tenofovir alafenamide vs tenofovir disoproxil

Av - 14 juni, 2021

J Hepatol. Most of these conditions are complex and involve highly effective meds. Henry Lik Yuen Chan 1, Young-Suk Lim 2, Wai Kay Seto 3, Qin Ning 4, … No confirmatory or comparative human LT data, however, are available. 2018;68:672-681. • Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.5). Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. Tenofovir alafenamide versus tenofovir disoproxil 8. Atherosclerotic CVD risk profile of tenofovir alafenamide vs tenofovir disoproxil fumarate [presentation no. Nucleotide analogs are nucleotides which contain a nucleic acid analogue, a sugar, and a phosphate groups with one to three phosphates.. Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1). Tenofovir disoproxil fumarate, tenofovir alafenamide, and adefovir are nucleotide reverse transcriptase inhibitors (NRTIs) that are used for the treatment of chronic hepatitis B virus (HBV) infection. [PubMed Abstract] GS-311-1089 Industry. 68, No. Sax PE, Wohl D, Yin MT, et al. Its efficacy in treatment and prevention has earned a good reputation as a combination of drug treatment for various health conditions. In animals, tenofovir alafenamide (TAF) has been found to have enhanced LT penetration compared with tenofovir disoproxil fumarate (TDF). Tenofovir alafenamide vs. tenofovir disoproxil fumarate in HIV-1 infected patients with normal kidney function In phase I studies in HIV-infected patients, TAF dem - onstrated more potent antiviral activity against HIV-1 than TDF and a good overall safety profile in the short term 17,34. Pilkington V et al. Background & aims Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n=333) vs. remain on tenofovir disoproxil … Lancet Gastroenterol Hepatol. 52-58 Phase 3 Studies Sax P, Wohl D, Yin M et al. Sax PE, Zolopa A, Brar I, et al. Background: Both tenofovir disoproxil fumarate (TDF)/emtricitabine and tenofovir alafenamide (TAF)/emtricitabine demonstrate excellent efficacy and safety overall, but concerns remain over specific changes in markers of bone and renal function. Here is an in-depth discussion for all things tenofovir interactions. Sax PE, Zolopa A, Brar I, et al. Background & aims Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). Pooled Cohort Risk Assessment Equations: Predicts 10-Year Risk for a First Atherosclerotic Cardiovascular Disease … Emtricitabine/tenofovir is used both to treat and to prevent HIV/AIDS. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Intracellularly, tenofovir is phosphorylated to the active moiety, tenofovir-diphosphate which is the same active moiety of tenofovir disoproxil fumarate. Tenofovir disoproxil has been around for many years. The mechanism of action of tenofovir disoproxil fumarate is associated with high plasma tenofovir concentrations which are thought to be the cause of serious renal and bone toxic effects especially in … Side effects may include trouble sleeping, weight gain, and rash. The pharmacokinetic boosters ritonavir (RTV) and cobicistat (COBI) significantly increase plasma area under the curve (AUC) concentrations of tenofovir disoproxil fumarate (TDF), by 25-37%. 2015. 96weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Cobicistat, elvitegravir, emtricitabine, and tenofovir. Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide. Lancet. Background: Tenofovir (TFV) is renally eliminated, and the prodrug, tenofovir disoproxil fumarate (TDF), has been associated with renal toxicity and reduced bone mineral density (BMD), and must be dose adjusted in patients with estimated glomerular filtration rate (eGFR) < 50mL/min. While clinical trial evidence suggests that TAF has more favorable outcomes related to kidney injury and loss of bone mineral density, TAF also leads to … • Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide. In: Journal of Hepatology, Vol. [PubMed: 29756595]. Didanosine. HIV prevention. Tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are recommended as the first-line oral drugs for patients with CHB. Lancet Gastroenterol Hepatol. J Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Tenofovir alafenamide (TAF) is a novel prodrug of TFV that is not renally eliminated and… Lancet Gastroenterol Hepatol, 1 (2016), pp. Medical uses. Mallon P et al. