Impact of the Background Regimen on Virologic Response to Etravirine: Pooled 48-Week Analysis of DUET-1 and -2

REFERENCES

• US Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guide-lines for the use of antiretroviral agents in HIV-1 -infected adults and adolescents. December 1,2009. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf Accessed January 8, 2010.
   Google Scholar
• Thompson MA, Aberg JA, Cahn P, et al. Antiretroviral treat-ment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. J Am Med Assoc. 2010;304:321–333.
   PubMed Web of Science ®Google Scholar
• Gazzard BG. British HIV Association guidelines for the treatment of HIV-1-infected adults with antiretroviral ther-apy 2008. HIV Med. 2008;9:563–608.
   PubMed Web of Science ®Google Scholar
• Clumeck N, Pozniak A, Raffi F, EACS Executive Committee. European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of HIV-infected adults. HIV Med. 2008;9:65–71.
   PubMed Web of Science ®Google Scholar
• Andries K, Azijn H, Thielemans T, et al. TMC125, a novel next-generation nonnucleoside reverse tran-scriptase inhibitor active against nonnucleoside reverse transcriptase inhibitor-resistant human immunode-ficiency virus type 1. Antimicrob Agents Chemother 2004;48:4680–4686.
   PubMed Web of Science ®Google Scholar
• Vingerhoets J, Azijn H, Fransen E, et al. TMC125 displays a high genetic barrier to the development of resistance: evidence from in vitro selection experiments. J Virol. 2005;79:12773–12782.
   PubMed Web of Science ®Google Scholar
• Madruga JV, Cahn P, Grinsztejn B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lan-cet. 2007;370:29–38.
   PubMed Web of Science ®Google Scholar
• Lazzarin A, Campbell T, Clotet B, et al. 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. Lan-cet. 2007;370:39–48.
   PubMed Web of Science ®Google Scholar
• Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled week 48 analysis of two randomized, controlled trials. AIDS. 2009;23:2289–2300.
   PubMed Web of Science ®Google Scholar
• Katlama C, Clotet B, Mills A, et al. Efficacy and safety of etravirine at Week 96 in treatment-experienced HIV-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther In press.
   Web of Science ®Google Scholar
• Tibotec Inc. INTELENCETm (etravirine) prescribing informa-tion. August 2009. www.intelence-info.com/intelence/assets/pdf/INTELENCE_Pl.pdf. Accessed September 29, 2009.
   Google Scholar
• INTELENCE (etravirine): summary of product characteristics (EM EA). www.emea.europa.eu/humandocs/Humans/EPAR/intelence/intelence.htm. Accessed September 29, 2009.
   Google Scholar
• Johnson VA, Brun-Vezinet F, Clotet B, et al. Update of the drug resistance mutations in HIV-1: Fall 2005. Top HIV Med 2005;13:125–131.
   PubMedGoogle Scholar
• Tambuyzer L, Vingerhoets J, Azijn H, et al. Development of a list of mutations associated with NNRTI resistance for use in clinical research. Presented at: 5th European HIV Drug Resistance Workshop; March 28–30, 2007; Cascais, Portugal. Abstract 67.
   Google Scholar
• De Meyer S, Dierynck I, Lathouwers E, et al. Identifica-tion of mutations predictive of a diminished response to darunavir/ritonavir: analysis of data from treatment-experienced patients in POWER 1,2,3 and DUET-1 and DUET-2. Presented at: 6th European HIV Drug Resistance Workshop; March 26–28, 2008; Budapest, Hungary. Abstract 54.
   Google Scholar
• Lapadula G, Calabresi A, Castelnuovo F, et al. Prevalence and risk factors for etravirine resistance among patients failing on non-nucleoside reverse transcriptase inhibitors. Antivir Ther 2008;13:601–605.
   PubMed Web of Science ®Google Scholar
• Scott C, Grover D, Nelson M. Is there a role for etravirine in patients with nonnucleoside reverse transcriptase inhibitor resistance? AIDS. 2008;22:989–990.
   Google Scholar
• Sungkanuparph S, Manosuthi W, Kiertiburanakul S, Piyavong B, Chantratita W. Evaluating the role of etra-virine in the second-line antiretroviral therapy after failing an initial non-nucleoside reverse transcriptase inhibitor-based regimen in a resource-limited setting. Curr HIV Res. 2008;6:474–476.
   PubMed Web of Science ®Google Scholar
• Picchio G, Vingerhoets J, Staes M, et al. Prevalence of etravirine (ETR; TMC125) resistance-associated muta-tions in a large panel of clinical isolates. Presented at: 15th Conference on Retroviruses and Opportunistic Infections; February 3–6, 2008; Boston, Massachusetts. Abstract 866.
   Google Scholar
• Clotet B, Bellos N, Molina JM, et al. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet. 2007;369:1169–1178.
   PubMed Web of Science ®Google Scholar
• Cooper DA, Steigbigel RT, Gatell JM, et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infec-tion. N Engl J Med. 2008;359:355–365.
   PubMed Web of Science ®Google Scholar
• Nelson M, Arasteh 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;40:404–412.
   PubMed Web of Science ®Google Scholar
• Hicks CB, Cahn P, Cooper DA, et al. Durable efficacy of tipranavir-ritonavir in combination with an optimized background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006;368:466–475.
