Descovy is available as tablets, each containing 200 mg of emtricitabine and either 10 or 25 mg of tenofovir alafenamide. Patients were stratified by the class of the third agent in their prior treatment regimen. In a separate study, emtricitabine and tenofovir alafenamide given with darunavir and cobicistat as a fixed-dose combination tablet was also associated with smaller reductions in BMD (as measured by hip and lumbar spine DXA analysis) through 48 weeks of treatment compared to darunavir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
HIV-1 Screening for Individuals Receiving DESCOVY for HIV-1 PrEP Screen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs) [see Indications and Usage (1.2), Contraindications (4), and Warnings and Precautions (5.2)].
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral deoxyribonucleic acidTenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue). At Week 48, the median percentage change in urine retinol binding protein to creatinine ratio was 4% in the Descovy group and 16% in those remaining on an abacavir/lamivudine containing regimen; and in urine beta-2 microglobulin to creatinine ratio it was 4% vs. 5%.In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet. The mean CRelative to fasting conditions, the administration of tenofovir alafenamide with a high fat meal (~800 kcal, 50% fat) resulted in a decrease in tenofovir alafenamide CMetabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose. It allows continued monitoring of the benefit/risk balance of the medicinal product. Most HIV-1 isolates from patients in both treatment groups who developed resistance mutations to elvitegravir in integrase also developed resistance mutations to emtricitabine in RT.In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet (E/C/F/TAF), for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis. Dose Descovy according to the concomitant antiretroviral (see section 4.2).Atazanavir/cobicistat (300 mg/150 mg once daily), tenofovir alafenamide (10 mg)The recommended dose of Descovy is 200/10 mg once daily.Atazanavir/ritonavir (300/100 mg once daily), tenofovir alafenamide (10 mg)The recommended dose of Descovy is 200/10 mg once daily.Darunavir/cobicistat (800/150 mg once daily), tenofovir alafenamide (25 mg once daily)The recommended dose of Descovy is 200/10 mg once daily.Darunavir/ritonavir (800/100 mg once daily), tenofovir alafenamide (10 mg once daily)The recommended dose of Descovy is 200/10 mg once daily.Lopinavir/ritonavir (800/200 mg once daily), tenofovir alafenamide (10 mg once daily)The recommended dose of Descovy is 200/10 mg once daily.Interaction not studied with either of the components of Descovy.Tipranavir/ritonavir results in P-gp induction. Precautions to prevent transmission should be taken in accordance with national guidelines.Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.The safety and efficacy of Descovy in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.Tenofovir alafenamide is active against hepatitis B virus (HBV). Thirteen percent of patients were identified as Hispanic/Latino.
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