GHP Q3 2018

26 GHP / Q3 2018 , Study meets primary endpoint, comparing efficacy of an investigational once a month injectable two-drug regimen to the standard of care daily, three-drug regimen. The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study of the first investigational long-acting injectable two-drug regimen (2DR) for the treatment of HIV-1. The ATLAS study results showed long-acting rilpivirine (Janssen Sciences Ireland UC) and cabotegravir (ViiV Healthcare), injected once a month, had similar efficacy to a standard of care daily, oral three-drug regimen at Week 48. The injectable treatment regimen met the primary endpoint for non-inferiority (the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/ mL] using the FDA Snapshot algorithm at Week 48). Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies. “These results offer new evidence that suggest this investigational, two-drug, once a month dosing regimen may reduce the impact of treatment on people’s lives,” said Wim Parys, M.D., Head of R&D, Global Public Health, Janssen Pharmaceutica N.V. “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.” The ATLAS study was designed to establish whether HIV-1- infected adult participants with current viral suppression on a daily oral regimen comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent (standard of care), remained suppressed upon switching to the novel, two-drug long-acting regimen of rilpivirine and cabotegravir. Full results of the ATLAS study co-funded by Janssen and ViiV Healthcare will be presented at an upcoming scientific meeting. Topline results from FLAIR, a second pivotal trial designed to evaluate the investigational long-acting, injectable regimen of rilpivirine and cabotegravir in people living with HIV, are also expected later this year. This novel regimen is being co-developed as part of a collaboration with ViiV Healthcare. Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1