Janssen receives FDA approval for Symtuza
Janssen announced that it has received FDA approval for Symtuza, a once-daily, single-tablet, darunavir-based HIV-1 regimen for treatment-naive and certain virologically suppressed adults.
"As clinicians, we may not always have the full picture of a patient's health or their risk for developing resistance when making treatment decisions,” Joseph Eron, MD, professor of medicine and director of the Clinical Core at the University of North Carolina Center for AIDS Research, said in a news release. “In key phase 3 clinical trials, Symtuza successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral therapy — including patients with more complex treatment histories or previous virologic failure — demonstrating its potential as an important new treatment option for a wide variety of patients.”
Symtuza is a standalone prescription medication that combines darunavir’s high barrier to drug resistance with the safety profile of tenofovir alafenamide and the convenience of a single-tablet regimen, according to the release. It contains 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide (D/C/F/TAF).
The FDA approval is based on data from two 48-week, noninferiority, pivotal phase 3 studies comparing the safety and efficacy of D/C/F/TAF with a control regimen. The AMBER trial evaluated the regimen in adults with no prior antiretroviral therapy history, and the EMERALD trial included virologically suppressed adults. D/C/F/TAF was found to be effective and well-tolerated in both studies and up to 95% of trial participants achieved or maintained virologic suppression (HIV-1 RNA <50 c/mL).
The regimen is recommended to be taken once daily with food and is not recommended for patients with a creatinine clearance below 30 mL per minute or individuals with severe hepatic impairment, according to the release. D/C/F/TAF has a boxed warning regarding post-treatment risk of acute exacerbation of hepatitis B virus infection. According to the release, patients should be screened for HBV and renal function, and renal function should be tested and monitored during therapy.
The European Commission and Health Canada also have approved D/C/F/TAF to treat HIV-1 in adults and adolescents aged 12 years and older with a body weight of at least 40 kg, according to the release.
“The FDA approval of Symtuza marks another important milestone in our quest to address real-world clinical challenges, combat HIV drug resistance and meet the diverse needs of those living with HIV," Brian Woodfall, MD, Janssen’s global head of late development, infectious diseases, said in the release. "There is more to be done in our fight to make HIV history, and we will not stop here. We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine."
Disclosures: Eron reports being a consultant and grant investigator for Janssen. Woodfall works for Janssen.