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Janssen announced positive topline results from a Phase 3 trial for an investigational long-acting 2-drug regimen for HIV-1 infection.
The ATLAS study enrolled 570 patients infected with HIV-1; participants were randomized to either the experimental or active comparator arms. The experimental group was administered oral cabotegravir (CAB) 30mg + rilpivirine (RPV) 25mg once daily for 4 weeks, then switched to long-acting (LA) formulations of both CAB LA 400mg + RPV LA 600mg injections every 4 weeks.
The comparator arm continued to receive their current antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI). The primary endpoint was non-inferiority of the 2-dose regimen to the current oral 3-drug regimen, defined as the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL using the FDA Snapshot algorithm at Week 48.
The primary endpoint was met but the full results have not been released; the data will be presented at an upcoming scientific meeting. The Company also stated that overall safety, virologic response, and drug resistance of the 2-drug regimen were consistent with results from the Phase 2 LATTE and LATTE-2 studies.
“This novel approach would signify a much-needed treatment evolution for people living with HIV, moving from dosing 365 days a year to just 12 times per year,” said Wim Parys, M.D., Head of R&D, Global Public Health, Janssen Pharmaceutica N.V.
Rilpivirine is currently approved to treat HIV in combination with other antiretrovirals, while cabotegravir is an investigational INI.
For more information visit clinicaltrials.gov.
This article originally appeared on MPR
