- 48-week primary endpoint (HIV-1 RNA ≥50 copies/mL): DOVATO 0.3% (1/369) vs TAF-containing regimens 0.5% (2/372)3
ITT–E=intent-to-treat–exposed.
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Virological Outcomes At 3 Years
ITT–E Snapshot analysis.
Adjusted Treatment Difference (95% CI)
Adapted from Osiyemi et al, 2022.2
ITT–E=intent-to-treat–exposed.
Changes in Quantifiable and Non-quantifiable VL Levels by Baseline VL Category Through Week 1444
These long-term virology data continue to demonstrate the potency and durability of DOVATO compared with 3DRs in maintaining virological suppression.
VL=viral load.
*”Blips”, defined as VLs between 50 and 200 copies/mL with adjacent VL value of <50 copies/mL, are included in this category.
†Five participants with baseline VL <40 copies/mL in the DOVATO arm and 1 participant with baseline VL ≥50 copies/mL in TBR arm not presented due to no post baseline VL data.
Virological Outcomes by Subgroup at 3 Years5
Adapted from Scholten et al, 2021.5
*In all 8 Snapshot non-responders on DOVATO with baseline CD4+ T-cell count <350 cells/mm3, Snapshot non-response occurred for non-virological reasons.
Adapted from Osiyemi et al, 2022.2
AE=adverse event.
*One participant was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.2
†All drug-related AEs through Week 96 were Grade 1 or 2; most drug-related AEs through Week 144 were Grade 1 or 2, except for 2 Grade 3 events (suicidal ideation and increased transaminases in the DTG/3TC group) and 1 Grade 4 event (angioedema in the TAF-containing regimen group). In the post Week 48 analysis of AEs, rates of drug-related AEs, serious AEs and AEs leading to discontinuation were similar between groups.2
‡Participants may have had ≥1 AE leading to withdrawal.2
§n=342 for both arms. Two drug-related serious AEs occurred through Week 144 (increased transaminases in the DTG/3TC group and angioedema in the TAF-containing group); 2 fatal AEs occurred in the DTG/3TC group through Week 96 (gunshot wound [homicide] and substance abuse [acute intoxication]), which were unrelated to study treatment; 1 additional fatal AE occurred in the DTG/3TC group through Week 144 (ischaemic hepatitis) and was unrelated to study treatment. 1 additional fatal AE occurred in the DTG/3TC group through Week 144 (ischaemic hepatitis) and was unrelated to study treatment. In the post Week 48 analysis of AEs, rates of drug-related AEs, serious AEs and AEs leading to discontinuation were similar between group.2
References:
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.
Date of preparation: May 2024 PM-IE-DLL-WCNT-200018