SPRING-2 STUDY
SPRING-2 is a Phase 3, randomised, double-blind, active-controlled, non-inferiority study of treatment-naïve patients with HIV-1 (N=822).
The study compared the safety and efficacy profiles of DTG (50 mg once daily) and RAL (400 mg twice daily), each given with co-formulated ABC/3TC or TDF/FTC. Primary analysis occurred at Week 48, with secondary analysis continuing until Week 96.1,2
Study design:1
Primary endpoint:1
Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48, determined by FDA snapshot analysis (-10% non-inferiority margin with pre-specified tests for superiority).
Results/outcomes:1,2
- DTG + 2 NRTIs was non-inferior to RAL + 2 NRTIs
- 88% vs 85% reached undetectability through to 48 weeks
- The adjusted treatment difference between groups was 2.5% (95% CI: -2.2 to 7.1%) meeting the non-inferiority criterion
- 81% vs 76% reached undetectability through to 96 weeks
- The adjusted treatment difference between groups was 4.5% (95% CI: -1.1 to 10.0%) confirming the non-inferiority criterion
- Both study drugs are effective, independent of viral load
- At Week 48, 90% (267/297) of DTG group and 89% (264/295) of RAL group with baseline HIV-1 RNA of ≥ 100,000 copies/mL
- At Week 48, 82% (94/114) of DTG group and 75% (87/116) of RAL group with baseline HIV-1 RNA of > 100,000 copies/mL
- The unadjusted difference in proportion supports the non-inferiority of DTG to RAL (P=0.236)
- No INI or NRTI resistance was detected through to 96 weeks with DTG
- DTG offered a similar safety profile to RAL
- 2% of patients in both groups reported AEs leading to discontinuation
- A similar safety profile was observed at Week 96 to that at Week 48.
- At Week 96, the most frequently reported clinical AEs were nausea (15% vs 14%), headache (14% vs 13%), nasopharyngitis (13% vs 14%) and diarrhoea (14% vs 13%)
References:
- Raffi F, et al. The Lancet. 2013;381:735–743.
- Raffi F, et al. The Lancet. 2013;13:927–935.
PM-GB-DLL-WCNT-210002 | April 2021
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