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Switch EFV to ETR - Efavirenz to Etravirine

Switch EFV to ETR - Efavirenz to Etravirine. Efavirenz to Etravirine switch in patients with CNS adverse events. Design. Randomisation 1 : 1. Blinded Phase W0-W12. Open-label Phase W12-W24. N = 20. HIV+ adults On 2 NRTI + EFV ≥ 12 weeks HIV-1 RNA < 50 c/mL CD4 > 50/mm 3

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Switch EFV to ETR - Efavirenz to Etravirine

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  1. Switch EFV to ETR • - Efavirenz to Etravirine

  2. Efavirenz to Etravirine switch in patients with CNS adverse events • Design Randomisation 1 : 1 Blinded Phase W0-W12 Open-label Phase W12-W24 N = 20 HIV+ adults On 2 NRTI + EFV ≥ 12 weeks HIV-1 RNA < 50 c/mL CD4 > 50/mm3 Ongoing CNS symptoms N = 18 • Endpoints • Primary: change in the proportion of patients experiencing grade 2-4 CNS toxicity at week 12 • Secondary: change in CNS score, median number of grade 2-4 CNS adverse events, viral suppression, CD4 change, fasting lipids, safety Waters L, AIDS 2011;25:65-71

  3. Efavirenz to Etravirine switch in patients with CNS adverse events • Baseline characteristics, 38 patients • Median age 43 years • Median duration of EFV: 21.4 months (range: 3.5 – 117.5) • Median CD4: 510/mm3 • NRTI backbone: TDF/FTC = 61% ; ABC/3TC = 29% • Similar frequency of individual grade 2-4 CNS adverse events (AE) in immediate and delayed ETR switch arm, except for insomnia (p=0.024) Grade 2-4 CNS AE: change frombaseline to Week 12 * Sum of total of all grades of CNS AE ; ** change in immediate vs delayed switch Waters L, AIDS 2011;25:65-71

  4. Efavirenz to Etravirine switch in patients with CNS adverse events • Combined analysis, at W12 of ETR in both arms • Grade 2-4 CNS AE • Significant reductions (baseline ; W12) in overall AE (89% ; 60% ; p=0.009), insomnia (63% ; 37% ; p=0.016), abnormal dreams (57% ; 20% ; p=0.001) and nervousness (29% ; 9% ; p=0.046) • Virologic and immunologic efficacy • HIV-1 RNA < 50 c/mL at all visits, median CD4 rise : + 43/mm3 • Fasting lipids • Reductions in total cholesterol (- 0.64 mmol/L, p<0.001) and LDL-cholesterol (- 0.58 mmol/L, p=0.021) • No rash or hepatotoxicity • Conclusion • Switching EFV to ETR led to a significant reduction in some but not all grade 2-4 CNS adverse events • Once-daily ETR is an efficacious, tolerable and lipid-friendly alternative to EFV in patients with persistent CNS toxicity Waters L, AIDS 2011;25:65-71

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