Tenofovir disoproxil fumarate (Viread®) for the treatment of HIV infection

Expert Review of Anti-Infective Therapy

Volumn 1, Issue 3, 2003, Pages 415-422

  Gallant, Joel E ^a   Pham, Paul A ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Antiretroviral therapy; HIV infection; Nucleotide analog reverse transcriptase inhibitor; Tenofovir

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; ACICLOVIR; ADEFOVIR DIPIVOXIL; AMDOXOVIR; AMPRENAVIR PHOSPHATE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ATAZANAVIR; CAPRAVIRINE; CIDOFOVIR; DARUNAVIR; DIDANOSINE; DPC 814; EFAVIRENZ; ELVUCITABINE; EMTRICITABINE; ETRAVIRINE; INTEGRASE INHIBITOR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SPD 754; STAVUDINE; T 1249; TENOFOVIR DISOPROXIL; TIPRANAVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALACICLOVIR;

ANTIBIOTIC RESISTANCE; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BONE DISEASE; CELL LEVEL; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CROSS RESISTANCE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG TOXICITY; FANCONI RENOTUBULAR SYNDROME; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLACTATEMIA; HYPOPHOSPHATEMIA; INFERTILITY; KIDNEY FAILURE; LACTIC ACIDOSIS; LIPODYSTROPHY; LIVER FAILURE; MITOCHONDRIAL TOXICITY; NEPHROTOXICITY; NONHUMAN; PERIPHERAL NEUROPATHY; TUBULAR DYSFUNCTION;

EID: 3042742035     PISSN: 14787210     EISSN: None     Source Type: Journal    
DOI: 10.1586/14787210.1.3.415     Document Type: Article

References (39)

