Through Week 144, the development of one or more primary emtricitabine, tenofovir alafenamide, or elvitegravir resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and E/C/F/TAF treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF group (12 of 867 patients [1.4%]). The mean baseline CD4+ cell count was 636 cells/mmOf the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to anti-HBe at Week 48. If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule. Based on these limited data, the safety profile of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet, in patients with HIV/HBV co-infection, was similar to that in patients with HIV-1 monoinfection (see section 4.4).Reporting suspected adverse reactions after authorisation of the medicinal product is important. with EVG+COBI subjects.In an open-label trial of antiretroviral treatment-naïve
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment.Descovy should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
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Treatment of overdose with Descovy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.Emtricitabine can be removed by haemodialysis, which removes approximately 30% of the emtricitabine dose over a 3 hour dialysis period starting within 1.5 hours of emtricitabine dosing. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment.
Seventy-nine percent were male, 63% were White, 18% were Black, and 14% were Asian. 6.1 Clinical Trials Experience Mellitus and Atherosclerotic Cardiovascular Disease 6.2 Postmarketing Experience .
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 4.8).There are no pharmacokinetic data on emtricitabine or tenofovir alafenamide in patients with end stage renal disease (estimated CrCl < 15 mL/min) not on chronic haemodialysis. hip. No special hazard for humans was revealed in conventional studies of carcinogenic potential and toxicity to reproduction and development. Dose Descovy according to the concomitant antiretroviral (see section 4.2).Interaction not studied with either of the components of Descovy.Co-administration of St. John's wort, a P-gp inducer, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.Co-administration of Descovy with St. John's wort is not recommended.Interaction not studied with either of the components of Descovy.Co-administration of ciclosporin, a potent P-gp inhibitor, is expected to increase plasma concentrations of tenofovir alafenamide.The recommended dose of Descovy is 200/10 mg once daily.Norgestimate (0.180/0.215/0.250 mg once daily), ethinylestradiol (0.025 mg once daily), emtricitabine/tenofovir alafenamide (200/25 mg once daily)No dose adjustment of norgestimate/ethinylestradiol is required.
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