SAILING STUDY
SAILING is a Phase 3, randomised, double-blind, active-controlled, double-placebo, multicentre, non-inferiority study in treatment-experienced, INI-naïve patients with HIV-1 with resistance to at least two classes of ARTs (N=715).
This study was designed to evaluate the safety, efficacy and virology outcomes in treatment-experienced, INI-naïve patients who received DTG and RAL alongside a background regimen. Primary analysis occurred at Week 48.1
Study design:1
Primary endpoint:1
Proportion of patients who achieved plasma HIV-1 RNA <50 copies/mL at Week 48 (12% non-inferiority margin).
Results/outcomes:1
- DTG was superior to RAL at 48 weeks
- 71% vs 64% achieving virological success at Week 48 (P=0.03)
- DTG had significantly fewer patients with protocol-defined virological failure vs RAL
- 6% vs 12% with virologic failure at 48 weeks (P=0.003)
- 1% vs 5% with INI resistance mutations at Week 48 (P=0.003)
- DTG was generally well tolerated and offered a similar safety profile to RAL
- 8% vs 9% reported drug-related Grade 2–4 AEs
- 9% vs 12% reported serious AEs
- 3% vs 4% reported AEs leading to discontinuation
- DTG was effective, independent of viral load
- 62% of patients on DTG compared with 47% on RAL with >50,000 copies/mL reached undetectability at Week 48
References:
- Cahn P, et al. The Lancet.2013;382:700–708.
PM-GB-DLL-WCNT-210002 | April 2021
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.
If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.
