Efavirenz plus Zidovudine and Lamivudine, Efavirenz plus Indinavir, and Indinavir plus Zidovudine and Lamivudine in the Treatment of HIV-1 Infection in Adults
Schlomo Staszewski, M.D., Javier Morales-Ramirez, M.D., Karen T. Tashima, M.D., Anita Rachlis, M.D., Daniel Skiest, M.D., James Stanford, M.D., Richard Stryker, M.D., Philip Johnson, M.D., Dominic F. Labriola, Ph.D., Dianne Farina, Ph.D., Douglas J. Manion, M.D., Nancy M. Ruiz, M.D., for The Study 006 Team
Background Efavirenz is a nonnucleoside reverse-transcriptaseinhibitor of human immunodeficiency virus type 1 (HIV-1). Wecompared two regimens containing efavirenz, one with a proteaseinhibitor and the other with two nucleoside reverse-transcriptaseinhibitors, with a standard three-drug regimen.
Methods The study subjects were 450 patients who had not previouslybeen treated with lamivudine or any nonnucleoside reverse-transcriptaseinhibitor or protease inhibitor. In this open-label study, patientswere randomly assigned to one of three regimens: efavirenz (600mg daily) plus zidovudine (300 mg twice daily) and lamivudine(150 mg twice daily); the protease inhibitor indinavir (800mg every eight hours) plus zidovudine and lamivudine; or efavirenzplus indinavir (1000 mg every eight hours).
Results Suppression of plasma HIV-1 RNA to undetectable levelswas achieved in more patients in the group given efavirenz plusnucleoside reverse-transcriptase inhibitors than in the groupgiven indinavir plus nucleoside reverse-transcriptase inhibitors(70 percent vs. 48 percent, P<0.001). The efficacy of theregimen of efavirenz plus indinavir was similar (53 percent)to that of the regimen of indinavir, zidovudine, and lamivudine.CD4 cell counts increased significantly with all combinations(range of increases, 180 to 201 cells per cubic millimeter).More patients discontinued treatment because of adverse eventsin the group given indinavir and two nucleoside reverse-transcriptaseinhibitors than in the group given efavirenz and two nucleosidereverse-transcriptase inhibitors (43 percent vs. 27 percent,P=0.005).
Conclusions As antiretroviral therapy in HIV-1–infectedadults, the combination of efavirenz, zidovudine, and lamivudinehas greater antiviral activity and is better tolerated thanthe combination of indinavir, zidovudine, and lamivudine.
Source Information
From the Klinikum der J.W. Goethe Universität, Frankfurt, Germany (S.S.); Clinical Research of Puerto Rico, San Juan (J.M.-R.); Miriam Hospital, Providence, R.I. (K.T.T.); Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Toronto (A.R.); University of Texas Southwestern Medical School, Dallas (D.S.); University of Missouri–Kansas City School of Medicine and the Kansas City AIDS Research Consortium, Kansas City (J.S.); Pacific Oaks Research, Beverly Hills, Calif. (R.S.); University of Texas Health Science Center, Houston (P.J.); and Dupont Pharmaceuticals Company, Wilmington, Del. (D.F.L., D.F., D.J.M., N.M.R.).
Address reprint requests to Dr. Manion at the Dupont Pharmaceuticals Company, Chestnut Run Plaza, Rm. HR 2003, 974 Centre Rd., Wilmington, DE 19805, or at douglas.j.manion{at}dupontpharma.com.
Efavirenz in HIV Infection
Casado J. L., Moreno S., Manion D. J., Ruiz N. M., Staszewski S.
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N Engl J Med 2000;
342:1290-1291, Apr 27, 2000.
Correspondence
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Walmsley, S., Bernstein, B., King, M., Arribas, J., Beall, G., Ruane, P., Johnson, M., Johnson, D., Lalonde, R., Japour, A., Brun, S., Sun, E., the M98-863 Study Team,
(2002). Lopinavir-Ritonavir versus Nelfinavir for the Initial Treatment of HIV Infection. NEJM
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King, R. W., Klabe, R. M., Reid, C. D., Erickson-Viitanen, S. K.
