Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study

Antonella Castagna, Franco Maggiolo, Giovanni Penco, David Wright, Anthony Mills, Robert Grossberg, Jean Michel Molina, Julie Chas, Jacques Durant, Santiago Moreno, Manuela Doroana, Mounir Ait-Khaled, Jenny Huang, Sherene Min, Ivy Song, Cindy Vavro, Garrett Nichols, Jane M. Yeo

Research output: Contribution to journalArticle

198 Scopus citations

Abstract

Background. The pilot phase IIb VIKING study suggested that dolutegravir (DTG), a human immunodeficiency virus (HIV) integrase inhibitor (INI), would be efficacious in INI-resistant patients at the 50 mg twice daily (BID) dose. Methods. VIKING-3 is a single-arm, open-label phase III study in which therapy-experienced adults with INIresistant virus received DTG 50 mg BID while continuing their failing regimen (without raltegravir or elvitegravir) through day 7, after which the regimen was optimized with ≥1 fully active drug and DTG continued. The primary efficacy endpoints were the mean change from baseline in plasma HIV-1 RNA at day 8 and the proportion of subjects with HIV-1 RNA <50 c/mL at week 24. Results. Mean change in HIV-1 RNA at day 8 was -1.43 log10 c/mL, and 69% of subjects achieved <50 c/mL at week 24. Multivariate analyses demonstrated a strong association between baseline DTG susceptibility and response. Response was most reduced in subjects with Q148 + ≥2 resistance-associated mutations. DTG 50 mg BID had a low (3%) discontinuation rate due to adverse events, similar to INI-naive subjects receiving DTG 50 mg once daily. Conclusions. DTG 50 mg BID-based therapy was effective in this highly treatment-experienced population with INI-resistant virus.

Original languageEnglish (US)
Pages (from-to)354-362
Number of pages9
JournalJournal of Infectious Diseases
Volume210
Issue number3
DOIs
StatePublished - Aug 1 2014

Keywords

  • DTG
  • Dolutegravir
  • Elvitegravir resistance
  • Integrase inhibitor
  • Raltegravir resistance

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Fingerprint Dive into the research topics of 'Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study'. Together they form a unique fingerprint.

  • Cite this

    Castagna, A., Maggiolo, F., Penco, G., Wright, D., Mills, A., Grossberg, R., Molina, J. M., Chas, J., Durant, J., Moreno, S., Doroana, M., Ait-Khaled, M., Huang, J., Min, S., Song, I., Vavro, C., Nichols, G., & Yeo, J. M. (2014). Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. Journal of Infectious Diseases, 210(3), 354-362. https://doi.org/10.1093/infdis/jiu051