Janssen Announces 48-week Results of Phase 3b Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment of Rilpivirine and Cabotegravir Administered Every Two Months

CORK, IRELAND, March 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson presented new data from its global Phase 3b trial today for the novel, investigational, long-acting (LA), two-drug injectable regimen – a combination of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir. The study – Antiretroviral Therapy as Long-Acting Suppression every 2 Months (ATLAS-2M) trial – met its primary endpoint at Week 48, showing that the therapy, injected every eight weeks, had similar safety and efficacy in maintaining viral suppression in adults living with HIV-1, as treatment every four weeks. These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI). “While controlling HIV is paramount, we also focus on improving the lives of people living with HIV,” said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D, Janssen Research & Development LLC. “We are excited to be a strategic partner in the development of the first long-acting injectable regimen of HIV medicines, potentially providing a completely new experience when it comes to managing the virus.” The global Phase 3b ATLAS-2M study met its primary endpoint, finding that every-eight-week (two-months) dosing of the LA regimen was noninferior to every-four-week (monthly) dosing. Non-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA ≥ 50 copies per milliliter (c/mL) using the ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news