Janssen and Viiv Healthcare announced new Phase 2b data from LATTE 2 for the first investigational, long-acting, all-injectable combination regimen of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) given together every 4–8 weeks for HIV infection.
LATTE 2 was a Phase 2b, multicenter, open label 96-week study investigating the safety and efficacy of the all-injectable combination regimen of rilpivirine (RPV LA) and cabotegravir (CAB LA) to maintain suppression of viral load. The study enrolled 309 HIV+ patients, who after reaching virologic suppression on investigational oral cabotegravir (CAB) 30mg + 2 nucleoside reverse transcriptase inhibitors (NRTIs), were randomized to receive either CAB LA + RPV LA injections every 4 weeks, 8 weeks, or continued on oral CAB + NRTIs.
Preliminary data demonstrated that the all-injectable rilpivirine/cabotegravir regimen showed comparable efficacy to a daily oral regimen of cabotegravir and 2 NRTIs at 32 weeks. Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) at 32 weeks for patients on CAB LA + RPV LA every 4 weeks (94%) or 8 weeks (95%) were comparable to the rate observed in patients continuing on oral CAB + NRTIs (91%). Full results of LATTE 2 will be presented at a forthcoming scientific conference.
If successfully developed and approved by regulatory authorities, the long acting, all-injectable CAB LA + RPV LA regimen may offer virologically-suppressed HIV+ patients an alternative option to the daily three-drug oral regimen, potentially maintaining viral suppression with just 6 or 12 injections of each drug per year.
Rilpivirine, marketed as Edurant in oral form, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and cabotegravir is an investigational integrase strand inhibitor (INSTI) and analogue of dolutegravir (Tivicay).
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