Pharmacokinetics of Tenofovir Alafenamide Fumarate and Tenofovir in the Chinese People: Effects of Non-Genetic Factors and Genetic Variations

References

• Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ. 2019;97(3):230–238. doi:10.2471/BLT.18.219469
   PubMed Web of Science ®Google Scholar
• Zhang S, Wang F, Zhang Z. Current advances in the elimination of hepatitis B in China by 2030. Front Med. 2017;11(4):490–501. doi:10.1007/s11684-017-0598-4
   PubMed Web of Science ®Google Scholar
• Trinh S, Le AK, Chang ET, et al. Changes in renal function in patients with chronic HBV infection treated with tenofovir disoproxil fumarate vs entecavir. Clin Gastroenterol Hepatol. 2019;17(5):948–956.e1. doi:10.1016/j.cgh.2018.08.037
   PubMed Web of Science ®Google Scholar
• Chung TL, Chen NC, Chen CL. Severe hypophosphatemia induced by denosumab in a patient with osteomalacia and tenofovir disoproxil fumarate-related acquired Fanconi syndrome. Osteoporos Int. 2019;30(2):519–523. doi:10.1007/s00198-018-4679-2
   Web of Science ®Google Scholar
• Quesada PR, Esteban LL, Garcia JR, et al. Incidence and risk factors for tenofovir-associated renal toxicity in HIV-infected patients. Int J Clin Pharm. 2015;37(5):865–872. doi:10.1007/s11096-015-0132-1
   PubMed Web of Science ®Google Scholar
• Ray AS, Fordyce MW, Hitchcock MJ. Tenofovir alafenamide: a novel prodrug of tenofovir for the treatment of human immunodeficiency virus. Antiviral Res. 2016;125:63–70. doi:10.1016/j.antiviral.2015.11.009
   PubMed Web of Science ®Google Scholar
• Zhao L, Li Z, Zhou Z, et al. Simultaneous determination of tenofovir alafenamide and tenofovir in human plasma by LC-MS/MS and its application to pharmacokinetics study in clinic. J Chromatogr B Analyt Technol Biomed Life Sci. 2019;1117:148–157. doi:10.1016/j.jchromb.2019.04.011
   PubMed Web of Science ®Google Scholar
• Tao X, Lu Y, Zhou Y, Zhang L, Chen Y. Efficacy and safety of the regimens containing tenofovir alafenamide versus tenofovir disoproxil fumarate in fixed-dose single-tablet regimens for initial treatment of HIV-1 infection: a meta-analysis of randomized controlled trials. Int J Infect Dis. 2020;93:108–117. doi:10.1016/j.ijid.2020.01.035
   PubMed Web of Science ®Google Scholar
• Chan HL, Fung S, Seto WK, et al. 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. Lancet Gastroenterol Hepatol. 2016;1(3):185–195. doi:10.1016/S2468-1253(16)30024-3
   PubMed Web of Science ®Google Scholar
• Serota DP, Franch HA, Cartwright EJ. Acute kidney injury in a patient on tenofovir alafenamide fumarate after initiation of treatment for hepatitis C virus infection. Open Forum Infect Dis. 2018;5(8):ofy189. doi:10.1093/ofid/ofy189
   Web of Science ®Google Scholar
• Novick TK, Choi MJ, Rosenberg AZ, McMahon BA, Fine D, Atta MG. Tenofovir alafenamide nephrotoxicity in an HIV-positive patient: a case report. Medicine (Baltimore). 2017;96(36):e8046. doi:10.1097/MD.0000000000008046
   PubMed Web of Science ®Google Scholar
• Giacomini KM, Yee SW, Ratain MJ, Weinshilboum RM, Kamatani N, Nakamura Y. Pharmacogenomics and patient care: one size does not fit all. Sci Transl Med. 2012;4(153):153ps118. doi:10.1126/scitranslmed.3003471
   Web of Science ®Google Scholar
• Mirsadeghi S, Larijani B. Personalized medicine: pharmacogenomics and drug development. Acta Med Iran. 2017;55(3):150–165.
