FDA Approves First Darunavir-Based Single-Tablet Regimen for HIV

The FDA has approved the first darunavir-based single-tablet treatment regimen for HIV, offering a new treatment option for adults living with the virus. Janssen announced the approval of Symtuza (darunavir 800 mg, cobistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg) for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed patients.

According to Janssen, Symtuza combines the high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of a single-tablet regimen.

“As clinicians, we may not always have the full picture of a patient’s health or their risk of developing resistance when making treatment decisions,” Joseph Eron, MS, professor of medicine and director, Clinical Core, University of North Carolina Center for AIDS Research, said in a statement. “In key phase 3 clinical trials, Symtuza successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral (ARV) 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.”

The approval is the result of data from two 48-week, noninferiority, pivotal phase 3 trials evaluating the safety and efficacy of Symtuza compared with control regimens in patients with no prior ARV history and in virologically suppressed adults.

In the AMBER trial, researchers compared Symtuza with darunavir/cobicistat plus emtricitabine/tenofovir disproxil fumarate. Researchers observed similar viral suppression rates between the treatments and low virologic failure rates at 48 weeks. Treatment with Symtuza was associated with less bone loss and a significant improvement in markers of renal function. The treatment also resulted in fewer discontinuations due to an adverse event.

The EMERALD study compared Symtuza with continuing treatment with a boosted protease inhibitor plus emtricitabine and tenofovir disoproxil fumarate. Treatment with Symtuza yielded low virologic failure rates and high virologic suppression rates, with no patients discontinuing treatment due to virologic failure. Switching to Symtuza was associated with improvement in bone mineral density and significant improvement in several markers of renal function.

Currently, HHS guidelines recommend darunavir-based treatments for treatment-naïve patients in certain clinical situations, including when a patient has an uncertain adherence or when ARV treatment should have been initiated before resistance test results are available.

Symtuza has a Boxed Warning regarding the risk of post-treatment acute exacerbation of hepatitis B. It is recommended that prior to or when initiating treatment with Symtuza, patients should be tested for hepatitis B and renal function, and renal function should be monitored as clinically appropriate during therapy.