Symtuza Approved to Treat HIV-1 Infection
July 18, 2018 – The U.S. FDA has approved Symtuza™ (darunavir 800mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg), manufactured by Janssen, to treat HIV-1 in treatment-naïve and certain virologically suppressed adults. It is the first complete darunavir-based single-tablet regimen approved in the United States to treat HIV-1 infection.
In clinical studies, Symtuza produced low virologic rates and high rates of virologic suppression by Week 48. Patients who received Symtuza experienced improved renal function and less bone loss when compared to treatment with darunavir/cobicistat (D/C) plus emtricitabine/tenofovir disoproxil fumarate (F/TDF). Bone mineral density improved in patients who switched to Symtuza from a boosted protease inhibitor plus emtricitabine and TDF.
Recommended dosing is one tablet per day, taken with food. Symtuza should not be used by patients who have severe hepatic impairment or creatinine clearance below 30 mL/minute. Patients should be tested for hepatitis B virus (HBV) infection and have their renal health assessed prior to starting on Symtuza. According to the product’s black box warning, patients coinfected with HBV and HIV-1 may experience severe acute exacerbation of HBV infection if treatment with Symtuza is discontinued. These patients should be closely monitored, and may require anti-hepatitis B therapy.
Gilead Sciences provides the Symtuza components cobicistat, emtricitabine and tenofovir alafenamide. Under the terms of a licensing agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution, and commercialization of Symtuza worldwide. Janssen has launched the product at an average wholesale price (AWP) of $4,178.40 per month.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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