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Thursday, March 7, 2019

J&J says rilpivirine/cabotegravir met primary endpoints in two Phase 3 studies

The Janssen Pharmaceutical Companies of Johnson & Johnson confirmed that the long-acting two-drug injectable regimen of rilpivirine and cabotegravir met its primary endpoints in two Phase 3 studies – the Antiretroviral Therapy as Long-Acting Suppression, or ATLAS, trial and the First Long-Acting Injectable Regimen, or FLAIR, trial. The 48-week results from both studies showed that Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir, injected every four weeks, had similar efficacy in maintaining viral suppression in adults living with HIV-1 when compared to a standard of care, daily, oral three-drug regimen. These data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections, or CROI. “The Phase 3 results from these studies show that a two-drug injectable treatment regimen may provide people living with HIV the option of managing their virus with just 12 injection regimens a year. If approved by regulators, this will be the first monthly dosing solution for people living with HIV and represents a major step for HIV treatment,” said Brian Woodfall, Global Head, Development, Infectious Diseases, Janssen Pharmaceutica NV.

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