Janssen Pharma Moves Forward Study of HIV Drug Injectibles

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced that Phase IIb data studying a combination regimen of two investigational long acting, injectable formulations of HIV medicines -- Janssen's rilpivirine and ViiV Healthcare's cabotegravir -- given together every 4 or 8 weeks show comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). The full results of the study, named LATTE 2, co-funded by Janssen and ViiV Healthcare will be presented at a forthcoming scientific conference.

"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, M.D. 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
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.

Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.[1]�It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.[1],[ 2],[ 3]�Standard three-drug oral therapy contains three active components taken daily: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor, protease inhibitor (PI) or integrase inhibitor (INI).