HIV (Pediatric)

August 1, 2016

ViiV Healthcare issued results of a phase IIIb, open-label, international, multicenter study of Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively. ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both non-inferiority and superiority endpoints were met, with superiority being driven by lower rates of both virological failures and discontinuations due to adverse events (AEs) in the Triumeq group. The safety profile of Triumeq was favorable compared to ATV/r plus TDF/FTC, with fewer drug-related AEs reported on the Triumeq arm (33% v. 49%); there were also fewer AEs leading to discontinuation compared to those in the ATV/r plus TDF/FTC arm (4% vs 7%). Drug-related AEs reported in the Triumeq arm included nausea (31 individuals/13%), diarrhoea (12/5%), headache (5/2%) and dyspepsia (4/2%). In the ATV/r plus TDF/FTC group, drug-related AEs included nausea (35/14%), diarrhoea (18/7%), ocular icterus (18/7%), dyspepsia (15/6%), headache (14/6%) and jaundice (13/5%).