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First Regimen Combining Long Acting Injectable Antiretrovirals; 32-Week LATTE 2 Study Results Presented at CROI

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Additional Relevant Details The LATTE-2 study is investigating the safety and efficacy of 2-drug IM ART, relative to 3-drug oral ART when used to maintain viral suppression in HIV-1 infected adults.Virologic responses (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for 309 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 response 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 those who continued on oral CAB + NRTIs (2%, n=1). The most common AE reported by patients was injection site pain (92% of injection recipients).LATTE-2 (31LB) is a phase IIb, multicenter, parallel group, and open-label study which recruited ART-naïve HIV-infected adults. Enrolled patients who had a plasma HIV-1 RNA, <50 c/ml during 20-week Induction Period (IP) with daily oral CAB 30 mg + ABC/3TC were randomised 2:2:1 to IM CAB LA + RPV LA every 4 weeks, every 8 weeks, or remained on oral CAB + ABC/3TC (PO) in the Maintenance Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot algorithm, protocol defined virologic failure, and safety at 32 weeks in the MP.
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Occurred on:
Feb 23, 2016
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Related Keywords Latte 2 Study Results, Antiretrovirals, Croi, Rilpivirine, Cabotegravir, Antiviral Activity, Nucleoside Reverse Transcriptase Inhibitors, Nrtis, Latte-2, Retroviruses, Opportunistic Infections