FLAMINGO STUDY
FLAMINGO is a multicentre, open-label, Phase 3b, non-inferiority study involving treatment-naïve adults with HIV-1 (N=484). DTG + 2 NRTIs was compared with DRV/r + 2 NRTIs.
Study visits were planned for baseline, Weeks 2, 4, 8, 12, 16 and 24 and every 12 weeks thereafter. Primary analysis occurred at Week 48, with further analysis at Week 96. Participants assigned to receive DRV/r were considered to have completed the study at Week 96. Participants assigned to receive DTG were able to enrol in an extension period. Participants in the extension period transitioned to commercially available DTG. For participants who chose not to participate in the extension phase, they were considered to have completed the study at Week 96.1,2
Study design:1,2
Primary endpoint:1,2
Proportion with HIV-1 RNA <50 copies/mL at Week 48 as determined with the FDA snapshot analysis algorithm(-12% non-inferiority margin).
Results/outcomes:1
- In treatment-naïve patients, DTG had statistically superior efficacy vs DRV/r
- 90% vs 83% were undetectable at Week 48 (P=0.025)
- 80% vs 68% remained undetectable at Week 96 (P=0.002)
- DTG was effective regardless of baseline viral load
- 93% (57/61) vs 70% (43/61) of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at Week 48 (P=0.005)
- 82% (50/61) vs 52% (32/61) of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at Week 96 (P=0.014).
- No treatment-emergent INI, PI or NRTI resistance was seen in either arm up to 96 weeks
- DTG was generally well tolerated up to 96 weeks
- Diarrhoea was more common in patients receiving DRV/r (18% vs 31%)
- Significantly fewer patients receiving DTG had ≥Grade 2 fasting LDL values vs DRV/r (7% vs 22%; P<0.0001) at 96 weeks
- Discontinuations due to AEs at 96 weeks were 3% for DTG and 6% for DRV/r
References:
- Clotet B, et al. Lancet. 2014;383:2222–2231 and Supplementary Appendix.
- Molina JM, et al. Lancet HIV. 2015;2(4):e127–e136
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.
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