Safety and tolerability of etravirine;Seguridad y tolerabilidad de etravirina

Enfermedades Infecciosas y Microbiologia Clinica

Volumn 27, Issue SUPPL. 2, 2009, Pages 21-26

  Portilla, Joaquín ^a  

^a HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

Author keywords

Adverse effects; Etravirine; HIV infection; Non nucleoside reverse transcriptase inhibitors; Rash

Indexed keywords

DARUNAVIR; ETRAVIRINE;

ARTICLE; CLINICAL TRIAL; DRUG ERUPTION; DRUG HALF LIFE; DRUG SAFETY; DRUG SOLUBILITY; DRUG TOLERABILITY; DYSLIPIDEMIA; GASTROINTESTINAL SYMPTOM; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIVER TOXICITY; NEUROLOGIC DISEASE; RECOMMENDED DRUG DOSE; SWALLOWING; TABLET;

ANIMALS; ANTI-HIV AGENTS; DRUG ERUPTIONS; DRUG EVALUATION, PRECLINICAL; DRUG-INDUCED LIVER INJURY; DYSLIPIDEMIAS; FEMALE; FETUS; GASTROINTESTINAL DISEASES; HIV INFECTIONS; HIV REVERSE TRANSCRIPTASE; HUMANS; MALE; MENTAL DISORDERS; MULTICENTER STUDIES AS TOPIC; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PYRIDAZINES; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REVERSE TRANSCRIPTASE INHIBITORS; SULFONAMIDES;

EID: 75149149567     PISSN: 0213005X     EISSN: 15781852     Source Type: Journal    
DOI: 10.1016/S0213-005X(09)73215-X     Document Type: Article

References (34)

