ViiV Healthcare presents phase III data from VIKING-3 study of dolutegravir in HIV-1 infected integrase inhibitor-resistant

ViiV Healthcare presents phase III data from VIKING-3 study of dolutegravir in 
HIV-1 infected integrase inhibitor-resistant adults 
MISSISSAUGA, ON, Nov. 16, 2012 /CNW/ - ViiV Healthcare announced 24-week data 
from the VIKING-3 Phase III study evaluating the investigational integrase 
inhibitor (INI) dolutegravir in HIV-1 infected adults with multiple class 
antiretroviral (ARV) resistance including resistance to integrase inhibitors 
(raltegravir and/or elvitegravir). In the study, mean HIV RNA levels declined 
by 1.4 log(10) copies/mL after 7 days of dolutegravir 50mg twice-daily 
treatment was added to the current failing regimen [95% confidence interval 
for the difference (1.3, 1.5; p<0.001)]. The proportion of study participants 
who were subsequently virologically suppressed (HIV-1 RNA <50 copies/mL) with 
optimised background regimen (OBR) was 63% at week 24. Overall, 3% (6/183) of 
study participants discontinued due to adverse events. The most common 
drug-related adverse events were diarrhoea, nausea, and headache, each 
reported in 5% of subjects. These data were presented at the 11th 
International Congress on Drug Therapy in HIV Infection in Glasgow. 
"At ViiV Healthcare we are committed to delivering treatment options for all 
populations of people living with HIV. VIKING-3 was designed to address a 
significant medical need in one of the most difficult populations to treat - 
those patients who have advanced disease and have developed resistance to 
integrase inhibitors as well as multiple other antiretroviral agents." said 
John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare. "We 
are encouraged by these results in integrase inhibitor-resistant patients and 
look forward to receiving further phase III data in treatment-experienced 
patients in the coming months." 
At baseline the 183 patients enrolled in the VIKING-3 study had been on 
antiretroviral therapy (ART) for an average of 13 years and all had a broad 
range of genotypic and phenotypic resistance to integrase inhibitors 
(raltegravir and/or elvitegravir). In addition, 79% had resistance to ≥2 
NRTIs, 75% had resistance to ≥1 NNRTI, 70% had ≥2 PI resistance-associated 
mutations and 61% of subjects had non-R5 HIV detected. Median baseline CD4+ 
counts were low at 140 cells/mL, with 56% of subjects classified as CDC Class 
C (patients who have one or more AIDS-defining illness). The study population 
included 23% women, 21% co-infected with HBV and/or HCV, and 27% of African 
American/African heritage. 
VIKING-3 Study Design 
VIKING-3 (ING112574) is a Phase III, multicentre, open-label, single arm study 
to assess the antiviral activity and safety of a dolutegravir containing 
regimen in HIV-1 infected, ART-experienced adults with historical or current 
evidence of resistance to integrase inhibitors (raltegravir and/or 
elvitegravir). VIKING-3 primary endpoints include the change at Day 8 from 
baseline in HIV-1 RNA with DTG 50mg BID added to the currently failing regimen 
(functional monotherapy) and the proportion of study participants with <50 
copies/mL plus optimised background regimen (OBR) at Week 24 and beyond. 
Patients enrolled were required to have documented genotypic and/or phenotypic 
resistance to at least one drug in two or more of the other approved classes 
of ART but also be able to include at least one fully active drug in the OBR 
to be started Day 8. 
About Dolutegravir and the Dolutegravir Clinical Trial Programme
S/GSK1349572 (dolutegravir, DTG) is an investigational integrase inhibitor 
currently in development for the treatment of HIV; it does not require an 
additional pharmacokinetic boosting drug to be added to the regimen. Integrase 
inhibitors block HIV replication by preventing the viral DNA from integrating 
into the genetic material of human immune cells (T-cells). This step is 
essential in the HIV replication cycle and is also responsible for 
establishing chronic infection. 
Data from the SAILING study investigating once-daily dolutegravir in 
treatment-experienced patients with no previous exposure to integrase 
inhibitors is due to be presented at upcoming scientific meetings. Data from 
SAILING, VIKING-3 and the previously disclosed data from the SPRING-2 and 
SINGLE studies will be part of global regulatory submissions for dolutegravir 
before the end of 2012. Dolutegravir is not yet approved as a treatment for 
HIV or any other indication anywhere in the world. 
About ViiV Healthcare 
ViiV Healthcare is a global specialist HIV company established in November 
2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to 
delivering advances in treatment and care for people living with HIV. Shionogi 
joined as a 10% shareholder in October 2012. The company's aim is to take a 
deeper and broader interest in HIV/AIDS than any company has done before and 
take a new approach to deliver effective and new HIV medicines as well as 
support communities affected by HIV. For more information on the company, its 
management, portfolio, pipeline and commitment, please visit 
Shionogi forward-looking statement: This announcement contains forward-looking 
statements. These statements are based on expectations in light of the 
information currently available, assumptions that are subject to risks and 
uncertainties which could cause actual results to differ materially from these 
statements. Risks and uncertainties include general domestic and international 
economic conditions such as general industry and market conditions, and 
changes of interest rate and currency exchange rate. These risks and 
uncertainties particularly apply with respect to product-related 
forward-looking statements. Product risks and uncertainties include, but are 
not limited to, completion and discontinuation of clinical trials; obtaining 
regulatory approvals; claims and concerns about product safety and efficacy; 
technological advances; adverse outcome of important litigation; domestic and 
foreign healthcare reforms and changes of laws and regulations. The company 
disclaims any intention or obligation to update or revise any forward-looking 
statements whether as a result of new information, future events or otherwise. 
This announcement contains information on pharmaceuticals (including compounds 
under development), but this information is not intended to make any 
representations or advertisements regarding the efficacy or effectiveness of 
these preparations nor provide medical advice of any kinds. 
GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation 
Reform Act of 1995, GSK cautions investors that any forward-looking statements 
or projections made by GSK, including those made in this announcement, are 
subject to risks and uncertainties that may cause actual results to differ 
materially from those projected. Factors that may affect GSK' s operations are 
described under 'Risk factors' in the 'Financial review & risk' section in the 
company's Annual Report 2011 included as exhibit 15.2 to the company's Annual 
Report on Form 20-F for 2011. 
Pfizer disclosure notice: Pfizer assumes no obligation to update any 
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information or future events or developments. This release contains 
forward-looking information about Pfizer, GlaxoSmithKline and ViiV Healthcare 
and about the prospects of the companies, including revenues from in-line 
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including, among other things, decisions by regulatory authorities regarding 
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potential of such product candidates; and competitive developments. A further 
list and description of risks and uncertainties can be found in Pfizer's 
Annual Report of Form 10-K for the fiscal year ended December 31, 2011 and in 
its reports on Form 10-Q and Form 8-K. 
ViiV UK/US/Canada Media enquiries:  Camilla Bull +44 (0) 20 8380 6226 Marc 
Meachem +1 919 483 8756  
GSK Global Media enquiries:  David Daley +44 (0) 20 8047 5502 Eleanor Bunch 
+44 (0) 20 8047 5502  GSK Analyst/Investor enquiries:  Sally Ferguson +44 
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McLaughlin + 1 215 751 7002 Ziba Shamsi + 44 (0) 20 8047 3289   
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