ViiV Healthcare starts clinical phase III programme of r Celsentri/Selzentry (maraviroc) (R) vs. Truvada (tenofovir + 3TC), in combination with an inhibitor of the protease in patients infected with HIV.

London, October 2011.- ViiV Healthcare Announces the beginning of the MODERN study of phase III (maraviroc once daily with darunavir boosted with ritonavir in a system of initiation of antiretroviral therapy), also called A4001095, which compares his antagonist of CCR5, Celsentri / Selzentry ® (maraviroc) with emtricitabine/tenofovir (Truvada ®), both in combination with darunavir/ritonavir. 96 Weeks study will evaluate a QD (once a day) regime of 2 drugs versus 3 drugs in patients infected with HIV-1 CCR5-tropic viruses and naive to antiretroviral treatment.

Antiretroviral treatment has come a long way, although it is essential that we continue looking for new treatment effective strategies that minimize toxicity at the same time to maximise the tolerability and convenience. The MODERN study is designed to achieve these objectives in a regime which includes Celsentri ® ”, points out Dr. John Pottage, director doctor and scientist from ViiV Healthcare. ” ViiV Healthcare is committed to understanding the needs of the patient and treat those needs through treatment approaches innovators that directly reflect what we learn”.

The research of regimes against the HIV virus that does not include an nuecleósido analog reverse transcriptase inhibitor (ITIAN), which is currently recommended as part of the standard in home therapy treatment, continues to be an area of interest given its potential to alleviate certain long-term toxicities associated with ITIAN schemes and to preserve future treatment options.

About the MODERN Studio

MODERN is a comparative phase III at 96 weeks, multicenter study, alatorizado and double-blind. It will include approximately 804 patients naive to treatment antiretroviral and CCR5-tropic HIV from over 250 centres in EU, US and Australia. The primary objective of the MODERN is the proportion of patients with HIV-1 RNA < 50 copies/ml at week 48. Secondary objectives include the proportion of patients with HIV-1 RNA below the detection limit per week 96; variation in the count of CD4 + and CD8 + at 48 and 96 weeks; assessment of the safety and tolerability of Celsentri / Selzentry ®, including the effect on the ratio of the distribution of the peripheral body fat and trunk/limbs; effect on bone mineral density; usefulness of genotípico and phenotypic test; change of tropism and evolution of viral resistance.

MODERN is also the first large phase III study that compares a genotípico test with a phenotypic test results and evaluates prospectively the CCR5 condition of patients to determine the eligibility of Celsentri / Selzentry ®. Patients were aleatorizarán to undergo a well genotypic or phenotypic screening test. Siemens Healthcare Diagnostics will facilitate the genotypic tropism test and Monogram Biosciences will make for phenotypic testing (Trofile ®).

About ViiV Healthcare

ViiV Healthcare is a global company specializing in HIV, created in November 2009 by GlaxoSmithKline (NYSE: GSK) and Pfizer (NYSE: PFE). It is dedicated to providing treatment and care to people living with HIV. Our goal is to focus in a way wider and deeper in the HIV/AIDS, as no other company has done before, focused on providing new and effective drugs for the treatment of HIV at the same time we support the communities affected by HIV.

On the tropism test

HIV enters the CD4 cell to join one of the two types of co-receptor expressed on their surface: CCR5 and CXCR4, defining the tropism according to what co-receptor use. To determine if patients can be suitable for the use of Celsentri / Selzentry ®, must undergo tropism tests to verify that they have only a R5-tropic virus. The use of Celsentri / Selzentry ® is not recommended in patients that submit an HIV-1 X 4 virus or dual/mixed, given that the effectiveness in this type of patients showed no in a phase II study of done.