FDA OKs First Darunavir-Based Single-Tablet Treatment Regimen for HIV

Officials with the FDA have approved Janssen’s Symtuza for the treatment of HIV-1 infection, according to a press release.

Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg) is the first and only complete darunavir-based single tablet regimen (STR) for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed adults.

Cobicistat, emtricitabine, and tenofovir alafenamide are from Gilead Sciences, Inc.

The approval is based on data from two phase 3 studies, AMBER and EMERALD, which evaluated the safety and efficacy of Symtuza compared with a control regimen in adults with no prior antiretroviral (ARV) history and in virologically suppressed adults.

The AMBER trial compared treatment with Symtuza to darunavir/cobicistat (D/C) plus emtricitabine/tenofovir disoproxil fumarate (F/TDF). According to the data, similar viral suppression rates were demonstrated between darunavir-based STR versus the control and low virologic rates at 48 weeks. Additionally, Symtuza showed less bone loss and a significant improvement in markers of renal function versus the control. Overall, the treatment was well-tolerated in participants.

In the EMERALD study, Symtuza was evaluated in comparison with continuing treatment with a boosted protease inhibitor plus emtricitabine and TDF. According to the data, the trial found there were low virologic rates and high virologic suppression rates at week 48. Patients who switched to Symtuza demonstrated improvement in bone mineral density and a significant improvement in some markers of renal function versus the control. The safety profile was similar to that of those patients with no prior ARV treatment history.

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“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, Clinical Core, University of North Carolina Centers for AIDS Research, said in a press 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.”

The recommended dosage of Symtuza is 1 tablet taken once-daily with food, according to Janssen. Symtuza is not recommended in patients with creatinine clearance below 30 mL per minute or those with severe hepatic impairment.

According to the prescribing information, prior to or when initiating treatment with Symtuza, patients should be tested for hepatitis B virus (HBV) infection and renal function, which should be monitored as clinically appropriate during therapy.

Symtuza has a boxed warning regarding the risk of post-treatment acute exacerbation of HBV.

Reference

Janssen Announces US FDA Approval of Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection [news release]. Janssen’s website. https://www.janssen.com/janssen-announces-us-fda-approval-symtuza-dcftaf-first-and-only-complete-darunavir-based-single-0. Accessed July 18, 2018.