Enfuvirtide (Fuzeon)

All References

• Baatz F, Nijhuis M, Lemaire M, et al. Impact of the HIV-1 env genetic context outside HR1-HR2 on resistance to the fusion inhibitor enfuvirtide and viral infectivity in clinical Isolates. PLoS One. 2011;6:e21535.
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• Bellibas SE, Siddique Z, Dorr A, et al. Pharmacokinetics of enfuvirtide in pediatric human immunodeficiency virus 1-infected patients receiving combination therapy. Pediatr Infect Dis J. 2004;23:1137-41.
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• Bonora S, Calcagno A, Cometto C, et al. Short-term additional enfuvirtide therapy is associated with a greater immunological recovery in HIV very late presenters: a controlled pilot study. Infection. 2012;40:69-75.
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• Boulet T, Pavie J, Charreau I, et al. Impact on health-related quality of life of a switch from enfuvirtide to raltegravir among multidrug-resistant HIV-1-infected patients: a randomized open-label trial (EASIER-ANRS 138). HIV Clin Trials. 2010;11:283-93.
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• Boyd MA, Dixit NM, Siangphoe U, et al. Viral decay dynamics in HIV-infected patients receiving ritonavir-boosted saquinavir and efavirenz with or without enfuvirtide: a randomized, controlled trial (HIV-NAT 012). J Infect Dis. 2006;194:1319-22.
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• Boyd MA, Truman M, Hales G, Anderson J, Dwyer DE, Carr A. A randomized study to evaluate injection site reactions using three different enfuvirtide delivery mechanisms (the OPTIONS study). Antivir Ther. 2008;13:449-53.
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• Boyd MA, Zhang X, Dorr A, et al. Lack of enzyme-inducing effect of rifampicin on the pharmacokinetics of enfuvirtide. J Clin Pharmacol. 2003;43:1382-91.
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• Charpentier C, Joly V, Ghosn J, et al. Change in HIV-1 DNA tropism despite virological success in patients receiving an enfuvirtide-based regimen. J Antimicrob Chemother. 2014;69:2588-90.
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• Charpentier C, Joly V, Larrouy L, et al. Role and evolution of viral tropism in patients with advanced HIV disease receiving intensified initial regimen in the ANRS 130 APOLLO trial. J Antimicrob Chemother. 2013;68:690-6.
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• Church JA, Cunningham C, Hughes M, et al. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002;21:653-9.
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• Church JA, Hughes M, Chen J, et al. Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2004;23:713-8.
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• Clotet B, Capetti A, Soto-Ramirez LE, et al. A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. J Antimicrob Chemother. 2008;62:1374-8.
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• Cohen CJ, Clumeck N, Molina JM, et al. Health-related quality of life with enfuvirtide (ENF; T-20) in combination with an optimized background regimen. J Acquir Immune Defic Syndr. 2004;37:1140-6.
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• Cooper DA, Cordery DV, Reiss P, et al. The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. HIV Med. 2011;12:31-9.
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• de Castro N, Braun J, Charreau I, et al. Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial. AIDS Res Ther. 2016;13:17.
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• De Castro N, Braun J, Charreau I, et al. Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial. Clin Infect Dis. 2009;49:1259-67.
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• Deeks SG, Lu J, Hoh R, et al. Interruption of enfuvirtide in HIV-1 infected adults with incomplete viral suppression on an enfuvirtide-based regimen. J Infect Dis. 2007;195:387-91.
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• DeJesus E, Gottlieb MS, Gathe JC Jr, Greenberg ML, Guittari CJ, Zolopa AR. Safety and efficacy of enfuvirtide in combination with darunavir-ritonavir and an optimized background regimen in treatment-experienced human immunodeficiency virus-infected patients: the below the level of quantification study. Antimicrob Agents Chemother. 2008;52:4315-9.
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• Fung HB, Guo Y. Enfuvirtide: a fusion inhibitor for the treatment of HIV infection. Clin Ther. 2004;26:352-78.
