Time to rethink endpoints for new antiretroviral regimen registration? HIV RNA re-suppression in the ADVANCE trial

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In the ADVANCE study of first-line treatment, there were 48 participants with HIV RNA ≥50 copies/mL in the week 48 window who had subsequent follow-up data available with no change in randomised treatment. More participants achieved virological re-suppression in the TAF/FTC/DTG and TDF/FTC/DTG arms (26/34, 76%) than on TDF/FTC/EFV (6/14 = 43%) (p = 0.0421). It is unclear whether participants with HIV RNA ≥50 copies/mL at week 48 should be termed ‘virological failures’ on integrase inhibitor-based treatment.

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