References
- Finzi D, Blankson J, Siliciano JD, et al. Latent infection of CD4+ T-cells provides a mechanism for lifelong persistence of HIV-1, even in patients on effective combination therapy. Nature Med. 5, 512–517 (1999).
- •Landmark paper demonstrating persistence of HIV in resting CD4 cells, suggesting that HIV infection cannot be eradicated using antiretroviral therapy.
- Wainberg MA, Miller MD, Quan Y, et al. hi Vinn selection and characterization of HIV-1 with reduced susceptibility to PMPA. Antiviral Ther. 4,87–94 (1999).
- Kearney BP, Isaacson E, Sayre J, Plummer A, Cheng A. Didanosine and tenofovir DF drug-drug interaction: assessment of didanosine dose reduction. 10th Con( Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 533).
- Taburet AM, Piketty C, Gerard 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 Con( Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 537).
- Viread package insert (2003).
- 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).
- 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).
- 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 Con! Retroviruses Opportunistic Infect. WA, USA February 24–28 (2002) (Abstract 414–W).
- •The most important study leading to approval of tenofovir disoproxil fumarate (DF) showing improved response to addition of tenofovir DF vs. placebo to a previously failing regimen.
- 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 tenofovir DF (TDF). 42ncl Interscience Conf Antimicrobial Agents Chernother CA, USA September 27–30 (2002) (Abstract H1077).
- Schooley RT, Ruane P, Myers RA, et al. Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study. AIDS16, 1257–1263 (2002).
- 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).
- Louie M, Hogan C, Hurley A, et al. Determining the antiviral activity of tenofovir disoproxil fumarate in treatment-naive chronically HIV-1-infected individuals. AIDS17,1151-1156 (2003).
- •Short-term monotherapy study demonstrating antiviral potency of tenofovir DE
- 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 Con( Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 564B).
- ••Large multicenter trial comparingtenofovir DF with stavudine in combination with lamivudine and efavirenz. The results of this trial led to inclusion of the tenofovir DF-based regimen as a preferred regimen in the DHHS guidelines.
- 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. Antimicrvb. Agents Chemother. 46, 3437–3446 (2002).
- Garcia-Lerma G, MacInnes H, Nidtha S, et al. hi Otmselection of the T215Y and K65R mutations by stavudine and demonstration of high-level resistance to stavudine. Antiviral Then 7,S28 (2002) (Abstract 31).
- 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).
- 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).
- •Characterization of resistance patterns among previously naive patients failing therapy in the 903 trial.
- Naeger LK, Margot NA, Miller MD. ATG-dependent removal of nucleoside reverse transcriptase inhibitors by human immunodeficiency virus Type I reverse transcriptase. Antimicrob. Agents Chemother. 46,2179–2184 (2002).
- 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 Con! Retroviruses Opportunistic Infect. WA, USA February 24–28 (2002) (Abstract 43).
- 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).
- •Determination of clinical cut-offs for tenofovir resistance for use in phenotypic resistance testing.
- Benhamou Y, Tubiana R, Thibault V. Tenofovir disoproxil fumarate in patients with HIV and lamivudine-resistant hepatitis B virus. N EngL I Med. 348, 177–178 (2003).
- 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).
- 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-a and lamivudine therapy have failed. J. Infect. Dis. 186, 1844–1847 (2002).
- 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).
- •Study assessing activity of tenofovir DF in patients with HIV-HBV coinfected patients, including patients with lamivudine-resistant HBV infection.
- 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 Con( Retroviruses Opportunistic Infect. MA, USA (2003) (Abstract 825).
- 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).
- 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).
- •Documents the unanticipated failure of the triple-NRTI regimen abacavir, lamivudine, plus tenofovir DE The reasons for the failure of this regimen are still unclear.
- 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: ES530009 unplanned interim analysis. 43rcl Interscience Con( Antimicrobial Agents and Chemother. IL, USA (2003) (Abstract 4496).
- •Documents the unanticipated failure of the triple-NRTI regimen abacavir, lamivudine, plus tenofovir DE The reasons for the failure of this regimen are still unclear.
- Birkus G, Hitchcock MJM, Cihlar T Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside analog transcriptase inhibitors. Antimicrobial Agents Chemother. 46, 716–723 (2002).
- •hi vitro study comparing relative mitochondrial toxicity of various nucleoside analogs as well as tenofovir.
- Birkus G, Hajek M, Kramata P, et al. Tenofovir diphosphate is a poor substrate and a weak inhibitor of rat DNA polymerases a, A and E. Antimicrob. Agents Chemother. 46, 1610–1613 (2002).
- 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. 42ncl Interscience Congress Antimicrobial Agents Chemother. SA, USA September 27–30 (2002) (Abstract 3983).
- 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).
- 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 Con( Retro viruses and Opportunistic Infect. MA, USA (2003) (Abstract 718).
- 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).
- FDA Antiviral Drug Products Advisory Committee Meeting, Tenofovir Disoproxil Fumarate. MA, USA October 3 (2001).
- Tarantal AF, Castillo A, Ekert JE, Bischofberger N, Martin RB. F, etal and maternal outcome after administration of tenofovir to gravid rhesus monkeys (Macaca mulatto). I Acquir. Immun. Delic. Synth: 29, 207 (2002).
- Tsai C-C, Follis KE, Sabo A, et al. Prevention of SW infection in macaques by (2-phosphonylmethoxypropy0 adenine. Science 270, 1197–1199 (1995).
- 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).
- Jackson JB, Becker-Pergola G, Guay LA, et al. Identification of the K1 03N resistance mutation in Ugandan women receiving nevirapine to prevent HIV-1 vertical transmission. AIDS'14, F111-F115 (2000).
Websites
- Panel on Clinical Practices for Treatment of HIV Infection, Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, July 14, 2003. HIV/AIDS Treatment Information Service Website: www.hivatis.org.
- ••Updated in July 2003. In addition toproviding treatment guidelines, it serves as a comprehensive review of the relevant literature and available data on antiretroviral therapy of HIV-infected patients.