Janssen’s new single-tablet regimen, Symtuza, has been approved by the European Commission and has moved one step closer to approval by the U.S. Food and Drug Administration. To date, it is the only once-daily combination regimen that uses the protease inhibitor darunavir (Prezista) as the primary ingredient.
In addition to darunavir, Symtuza contains emtricitabine and tenofovir alafenamide (both reverse transcriptase inhibitors) as well as the booster cobicistat. This combination capitalizes on the high genetic barrier to resistance that darunavir offers while avoiding the negative kidney and bone density impacts of tenofovir disoproxil fumarate.
“A darunavir-based [regimen] represents a significant evolution in treatment options for HIV patients,” Jean-Michel Molina, a professor of infectious diseases at the University of Paris Diderot, France, and head of the infectious diseases department at the Saint-Louis Hospital in Paris, told reporters. “This is a true advancement in helping patients achieve an undetectable viral load and improving quality of life.”
The EU commission’s decision was based on positive Phase 3 findings showing that those who switched to Symtuza remained virally suppressed. Those findings were reiterated at the 16th European AIDS Conference in Milan, Italy, where Chloe Orkin of the Royal London Hospital confirmed that research showed Symtuza is just as effective as another multi-pill combination in previously untreated people with HIV.
The study recruited 725 participants in Europe and North America, predominantly male (88 percent) and white (83 percent). After 48 weeks of treatment, 91.4 percent of those receiving Symtuza had viral loads below 50 copies/ml, compared to 88.4 percent of the control group. Virologic failure occurred in 4.4 percent of the Symtuza group compared to 3.3 percent of the control group. No participant experiencing virological rebound developed resistance to darunavir or tenofovir; but one developed resistance to emtricitabine.
Discontinuations due to adverse reactions occurred less frequently in the Symtuza group (only 1.9 percent versus 4.4 percent in the control group) although the incidence of serious adverse events was similar in both groups. The most common adverse events were diarrhea, rash, and nausea.
With darunavir now available in a single pill combinatiom, more people will be able to reduce what Molina called “the pill burden,” giving HIV-positive people “greater freedom and flexibility, and through this we may also improve treatment adherence.”
Adherence is particularly important in reaching and maintaining undetectable viral loads as well as keeping drug resistance at bay. As of press time, an application for U.S. approval of Symtuza is currently with the FDA.