- Johnson & Johnson on Tuesday touted positive interim data from a pivotal study of its single, once-a-day regimen for HIV.
- Data from the Phase 3 EMERALD trial showed patients who switched from a boosted protease inhibitor (PI) regimen to a tablet containing Johnson & Johnson's darunavir and a trio of drugs from Gilead had an overall confirmed viral load or premature discontinuation rate of 1.8% and a virologic suppression rate of 96.3% at 24 weeks.
- Participants in the control arm, conversely, received treatment that included a boosted PI and the drugs emtricitabine and tenofovir disoproxil fumarate (TDF). Collectively, those patients demonstrated a viral load or premature discontinuation rate of 2.1% and a virologic suppression rate of 95.5%.
HIV drugmakers have gotten better and better at developing products that adequately control viral loads. But in order to hold onto their market share, many have turned their attention to crafting new regimens that are either easier to adhere to or that offer more tailored therapy.
In EMERALD, Johnson & Johnson enrolled adults who are positive for type 1 HIV and virologically suppressed. Aside from the its regimen being "effective and well tolerated," the big pharma highlighted the benefits of a once-daily, single-tablet product. As the industry knows all too well, adherence tends to rise when treatments are administered orally, and improve even further when patients don't have to take frequent doses.
"If approved, [the regimen] has the potential to not only offer the benefits of darunavir but could also reduce the treatment burden faced by those taking life-long HIV therapy, which may help to address the issues of both adherence and resistance," Lawrence Blatt, Janssen's global therapeutic area head for infectious disease therapeutics, said in a July 25 statement.
Johnson and Johnson's regimen consists of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (TAF), the respective active ingredients in Prezista, Tybost, Emtriva and Vemlidy. The drugmaker, as well as Gilead, have also developed combination treatments using those active ingredients.
Gilead, for instance, reported on Monday positive results from two late-stage studies testing the triple combo of bictegravir, a novel investigational integrase strand transfer inhibitor (INSTI), with emtricitabine and tenofovir alafenamide.
Safety profiles or Johnson & Johnson's EMERALD study were similar across the trial arms; both the control and experimental groups reported grade 3 or grade 4 adverse events (AEs) at 4.5% and discontinuations of 2.9%. Serious AEs occurred in 3.2% and 2.6%, respectively, in those groups.
Though these results are only interim data — more complete results from the 48-week study will come later — its a good sign for Johnson & Johnson that the regimen is already demonstrating non-inferiority.
Should the drug gain approval, it could help offset a weakening performance from Prezista, which saw sales fall about 5% to $430 million during the first quarter compared to the same period in 2016.