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was the only option for HIV preexposure prophylaxis (PrEP) until 2019, when FTC/tenofovir alafenamide (TAF) was approved. [PubMed Abstract] J Acquir Immune Defic Syndr. Tenofovir is an antiretroviral (ARV) medication used to prevent and treat HIV and to treat chronic hepatitis B. Tenofovir disoproxil fumarate (TDF), approved in 2001 for HIV and 2008 for chronic hepatitis B, is historically one of the most commonly used ARV agents for these conditions. After oral administration, TDF is well absorbed 17,18 and is so rapidly metabolized to TFV that TDF itself cannot be measured in blood (even when plasma is sampled within 5 minutes of administration). Epub 2016 Sep 22. Lancet Gastroenterol Hepatol. Epub 2016 Sep 22. Generic Name: cobicistat, elvitegravir, emtricitabine, and tenofovir (koe BIK i stat, EL vi TEG ra vir, EM trye SYE ta been, and ten OF oh vir) Brand Name: Genvoya, Stribild Dosage Forms: oral tablet (150 mg-150 mg-200 mg-10 mg; 150 mg-150 mg-200 mg-300 mg) 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. The original tenofovir disoproxil fumarate (TDF) version was developed at a dose of 300 mg once daily. Agarwal K, Brunetto M, Seto WK, et al. Weight gain before and after switch from TDF to TAF. European Medicines Agency - CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection During the study period, there was no patient who discontinued antiviral therapy due to drug related adverse effects. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. 2016 Nov;1(3):185-195. doi: … doi: 10.1097/QAD.0000000000002699. Tenofovir alafenamide (AF) [Vemlidy®], an oral prodrug of tenofovir, was developed to optimize the antiviral potency and clinical safety of the active moiety tenofovir diphosphate (selective reverse transcriptase nucleotide inhibitor). Comments:-A pregnancy exposure registry is available. J Acquir Immune Defic Syndr. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. In fact, ART has demonstrated toxicity. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF) through more efficient delivery of tenofovir to hepatocytes. … Lancet HIV. It is taken by mouth. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. This approval was based on results from DISCOVER, an ongoing manufacturer-sponsored trial, which have now been published. Tenofovir Alafenamide versus Tenofovir Disoproxil Fumarate. The objective of this work was to compare the LT pharmacokinetics (PK) of TAF and TDF in HIV-infected persons. J Acquire Immune Defic Syndr, 67(1), pp. 4, 04.2018, p. 672-681. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir, enabling treatment of patients with hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF), via more efficient delivery of tenofovir to the hepatocytes. AIDS, 34: 2259-2268, 2020. 196-206. Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) in Hispanic/Latinx and Black Participants: Efficacy, Bone and Renal Safety Results from a Pooled Analysis of 7 Clinical Trials Edwin DeJesus, MD, Edwin DeJesus, MD Orlando Immunology Center, University of Central Florida College of Medicine Nucleoside and nucleotide analogues can be used in therapeutic drugs, include a range of antiviral products used to prevent viral replication in infected cells. A randomized, double-blind comparison of tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir, cobicistat, and emtricitabine (E/C/F) for initial HIV-1 treatment: week 144 results. When combined with RTV or COBI, the dose of tenofovir alafenamide (TAF) is lowered … It is a combination of dolutegravir, lamivudine, and tenofovir disoproxil. 1 Both of these prodrugs were first created to cover the polar phosphonic acid group on tenofovir by using a novel oxycarbonyloxymethyl linkers to improve the oral bioavailability and intestinal diffusion. Nucleos(t)ide analogues (NAs), including entecavir (ETV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide fumarate (TAF), as well as interferons (IFNs), are widely used for treatment of chronic HBV infection worldwide (1,2,4,5). 7. Background: Higher plasma tenofovir concentrations are associated with higher risks of renal and bone adverse events. J Acquir Immune Defic Syndr. 2015;385:2606-15. World Health Organization. 0001). BACKGROUND:Both tenofovir disoproxil fumarate (TDF)/emtricitabine and tenofovir alafenamide (TAF)/emtricitabine demonstrate excellent efficacy and safety overall, but concerns remain over specific changes in markers of bone and renal function. Pilkington V, Hughes SL, Pepperrell T, McCann K, Gotham D, Pozniak AL, et al. It may be used for prevention of HIV/AIDS among those at high risk before exposure, and after a needlestick injury or other potential exposure. Open access. 2015;385: 2606-2615. These treatments inhibit the reverse transcription of the HBV genome and HBV DNA in the serum can be reduced rapidly. Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. K. Agarwal, M. Brunetto, W.K. J Acquir Immune Defic Syndr. Tenofovir disoproxil fumarate (TDF) has been associated with potential nephrotoxicity. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate. Tenofovir alafenamide is hydrolyzed in cells and turns into an active metabolite called tenofovir diphosphate. Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide) are both prescription brand-name medications. 30. Renally eliminated medicinal … Hip and spine BMD improved in patients assigned to the tenofovir alafenamide group compared with the tenofovir disoproxil fumarate group, irrespective of previous treatment. cobicistat, emtricitabine, and another salt form of tenofovir, tenofovir disoproxil fumarate, is currently available as Stribild®. Recently, tenofovir alafenamide (TAF) was … Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The most common adverse events overall were upper respiratory tract infection (51 [9%] of 581 patients receiving tenofovir alafenamide vs 22 [8%] of 292 patients receiving tenofovir disoproxil fumarate), nasopharyngitis (56 [10%] vs 16 [5%]), and headache (42 [7%] vs 22 [8%]). HBV can … Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. Tenofovir is one of the newer, more tolerable, nucleotide reverse transcriptase inhibitors on the market; is a mainstay of many antiretroviral therapy combinations; and is now available in 2 different formulations, tenofovir disoproxil fumarate (TDF) and, the more recent, tenofovir alafenamide (TAF). A subsequent pro-drug formulation, tenofovir alafenamide (TAF), has recently been launched in North America and Europe at doses of 10 or 25 mg once daily. / GS-US-320-0110; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. ETV, entecavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; ALT, alanine aminotransferase; AST, aspartate Aminotransferase; MELD, Model for End-stage Liver Disease. Tenofovir alafenamide is an antiviral prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of hepatitis B virus infection (HBV) in adults who meet certain requirements, as determined by a health care provider. 2018;68(4):672-81. doi: 10.1016/j.jhep.2017.11.039. Through 48 weeks, more than 90% of patients given E/C/F/tenofovir alafenamide or E/C/F/tenofovir disoproxil fumarate had virological success. BACKGROUND: Tenofovir alafenamide (TAF) is a new formulation of tenofovir disoproxil fumarate (TDF) that was approved in 2015. IDDF2020-ABS-0061 Impact of treatment with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) on hepatocellular carcinoma (HCC) incidence in patients with chronic hepatitis B (CHB) Free. Lower plasma tenofovir concentrations are seen with TAF and in unboosted regimens. Pilkington V et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. J Hepatol. 18. Changes in body weight during the tenofovir disoproxil fumarate (TDF) [1-year period before switching from TDF to tenofovir alafenamide (TAF)] and TAF periods (1-year period after the switching), stratified by the third antiretroviral agent [integrase inhibitors (INSTIs) vs. non-INSTIs). 292-0109 that a total of 2 patients in the STB stratum from the emtricitabine/tenofovir disoproxil (FTC/TDF) arm had discontinued treatment due to adverse events (AEs) in the course of the 2920109 study. 68, No. TAF (tenofovir alafenamide) 10 mg + elvitegravir 150 mg + cobicistat 150 mg + FTC 200 mg (866 people) TDF (tenofovir disoproxil fumarate) 300 mg + elvitegravir 150 mg + cobicistat 150 mg + FTC 200 mg (867 people) Prior to the study none of the participants had taken potent combination anti-HIV therapy (commonly called ART). Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was the only option for HIV preexposure prophylaxis (PrEP) until 2019, when FTC/tenofovir alafenamide (TAF) was approved. 2018;68:S184-S1353. Epub 2017 Mar 2. The corresponding TDF combinations are Stribild and Complera. 4, 5 Furthermore, these drugs exert good effect on the suppression of HBV replication, provide histologic improvement, and reduce the incidence of HCC after the long-term nucleos(t)ide analogue therapy. Tenofovir alafenamide (TAF), a new prodrug of tenofovir, has shown non-inferior efficacy to TDF in patients with chronic hepatitis B virus (HBV) infection, with … Article Download PDF View Record in Scopus Google Scholar. Tenofovir alafenamide vs tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomised phase 2 study. 19 TFV is the main compound that is measurable in plasma after TDF administration. Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. 58. This approval was based on results from DISCOVER, an ongoing manufacturer-sponsored trial, which have now been published. We compared the efficacy and safety of TDF and TAF and investigated switching from TDF to TAF therapy. Seto, et al. The elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/TAF combination is marketed as Genvoya, and FTC/rilpivirine (RPV)/TAF as Odefsey. Erratum in: Lancet Gastroenterol Hepatol. 1. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Safety. See references It is a tablet taken by mouth. Lower plasma tenofovir concentrations are seen with TAF and in unboosted regimens. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. As the research paced ahead with a prodrug of tenofovir DF with the new version (tenofovir alafenamide) of an active substance that is more tolerable, tenofovir is known to cause adverse drug-disease interactions. Gallant JE, Rodriguez AE, Weinberg WG, et al; ESS30009 Study. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. 23rd International AIDS Conference, abstract 3283, 2020. HIV-1 infection. Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil. Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials. The aim of our study was to assess the impact of switching from TDF to tenofovir alafenamide (TAF) on functional nephropathy and lipid parameters in a real‐life setting. 2015. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Tenofovir alafenamide is a prodrug of tenofovir. / GS-US-320-0110; GS-US-320-0108 Investigators. 2018;68(4):672–681. IDDF2020-ABS-0061 Impact of treatment with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) on hepatocellular carcinoma (HCC) incidence in patients with chronic hepatitis B (CHB) Free. A 10 mg dose of tenofovir alafenamide in Genvoya ® provides more than 4 times the concentration of tenofovir diphosphate in PBMCs. P13]. tenofovir disoproxil fumarate, allowing for much lower doses of tenofovir alafenamide versus tenofovir disoproxil fumarate.11 Because of tenofovir alafenamide’s reduced dose and the improved stability, plasma exposure of tenofovir is 90% lower with tenofovir alafenamide than with tenofovir disoproxil fumarate, which is believed to Sax PE, Zolopa A, Brar I, et al. In: Journal of Hepatology, Vol. American Association for the Study of Liver Diseases. TENOFOVIR DISOPROXIL FUMARATE (DF): Bioavailability of tenofovir is very poor; it is available as tenofovir disoproxil fumarate (more bioavailable), which is metabolized intracellularly to tenofovir diphosphate (active metabolite). The time points of the treatment discontinuations were day- 193 and 430. It is generally recommended for use with other antiretrovirals. -Emtricitabine-tenofovir alafenamide: Insufficient data available on use of tenofovir alafenamide in pregnant women to inform a drug-related risk.-Emtricitabine-tenofovir disoproxil fumarate (DF): Malformative risk with use of this product in pregnant women is unlikely. Abstract. The U.S. National Institutes of Health (NIH) recommends antiretroviral therapy (ART) for all people with HIV/AIDS. Nucleoside analogues are nucleosides which contain a nucleic acid analogue and a sugar. 7), showing non-inferiority of tenofovir alafenamide to tenofovir disoproxil fumarate. 2014;67:52-8. Lancet. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Wohl, D, Oka, S, Clumeck, N. Brief report: a randomized, double-blind comparison of tenofovir alafenamide vs tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine, for initial HIV-1 treatment: week 96 results. Methods. Lancet. Renal and bone effects were significantly reduced in patients given E/C/F/tenofovir alafenamide. Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, et al. Non-INSTIs comprised protease inhibitors and nonnucleoside reverse transcriptase inhibitors. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. 18th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV (CADRH) (New York, NY). Both TDF and TAF are prodrugs of the NRTI TFV. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir, enabling treatment of patients with hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF), via more efficient delivery of tenofovir to the hepatocytes. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Patient health is paramount and it’s your responsibility not to take tenofovir without first consulting with a doctor. Tenofovir alafenamide is a novel tenofovir prodrug developed in order to improve renal safety when compared to the counterpart tenofovir disoproxil. 