Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
ALT flares generally were not associated with coincident elevations in bilirubin, occurred within the first 12 weeks of treatment, and resolved without recurrence.Based on the Week 120 analysis, the frequencies of lab abnormalities in subjects who remained on VEMLIDY in the open-label phase were similar to those in subjects who switched from TDF to VEMLIDY at Week 96.At Week 96, in Trials 108 and 110, eight subjects treated with VEMLIDY with elevated amylase levels had associated symptoms, such as nausea, low back pain; abdominal tenderness, pain, and distension; and biliary pancreatitis and pancreatitis.
©2020 Gilead Sciences, Inc. All rights reserved. Concomitant use w/ products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil; certain anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin & rifapentine) or St. John's wort; strong P-gp inhibitors (eg, itraconazole & ketoconazole).
adults with compensated liver disease.Director of the Liver Center University Gastroenterology, Providence, RI
The mean age was 46 years, 61% were male, 72% were Asian, 25% were White, 2% were Black, and 1% were other races. Methodologic limitations of the APR include the use of MACDP as the external comparator group.
Tenofovir alafenamide is taken up by cells, where it undergoes hydrolysis by cathepsin A to form tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.
The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. HBV isolates expressing the lamivudine resistance-associated substitutions rtM204V/I (±rtL180M±rtV173L) and expressing the entecavir resistance-associated substitutions rtT184G, rtS202G, or rtM250V in the presence of rtL180M and rtM204V showed less than 2-fold reduced susceptibility (within the inter-assay variability) to tenofovir alafenamide. At baseline, mean serum ALT was 27 U/L, and 16% of patients had a history of cirrhosis.The primary efficacy endpoint was the proportion of subjects with plasma HBV DNA levels ≥20 IU/mL at Week 48. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of VEMLIDY. Tenofovir was excreted into the milk of lactating rats following oral administration of TDF (up to 600 mg/kg/day) at up to approximately 24% of the median plasma concentration in the highest dosed animals at lactation day 11 (see Safety and effectiveness of VEMLIDY in pediatric patients less than 18 years of age have not been established.Clinical trials of VEMLIDY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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In an open-label trial of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg, tenofovir alafenamide and tenofovir AUC was evaluated in a subset of virologically suppressed HIV-1 infected subjects with ESRD receiving chronic hemodialysis (Table 7) [see Relative to subjects with normal hepatic function, tenofovir alafenamide and tenofovir systemic exposures were 7.5% and 11% lower in subjects with mild hepatic impairment, respectively.The pharmacokinetics of tenofovir alafenamide have not been fully evaluated in subjects coinfected with The effects of coadministered drugs on the exposure of tenofovir alafenamide are shown in Table 8. Tenofovir alafenamide use in pregnant and lactating women living with HIV. VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment [see Tablets: 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate) — yellow, round, film-coated tablets, debossed with “GSI” on one side of the tablet and “25” on the other side.Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404.
The safety and efficacy of VEMLIDY in patients with decompensated cirrhosis (Child-Pugh B or C) have not been established; therefore, VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment [see If overdose occurs, monitor patient for evidence of toxicity.
The tablets are green, capsule-shaped, film-coated tablets, debossed with “GSI” on one side of the tablet and the number “510” on the other side of the tablet. Since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to TDF, another prodrug for tenofovir administration, a pre/postnatal development study in rats was conducted only with TDF.