(2002). Potency of Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs) Used in Combination with Other Human Immunodeficiency Virus NNRTIs, NRTIs, or Protease Inhibitors. Antimicrob. Agents Chemother.
46: 1640-1646
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Joly, V., Flandre, P., Meiffredy, V., Brun-Vezinet, F., Gastaut, J.-A., Goujard, C., Remy, G., Descamps, D., Ruffault, A., Certain, A., Aboulker, J.-P., Yeni, P.
(2002). Efficacy of Zidovudine Compared to Stavudine, Both in Combination with Lamivudine and Indinavir, in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine, Stavudine, or Protease Inhibitors (Novavir Trial). Antimicrob. Agents Chemother.
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Demeter, L. M., Bosch, R. J., Coombs, R. W., Fiscus, S., Bremer, J., Johnson, V. A., Erice, A., Jackson, J. B., Spector, S. A., Squires, K. M., Fischl, M. A., Hughes, M. D., Hammer, S. M.
(2002). Detection of Replication-Competent Human Immunodeficiency Virus Type 1 (HIV-1) in Cultures from Patients with Levels of HIV-1 RNA in Plasma Suppressed to Less Than 500 or 50 Copies Per Milliliter. J. Clin. Microbiol.
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Manfredi, R., Calza, L., Chiodo, F.
(2002). A prospective comparison of the two main indications of efavirenz in 2001 highly active antiretroviral therapy (HAART) regimens: first-line versus salvage use. J Antimicrob Chemother
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Goldie, S. J., Kaplan, J. E., Losina, E., Weinstein, M. C., Paltiel, A. D., Seage III, G. R., Craven, D. E., Kimmel, A. D., Zhang, H., Cohen, C. J., Freedberg, K. A.
(2002). Prophylaxis for Human Immunodeficiency Virus-Related Pneumocystis carinii Pneumonia: Using Simulation Modeling to Inform Clinical Guidelines. Arch Intern Med
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Jordan, R., Gold, L., Cummins, C., Hyde, C.
(2002). Systematic review and meta-analysis of evidence for increasing numbers of drugs in antiretroviral combination therapy. BMJ
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van Praag, R. M. E., van Weert, E. C. M., van Heeswijk, R. P. G, Zhou, X.-J., Sommadossi, J.-P., Jurriaans, S., Lange, J. M. A., Hoetelmans, R. M. W., Prins, J. M.
(2002). Stable Concentrations of Zidovudine, Stavudine, Lamivudine, Abacavir, and Nevirapine in Serum and Cerebrospinal Fluid during 2 Years of Therapy. Antimicrob. Agents Chemother.
46: 896-899
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Katz, M. H., Schwarcz, S. K., Kellogg, T. A., Klausner, J. D., Dilley, J. W., Gibson, S., McFarland, W.
(2002). Impact of Highly Active Antiretroviral Treatment on HIV Seroincidence Among Men Who Have Sex With Men: San Francisco. Am. J. Public Health
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Domingo, P., Barcelo, M.
(2002). Efavirenz-Induced Leukocytoclastic Vasculitis. Arch Intern Med
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Yoshimura, K., Kato, R., Kavlick, M. F., Nguyen, A., Maroun, V., Maeda, K., Hussain, K. A., Ghosh, A. K., Gulnik, S. V., Erickson, J. W., Mitsuya, H.
(2002). A Potent Human Immunodeficiency Virus Type 1 Protease Inhibitor, UIC-94003 (TMC-126), and Selection of a Novel (A28S) Mutation in the Protease Active Site. J. Virol.
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Olivieri, J
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Demeter, L. M., Hughes, M. D., Coombs, R. W., Jackson, J. B., Grimes, J. M., Bosch, R. J., Fiscus, S. A., Spector, S. A., Squires, K. E., Fischl, M. A., Hammer, S. M.
