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

Glasgow, UK - 13 November, 2012 – ViiV Healthcare today 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 log10 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 www.viivhealthcare.com.

ViiV UK/US Media enquiries:

Rebecca Hunt

+44 (0) 20 8380 6275
  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 (0) 20 8047 5543
  Lucy Budd +44 (0) 20 8047 2248
  Tom Curry + 1 215 751 5419
  Gary Davies + 44 (0) 20 8047 5503
  James Dodwell + 44 (0) 20 8047 2406
  Jeff McLaughlin + 1 215 751 7002
  Ziba Shamsi + 44 (0) 20 8047 3289
     

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 forward-looking statements contained in this release as a result of new 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 products and the potential benefits of product candidates that will be contributed to that company, as well as the potential financial impact of the transaction. Such information involves substantial risks and uncertainties including, among other things, decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial 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.