Antiviral activity of dolutegravir in subjects with failure on an integrase inhibitor‐based regimen: week 24 phase 3 results from VIKING‐3

• Published in: Journal of the International AIDS Society 2012-11, Vol.15 (S4), p.n/a
• Main Authors: Nichols, G, Mills, A, Grossberg, R, Lazzarin, A, Maggiolo, F, Molina, J, Pialoux, G, Wright, D, Ait‐Khaled, M, Huang, J, Vavro, C, Wynne, B, Yeo, J
• Format: Article
• Language: English
• Subjects: Acquired immune deficiency syndrome; AIDS; Antiretroviral drugs; Antiviral drugs; Mutation
• ISSN: 1758-2652; 1758-2652
• DOI: 10.7448/IAS.15.6.18112

Background VIKING‐3 aimed to examine efficacy and safety of dolutegravir (DTG) 50 mg twice daily in patients with resistance to multiple ARV classes, including integrase inhibitors (INI). Methods RAL and/or EVG‐resistant (current or historical) adult subjects with screening plasma HIV‐1 RNA ≥500 c/mL and resistance to ≥2 other ART classes received open‐label DTG 50 mg BID while continuing their failing regimen (without RAL/EVG). At Day 8 the background regimen was optimised and DTG continued. Activity of the optimized background regimen (OBR) was determined by Monogram Net Assessment. Primary endpoints were antiviral efficacy at Day 8 and Week 24. Results 183 subjects enrolled, 124 with INI‐resistance at screening and 59 with historical (but no screening) resistance. Population was advanced: at BL, median CD4 140, prior ART 13 yrs, 56% CDC Class C; 79% had >2 NRTI, 75% >1 NNRTI, and 70% >2 PI resistance‐associated mutations, and 61% had non‐R5 HIV detected. Of the 114 subjects who had the opportunity to complete 24 weeks on study before data cutoff, 72 (63%) had 1 log HIV RNA decline of