New switch data reinforcing Symtuza for treatment of HIV-1 regardless of prior regimen and for initiating the drug in the newly diagnosed.- Janssen Pharma.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data reinforcing the safety and efficacy of switching to Symtuza (D/C/F/TAF) for the treatment of HIV-1 regardless of prior treatment regimen among treatment-experienced patients . Data presented from another Phase III study also provide evidence to support a darunavir-based regimen when rapidly initiating treatment in people who are newly diagnosed with HIV-1.

Analyses from the pivotal Phase III EMERALD trial further support the efficacy and safety of switching from boosted protease inhibitor-based (bPI) regimens to D/C/F/TAF for the treatment of HIV-1 regardless of prior treatment regimen in virologically suppressed, treatment-experienced adults as previously published in The Lancet. Results from EMERALD showed similar virologic response rates at Week 48 (HIV-1 RNA <50 copies/mL: 95% vs 94%; HIV-1 RNA ?50 copies/mL: 1% vs 1%) and rates of virologic rebound (2.5% vs 2.1%) were demonstrated with D/C/F/TAF compared to continuation of previous treatment in the overall population. In the new analyses, data is presented in subgroups according to baseline regimen. Results were consistent across subgroups based on bPI regimens used at screening. The EMERALD trial investigates the proportion of patients with virologic rebound cumulative through Week 48.

Additionally, interim results from the Phase III DIAMOND study provide evidence to support the use of a darunavir-based regimen when rapidly initiating treatment in newly diagnosed HIV-1 patients, as recommended by the U.S. Department of Health and Human Services guidelines. DIAMOND is the first Phase III trial for a single-tablet regimen conducted in a rapid initiation scenario. In this study, no patients met predefined resistance stopping rules and 81% of patients achieved virologic suppression <50 copies/mL at Week 24 in an intent-to-treat (ITT) analysis. 90% of patients achieved virologic suppression <50 copies/ML at Week 24 based on as-observed analysis. Analysis at 24 Weeks is interim, and the primary endpoint will be at 48 Weeks. No patients stopped due to protocol-defined virologic failure, or lack of efficacy, and only one patient discontinued due to an adverse event.