   Google Scholar
• Murakami E, Wang T, Park Y, et al. Implications of efficient hepatic delivery by tenofovir alafenamide (GS-7340) for hepatitis B virus therapy. Antimicrob Agents Chemother. 2015;59(6):3563–3569. doi:10.1128/AAC.00128-15
   PubMed Web of Science ®Google Scholar
• Ray AS, Cihlar T, Robinson KL, et al. Mechanism of active renal tubular efflux of tenofovir. Antimicrob Agents Chemother. 2006;50(10):3297–3304. doi:10.1128/AAC.00251-06
   PubMed Web of Science ®Google Scholar
• Bam RA, Birkus G, Babusis D, Cihlar T, Yant SR. Metabolism and antiretroviral activity of tenofovir alafenamide in CD4+ T-cells and macrophages from demographically diverse donors. Antivir Ther. 2014;19(7):669–677. doi:10.3851/IMP2767
   PubMed Web of Science ®Google Scholar
• Byrne R, Carey I, Agarwal K. Tenofovir alafenamide in the treatment of chronic hepatitis B virus infection: rationale and clinical trial evidence. Therap Adv Gastroenterol. 2018;11:1756284818786108. doi:10.1177/1756284818786108
   Web of Science ®Google Scholar
• Bednasz CJ, Venuto CS, Ma Q, et al. Race/ethnicity and protease inhibitor use influence plasma tenofovir exposure in adults living with HIV-1 in AIDS clinical trials group study A5202. Antimicrob Agents Chemother. 2019;63(4):e01638–18. doi:10.1128/AAC.01638-18
   Web of Science ®Google Scholar
• Moss DM, Neary M, Owen A. The role of drug transporters in the kidney: lessons from tenofovir. Front Pharmacol. 2014;5:248. doi:10.3389/fphar.2014.00248
   PubMed Web of Science ®Google Scholar
• Ezinga M, Wetzels JF, Bosch ME, van der Ven AJ, Burger DM. Long-term treatment with tenofovir: prevalence of kidney tubular dysfunction and its association with tenofovir plasma concentration. Antivir Ther. 2014;19(8):765–771. doi:10.3851/IMP2761
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA), Center for Drug Evaluation and Research [webpage on the Internet]. Number: 208464Orig1s000: clinical pharmacology and biopharmaceutics review(s); 2016. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208464Orig1s000ClinPharmR.pdf. Accessed November 1, 2016.
   Google Scholar
• Baxi SM, Greenblatt RM, Bacchetti P, et al. Common clinical conditions - age, low BMI, ritonavir use, mild renal impairment - affect tenofovir pharmacokinetics in a large cohort of HIV-infected women. AIDS. 2014;28(1):59–66. doi:10.1097/QAD.0000000000000033
   PubMed Web of Science ®Google Scholar
• Kumarasamy N, Sundaram S, Poongulali S, Ezhilarasi C, Pradeep A, Chitra D. Prevalence and factors associated with renal dysfunction in patients on tenofovir disoproxil fumarate-based antiretroviral regimens for HIV infection in Southern India. J Virus Erad. 2018;4(1):37–40. doi:10.1016/S2055-6640(20)30245-4
   Web of Science ®Google Scholar
• Lepist EI, Phan TK, Roy A, et al. Cobicistat boosts the intestinal absorption of transport substrates, including HIV protease inhibitors and GS-7340, in vitro. Antimicrob Agents Chemother. 2012;56(10):5409–5413. doi:10.1128/AAC.01089-12
   PubMed Web of Science ®Google Scholar
• Kim SW, Lee JH, Lee SH, Hong HJ, Lee MG, Yook KH. ABCB1 c.2677G>T variation is associated with adverse reactions of OROS-methylphenidate in children and adolescents with ADHD. J Clin Psychopharmacol. 2013;33(4):491–498. doi:10.1097/JCP.0b013e3182905a8d
   Web of Science ®Google Scholar
• Tague LK, Byers DE, Hachem R, et al. Impact of SLCO1B3 polymorphisms on clinical outcomes in lung allograft recipients receiving mycophenolic acid. Pharmacogenomics J. 2020;20(1):69–79. doi:10.1038/s41397-019-0086-0
   PubMed Web of Science ®Google Scholar
• Miura M, Satoh S, Inoue K, et al. Influence of SLCO1B1, 1B3, 2B1 and ABCC2 genetic polymorphisms on mycophenolic acid pharmacokinetics in Japanese renal transplant recipients. Eur J Clin Pharmacol. 2007;63(12):1161–1169. doi:10.1007/s00228-007-0380-7
   PubMed Web of Science ®Google Scholar
• Rungtivasuwan K, Avihingsanon A, Thammajaruk N, et al. Influence of ABCC2 and ABCC4 polymorphisms on tenofovir plasma concentrations in Thai HIV-infected patients. Antimicrob Agents Chemother. 2015;59(6):3240–3245. doi:10.1128/AAC.04930-14
   PubMed Web of Science ®Google Scholar
• Likanonsakul S, Suntisuklappon B, Nitiyanontakij R, et al. A single-nucleotide polymorphism in ABCC4 is associated with tenofovir-related Beta2-microglobulinuria in Thai patients with HIV-1 infection. PLoS One. 2016;11(1):e0147724. doi:10.1371/journal.pone.0147724
   PubMed Web of Science ®Google Scholar
• Manosuthi W, Sukasem C, Thongyen S, Nilkamhang S, Sungkanuparph S. ABCC2*1C and plasma tenofovir concentration are correlated to decreased glomerular filtration rate in patients receiving a tenofovir-containing antiretroviral regimen. J Antimicrob Chemother. 2014;69(8):2195–2201. doi:10.1093/jac/dku129
   PubMed Web of Science ®Google Scholar