Switch studies in virologically suppressed patients

Switch to LPV/r monotherapy
M03-613 Study: Switch to LPV/r monotherapy
Original article : J Infect Dis. 2008 Jul 15;198(2):234-40 – DW Cameron
Last update : 28/03/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • LPV/r monotherapy was less effective than EFV + ZDV/3TC in maintaining virologic suppression: time to confirmed virologic rebound was shorter with LPV/r monotherapy
  • Lipoatrophy was significantly lower in the LPV/r monotherapy group

Design :

Endpoint :

  • Primary: proportion of patients with HIV-1 RNA < 50 c/mL at W96 (ITT-exposed, previous-failure = failure analysis) ; 80% power to detect a difference of 25% in response rate
  • Secondary: lipoatrophy (> 20% loss in limb fat) at W96 ; 70% power to detect a 20% difference in the mean change in limb fat percentage

Baseline characteristics and patient disposition :

  • 79% of patients were male
  • 65% were white
  • Mean age was 38 years
  • Mean baseline HIV-1 RNA was 4.9 log10 c/mL
  • Patients in the LPV/r group had a higher mean baseline HIV-1 RNA and a higher mean age
  • 112 patients (57% in the LPV/r group and 69% in the EFV group) completed their assigned treatment regimen out to week 96
  • In the LPV/r group, after a median of 24 weeks, 92 patients (88%) simplified to LPV/r monotherapy

Outcome at week 96 :

HIV-1 RNA level and discontinuation status, by visit, through 96 weeks :

 

Adverse events :

  • Most common (frequency > 5%) moderate or severe adverse events related to treatment
    • LPV/r monotherapy group
      • Diarhoea: 15%
      • Nausea: 14%
    • EFV group
      • Asthenia: 12%
      • Dizziness: 12%
      • Insomnia: 12%
      • Rash: 10%
      • Depression: 6%
  • Most frequent grade 3 or 4 laboratory abnormalities
    • LPV/r monotherapy group
      • Total cholesterol > 7.8 mmol/L: 12% ; Triglycerides > 8.5 mmol/L: 7%
      • Amylase > 2 ULN: 6%
    • EFV group
      • Amylase > 5 ULN: 10%
      • ALAT > 5 ULN: 6%

 

 

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