(2001). Predictors of Virologic and Clinical Outcomes in HIV-1-Infected Patients Receiving Concurrent Treatment with Indinavir, Zidovudine, and Lamivudine: AIDS Clinical Trials Group Protocol 320. ANN INTERN MED
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Phillips, A. N., Staszewski, S., Weber, R., Kirk, O., Francioli, P., Miller, V., Vernazza, P., Lundgren, J. D., Ledergerber, B., for the Swiss HIV Cohort Study, the Frankfurt HIV,
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Schackman, B. R., Goldie, S. J., Weinstein, M. C., Losina, E., Zhang, H., Freedberg, K. A.
(2001). Cost-Effectiveness of Earlier Initiation of Antiretroviral Therapy for Uninsured HIV-Infected Adults. Am. J. Public Health
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Albrecht, M. A., Bosch, R. J., Hammer, S. M., Liou, S.-H., Kessler, H., Para, M. F., Eron, J., Valdez, H., Dehlinger, M., Katzenstein, D. A., the AIDS Clinical Trials Group 364 Study Team,
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Torti, C., Pozniak, A., Nelson, M., Hertogs, K., Gazzard, B. G.
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Sepkowitz, K. A.
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Bacheler, L., Jeffrey, S., Hanna, G., D'Aquila, R., Wallace, L., Logue, K., Cordova, B., Hertogs, K., Larder, B., Buckery, R., Baker, D., Gallagher, K., Scarnati, H., Tritch, R., Rizzo, C.
(2001). Genotypic Correlates of Phenotypic Resistance to Efavirenz in Virus Isolates from Patients Failing Nonnucleoside Reverse Transcriptase Inhibitor Therapy. J. Virol.
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Kodama, E.-I., Kohgo, S., Kitano, K., Machida, H., Gatanaga, H., Shigeta, S., Matsuoka, M., Ohrui, H., Mitsuya, H.
(2001). 4'-Ethynyl Nucleoside Analogs: Potent Inhibitors of Multidrug-Resistant Human Immunodeficiency Virus Variants In Vitro. Antimicrob. Agents Chemother.
45: 1539-1546
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Maga, G., Hübscher, U., Pregnolato, M., Ubiali, D., Gosselin, G., Spadari, S.
(2001). Potentiation of Inhibition of Wild-Type and Mutant Human Immunodeficiency Virus Type 1 Reverse Transcriptases by Combinations of Nonnucleoside Inhibitors and D- and L-({beta})-Dideoxynucleoside Triphosphate Analogs. Antimicrob. Agents Chemother.
45: 1192-1200
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Freedberg, K. A., Losina, E., Weinstein, M. C., Paltiel, A. D., Cohen, C. J., Seage, G. R., Craven, D. E., Zhang, H., Kimmel, A. D., Goldie, S. J.
(2001). The Cost Effectiveness of Combination Antiretroviral Therapy for HIV Disease. NEJM
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Staszewski, S., Keiser, P., Montaner, J., Raffi, F., Gathe, J., Brotas, V., Hicks, C., Hammer, S. M., Cooper, D., Johnson, M., Tortell, S., Cutrell, A., Thorborn, D., Isaacs, R., Hetherington, S., Steel, H., Spreen, W., for the CNAAB3005 International Study Team,
(2001). Abacavir-Lamivudine-Zidovudine vs Indinavir-Lamivudine-Zidovudine in Antiretroviral-Naive HIV-Infected Adults: A Randomized Equivalence Trial. JAMA
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Kanmaz, T. J., Lee, N. J.
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Archer, R. H., Dykes, C., Gerondelis, P., Lloyd, A., Fay, P., Reichman, R. C., Bambara, R. A., Demeter, L. M.
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Bacheler, L. T., Anton, E. D., Kudish, P., Baker, D., Bunville, J., Krakowski, K., Bolling, L., Aujay, M., Wang, X. V., Ellis, D., Becker, M. F., Lasut, A. L., George, H. J., Spalding, D. R., Hollis, G., Abremski, K.
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