GlaxoSmithKline: Two drug injectable regimen for HIV therapy study shows positive result

ViiV Healthcare, a global specialist HIV company with GSK (GlaxoSmithKline), Pfizer Inc. and Shionogi Limited as shareholders, announced on Tuesday 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), GSK said

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%).

According to GSK, 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 onoral 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.