Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch PI to NNRTI
» EFV/FTC/TDF

Drugs
EFV, FTC/TDF, TDF, FTC

• Patients with stable ARV treatment and virologically suppressed on NNRTI- or PI-based therapy maintained high rates of virological suppression after simplification to a single-tablet regimen of TDF/FTC/EFV
• TDF/FTC/EFV was virologically non inferior to maintenance of prior suppressive ARV regimen
• Patients on prior PI-based therapy were more likely to experience transient nervous system and psychiatric symptoms ; for 2% of patients, these adverse eventswere treatment-limiting

Design :

Objective :

• Non inferiority in the proportion of patients with HIV-1 RNA < 200 c/mL at W48 (Intent-to-treat analysis, non completer = failure, TLOVR algorithm) ;lower limit of the 95% CI for the difference = -15%, 80% power

Baseline characteristics and patient disposition :

Outcome at Week 48 :

Virologic response (ITT, NC = F, TLOVR) for the whole population and by prior treatment stratum

Other endpoints :

• Virologic failure
  • SBR, N = 1 (1.03%)
  • TDF/FTC/EFV, N = 3 (1.48%)
• No significant changes in CD4 cell counts within or betweentreatment arms
• Nervous System and Psychiatric Symptoms
  • Nervous System Symptoms = SBR: 13% vs TDF/FTC/EFV: 22%
  • Psychiatric Symptoms = SBR: 8% vs TDF/FTC/EFV: 28%
  • Study drug discontinuation, N = 5, all in TDF/FTC/EFV group(prior PI stratum)
• Renal Adverse events
  • Discontinuation for increase in creatinine, N = 1, on TDF/FTC/EFV
  • Grade 1 treatment-emergent creatinine elevations = SBR: 3% vs TDF/FTC/EFV: 2%. No Grade ≥ 2 elevation of creatinine

Changes in glomerular filtration rate* (mL/min/1.73 m2) :

Fasting lipid changes :

• Overall, no significant differences were seen between treatment arms for fasting total cholesterol and LDL cholesterol
• No change in HDL cholesterol overall or in the prior NNRTI stratum
• Significant increase in HDL cholesterol in the TDF/FTC/EFV group vs SBR group for patients in the prior PI regimen
• For triglycerides, decrease of levels were significantly higher in the TDF/FTC/EFV group and was greatest in the prior PI stratum

Patients' questionnaires :

• Preference of TDF/FTC/EFV over the previous regimen
• TDF/FTC/EFV regimen considered easier than SBR (p < 0.001)
• Patients in the TDF/FTC/EFV group had more symptoms of dizziness or light-headedness compared with the SBR, at W4 (p = 0.018)
• Improvement in diarrhoea and loose bowel movements in the TDF/FTC/EFV group for patients with prior PI-based regimen (p = 0.002)