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ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, 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 inpatients continuing with a three drug oral regimen of investigational CAB + NRTIs (91%).
Patients switching to CAB LA and RPV LAadministered 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 LATTE1, 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).
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