • hypersensitivity reactions
  • immune reconstitution inflammatory syndrome

Pharmacokinetics (ADME)

Absorption moderate bioavailability; administer with or without food (HD tablet requires feeding)
Distribution widely distributed; 83% protein-bound
Metabolism primarily UGT1A1 (glucuronidation) — NO significant CYP3A4 involvement
Excretion fecal (51%) and renal (32%)
Half-life 9 hours
Onset 1–2 hours
Peak 1–1.5 hours
Duration twice daily (standard) or once-daily HD 1200 mg
Protein Binding 83%
Vd moderate

Drug Interactions

Drug / Agent Mechanism Severity
rifampin UGT1A1 induction reduces raltegravir AUC by 40–61%; increase raltegravir to 800 mg BID with rifampin major
polyvalent cations (antacids with calcium, magnesium) chelation reduces absorption; take separately moderate

Nursing Considerations

  1. Raltegravir's lack of CYP3A4 metabolism makes it the preferred INSTI for patients with complex drug interactions involving CYP3A4.
  2. Twice-daily dosing of standard tablets can be challenging for adherence; the HD formulation (1200 mg once-daily) offers a once-daily option.
  3. Monitor CPK in patients with myopathy risk; rhabdomyolysis has been reported.
  4. Administer antacids separately by ≥2–4 hours to avoid chelation.

Clinical Pearls

  • Raltegravir was the first FDA-approved INSTI, proving the integrase inhibitor concept in HIV therapy; its lack of CYP3A4 metabolism distinguishes it pharmacokinetically from subsequent INSTIs (dolutegravir, bictegravir) but lower genetic barrier to resistance limits its use.
  • Due to its lack of pharmacokinetic boosting requirements and minimal drug interactions, raltegravir is a preferred regimen component during pregnancy when initiating antiretroviral therapy late in pregnancy.

Safety Profile

Pregnancy use-with-caution
Lactation avoid
Renal Adjustment Not required
Hepatic Adjustment Not required
TDM Not required