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Recombinant Human Erythropoietin in the Treatment of Anemia Associated with Human Immunodeficiency Virus (HIV) Infection and Zidovudine Therapy
Overview of Four Clinical Trials
- David H. Henry, MD;
- Gildon N. Beall, MD;
- Constance A. Benson, MD;
- John Carey, MD;
- Lawrence A. Cone, MD;
- Lawrence J. Eron, MD;
- Milan Fiala, MD;
- Margaret A. Fischl, MD;
- Stephen J. Gabin, MD;
- Michael S. Gottlieb, MD;
- Jeffrey E. Galpin, MD;
- Jerome E. Groopman, MD;
- Thomas M. Hooton, MD;
- Joseph G. Jemsek, MD;
- Randy L. Levine, MD;
- Steven A. Miles, MD;
- John J. Rinehart, MD;
- Adan Rios, MD;
- William J. Robbins, MD;
- John C. Ruckdeschel, MD;
- Jean A. Smith, MD;
- Spotswood L. Spruance, MD;
- Barbara Starrett, MD;
- John Toney, MD;
- Ralph Zalusky, MD;
- Robert I. Abels, MD;
- Edward C. Bryant, DrPH;
- Kay M. Larholt, ScD;
- Allan R. Sampson, PhD; and
- Seth A. Rudnick, MD
Abstract
▪ Objective: To assess the effect of recombinant human erythropoietin (r-HuEPO) on anemia in patients with the acquired immunodeficiency syndrome (AIDS) who are receiving zidovudine therapy.
▪ Design: Combined analysis of four 12-week, randomized, double-blind, controlled clinical trials.
▪ Setting: Multiple centers in the United States.
▪ Patients: Two hundred and ninety-seven anemic (hematocrit < 30%) patients with AIDS who were receiving zidovudine therapy. Of the 297 patients, 255 were evaluable for efficacy, but all patients were included in analysis of safety.
▪ Intervention: Patients were randomly assigned to receive either r-HuEPO (100 to 200 U/kg body weight) or placebo, intravenously or subcutaneously, three times per week for up to 12 weeks.
▪ Measurements: Changes in mean hematocrit, transfusion requirement, and quality of life.
▪ Results: Sixty-nine percent of patients had endogenous serum erythropoietin levels less than or equal to 500 IU/L, and 31% had erythropoietin levels greater than 500 IU/L. In patients with low erythropoietin levels (≤ 500 IU/L), r-HuEPO therapy decreased the mean number of units of blood transfused per patient when compared with placebo (3.2 units and 5.3 units, respectively; P = 0.003) and increased the mean hematocrit from the baseline level (4.6 percentage points and 0.5 percentage points, respectively; P < 0.001). Overall quality of life improved in patients on r-HuEPO therapy (P= 0.13). Patients with erythropoietin levels greater than 500 IU/L showed no benefit from r-HuEPO in any outcome variable. Placebo and r-HuEPO recipients did not differ in the incidence of adverse effects or opportunistic infections.
▪ Conclusion: Therapy with r-HuEPO can increase the mean hematocrit and decrease the mean transfusion requirement in anemic patients with AIDS who are receiving zidovudine and have endogenous low erythropoietin levels (< 500 IU/L). Such therapy is of no apparent benefit in patients whose endogenous erythropoietin levels are higher than 500 IU/L.
Article and Author Information
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For current author affiliations and addresses, see end of text.
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Grant Support: In part by grants from the R.W. Johnson Pharmaceutical Research Institute.
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Requests for Reprints: David H. Henry, MD, Graduate Hospital, 1840 South Street, Philadelphia, PA 19146.
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Current Author Addresses: Dr. Henry: The Tuttleman Center, Second Floor, Hematology/Oncology, 1840 South Street, Philadelphia, PA 19146.
Dr. Beall: Division of Allergy and Clinical Immunology, Harbor-UCLA Medical Center, Box 459, 1000 West Carson Street, Torrance, CA 90509.
Dr. Benson: 1750 West Harrison, Suite 140 Ad Fac, Chicago, IL 60612.
Dr. Carey: University Hospital of Cleveland, Department of Infectious Diseases, 2074 Abington Road, Cleveland, OH 44106.
Dr. Cone: Eisenhower Medical Center, Probst Building, Suite 308, 39000 Bob Hope Drive, Rancho Mirage, CA 92270.
Dr. Eron: Infectious Diseases Physicans Inc., 3289 Woodburn Road, #200, Annandale, VA 22003.
Dr. Fiala: Department of Neurology, UCLA School of Medicine, 710 Westwood Plaza, Los Angeles, CA 90024-1769.
Dr. Fischl: University of Miami School of Medicine, P.O. Box 016960 (R-60A), Miami, FL 33101.
Dr. Gabin: 2080 Century Park East, Suite 710, Los Angeles, CA 90067.
Dr. Gottlieb: The Gottlieb Medical Group, 4955 Van Nuys Boulevard, Suite 715, Sherman Oaks, CA 91403.
Dr. Galpin: 5525 Etiwanda Avenue, Suite 222, Tarzana, CA 91356.
Dr. Groopman: Hematology/Oncology, New England Deaconess Hospital, 110 Francis Street, Suite 4A, Boston, MA 02215.
Dr. Hooton: Department of Medicine, Harborview Medical Center, ZA-89, 325 Ninth Avenue, Seattle, WA 98104.
Dr. Jemsek: Nalle Clinic, 1350 South Kings Drive, Charlotte, NC 28207.
Dr. Levine: Transfusion Services, Roosevelt Hospital, 425 West 59th Street, Suite 4B, New York, NY 10019.
Dr. Miles: UCLA CARE Center, Room BH 412C, CHS Code 179320, Los Angeles, CA 90024-1793.
Dr. Rinehart: Scott and White Clinic, 2401 South 31st Street, Temple, TX 76508.
Dr. Rios: Two Memorial Southwest Hospital, 7737 S.W. Freeway, Suite 730, Houston, TX 77074.
Dr. Robbins: 5385 Conroy Road, Suite 100, Orlando, FL 32811.
Dr. Ruckdeschel, H. Lee Moffitt Cancer Center, 12902 Magnolia Boulevard, Tampa, FL 33612.
Dr. Smith: Division of Infectious Diseases, University of Texas Health Science Center, 7703 Floyd Curl Drive, San Antonio, TX 78284.
Dr. Spruance: Division of Infectious Diseases, University of Utah School of Medicine, 50 N. Medical Drive, Salt Lake City, UT 84132.
Dr. Starrett: 14 East 4th Street, Suite 505, New York, NY 10012.
Dr. Toney: Division of Infectious and Tropical Diseases, University of South Florida, 1901 Bruce B. Downs Boulevard, Box 19, Tampa, FL 33612.
Dr. Zalusky: Beth Israel Hospital, Dazian Pavilion, 10th Floor, First Avenue and 16th Street, New York, NY 10003.
Drs. Abels, Bryant, and Larholt: The R.W. Johnson Pharmaceutical Research Institute, Route 202, Raritan, NJ 08869.
Dr. Sampson: Department of Mathematics and Statistics, University of Pittsburgh, Pittsburgh, PA 15260.
Dr. Rudnick: Cellular Transplants, Inc., 2 Richmond Square, Providence, RI 02906.
- © 1992 American College of Physicians
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