ViiV Healthcare Announces Positive Headline Results from a Study of Two Drug Injectable Regimen for HIV Maintenance Therapy

London (ots/PRNewswire) -

ViiV Healthcare, a global specialist HIV company with GSK, Pfizer
Inc. and Shionogi Limited as shareholders, today announced that the
Phase IIb study LATTE 2 (NCT02120352) met its primary endpoint at 32
weeks. These results show that the investigational, long acting,
injectable formulations of cabotegravir (ViiV Healthcare) and
rilpivirine (Janssen) were comparable in maintaining viral
suppression rates to a three drug oral regimen of investigational
cabotegravir and two nucleoside reverse transcriptase inhibitors
(NRTIs). The 32 week results of LATTE 2 will be presented at a
forthcoming scientific conference. ViiV Healthcare and Janssen
Sciences Ireland UC (Janssen) are collaborating to conduct LATTE 2.

Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA snapshot
analysis) for patients at 32 weeks receiving two drug maintenance
therapy with investigational long acting cabotegravir (CAB LA) and
long acting rilpivirine (RPV LA) dosed every 8 weeks (Q8W, 95%) or
every 4 weeks (Q4W, 94%) were comparable to the rate observed in
patients continuing with a three drug oral regimen of investigational
CAB + NRTIs (91%).

Patients switching to CAB LA and RPV LA administered Q4W reported
more adverse events (AEs) leading to withdrawal (5%; n=6) compared
with those receiving an injection Q8W (2%; n=2) or who continued on
oral CAB + NRTIs (2%, n=1). The most common adverse event (AE)
reported by patients was injection site pain (93% of injection
recipients). Two patients in the Q8W arm (none in the Q4W arm)
withdrew for injection intolerance. Two patients met protocol defined
virologic failure criteria, Q8W (n=1), oral (n=1); neither patient
had evidence of resistance at failure.

"ViiV Healthcare is committed to identifying new therapeutic
options for physicians and people living with HIV. These initial
phase IIb data investigating long-acting cabotegravir and rilpivirine
are promising and build on the results we have seen to date. We look
forward to seeing further results as we move into phase III,"
said John C Pottage, Jr, MD, Chief Scientific and Medical Officer,
ViiV Healthcare.

Following the results of the proof of concept two-drug oral
dose-ranging study LATTE[1] , LATTE 2 was initiated as a phase IIb,
multicentre, open label 96 week study investigating CAB LA with RPV
LA as a two-drug antiretroviral (ART) regimen for suppressive
maintenance therapy in ART-naive, HIV infected adults. LATTE 2
included adults (n=309) who, after reaching virologic suppression on
oral therapy with once-daily investigational oral cabotegravir 30mg +
2 NRTIs (n=286, 93%), were subsequently randomised to one of three
study arms to receive either CAB LA + RPV LA injections every 4 weeks
(n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB + NRTIs
(n=56).

About cabotegravir

Cabotegravir is an investigational integrase strand transfer
inhibitor (INSTI) and analogue of dolutegravir (Tivicay(R)).
Cabotegravir is being developed by ViiV Healthcare for the treatment
and prevention of HIV and is currently being evaluated as a
once-daily oral tablet formulation and as a LA nanosuspension
formulation for intramuscular (IM) injection.

About Edurant(R) (rilpivirine)

Rilpivirine is a once daily non-nucleoside reverse transcriptase
inhibitor (NNRTI) used for the treatment of human immunodeficiency
virus (HIV-1) infection in combination with other antiretroviral
agents in antiretroviral treatment-naive adult patients with a viral
load less than or equal to 100,000 HIV RNA copies/mL.

Rilpivirine was developed by Janssen. Rilpivirine is approved in
US and EU as EDURANT (R) as a single agent tablet dosed at 25mg taken
once a day. The overall safety profile of rilpivirine is based on
Phase III clinical studies. Rilpivirine is also available in the
United States (US) and the European Union as part of a once daily
fixed dose antiretroviral combination with Gilead Sciences Inc's
tenofovir and emtricitabine. This combination, known as COMPLERA(R)
(US) or EVIPLERA(R).

Rilpivirine is currently being developed as a long-acting
nanosuspension formulation for intramuscular (IM) injection.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering
advances in treatment and care for people living with HIV. Shionogi
joined 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 http://www.viivhealthcare.com

References:

1. Margolis DA et al., Cabotegravir plus rilpivirine, once a day,
after induction with cabotegravir plus nucleoside reverse
transcriptase inhibitors in antiretroviral-naive adults with HIV-1
infection (LATTE): a randomised phase 2b dose-ranging trial. Lancet
Inf Dis 2015:15(10):1145-55

ots Originaltext: ViiV Healthcare
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Contact:
ViiV Healthcare Contacts: Sébastien Desprez (UK), Global
Communications, ViiV Healthcare, +44-7920-567-707; Marc Meachem (US),
US
Communications, ViiV Healthcare, +1-919-483-8756. GSK enquiries: UK
Media
enquiries: Simon Steel, +44-(0)20-8047-5502 (London) / David Daley,
+44-(0)20-8047-5502 (London); US Media enquiries: Sarah Alspach,
+1-202-715-1048 (Washington, DC) / Sarah Spencer +1-215-751-3335
(Philadelphia); Analyst/Investor enquiries: Ziba Shamsi,
+44-(0)20-8047-5543 (London) / Tom Curry, +1-215-751-5419
(Philadelphia) /
Gary Davies, +44-(0)20-8047-5503 (London) / James Dodwell,
+44-(0)20-8047-2406 (London) / Jeff McLaughlin +1-215-751-7002
(Philadelphia).