Ait-Khaled, M

Cuffe, R

Eron, J

Fujiwara, T

Hawkins, T

Katlama, C

Lazzarin, A

Livrozet, JM

Min, S

Morlat, P

Santiago, J

Vavro, C

Yeo, JM

Journal of the International AIDS Society

English

PubMed

J Eron

JM Livrozet

P Morlat

A Lazzarin

C Katlama

T Hawkins

T Fujiwara

R Cuffe

C Vavro

J Santiago

M Ait-Khaled

S Min

JM Yeo

Crossref

Activity of the integrase inhibitor S/GSK1349572 in subjects with HIV exhibiting raltegravir resistance: week 24 results of the VIKING study (ING112961)

Springer - Publisher Connector

ORAL PRESENTATION Open Access
Activity of the integrase inhibitor S/GSK1349572
in subjects with HIV exhibiting raltegravir
resistance: week 24 results of the VIKING study
(ING112961)
J Eron1, JM Livrozet2, P Morlat3, A Lazzarin4, C Katlama5, T Hawkins6, T Fujiwara7, R Cuffe8, C Vavro9, J Santiago10,
M Ait-Khaled8, S Min9*, JM Yeo8
From Tenth International Congress on Drug Therapy in HIV Infection
Glasgow, UK. 7-11 November 2010
Background
S/GSK1349572(572) showed potent activity in Phase 2
studies in INI-naive HIV-infected subjects and limited
cross-resistance to raltegravir (RAL) and elvitegravir in
vitro. VIKING is an ongoing 24-week Phase 2b pilot
study assessing 572 in subjects with RAL-resistant HIV.
A good antiviral response during the functional mono-
therapy phase (through Day 11) of this pilot study was
observed with a strong correlation between baseline sus-
ceptibility to 572 and response.
Methods
27 RAL-experienced, adult subjects, with screening
plasma HIV-1 RNA ≥1000c/mL and genotypic resis-
tance to RAL and ≥ 2 other ART classes, received 572
50mg QD in Cohort I while continuing their failing
regimen (without RAL). At Day 11 the background regi-
men was optimised, where feasible, and 572 continued.
The antiviral activity (primary end-point at Day 11), tol-
erability, safety and virology data through Week 24 of
Cohort I are presented. A higher dose is being assessed.
Results
At Baseline, subjects harboured viruses displaying high
level resistance to RAL (median fold change in suscept-
ibility [FC] 161, range: 0.57- >166) and low median FC
to 572 (1.46, range: 0.55-35). Median (IQR) Baseline
CD4+ and plasma HIV-1 RNA were 110 cells/mm3 (40,
230) and 4.47 log10c/mL (3.9, 4.9), respectively. Median
number (range) of prior ART drugs was 18 (10, 23).
Twenty one (78%) subjects achieved plasma HIV-1
RNA<400 c/mL (n=11) or ≥ 0.7 log10 c/mL decline
(n=10) at Day 11 (primary end-point). Post Day 11, the
optimised background regimen (OBR) phenotypic sus-
ceptibility score (PSS) was 0, 1 and ≥ 2 for 12 (44%), 7
(26%) and 8 (30%) subjects, respectively. 17 subjects
continued therapy through Week 24 when 14/27 (52%)
and 11/27 (41%) subjects achieved < 400 c/mL and < 50
c/mL, respectively by TLOVR. Response correlated with
OBR PSS: 2/12 (17%) subjects with PSS =0, 4/7 (57%)
with PSS=1 and 8/8 (100%) with PSS ≥2 achieved <400
c/mL at Week 24. Drug related AEs (any grade) were
observed in 6 (22%) subjects. Two subjects with
advanced AIDS died after withdrawal from study for
SAEs (brain mass, non-Hodgkin’s lymphoma with febrile
bone marrow aplasia) unrelated to 572.
Conclusions
Despite high level baseline resistance to RAL and the
limited activity of the OBR co-administered with 572,
the majority of subjects achieved < 400 c/mL at Week
24 with improved response rates in those receiving at
least one active background ART. S/GSK1349572 was
generally well tolerated in this advanced population.
Author details
1UNC School of Medicine, Center for AIDS Research Clinical Care, NC, USA.
2Hopital Edouard Herriot, Lyon, France. 3Service de médecine interne et
maladies infectieuses, Hôpital Saint André (CHU), Bordeaux, France. 4San
Raffaele Scientific Institute, Milan, Italy. 5Hopital de la Pitie-Salpetriere, Paris,
France. 6Southwest CARE Center, Santa Fe, USA. 7Shionogi & Co. Ltd., Osaka,9GlaxoSmithKline, Research Triangle Park, USA
Full list of author information is available at the end of the article
Eron et al. Journal of the International AIDS Society 2010, 13(Suppl 4):O51
http://www.jiasociety.org/content/13/S4/O51
© 2010 Min et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Japan. 8GlaxoSmithKline, Uxbridge, UK. 9GlaxoSmithKline, Research Triangle
Park, USA. 10GlaxoSmithKline, Mississauga, Canada.
Published: 8 November 2010
doi:10.1186/1758-2652-13-S4-O51
Cite this article as: Eron et al.: Activity of the integrase inhibitor S/
GSK1349572 in subjects with HIV exhibiting raltegravir resistance: week
24 results of the VIKING study (ING112961). Journal of the International
AIDS Society 2010 13(Suppl 4):O51.
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Eron et al. Journal of the International AIDS Society 2010, 13(Suppl 4):O51
http://www.jiasociety.org/content/13/S4/O51
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Activity of the integrase inhibitor S/GSK1349572 in subjects with HIV exhibiting raltegravir resistance: week 24 results of the VIKING study (ING112961)

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