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For the first time, fluoroquinolone exposure was tied to aortic complications in patients with established aortic disease in a large study.
In the cohort study from Taiwan, people with an existing aortic dissection (AD) or aortic aneurysm (AA) were at higher risk of adverse outcomes during the periods they were exposed to fluoroquinolones:
All-cause death: adjusted HR 1.61 (95% CI 1.50-1.73)
Aortic death: adjusted HR 1.80 (95% CI 1.50-2.15)
Aortic open surgery: adjusted HR 1.49 (95% CI 1.24-1.79)
Aortic stent placement: adjusted HR 1.64 (95% CI 1.30-2.06)
By contrast, amoxicillin (Amoxil) exposure was not associated with any of these outcomes over follow-up averaging 3.5 years, according to Shao-Wei Chen, MD, PhD, of Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan, and colleagues.
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TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen s rilpivirine and ViiV Healthcare s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resist
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Findings from pivotal phase III BRIGHTE study demonstrated that the majority (60%) of heavily treatment-experienced adults randomised to receive fostemsavir with an optimised background therapy achieved and maintained viral suppression at 96 weeks
Fostemsavir addresses a critical unmet need in HIV care for those with little to no treatment options left
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ( GSK ), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Rukobia (fostemsavir) 600 mg extended-release tablets, a novel attachment inhibitor for the treatment of HIV-1 infection. Fostemsavir, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppre