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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
[+] Article, Author, and Disclosure Information

Grant Support: In part by grants from the R.W. Johnson Pharmaceutical Research Institute.

Requests for Reprints: David H. Henry, MD, Graduate Hospital, 1840 South Street, Philadelphia, PA 19146.

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 PhysiciansAmerican College of Physicians

Ann Intern Med. 1992;117(9):739-748. doi:10.7326/0003-4819-117-9-739
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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.





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