FDA recently approved the first and only complete darunavir-based single-tablet regiment to treat HIV-1 in treatment-naïve and certain virologically suppressed adults.
FDA recently approved the first and only complete darunavir-based single-tablet regiment to treat HIV-1 in treatment-naÃ¯ve and certain virologically suppressed adults.
Symtuza (Janssen/ Johnson & Johnson) combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR, Janssen said in a statement.
HHS guidelines recommend darunavir-based therapies for treatment-naÃ¯ve patients in certain clinical situations, including when a person may have uncertain adherence or when ARV treatment should be initiated before resistance test results are available.
"Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication-or even an entire class of medications-to stop working," said Joseph Eron, MD, professor of medicine and director, Clinical Core at the University of North Carolina Center for AIDS Research in Chapel Hill, N.C., in the statement.
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In 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," Eron added.
Results from two 48-week, non-inferiority, pivotal phase 3 studies demonstrated that Symtuza was effective and well-tolerated, with up to 95% of patients achieving or maintaining virologic suppression.
Symtuza includes a Boxed Warning regarding the risk of post-treatment acute exacerbation of hepatitis B.
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