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Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir resistant HIV-1: 24-week results of the Phase III VIKING-3 StudyGå till Stäng Överst

Castagna A, Maggiolo F, Penco G, Wright D, Mills A, Grossberg R, Molina JM, Chas J, Durant J, Moreno S, Doroana M, Ait-Khaled M, Huang J, Min S, Song I, Vavro C, Nichols G, Yeo JM; for the VIKING-3 Study Group

J Infect Dis. 2014 Aug 1;210(3):354-62.

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 INI-resistant 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.

Clinical trials registration

www.clinicaltrials.gov (NCT01328041) and www.gsk-clinicalstudyregister.com (112574).

Abstract copyright: ©The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
Use is by express license from the owner.