EU Approves Janssen’s Single-Tablet HIV Regimen Symtuza
The European Commission (EC) has now approved the use of Symtuza- Janssen’s once-daily pill for human immunodeficiency virus type 1. Symtuza is the only once-daily darunavir-based single-tablet regimen (STR) indicated to treat HIV-1 adults and adolescents aged 12 and older with a body weight of at least 40kg in the European Union.
“There are almost one million people in the European Union currently living with HIV. The availability of a single-treatment regimen with a high barrier to resistance mutations eliminates the need for separate tablets, reducing the burden of pills on daily life for patients, and helping them to achieve improved treatment adherence and viral suppression,” said Jean-Michel Molina, Professor of Infectious Diseases at the University of Paris Diderot.
“At Janssen, we are committed to developing effective and innovative treatments which address the issues of adherence and resistance. Today’s approval by the European Commission demonstrates our efforts to treat HIV more simply, helping all those living with HIV to achieve an undetectable viral load while enjoying an improved quality of life,” said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Janssen Infectious Diseases Therapeutics.
Darunavir is one of the most widely used HIV treatments
due to its ability to control the HIV virus and offer a high barrier to resistance. The once-daily STR combines darunavir 800 mg, cobicistat 150 mg and emtricitabine/tenofovir alafenamide 200 mg/10 mg fixed-dose combination.HIV patients taking once-daily STR was compared with patients separately taking the four ingredients of the STR in a fixed dose. Once-daily STR was found to be bioequivalent to the combined administration of the separate agents, as well as STR was well tolerated by the patients.
Symtuza was found to have a high virologic suppression rate at 24 weeks in HIV-1 positive patients.
Results from a bioequivalence study that compared Symtuza with the combined administration of the separate agents darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination were presented at the International AIDS Society (IAS) conference in Paris, France in July. These results confirmed that the once-daily STR is bioequivalent to the combined administration of the separate agents, as well as demonstrating that the STR is well tolerated.
In addition, results from the pivotal Phase 3 EMERALD study presented at IAS showed that the once-daily STR containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg [D/C/F/TAF] had a low cumulative virologic rebound rate and a high virologic suppression rate at 24 weeks in HIV-1 positive, virologically suppressed adults who switched from a standard boosted protease inhibitor (PI) plus tenofovir/emtricitabine regimen. A Phase 3 clinical trial programme investigating the efficacy and safety of the darunavir-based combination is ongoing. In October, EMERALD 48-week data will be presented at ID Week 2017 in San Diego, California, USA, and 48-week data from the Phase 3 AMBER trial in antiretroviral therapy (ART) naïve patients will be presented at the European AIDS Clinical Society (EACS) Conference in Milan, Italy.