   PubMed Web of Science ®Google Scholar
• Fatkenheuer G, Nelson M, Lazzarin A, et al. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infec-tion. N Engl J Med. 2008;359:1442–1455.
   PubMed Web of Science ®Google Scholar
• Vingerhoets J, Tambuyzer L, Azijn H, et al. Resistance profile of etravirine: combined analysis of baseline geno-typic and phenotypic data from the DUET studies. AIDS. 2010;24:503–514.
   PubMed Web of Science ®Google Scholar
• Clumeck N, Clotet B, Johnson M, Peeters M, Vinger-hoets J, Beets G, De Smedt G. Virological response with fully active etravirine after 48 weeks of treatment: pooled results from the DUET-1 and DUET-2 trials. Pre-sented at: 9th International Congress on Drug Therapy in HIV Infection; November 9–13, 2008; Glasgow, UK. Abstract P023.
   Google Scholar
• Yazdanpanah Y, Fagard C, Descamps D, et al. High rate of virologic suppression with raltegravir plus etravirine and darunavir/ritonavir among treatment-experienced patients infected with multidrug-resistant HIV: results of the ANRS 139 TRIO trial. Clin Infect Dis. 2009;49:1441–1449.
   PubMed Web of Science ®Google Scholar
• Nozza S, Visco F, Soria A, et al. Excellent short-term CD4 recovery with a Pl- and NRTI-sparing regimen in triple-class failure HIV-infected patients: raltegravir, maraviroc, etravirine. Presented at: 9th International Congress on Drug Therapy in HIV Infection; November 9–13, 2008; Glasgow, UK. Abstract P45.
   Google Scholar
• Towner W, Lalezari J, Sension MG, et al. Efficacy, safety, and tolerability of etravirine with and without darunavir/ ritonavir or raltegravir in treatment-experienced patients: analysis of the etravirine early access program in the United States. AIDS. 2010;53:614–618.
   Google Scholar
• Anderson MS, Kakuda TN, Hanley W, et al. Minimal phar-macokinetic interaction between the HIV non-nucleoside reverse transcriptase inhibitor etravirine and the integrase inhibitor raltegravir in healthy subjects. Antimicrob Agents Chemother 2008;52:4228–4232.
   PubMed Web of Science ®Google Scholar
• Davis J, Schäller-GyOre M, Kakuda TN, et al. An open, randomized, two-period, crossover study in two cohorts to investigate the effect of steady-state TMC125 (etra-virine) and the combination of TMC125/darunavir/ritonavir on the steady-state pharmacokinetics of oral maraviroc in healthy subjects. Presented at: 11th European AIDS Con-ference; October 24–27, 2007; Madrid, Spain. Abstract P4.3/02.
   Google Scholar
• Schäller-GyOre M, Kakuda TN, Sekar V, et al. Pharma-cokinetics of darunavir/ritonavir and TMC125 alone and coadministered in HIV-negative volunteers. Antivir Ther. 2007;12:789–796.
   PubMed Web of Science ®Google Scholar
• Kakuda TN, Schäller-GyOre M, Hoetelmans RMW. Clinical perspective on antiretroviral drug-drug interactions with the non-nucleoside reverse transcriptase inhibitor etra-virine. Antivir Ther In press.
   Google Scholar
• Schäller-GyOre M, Woodfall B, Bollen S, Peeters M, Vandermeulen K, Hoetelmans R. Pharmacokinetics of amprenavir and TMC125 in HIV-infected volunteers receiv-ing TMC125 with fosamprenavir/ritonavir. Presented at: 46th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 27–30, 2006; San Francisco, California, USA. Abstract A–370.
   Google Scholar
• Kakuda TN, Schäller-GyOre M, De Smedt G, et al. Assess-ment of the steady-state pharmacokinetic interaction between etravirine administered as two different formula-tions and tenofovir disoproxil fumarate in healthy volun-teers. HIV Med. 2009;10:173–181.
   PubMed Web of Science ®Google Scholar
• Katlama C, Esposito R, Gatell JM, et al. Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1. AIDS. 2007;21:395–402.
   PubMed Web of Science ®Google Scholar
• Haubrich R, Berger D, Chiliade P, et al. Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients. AIDS. 2007;21:F11—F18.
   PubMed Web of Science ®Google Scholar
• Schäller M, Kraft M, Hoetelmans R, et al. Significant decrease in TMC125 exposures when co-administered with tipranavir boosted with ritonavir in healthy subjects. Presented at: 13th Conference on Retroviruses and Oppor-tunistic Infections; February 5–8, 2006; Denver, Colorado, USA. Abstract 583.
   Google Scholar
• Schapiro J, Vingerhoets J, Nijs S, et al. Combined pro-tease inhibitor (PI) and NNRTI resistance analysis of the pooled DUET trial: towards a regimen-based resistance interpretation. Presented at: 6th European HIV Drug Resis-tance Workshop; March 26–28, 2008; Budapest, Hungary. Abstract 46.
   Google Scholar
• Haubrich R, Schapiro J, Vingerhoets J, et al. Combined darunavir and etravirine resistance analysis of the pooled DUET trials: when can we spare the other new classes? Presented at: 17th International AIDS Conference; August 3–8, 2008; Mexico City, Mexico. Abstract TUPE0048.
   Google Scholar