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

PR62417

LONDON, Nov. 4 /PRNewswire=KYODO JBN/ --

    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 (LSE: GSK) and Pfizer (NYSE: PFE) 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

SOURCE: ViiV Healthcare