Abstract:
BACKGROUND:The World Health Organization (WHO) recommends viral load (VL) measurement as the preferred monitoring strategy for HIV-infected individuals on antiretroviral therapy (ART) in resource-limited settings. The new WHO guidelines 2016 continue to define virologic failure as two consecutive VL ≥1000 copies/mL (at least 3 months apart) despite good adherence, triggering switch to second-line therapy. However, the threshold of 1000 copies/mL for defining virologic failure is based on low-quality evidence. Observational studies have shown that individuals with low-level viremia (measurable but below 1000 copies/mL) are at increased risk for accumulation of resistance mutations and subsequent virologic failure. The SESOTHO trial assesses a lower threshold for switch to second-line ART in patients with sustained unsuppressed VL. METHODS:In this multicenter, parallel-group, open-label, randomized controlled trial conducted in Lesotho, patients on first-line ART with two consecutive unsuppressed VL measurements ≥100 copies/mL, where the second VL is between 100 and 999 copies/mL, will either be switched to second-line ART immediately (intervention group) or not be switched (standard of care, according to WHO guidelines). The primary endpoint is viral resuppression (VL < 50 copies/mL) 9 months after randomization. We will enrol 80 patients, giving us 90% power to detect a difference of 35% in viral resuppression between the groups (assuming two-sided 5% alpha error). For our primary analysis, we will use a modified intention-to-treat set, with those lost to care, death, or crossed over considered failure to resuppress, and using logistic regression models adjusted for the prespecified stratification variables. DISCUSSION:The SESOTHO trial challenges the current WHO guidelines, assessing an alternative, lower VL threshold for patients with unsuppressed VL on first-line ART. This trial will provide data to inform future WHO guidelines on VL thresholds to recommend switch to second-line ART. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT03088241 ), registered May 05, 2017.
journal_name
BMC Infect Disjournal_title
BMC infectious diseasesauthors
Amstutz A,Nsakala BL,Vanobberghen F,Muhairwe J,Glass TR,Achieng B,Sepeka M,Tlali K,Sao L,Thin K,Klimkait T,Battegay M,Labhardt NDdoi
10.1186/s12879-018-2979-ysubject
Has Abstractpub_date
2018-02-12 00:00:00pages
76issue
1issn
1471-2334pii
10.1186/s12879-018-2979-yjournal_volume
18pub_type
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