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• Gallien S, Braun J, Delaugerre C, et al. Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. J Antimicrob Chemother. 2011;66:2099-106.
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• Gandhi RT, Bosch RJ, Aga E, et al. No evidence for decay of the latent reservoir in HIV-1-infected patients receiving intensive enfuvirtide-containing antiretroviral therapy. J Infect Dis. 2010;201:293-6.
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• Gottlieb M, Thommes JA. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13:723-7.
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• Greenberg ML, Cammack N. Resistance to enfuvirtide, the first HIV fusion inhibitor. J Antimicrob Chemother. 2004;54:333-40.
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• Joly V, Fagard C, Grondin C, et al. Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo). Antimicrob Agents Chemother. 2013;57:758-65.
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• Joly V, Jidar K, Tatay M, Yeni P. Enfuvirtide: from basic investigations to current clinical use. Expert Opin Pharmacother. 2010;11:2701-13.
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• Kilby JM, Lalezari JP, Eron JJ, et al. The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults. AIDS Res Hum Retroviruses. 2002;18:685-93.
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• Lalezari JP, DeJesus E, Northfelt DW, et al. A controlled Phase II trial assessing three doses of enfuvirtide (T-20) in combination with abacavir, amprenavir, ritonavir and efavirenz in non-nucleoside reverse transcriptase inhibitor-naive HIV-infected adults. Antivir Ther. 2003;8:279-87.
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• Lalezari JP, Henry K, O'Hearn M, et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003;348:2175-85.
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• Lalezari JP, Saag M, Walworth C, Larson P. An open-label safety study of enfuvirtide injection with a needle-free injection device or needle/syringe: the Biojector 2000 Open-label Safety Study (BOSS). AIDS Res Hum Retroviruses. 2008;24:805-13.
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• Lazzarin A, Clotet B, Cooper D, et al. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003;348:2186-95.
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• Lazzarin A. Enfuvirtide: the first HIV fusion inhibitor. Expert Opin Pharmacother. 2005;6:453-64.
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• Melby T, Sista P, DeMasi R, et al. Characterization of envelope glycoprotein gp41 genotype and phenotypic susceptibility to enfuvirtide at baseline and on treatment in the phase III clinical trials TORO-1 and TORO-2. AIDS Res Hum Retroviruses. 2006;22:375-85.
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• Melby TE, Despirito M, Demasi RA, et al. Association between specific enfuvirtide resistance mutations and CD4 cell response during enfuvirtide-based therapy. AIDS. 2007;21:2537-9.
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• Mirza RA, Turiansky GW. Enfuvirtide and cutaneous injection-site reactions. J Drugs Dermatol. 2012;11:e35-8.
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• Morand-Joubert L, Ghosn J, Delaugerre C, et al. Lack of benefit of 3-month intensification with enfuvirtide plus optimized background regimen (OBR) versus OBR alone in patients with multiple therapeutic failures: the INNOVE study. J Med Virol. 2012;84:1710-8.
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• Nelson M, Arastéh K, Clotet B, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr. 2005;40:404-12.
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• Raffi F, Katlama C, Saag M, et al. Week-12 response to therapy as a predictor of week 24, 48, and 96 outcome in patients receiving the HIV fusion inhibitor enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) trials. Clin Infect Dis. 2006;42:870-7.
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• Reynes J, Arastéh K, Clotet B, et al. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care STDS. 2007;21:533-43.
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• Rockstroh J, Dejesus E, Donatacci L, et al. Adherence to enfuvirtide and its impact on treatment efficacy. AIDS Res Hum Retroviruses. 2008;24:141-8.
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• Ruane P, Alas B, Ryan R, Perniciaro A, Witek J. A 48-week pilot study switching suppressed patients to darunavir/ritonavir and etravirine from enfuvirtide, protease inhibitor(s), and non-nucleoside reverse transcriptase inhibitor(s). AIDS Res Hum Retroviruses. 2010;26:1215-9.