1. + T-cells provides a mechanism for lifelong persistence of HIV-1, even in patients on effective combination therapy. Nature Med. 5, 512-517 (1999).
2. Wainberg MA, Miller MD, Quan Y et al. In vitro selection and characterization of HIV-1 with reduced susceptibility to PMPA. Antiviral Ther. 4, 87-94 (1999).
3. Kearney BP, Isaacson E, Sayre J, Plummer A, Cheng A. Didanosine and tenofovir DF drug-drug interaction: assessment of didanosine dose reduction. 10th Conf. Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 533).
4. Taburet AM, Piketty C, Gérard L et al. Pharmacokinetic parameters of atazanavir/ritonavir when combined to tenofovir in HIV infected patients with multiple treatment failures: a sub-study of Puzzle-2-ANRS 107 trial. 10th Conf. Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 537).
5. Viread package insert (2003).
6. Kearney BP, Liaw S, Yale K et al. Pharmacokinetics following single dose administration of tenofovir df in subjects with renal impairment. 6th Internat. Congress Drug Ther. HIV Infection Scotland, UK (2002) (Abstract).
7. Squires K, Pozniak AL, Pierone G et al. Tenofovir DF in antiretroviral-experienced, nucleoside-resistant HIV-1 infected patients with incomplete viral suppression. Ann. Intern. Med. 139, 313-320 (2003).
8. Margot NA, Johnson A, Cheng A, Coakley, DF, Miller MD. Final 48 week genotypic and phenotypic analyses of study 907: tenofovir DF added to stable background regimens. 9th Conf. Retroviruses Opportunistic Infect. WA, USA February 24-28 (2002) (Abstract 414-W).
9. Margot NA, Zhong L, Wulfsohn M, Cheng AK, Miller MD. Probability and durability of achieving <50 copies/ml of HIV RNA by treatment intensification with tenofavir DF (TDF). 42nd Interscience Conf. Antimicrobial Agents Chemother. CA, USA September 27-30 (2002) (Abstract H1077).
10. Schooley RT, Ruane P, Myers RA et al. Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study. AIDS 16, 1257-1263 (2002).
11. Barditch-Crovo P, Deeks SG, Collier A et al. Phase I/II trial of the pharmacokinetics, safety and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob. Agents Chemother. 45, 2733-2739 (2001).
12. Louie M, Hogan C, Hurley A et al. Determining the antiviral activity of tenofovir disoproxil fumarate in treatment-naive chronically HIV-1-infected individuals. AIDS 17, 1151-1156 (2003).
13. Staszewski S, Gallant JE, Pozniak AL et al. Efficacy and safety of tenofovir DF vs. stavudine when used in combination with lamivudine and efavirenz in antiretroviral naive patients: 96-week preliminary interim results. 10th Conf. Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 564B).
14. White KL, Margot NA, Wrin T, Petropoulos CH, Miller MD, Naeger LK. Molecular mechanisms of resistance to human immunodeficiency virus Type I with reverse transcriptase mutations K65R and K65R + M184V and their effects on enzyme function and viral replication capacity. Antimicrob. Agents Chemother. 46, 3437-3446 (2002).
15. Garcia-Lerma G, MacInnes H, Nidtha S et al. In vitro selection of the T215Y and K65R mutations by stavudine and demonstration of high-level resistance to stavudine. Antiviral Ther. 7, S28 (2002) (Abstract 31).
16. Miller MD, Margot NA, McColl DJ, Coakley DF, Cheng AK. Characterization of virologic failure through 96 weeks among treatment-naive patients taking tenofovir DF (TDF) or stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV). Antiviral Ther 8, S233 (2003) (Abstract 553).
17. McColl DJ, Margot NA, Cheng AK, Miller MD. Development of K65R versus thymidine analog-association mutations (TAMs) in antiretroviral-treated patients. 6th Internat. Congress on Drug Ther. HIV Infect. Scotland, UK November 17-21 (2002) (Abstract P206).
18. Naeger LK, Margot NA, Miller MD. ATG-dependent removal of nucleoside reverse transcriptase inhibitors by human immunodeficiency vinis Type I reverse transcriptase. Antimicrob. Agents Chemother. 46, 2179-2184 (2002).
19. Miller MD, Margot NA, Lu B. Effect of baseline nucleoside-associated resistance on response to tenofovir DF (TDF) therapy: integrated analyses of studies 902 and 907. 9th Conf. Retroviruses Opportunistic Infect. WA, USA February 24-28 (2002) (Abstract 43).
20. Lu B, Hellman NS, Bates M, Dawson K, Rooney J, Miller MD. Determination of clinical cut-offs for reduced response to tenofovir DF therapy in antiretroviral-experienced patients. Antiviral Ther. 7, S104 (2002).
21. Benhamou Y, Tubiana F, Thibault V. Tenofovir disoproxil fumarate in patients with HIV and lamivudine-resistant hepatitis B virus. N. Engl. J. Med. 348, 177-178 (2003).
22. Nunez M, Perez-Olmeda M, Diaz B, Rios P, Gonzalez-Lahoz J, Soriano V. Activity of tenofovir on hepatitis B virus replication in HIV-coinfected patients failing or partially responsive to lamivudine. AIDS 16, 2352-2354 (2002).
23. Ristig MB, Crippin J, Aberg JA et al. Tenofovir disoproxil fumarate therapy for chronic hepatitis B in human immunodeficiency virus/hepatitis B virus-coinfected individuals for whom interferon-α and lamivudine therapy have failed. J. Infect. Dis. 186, 1844-1847 (2002).
24. Nelson M, Portsmouth S, Stebbing J et al. An open-label study of tenofovir in HIV-1 and hepatitis B virus co-infected individuals. AIDS 17, F5-10 (2003).
25. Cooper D, Dore G, Pozniak A et al. Tenofovir DF and lamivudine combination therapy compared to lamivudine alone for HBV in therapy-naive HIV/HBV co-infected patients: 48 week interim results. 10th Conf. Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 825).
26. Gulick RM, Ribaudo HJ, Shikuma CM et al. ACTG 5095: a comparative study of 3 protease inhibitor-sparing antiretroviral regimens for the initial treatment of HIV infection. Antiviral Ther. 8, S194-S195 (2003) (Abstract 41).
27. Farthing C, Khanlou H, Yeh V. Early virologic failure in a pilot study evaluating the efficacy of abacavir, lamivudine and tenofovir in the treatment naive HIV-infected patients. Antiviral Ther. 8, S195 (2003) (Abstract 43).
28. Gallant JE, Rodriguez AE, Weinberg W et al. Early non-response to tenofovir DF (TDF) plus abacavir (ABC), and lamivudine (3TC) in a randomized trial compared to efavirenz plus ABC and 3TC: ESS30009 unplanned interim analysis. 43rd Interscience Conf. Antimicrobial Agents and Chemother. IL, USA (2003) (Abstract 4496).
29. Birkus G, Hitchcock MJM, Cihlar T. Assessment of mitochondrial toxicity in human cells treated with renofovir: comparison with other nucleoside analog transcriptase inhibitors. Antimicrobial Agents Chemother. 46, 716-723 (2002).
30. Birkus G, Hajek M, Kramata P et al. Tenofovir diphosphate is a poor substrate and a weak inhibitor of rat DNA polymerases α, Δ and E. Antimicrob. Agents Chemother. 46, 1610-1613 (2002).
31. Gallant JE, Staszewski S, Pozniak AL et al. Favorable lipid and mitochondrial (mt) DNA profile for tenofovir disoproxil fumarate (TDF) compared to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) in antiretroviral therapy (ART) naive patients: a 48 week interim analysis. 42nd Interscience Congress Antimicrobial Agents Chemother. SA, USA September 27-30 (2002) (Abstract 3983).
32. Reynes J, Peyriere H, Merle De Boever C, Le Moing V. Renal tubular injury and severe hypophosphoremia (Fanconi Syndrome) associated with tenofovir therapy. 10th Conference Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 717).
33. Blick G, Grieger-Zanlungo, Garton T, Hatton E, Lopez RJ. Tenofovir may cause severe hypophosphatemia in HIV/AIDS patients with prior adefovir-induced renal tubular acidosis. 10th Conf. Retroviruses and Opportunistic Infect. MA, USA (2003) (Abstract 718).
34. Karras A, Lafaurie M, Furco A et al. Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, Fanconi syndrome and nephrogenic diabetes insipidus. Clin. Infect. Dis. 36, 1070-1073 (2003).
35. FDA Antiviral Drug Products Advisory Committee Meeting, Tenofovir Disoproxil Fumarate. MA, USA October 3 (2001).
36. Tarantal AF, Castillo A, Ekert JE, Bischofberger N, Martin RB. Fetal and maternal outcome after administration of tenofovir to gravid rhesus monkeys (Macaca mulatta). J. Acquir. Immun. Defic. Syndr. 29, 207 (2002).
37. Tsai C-C, Follis KE, Sabo A et al. Prevention of SIV infection in macaques by (R)-9-(2-phosphonylmethoxypropyl) adenine. Science 270, 1197-1199 (1995).
38. Guay LA, Musoke P, Fleming T et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 354, 795-802 (1999).
39. Jackson JB, Becker-Pergola G, Guay LA et al. Identification of the K103N resistance mutation in Ugandan women receiving nevirapine to prevent HIV-1 vertical transmission. AIDS 14, F111-F115 (2000).