CORK, Ireland, November 3, 2015 /PRNewswire/ --
Injectable combinations once every 4 or 8 weeks show comparable efficacy versus daily
oral combination therapy
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.
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"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