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J Infect Dis. 2014 Aug 1;210(3):354-62. doi: 10.1093/infdis/jiu051. Epub 2014 Jan 19.

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

Author information

1
San Raffaele Scientific Institute, Milan.
2
Ospedale Riuniti, Bergamo.
3
Ospedale Galliera, Genova, Italy.
4
Central Texas Clinical Research, Austin, Texas.
5
Anthony Mills MD Inc, Los Angeles, California.
6
Montefiore Medical Center, New York, New York.
7
Hôpital Saint-Louis, Paris.
8
Hôpital Tenon, Paris.
9
Hôpital de L'Archet, Nice, France.
10
Hospital Universitario Ramón y Cajal, Madrid, Spain.
11
Hospital de Santa Maria, Lisbon, Portugal.
12
GlaxoSmithKline, London, United Kingdom.
13
GlaxoSmithKline, Mississauga, Ontario, Canada.
14
GlaxoSmithKline, Research Triangle Park, North Carolina.

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 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 http://www.gsk-clinicalstudywww.gsk-clinicalstudyregister.com (112574).

KEYWORDS:

DTG; dolutegravir; elvitegravir resistance; integrase inhibitor; raltegravir resistance

PMID:
24446523
PMCID:
PMC4091579
DOI:
10.1093/infdis/jiu051
[Indexed for MEDLINE]
Free PMC Article

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