The Janssen Pharmaceutical Companies of Johnson & Johnson announced post-hoc analyses from the pivotal Emerald and Amber Phase 3 trials of its investigational, complete, once-daily, single-tablet regimen (STR) of darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (D/C/F/TAF) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.
The analyses were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. Results from 48-week sub-analyses were consistent with the primary data presentation of the pivotal Phase 3 data from the Emerald and Amber clinical trials. Subgroups of patients were analyzed and included patients who had varying levels of treatment experience, virologic failure (VF) to non-darunavir based regimens, experience with multiple antiretrovirals (ARVs), and in some cases, unknown baseline resistance-associated mutations (RAMS) to agents other than study drugs.
“When patients present in a doctor’s office, we don’t always have a full picture of their health, lifestyle or past treatment. These analyses—given the more inclusive trial entry criteria—are relevant to the real-life clinical challenges that physicians face, and the darunavir-based single-tablet regimen could be an important option for a wide range of patients, including patients with more complex treatment history,” says Joseph Eron, MD, Emerald and Amber Phase 3 trial investigator, professor of medicine and director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C.
Filed Under: Drug Discovery