Newly EU-Approved HIV Drug First of Its Kind

Janssen’s new single-tablet regimen, Symtuza, has been approved by the European Commission, according to Labiotech.eu. To date, it is the only once-daily combination regimen that uses darunavir (Prezista) as the primary ingredient.

In addition to the protease inhibitor, darunavir, Symtuza contains emtricitabine and tenofovir alafenamide (both reverse transcriptase inhibitors) as well as the booster cobicistat.

This STR combines the proven efficacy and durability of darunavir with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate), and will be the only treatment to deliver the adherence advantages of an STR coupled with the high genetic barrier to resistance that darunavir offers. 

“Darunavir is one of the most widely used HIV treatments,” noted Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Janssen Infectious Diseases Therapeutics, earlier this year. The reason is “due to its ability to control the HIV virus while offering a high barrier to resistance.”

Drug resistance is a growing concern in the treatment of HIV as more people stay on antiretroviral drugs long-term.

“A darunavir-based [regimen] represents a significant evolution in treatment options for HIV patients,” Jean-Michel Molina from the University of Paris Diderot said in a statement to the press. “With around two million people in Europe currently managing their HIV, this is a true advancement in helping patients achieve an undetectable viral load and improving quality of life.”

With darunavir now in a single pill combination, 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.

The EU decision was based on positive Phase 3 findings showing that those who switched from previous regimens to Symtuza continued to remain virally suppressed.

Unfortunately, Symtuza has not yet been approved by the Federal Drug Administration in the United States, but that decision should be made in the near future.