Long-Acting 2-Drug Injectable Noninferior to Oral 3-Drug Combo in HIV Study
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.