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J Hepatol. Most of these conditions are complex and involve highly effective meds. Henry Lik Yuen Chan 1, Young-Suk Lim 2, Wai Kay Seto 3, Qin Ning 4, … No confirmatory or comparative human LT data, however, are available. 2018;68:672-681. • Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.5). Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. Tenofovir alafenamide versus tenofovir disoproxil 8. Atherosclerotic CVD risk profile of tenofovir alafenamide vs tenofovir disoproxil fumarate [presentation no. Nucleotide analogs are nucleotides which contain a nucleic acid analogue, a sugar, and a phosphate groups with one to three phosphates.. Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1). Tenofovir disoproxil fumarate, tenofovir alafenamide, and adefovir are nucleotide reverse transcriptase inhibitors (NRTIs) that are used for the treatment of chronic hepatitis B virus (HBV) infection. [PubMed Abstract] GS-311-1089 Industry. 68, No. Sax PE, Wohl D, Yin MT, et al. Its efficacy in treatment and prevention has earned a good reputation as a combination of drug treatment for various health conditions. In animals, tenofovir alafenamide (TAF) has been found to have enhanced LT penetration compared with tenofovir disoproxil fumarate (TDF). Tenofovir alafenamide vs. tenofovir disoproxil fumarate in HIV-1 infected patients with normal kidney function In phase I studies in HIV-infected patients, TAF dem - onstrated more potent antiviral activity against HIV-1 than TDF and a good overall safety profile in the short term 17,34. Pilkington V et al. Background & aims Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n=333) vs. remain on tenofovir disoproxil … Lancet Gastroenterol Hepatol. 52-58 Phase 3 Studies Sax P, Wohl D, Yin M et al. Sax PE, Zolopa A, Brar I, et al. Background: Both tenofovir disoproxil fumarate (TDF)/emtricitabine and tenofovir alafenamide (TAF)/emtricitabine demonstrate excellent efficacy and safety overall, but concerns remain over specific changes in markers of bone and renal function. Here is an in-depth discussion for all things tenofovir interactions. Sax PE, Zolopa A, Brar I, et al. Background & aims Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). Pooled Cohort Risk Assessment Equations: Predicts 10-Year Risk for a First Atherosclerotic Cardiovascular Disease … Emtricitabine/tenofovir is used both to treat and to prevent HIV/AIDS. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Intracellularly, tenofovir is phosphorylated to the active moiety, tenofovir-diphosphate which is the same active moiety of tenofovir disoproxil fumarate. Tenofovir disoproxil has been around for many years. The mechanism of action of tenofovir disoproxil fumarate is associated with high plasma tenofovir concentrations which are thought to be the cause of serious renal and bone toxic effects especially in … Side effects may include trouble sleeping, weight gain, and rash. The pharmacokinetic boosters ritonavir (RTV) and cobicistat (COBI) significantly increase plasma area under the curve (AUC) concentrations of tenofovir disoproxil fumarate (TDF), by 25-37%. 2015. 96weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Cobicistat, elvitegravir, emtricitabine, and tenofovir. Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide. Lancet. Background: Tenofovir (TFV) is renally eliminated, and the prodrug, tenofovir disoproxil fumarate (TDF), has been associated with renal toxicity and reduced bone mineral density (BMD), and must be dose adjusted in patients with estimated glomerular filtration rate (eGFR) < 50mL/min. While clinical trial evidence suggests that TAF has more favorable outcomes related to kidney injury and loss of bone mineral density, TAF also leads to … • Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide. In: Journal of Hepatology, Vol. [PubMed: 29756595]. Didanosine. HIV prevention. Tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are recommended as the first-line oral drugs for patients with CHB. Lancet Gastroenterol Hepatol. J Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Tenofovir alafenamide (TAF) is a novel prodrug of TFV that is not renally eliminated and… Lancet Gastroenterol Hepatol, 1 (2016), pp. Medical uses. Mallon P et al. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was the only option for HIV preexposure prophylaxis (PrEP) until 2019, when FTC/tenofovir alafenamide (TAF) was approved. [PubMed Abstract] J Acquir Immune Defic Syndr. Tenofovir is an antiretroviral (ARV) medication used to prevent and treat HIV and to treat chronic hepatitis B. Tenofovir disoproxil fumarate (TDF), approved in 2001 for HIV and 2008 for chronic hepatitis B, is historically one of the most commonly used ARV agents for these conditions. After oral administration, TDF is well absorbed 17,18 and is so rapidly metabolized to TFV that TDF itself cannot be measured in blood (even when plasma is sampled within 5 minutes of administration). Epub 2016 Sep 22. Lancet Gastroenterol Hepatol. Epub 2016 Sep 22. Generic Name: cobicistat, elvitegravir, emtricitabine, and tenofovir (koe BIK i stat, EL vi TEG ra vir, EM trye SYE ta been, and ten OF oh vir) Brand Name: Genvoya, Stribild Dosage Forms: oral tablet (150 mg-150 mg-200 mg-10 mg; 150 mg-150 mg-200 mg-300 mg) 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. The original tenofovir disoproxil fumarate (TDF) version was developed at a dose of 300 mg once daily. Agarwal K, Brunetto M, Seto WK, et al. Weight gain before and after switch from TDF to TAF. European Medicines Agency - CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection During the study period, there was no patient who discontinued antiviral therapy due to drug related adverse effects. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. 2016 Nov;1(3):185-195. doi: … doi: 10.1097/QAD.0000000000002699. Tenofovir alafenamide (AF) [Vemlidy®], an oral prodrug of tenofovir, was developed to optimize the antiviral potency and clinical safety of the active moiety tenofovir diphosphate (selective reverse transcriptase nucleotide inhibitor). Comments:-A pregnancy exposure registry is available. J Acquir Immune Defic Syndr. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. In fact, ART has demonstrated toxicity. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF) through more efficient delivery of tenofovir to hepatocytes. … Lancet HIV. It is taken by mouth. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. This approval was based on results from DISCOVER, an ongoing manufacturer-sponsored trial, which have now been published. Tenofovir Alafenamide versus Tenofovir Disoproxil Fumarate. The objective of this work was to compare the LT pharmacokinetics (PK) of TAF and TDF in HIV-infected persons. J Acquire Immune Defic Syndr, 67(1), pp. 4, 04.2018, p. 672-681. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir, enabling treatment of patients with hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF), via more efficient delivery of tenofovir to the hepatocytes. AIDS, 34: 2259-2268, 2020. 196-206. Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) in Hispanic/Latinx and Black Participants: Efficacy, Bone and Renal Safety Results from a Pooled Analysis of 7 Clinical Trials Edwin DeJesus, MD, Edwin DeJesus, MD Orlando Immunology Center, University of Central Florida College of Medicine Nucleoside and nucleotide analogues can be used in therapeutic drugs, include a range of antiviral products used to prevent viral replication in infected cells. A randomized, double-blind comparison of tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir, cobicistat, and emtricitabine (E/C/F) for initial HIV-1 treatment: week 144 results. When combined with RTV or COBI, the dose of tenofovir alafenamide (TAF) is lowered … It is a combination of dolutegravir, lamivudine, and tenofovir disoproxil. 1 Both of these prodrugs were first created to cover the polar phosphonic acid group on tenofovir by using a novel oxycarbonyloxymethyl linkers to improve the oral bioavailability and intestinal diffusion. Nucleos(t)ide analogues (NAs), including entecavir (ETV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide fumarate (TAF), as well as interferons (IFNs), are widely used for treatment of chronic HBV infection worldwide (1,2,4,5). 7. Background: Higher plasma tenofovir concentrations are associated with higher risks of renal and bone adverse events. J Acquir Immune Defic Syndr. 2015;385:2606-15. World Health Organization. 0001). BACKGROUND:Both tenofovir disoproxil fumarate (TDF)/emtricitabine and tenofovir alafenamide (TAF)/emtricitabine demonstrate excellent efficacy and safety overall, but concerns remain over specific changes in markers of bone and renal function. Pilkington V, Hughes SL, Pepperrell T, McCann K, Gotham D, Pozniak AL, et al. It may be used for prevention of HIV/AIDS among those at high risk before exposure, and after a needlestick injury or other potential exposure. Open access. 2015;385: 2606-2615. These treatments inhibit the reverse transcription of the HBV genome and HBV DNA in the serum can be reduced rapidly. Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. K. Agarwal, M. Brunetto, W.K. J Acquir Immune Defic Syndr. Tenofovir disoproxil fumarate (TDF) has been associated with potential nephrotoxicity. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate. Tenofovir alafenamide is hydrolyzed in cells and turns into an active metabolite called tenofovir diphosphate. Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide) are both prescription brand-name medications. 30. Renally eliminated medicinal … Hip and spine BMD improved in patients assigned to the tenofovir alafenamide group compared with the tenofovir disoproxil fumarate group, irrespective of previous treatment. cobicistat, emtricitabine, and another salt form of tenofovir, tenofovir disoproxil fumarate, is currently available as Stribild®. Recently, tenofovir alafenamide (TAF) was … Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The most common adverse events overall were upper respiratory tract infection (51 [9%] of 581 patients receiving tenofovir alafenamide vs 22 [8%] of 292 patients receiving tenofovir disoproxil fumarate), nasopharyngitis (56 [10%] vs 16 [5%]), and headache (42 [7%] vs 22 [8%]). HBV can … Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. Tenofovir is one of the newer, more tolerable, nucleotide reverse transcriptase inhibitors on the market; is a mainstay of many antiretroviral therapy combinations; and is now available in 2 different formulations, tenofovir disoproxil fumarate (TDF) and, the more recent, tenofovir alafenamide (TAF). A subsequent pro-drug formulation, tenofovir alafenamide (TAF), has recently been launched in North America and Europe at doses of 10 or 25 mg once daily. / GS-US-320-0110; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. ETV, entecavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; ALT, alanine aminotransferase; AST, aspartate Aminotransferase; MELD, Model for End-stage Liver Disease. Tenofovir alafenamide is an antiviral prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of hepatitis B virus infection (HBV) in adults who meet certain requirements, as determined by a health care provider. 2018;68(4):672-81. doi: 10.1016/j.jhep.2017.11.039. Through 48 weeks, more than 90% of patients given E/C/F/tenofovir alafenamide or E/C/F/tenofovir disoproxil fumarate had virological success. BACKGROUND: Tenofovir alafenamide (TAF) is a new formulation of tenofovir disoproxil fumarate (TDF) that was approved in 2015. IDDF2020-ABS-0061 Impact of treatment with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) on hepatocellular carcinoma (HCC) incidence in patients with chronic hepatitis B (CHB) Free. Lower plasma tenofovir concentrations are seen with TAF and in unboosted regimens. Pilkington V et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. J Hepatol. 18. Changes in body weight during the tenofovir disoproxil fumarate (TDF) [1-year period before switching from TDF to tenofovir alafenamide (TAF)] and TAF periods (1-year period after the switching), stratified by the third antiretroviral agent [integrase inhibitors (INSTIs) vs. non-INSTIs). 292-0109 that a total of 2 patients in the STB stratum from the emtricitabine/tenofovir disoproxil (FTC/TDF) arm had discontinued treatment due to adverse events (AEs) in the course of the 2920109 study. 68, No. TAF (tenofovir alafenamide) 10 mg + elvitegravir 150 mg + cobicistat 150 mg + FTC 200 mg (866 people) TDF (tenofovir disoproxil fumarate) 300 mg + elvitegravir 150 mg + cobicistat 150 mg + FTC 200 mg (867 people) Prior to the study none of the participants had taken potent combination anti-HIV therapy (commonly called ART). Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was the only option for HIV preexposure prophylaxis (PrEP) until 2019, when FTC/tenofovir alafenamide (TAF) was approved. 2018;68:S184-S1353. Epub 2017 Mar 2. The corresponding TDF combinations are Stribild and Complera. 4, 5 Furthermore, these drugs exert good effect on the suppression of HBV replication, provide histologic improvement, and reduce the incidence of HCC after the long-term nucleos(t)ide analogue therapy. Tenofovir alafenamide (TAF), a new prodrug of tenofovir, has shown non-inferior efficacy to TDF in patients with chronic hepatitis B virus (HBV) infection, with … Article Download PDF View Record in Scopus Google Scholar. Tenofovir alafenamide vs tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomised phase 2 study. 19 TFV is the main compound that is measurable in plasma after TDF administration. Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. 