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"As clinicians, we do not always have a complete picture of the patient's health or his" Joseph Eron, MD, professor of medicine, director, Clinical Core, AIDS Research Center of The University of North Carolina said at the announcement: "In key phase 3 clinical trials, SYMTRUZA has successfully treated patients as well as those who have been stably deleted on antiretroviral therapy." (ARV) – including patients with more complex treatment history or prior virologic failure – demonstrating its potential as a new treatment option important for a wide variety of patients. "
for the drug based on 2 phase 3 studies, AMBER and EMERALD that evaluated the safety and efficacy of the drug compared to an adult control diet In the AMBER trial, the drug was compared darunavir / cobicistat and emtricitabine / tenofovir disoproxil fumarate. The results showed similar suppression rates between darunavir-based STR vs 91.4% vs 88.4% and low rates of virologic failure (HIV-1 RNA ≥ 50 c / mL, 4.4 % vs. 3.3%) at 48 weeks. In the EMERALD trial, darunavir-based STR was compared with continuous treatment with an amplified protease inhibitor (IPB) plus emtricitabine and TDF. The results revealed low rates of virologic failure (HIV-1 RNA ≥50c / mL, 0.8% vs. 0.5%) and high virological suppression rates (HIV-1 RNA <50c). / mL, 94.9% vs 93.7%) at week 48, without interruption of treatment due to virologic failure.
The recommended dose is 1 tablet daily with food. Darunavir-based STR is not recommended in patients with creatine clearance below 30 mL per minute or in patients with severe hepatic impairment. In addition, patients should be tested for infection with the hepatitis B virus and renal function should be monitored during treatment.
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