1. R. Pauwels New non-nucleoside reverse transcriptase inhibitors (NNRTIs) in development for the treatment of HIV infections Curr Opin Pharmacol 4 2004 437 446 (Pubitemid 40533003)
2. L.J. Scott, and C.M. Perry Delavirdine. A review of its use in HIV infection Drugs 60 2000 1411 1444 (Pubitemid 32039394)
3. A. Rivero, J.A. Mira, and J.A. Pineda Liver toxicity induced by non-nucleoside reverse transcriptase inhibitors J Antimicrob Chemother 59 2007 342 346 (Pubitemid 47073440)
4. Panel de Expertos de Gesida, Plan Nacional Sobre El Sida Recommendations from the GESIDA/Spanish AIDS Plan regarding antiretroviral treatment in adults with human immunodeficiency virus infection (update February 2009) Enferm Infecc Microbiol Clin 27 2009 222 235
5. J.S. Montaner, P. Cahn, C. Zala, L.I. Cassetti, M. Losso, and D.B. Hall Randomized, controlled study of the effects of short course of prednisone on the incidence of rash associated with nevirapine in patients infected with HIV-1 J Acquir Immene Defic Syndr 33 2003 41 46 (Pubitemid 36547240)
6. H. Knobel, J.M. Miró, B. Mahillo, P. Domingo, A. Rivero, and E. Ribera Failure of cetirizine to prevent nevirapine-associated rash: a double-blind placebo-controlled trial for the GESIDA 26/01 Study J Acquir Immune Defic Syndr 37 2004 1276 1281 (Pubitemid 39281509)
7. F. Van Leth, P. Phanuphak, K. Ruxrungtham, E. Baraldi, S. Miller, and B. Gazzard Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study Lancet 363 2004 1253 1263 (Pubitemid 38496486)
8. D.B. Clifford, S. Evans, Y. Yang, E.P. Acosta, K. Goodkin, and K. Tashima Impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals Ann Intern Med 143 2005 714 721 (Pubitemid 41693787)
9. J. Blanch, E. Martínez, A. Rousaud, J.L. Blanco, M.A. García-Viejo, and J.M. Peri Preliminary data of a prospective study on neuropsychiatric side effects after initiation of efavirenz J Acquir Immune Defic Syndr 27 2001 336 343 (Pubitemid 32729079)
10. C.R. Fumaz, J.A. Muñoz-Moreno, J. Moltó, E. Negredo, M.J. Ferrer, and G. Sirera Longterm neuropsychiatric disorders on efavirenz-based approaches: quality of life, psycologic issues and adherence J Acquir Immune Defic Syndr 38 2005 560 565 (Pubitemid 40524478)
11. V. Journot, G. Chene, N. De Castro, C. Rancinan, J.P. Cassuto, and C. Allard Use of efavirenz is not associated with a higher risk of depressive disorders: a substudy of the randomized clinical trial ALIZE-ANRS 099 Clin Infect Dis 42 2006 1790 1799 (Pubitemid 43839448)
12. E. Arroyo, B. Valenzuela, J. Portilla, E. Climent-Grana, J.J. Pérez-Ruixo, and E. Merino Pharmacokinetics of methadone in human-immunodeficiency-virus-infected patients receiving nevirapine once daily Eur J Clin Pharmacol 63 2007 669 675 (Pubitemid 46911339)
13. F. Van Leth, P. Phanuphak, E. Stroes, B. Gazzard, P. Cahn, RaffiF F., et al. Nevirapine and efavirenz elicit different changes in lipid profiles in antiretroviral-therapy-naïve patients infected with HIV-1 PLos Med 1 2004 e19
14. R.H. Haubrich, S.A. Riddler, A.G. DiRienzo, L. Komarow, W.G. Powderly, K. Klingman, et al. Metabolic outcomes in a randomized trial of nucleoside, nonnucleoside and protease inhibitor-sparing regimens for initial HIV treatment AIDS 23 2009 1109 1118
15. J.R. Arribas, A.L. Pozniak, J.E. Gallant, E. DeJesus, B. Gazzard, and R.E. Campo Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis J Acquir Immune Defic Syndr 47 2008 74 78 (Pubitemid 351619372)
16. E. DeJesus, G. Herrera, E. Teofilo, J. Gerstoft, C.B. Buendía, and J.D. Brand Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults Clin Infect Dis 39 2004 1038 1046 (Pubitemid 39313463)
17. Sustiva(r), ficha técnica [consultado 15-7-2009] Disponible en: http://www.emea.europa.eu/humandocs/Humans/EPAR/sustiva/sustiva.htm
18. Viramune(r), ficha técnica [consultado 15-7-2009] Disponible en: http://www.emea.europa.eu/humandocs/Humans/EPAR/viramune/viramune.htm
19. E.D. Deeks, and G.M. Keating Etravirine Drugs 68 2008 2357 2372
20. L.B. Johnson, and L.D. Saravolatz Etravirine, a next-generation nonnucleoside reversetranscriptase inhibitor Clin Infect Dis 48 2009 1123 1128
21. L. Garvey, and A. Winston Rilpivirine: a novel non-nucleoside reverse transcriptase inhibitor Expert Opin Investig Drugs 18 2009 1035 1041
22. Intelence(r), ficha técnica [consultado 15-7-2009] Disponible en: http://www.emea.europa.eu/humandocs/Humans/EPAR/intelence/intelence.htm
23. M. Peeters, K. Janssen, T.N. Kakuda, M. Schöller-Gyüre, R. Lachaert, and R.M. Hoetelmans Etravirine has no effect on qt and corrected QT interval in HIV-negative volunteers Ann Pharmacoth 42 2008 757 765 (Pubitemid 351778082)
24. J. Lalezari, E. DeJesus, O. Osiyemi, P. Ruane, Z. Haigney, R. Ryan, et al. Pharmacokinetics of once-daily etravirine without or with once-daily darunavir/ritonavir in antirretroviral-naive HIV-1 infected patients Ninth International Congress on Drug Therapy in HIV Infection (HIV9) Glasgow. November 9-13 2008 Abstract O413
25. J.V. Madruga, D. Berger, M. McMurchie, F. Suter, D. Banhegyi, and K. Ruxrungtham Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial Lancet 370 2007 49 58 (Pubitemid 47023100)
26. A. Lazzarin, T. Campbell, B. Clotet, M. Johnson, C. Katlama, and A. Moll Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial Lancet 370 2007 39 48 (Pubitemid 47017467)
27. R. Haubrich, P. Cahn, B. Grinsztejn, J. Lalezari, J. Valdez Madruga, A. Mills, et al. DUET-1: week-48 results of a phase III randomized double-blind trial to evaluate the efficacy and safety of etravirine (ETR; TMC125) versus placebo in 612 treatmentexperienced HIV-1 infected patients 15th Conference on Retroviruses and Opportunistic Infections Boston 2008 Feb 3-6. Abstract 790
28. M. Johnson, T. Campbell, B. Clotet, C. Katlama, A. Lazzarin, W. Towner, et al. DUET-2: week-48 results of a phase III randomized double-blind trial to evaluate the efficacy and safety of etravirine (ETR; TMC125) versus placebo in 591 treatment-experienced HIV-1 infected patients 15th Conference on Retroviruses and Opportunistic Infections Boston 2008 Feb 3-6. Abstract 791
29. G. Di Perri, P.M. Girard, N. Clumeck, M. Peeters, M. Janssens, G. De Smedt, et al. Pooled 24-week results of DUET-1 and -2; TMC125 (etravirine) safety and tolerability in treatment-experienced HIV-1-infected patients 11 th European AIDS Conference Madrid 2007 Oct 24-27. Abstract P7.3/17
30. Campbell T, Mills A, Morlat P, Schechter M, De Smedt G, Peeters M, et al. TMC125 safety and tolerability in treatment experienced patientes hepatitis B or C coinfected patients in DUET-1 and DUET-2. HEP DART: Frontiers in Drug Development for Antiretroviral Therapies. Lahaina (HI), USA. 2007, Dec 9-13. Abstract 96.
31. J. Gatell, G. Beatty, M. Johnson, S. Martin, M. Peeters, and B. Woodfall Impact of TMC125, a next generation NNRTI, on clinical outcomes (AIDS-defining illnesses and deaths): 24-week findings from a planned pooled analysis of the DUET studies 11th European AIDS Conference Madrid 2007 Oct 24-27. Abstract P4.3/67
32. K. Peeters, M. Viala, H. Gilet, B. Woodfall, D. Dubois, and D. Cella Health-related quality of life (HRQL) as measured by the Functional Assesment of HIV Infection (FAHI) questionnaire in treatment-experienced HIV-1 infected patients: 24-week results from the pooled DUET trials 11 th European AIDS Conference Madrid 2007 Oct 24-27. Abstract P7.2/109
33. R.K. Lodwick, C.J. Smith, M. Youle, F.C. Lampe, M. Tyrer, and S. Bhagani Stability of antiretroviral regimens in patients with viral suppression AIDS 22 2008 1039 1046 (Pubitemid 351769742)
34. J.L. Martínez-Cajas, and M.A. Wainberg Antiretroviral therapy. Optimal sequencing of therapy to avoid resistance Drugs 68 2008 43 72