58. This approval was based on results from DISCOVER, an ongoing manufacturer-sponsored trial, which have now been published. We compared the efficacy and safety of TDF and TAF and investigated switching from TDF to TAF therapy. Seto, et al. The elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/TAF combination is marketed as Genvoya, and FTC/rilpivirine (RPV)/TAF as Odefsey. Erratum in: Lancet Gastroenterol Hepatol. 1. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Safety. See references It is a tablet taken by mouth. Lower plasma tenofovir concentrations are seen with TAF and in unboosted regimens. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. As the research paced ahead with a prodrug of tenofovir DF with the new version (tenofovir alafenamide) of an active substance that is more tolerable, tenofovir is known to cause adverse drug-disease interactions. Gallant JE, Rodriguez AE, Weinberg WG, et al; ESS30009 Study. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. 23rd International AIDS Conference, abstract 3283, 2020. HIV-1 infection. Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil. Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials. The aim of our study was to assess the impact of switching from TDF to tenofovir alafenamide (TAF) on functional nephropathy and lipid parameters in a real‐life setting. 2015. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Tenofovir alafenamide is a prodrug of tenofovir. / GS-US-320-0110; GS-US-320-0108 Investigators. 2018;68(4):672–681. IDDF2020-ABS-0061 Impact of treatment with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) on hepatocellular carcinoma (HCC) incidence in patients with chronic hepatitis B (CHB) Free. A 10 mg dose of tenofovir alafenamide in Genvoya ® provides more than 4 times the concentration of tenofovir diphosphate in PBMCs. P13]. tenofovir disoproxil fumarate, allowing for much lower doses of tenofovir alafenamide versus tenofovir disoproxil fumarate.11 Because of tenofovir alafenamide’s reduced dose and the improved stability, plasma exposure of tenofovir is 90% lower with tenofovir alafenamide than with tenofovir disoproxil fumarate, which is believed to Sax PE, Zolopa A, Brar I, et al. In: Journal of Hepatology, Vol. American Association for the Study of Liver Diseases. TENOFOVIR DISOPROXIL FUMARATE (DF): Bioavailability of tenofovir is very poor; it is available as tenofovir disoproxil fumarate (more bioavailable), which is metabolized intracellularly to tenofovir diphosphate (active metabolite). The time points of the treatment discontinuations were day- 193 and 430. It is generally recommended for use with other antiretrovirals. -Emtricitabine-tenofovir alafenamide: Insufficient data available on use of tenofovir alafenamide in pregnant women to inform a drug-related risk.-Emtricitabine-tenofovir disoproxil fumarate (DF): Malformative risk with use of this product in pregnant women is unlikely. Abstract. The U.S. National Institutes of Health (NIH) recommends antiretroviral therapy (ART) for all people with HIV/AIDS. Nucleoside analogues are nucleosides which contain a nucleic acid analogue and a sugar. 7), showing non-inferiority of tenofovir alafenamide to tenofovir disoproxil fumarate. 2014;67:52-8. Lancet. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Wohl, D, Oka, S, Clumeck, N. Brief report: a randomized, double-blind comparison of tenofovir alafenamide vs tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine, for initial HIV-1 treatment: week 96 results. Methods. Lancet. Renal and bone effects were significantly reduced in patients given E/C/F/tenofovir alafenamide. Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, et al. Non-INSTIs comprised protease inhibitors and nonnucleoside reverse transcriptase inhibitors. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. 18th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV (CADRH) (New York, NY). Both TDF and TAF are prodrugs of the NRTI TFV. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir, enabling treatment of patients with hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF), via more efficient delivery of tenofovir to the hepatocytes. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Patient health is paramount and it’s your responsibility not to take tenofovir without first consulting with a doctor. Tenofovir alafenamide is a novel tenofovir prodrug developed in order to improve renal safety when compared to the counterpart tenofovir disoproxil.

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