Dolutegravir (GSK/ViiV Integrase) Treatment (with 50mg Once & Twice Daily) of HIV Subjects with Raltegravir Resistance & 3-Class ART Resistance: viral suppression at Week 24 in the VIKING Study
Reported by jules Levin
EACS 2011 Oct 12-12 Belgrade Serbia
Week 24 efficacy/safety data from Cohort II (50mg twice daily) support the choice of 50mg twice daily for the ongoing VIKING-3 (Phase III study in Integrase inhibitor-resistant subjects)
This study looked at raltegravir-resistant patients receiving either 50mg once daily or 50 mg twice daily. Patients had raltegravir resistance mutations and had been on raltegravir for an average of 27-29 months (3-63 mos). Baseline raltegravir fold-change resistance was an average of >128 to >161 FC. Patients were very treatment experienced with an average on ARTs for 14-15 years and on an average of 15+ ARTs, and 40% to 85% had prior treatment with etravirine, T20, darunavir/r, and maraviroc. Of note, 3 patients (11%) in cohort 1 (50mg once daily) had the Q148 mutation +>/2 and 2 patients (8%) had these mutations in Cohort II (50mg twice daily). 4 patients in Cohort i had Q148+1 and 8 patients in Cohort 2 had Q148+1. You can see in this graph (or download the attached report to see the graph and all the slides) that these patients had better viral load reductions on the twice daily dose with usually between 1 to 2.5 log reductions with 75% of patients in Cohort II achieving <50 c/ml.