Population pharmacokinetics and model-informed precision dosing of lamivudine in Chinese HIV-infected patients with mild and moderate impaired renal function

References

• Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the international antiviral society–USA panel. JAMA. 2018 Jul 24 320(4):379–396.
   Google Scholar
• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. [Aug 16th, 2021]
   Google Scholar
• Wonganan P, Limpanasithikul W, Jianmongkol S, et al. Pharmacokinetics of nucleoside/nucleotide reverse transcriptase inhibitors for the treatment and prevention of HIV infection. Expert Opin Drug Metab Toxicol. 2020 Jul;16(7):551–564.
   Google Scholar
• World Health Organization. Antiretroviral therapy for HIV infection in infants and children: towards universal access. World Heal Organ. 2010;4911:117.
   Google Scholar
• Johnson MA, Moore KHP, Yuen GJ, et al. Clinical Pharmacokinetics of Lamivudine. Clin Pharmacokinet. 1999 Jan;36(1):41–66.
   Google Scholar
• Else LJ, Jackson A, Puls R, et al. Pharmacokinetics of lamivudine and lamivudine-triphosphate after administration of 300 milligrams and 150 milligrams once daily to healthy volunteers: results of the ENCORE 2 study. Antimicrob Agents Chemother. 2012 Mar;56(3):1427–1433.
   Google Scholar
• Kumar PN, Patel P. Lamivudine for the treatment of HIV. Expert Opin Drug Metab Toxicol. 2010 Jan;6(1):105–114.
   Google Scholar
• GlaxoSmithKline. EPIVIR(lamivudine) package insert, Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf [Aug 16th, 2021]
   Google Scholar
• Panhard X, Legrand M, Taburet A-M, et al. Population pharmacokinetic analysis of lamivudine, stavudine and zidovudine in controlled HIV-infected patients on HAART. Eur J Clin Pharmacol. 2007 Nov;63(11):1019–1029.
   Google Scholar
• Benaboud S, Tréluyer JM, Urien S, et al. Pregnancy-related effects on lamivudine pharmacokinetics in a population study with 228 women. Antimicrob Agents Chemother. 2012 Feb;56(2):776–782.
   Google Scholar
• Tremoulet AH, V CE, Patel P, et al. Population pharmacokinetics of lamivudine in human immunodeficiency virus-exposed and -infected infants. Antimicrob Agents Chemother. 2007 Dec;51(12):4297–4302.
   Google Scholar
• Archary M, Mcllleron H, Bobat R, et al. Population pharmacokinetics of Abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes. Br J Clin Pharmacol. 2019 Sep;85(9):2066–2075.
   Google Scholar
• Du X, Peng W, Fu Q, et al. A review of clinical pharmacokinetic and pharmacodynamic profiles of select antiretrovirals: focus on differences among Chinese patients. Pharmacotherapy. 2019 Dec;39(12):1179–1189.
   Google Scholar
• Jiang J, Hu P, Xie H, et al. The pharmacokinetics of lamivudine in healthy Chinese subjects. Br J Clin Pharmacol. 1999 Aug;48(2):250–253.
   Google Scholar
• Ye M, Wang L, Fu Q, et al. Steady-state pharmacokinetics of lamivudine once-daily versus twice-daily dosing in Chinese HIV-infected patients. HIV Clin Trials. 2010 Jul-Aug;11(4):230–237.
   Google Scholar
• Niu W, Sun T, Liu L, et al. Population pharmacokinetics and dosing regimen optimisation of lopinavir in Chinese adults infected with HIV. Basic Clin Pharmacol Toxicol. 2019 Apr;124(4):456–465.
   Google Scholar
• Zhang L-J, Yao Y-M, Sun -J-J, et al. An LC–MS/MS method for simultaneous quantification of seven Anti-HIV medicines in plasma of HIV-infected patients. Pharm Anal Acta. 2010;1(1):102.
   Google Scholar
• Byon W, Smith M, Chan P, et al. Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance. CPT Pharmacometrics Syst Pharmacol. 2013 Jul 3 2(7):e51.
   Google Scholar
• Ahn JE, Karlsson MO, Dunne A, et al. Likelihood based approaches to handling data below the quantification limit using NONMEM VI. J Pharmacokinet Pharmacodyn. 2008 Aug;35(4):401–421.
   Google Scholar
• Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development. CPT Pharmacometrics Syst Pharmacol. 2012 Sep 26; 1(9):e6.
   Google Scholar
• Moore KHP, Yuen GJ, Hussey EK, et al. Population pharmacokinetics of lamivudine in adult human immunodeficiency virus-infected patients enrolled in two phase III clinical trials. Antimicrob Agents Chemother. 1999 Dec;43(12):3025–3029.
   Google Scholar
• Janssen EJH, Bastiaans DET, Välitalo PAJ, et al. Dose evaluation of lamivudine in human immunodeficiency virus-infected children aged 5 months to 18 years based on a population pharmacokinetic analysis. Br J Clin Pharmacol. 2017 Jun;83(6):1287–1297.
   Google Scholar
• Heald AE, Hsyu PH, Yuen GJ, et al. Pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with renal dysfunction. Antimicrob Agents Chemother. 1996 Jun;40(6):1514–1519.
   Google Scholar
• Fletcher CV, Kawle SP, Kakuda TN, et al. Zidovudine triphosphate and lamivudine triphosphate concentration-response relationships in HIV-infected persons. AIDS. 2000 Sep 29 14(14):2137–2144.
   Google Scholar
• Bonnet F, Bonarek M, Morlat P, et al. Risk factors for lactic acidosis in HIV-infected patients treated with nucleoside reverse-transcriptase inhibitors: a case-control study. Clin Infect Dis. 2003 May 15 36(10):1324–1328.
   Google Scholar
• Arenas-Pinto A, Grant AD, Edwards S, et al. Lactic acidosis in HIV infected patients: a systematic review of published cases. Sex Transm Infect. 2003 Aug;79(4):340–343. •• The PPK study that proposed the same dosing regimen for patients with moderate impaired renal function in Caucasian patients
   Google Scholar
• Bouazza N, Tréluyer J-M, Ghosn J, et al. Evaluation of effect of impaired renal function on lamivudine pharmacokinetics. Br J Clin Pharmacol. 2014 Oct;78(4):847–854.
   Google Scholar
• Mounzer K, Brunet L, Wyatt CM, et al. To dose-adjust or not to dose-adjust: lamivudine dose in kidney impairment. AIDS. 2021 Jul;35(8):1201–1208.
   Google Scholar
• Neely M, Jelliffe R. Practical therapeutic drug management in HIV-infected patients: use of population pharmacokinetic models supplemented by individualized Bayesian dose optimization. J Clin Pharmacol. 2008 Sep;48(9):1081–1091.
   Google Scholar
• Zhang L, Jia X, Jin J, et al. Recent 5-year findings and technological advances in the proteomic study of HIV-associated disorders. Genomics Proteomics Bioinformatics. 2017 Apr;15(2):110–120.
   Google Scholar
• Yang L, Shao B, Li Q, et al. Clinical research and application of tang herb tablet. Chinese Medicine Modern Distance Education of China Chinese. 2015;13:14–17.
   Google Scholar
• Anderson PL, Kakuda TN, Kawle S, et al. Antiviral dynamics and sex differences of zidovudine and lamivudine triphosphate concentrations in HIV-infected individuals. AIDS. 2003 Oct 17 17(15):2159–2168.
   Google Scholar