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• Sax PE, Losina E, Weinstein MC, et al. Cost-effectiveness of enfuvirtide in treatment-experienced patients with advanced HIV disease. J Acquir Immune Defic Syndr. 2005;39:69-77.
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• Shust GF, Jao J, Rodriguez-Caprio G, et al. Salvage Regimens Containing Darunavir, Etravirine, Raltegravir, or Enfuvirtide in Highly Treatment-Experienced Perinatally Infected Pregnant Women. J Pediatric Infect Dis Soc. 2014;3:246-50.
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• Silva EF, Charreau I, Gourmel B, et al. Decreases in inflammatory and coagulation biomarkers levels in HIV-infected patients switching from enfuvirtide to raltegravir: ANRS 138 substudy. J Infect Dis. 2013;208:892-7.
  [PubMed Abstract]
• Sista PR, Melby T, Davison D, et al. Characterization of determinants of genotypic and phenotypic resistance to enfuvirtide in baseline and on-treatment HIV-1 isolates. AIDS. 2004;18:1787-94.
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• Soy D, Aweeka FT, Church JA, et al. Population pharmacokinetics of enfuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships. Clin Pharmacol Ther. 2003;74:569-80.
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• Streinu-Cercel A, de Gorgolas M, Müller M, et al. Switching from a toxicity-causing antiretroviral to enfuvirtide in patients with HIV: the SWITCH TOX study. HIV Clin Trials. 2008;9:375-86.
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• Tashima KT, Mollan KR, Na L, et al. Regimen selection in the OPTIONS trial of HIV salvage therapy: drug resistance, prior therapy, and race-ethnicity determine the degree of regimen complexity. HIV Clin Trials. 2015;16:147-56.
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• Tebas P, Bellos N, Lucasti C, et al. Enfuvirtide does not require dose adjustment in patients with chronic kidney failure: results of a pharmacokinetic study of enfuvirtide in HIV-1-infected patients with impaired kidney function. J Acquir Immune Defic Syndr. 2008;47:342-5.
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• Thompson M, DeJesus E, Richmond G, et al. Pharmacokinetics, pharmacodynamics and safety of once-daily versus twice-daily dosing with enfuvirtide in HIV-infected subjects. AIDS. 2006;20:397-404.
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• Towner W, Klein D, Kerrigan HL, Follansbee S, Yu K, Horberg M. Virologic outcomes of changing enfuvirtide to raltegravir in HIV-1 patients well controlled on an enfuvirtide based regimen: 24-week results of the CHEER study. J Acquir Immune Defic Syndr. 2009;51:367-73.
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• Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr. 2005;40:413-21.
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• Viard JP, Fagard C, Chaix ML, et al. Immunological success is predicted by enfuvirtide but not interleukin-2 therapy in immunodepressed patients. AIDS. 2009;23:1383-8.
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• Wallace BJ, Tan KB, Pett SL, Cooper DA, Kossard S, Whitfeld MJ. Enfuvirtide injection site reactions: a clinical and histopathological appraisal. Australas J Dermatol. 2011;52:19-26.
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• Walmsley S, Henry K, Katlama C, et al. Enfuvirtide (T-20) cross-reactive glycoprotein 41 antibody does not impair the efficacy or safety of enfuvirtide. J Infect Dis. 2003;188:1827-33.
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• Wei X, Decker JM, Liu H, et al. Emergence of resistant human immunodeficiency virus type 1 in patients receiving fusion inhibitor (T-20) monotherapy. Antimicrob Agents Chemother. 2002;46:1896-905.
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• Wright D, Rodriguez A, Godofsky E, et al. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008;9:73-82.
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• Zhang X, Lalezari JP, Badley AD, et al. Assessment of drug-drug interaction potential of enfuvirtide in human immunodeficiency virus type 1-infected patients. Clin Pharmacol Ther. 2004;75:558-68.
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• Zhang X, Lin T, Bertasso A, et al. Population pharmacokinetics of enfuvirtide in HIV-1-infected pediatric patients over 48 weeks of treatment. J Clin Pharmacol. 2007;47:510-7.
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