First investigational all injectable long acting HIV combination regimen study results at 32 weeks announced

Injectable combinations once every 4 or 8 weeks show comparable efficacy versus daily oral combination therapy.

“Despite great progress in HIV treatments, the burden of treating HIV patients remains high. Long-acting injectable drug formulations may offer another option for HIV maintenance therapy,” says Paul Stoffels, Chief Scientific Officer and Worldwide Chairman Pharmaceuticals, Johnson & Johnson. “Our hope in studying such combinations is to make HIV infection manageable with a potentially transformational all injectable regimen.”

If successfully developed and approved by regulatory authorities, this regimen could offer people living with HIV who are virologically suppressed an option to switch from a standard daily regimen of three-drug therapy to a long acting all-injectable regimen that could potentially maintain viral suppression with just six or twelve injections of each drug per year.

Following the results of the proof of concept two-drug oral dose-ranging study LATTE, LATTE 2 was initiated as a Phase IIb, multicentre, open label 96 week study investigating the safety and efficacy of this first all-injectable long acting combination regimen of rilpivirine and cabotegravir to maintain suppression of viral load. 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 randomized 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).

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) whether 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 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.