Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho

by Alain Amstutz, Bienvenu Lengo Nsakala, Fiona Vanobberghen, Josephine Muhairwe, Tracy Ren ée Glass, Tilo Namane, Tlali Mpholo, Manuel Battegay, Thomas Klimkait, Niklaus Daniel Labhardt BackgroundCurrent World Health Organization (WHO) antiretroviral therapy (ART) guidelines define virologic failure as two consecutive viral load (VL) measurements ≥1,000 copies/mL, triggering empiric switch to next-line ART. This trial assessed if patients with sustained low-level HIV-1 viremia on first-line ART benefit from a switch to second-line treatment. Methods and findingsThis multicenter, parallel-group, open-label, superiority, randomized controlled trial enrolled patients on first-line ART containing non-nucleoside reverse transcriptase inhibitors (NNRTI) with two consecutive VLs ≥100 copies/mL, with the second VL between 100–999 copies/mL, from eight clinics in Lesotho. Consenting participants were randomly assigned (1:1), stratified by facility, demographic group, and baseline VL, to either switch to second-line ART (switch group) or continued first-line ART (control g roup; WHO guidelines). The primary endpoint was viral suppression (
Source: PLoS Medicine - Category: Internal Medicine Authors: Source Type: research