LONDON, November 3, 2015 /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-naïve, 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®).
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® (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-naïve adult patients with a
viral load ≤ 100,000 HIV RNA copies/mL.
Rilpivirine was developed by Janssen. Rilpivirine is approved in
US and EU as EDURANT® 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® (US) or EVIPLERA®.
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