1. Morbidity and Toxic Effects Associated With Ganciclovir or Foscarnet Therapy in a Randomized Cytomegalovirus Retinitis Trial
- Author
-
Robert Nussenblatt, Tobias Samo, Joyce A. Korvick, Michele Donithan, Michael C. Smith, Joan M. Kline, Dale Henderly, Karen L. Binder, Gary Stewart, Mary Ann Simanello, Matthew D. Davis, William Freeman, Alan H. Friedman, B. Barron, Camara P. Jones, Suzette Chafey, Richard Haubrich, Pamela Clogston, Karen Tolson, Kathleen Naughton, Jan A. Markowitz, Milana R. Isaacson, Sarah H. Cheeseman, Paul Mendez, Jose I. Quiceno, Harry Kachadoorian, Henry S. Sacks, Yuan-I Min, Larry Hubbard, Dorothy N. Friedberg, Byron W. Brown, Jude Brown-Bellamy, James P. Dunn, Harmon Smith, James Larson, John P. Phair, James Tonascia, John P. Mills, Stephen A. Spector, Susanne Wise-Campbell, Amy C. Klemm, T. Flynn, Maria Agres-Segal, Elaine Chuang, Gordon R. Sandford, Lee M. Jampol, Ronald Gross, Nancy Fink, Bruce Polsky, Robert L. Murphy, Douglas A. Jabs, Pamela S. Clogston, Leland Rickman, Alexander Irvine, Adrienne Addessi, Rudolph Franklin, Colette Severin, Stuart Seiff, Rosetta M. Owens, Ginger Freitag, Dolores Hurlburt, Linda Kastorff, Rosemary King, Kathleen Miner, Mark A. Jacobson, Lois Eldred, Gholam Peyman, Brian Conway, Gary N. Holland, Suzanne Thomas, John W. Gittinger, Judith Feinberg, W. David Hardy, Mark L. Van Natta, Janet T. Holbrook, Marilyn Vanderhoof-Young, Murk-Hein Heinemann, Kathleen Squires, Lesley J. MacArthur, Jo Leslie, Richard A. Lewis, Lisa Welch, Ruth Vandenbroucke, Richard Mowery, Ronald Brookmeyer, Charlotte Gerczak, David S. Weinberg, Stephen Singer, Janet Davis, Chris Kimbrell, John Dodge, William R. Freeman, Maria Stevens, Victor Fainstein, Susan S. Ellenberg, James O'Donnell, Kevin Frost, Colette Tuttle, Deborah Greenspan, Steven Teich, Colin Jordan, Douglas Dieterich, Yvonne Magli, Norma Justin, T. Clark, Alfred J. Saah, John G. Bartlett, Curtis L. Meinert, Fred R. Sattler, Tony W. Cheung, J. L. Meinert, Vivian E. Brown, Holly Fall, Rene Webb, James Grizzle, Maxine Wanner, Timothy J. Peterson, Robert A. Hughes, Linda Meixnert, Deborah J. Nowakowski, Alice L. Sternberg, Linda Apuzzo, Jacqueline Hoffman, Jane Armstrong, Millie Espinal, Charlene R. Levine, Betty J. Collison, Cynthia Le-Count, and Laura Coleson
- Subjects
Ganciclovir ,Foscarnet ,medicine.medical_specialty ,business.industry ,Incidence (epidemiology) ,virus diseases ,biochemical phenomena, metabolism, and nutrition ,Neutropenia ,medicine.disease ,Gastroenterology ,Nephrotoxicity ,Surgery ,Internal medicine ,Internal Medicine ,medicine ,Initial treatment ,In patient ,Cytomegalovirus retinitis ,business ,medicine.drug - Abstract
Background: The Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial compared the use of either ganciclovir or foscarnet for the initial treatment of cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome. We previously reported that patients treated with foscarnet lived longer but were more likely to have their treatment switched, the latter suggesting foscarnet may not have been as well tolerated as ganciclovir. This study compared the morbidity and toxic reactions reported during the trial. Methods: Two hundred thirty-four patients with the acquired immunodeficiency syndrome and previously untreated cytomegalovirus retinitis at 11 university centers were randomly assigned to receive intravenously either foscarnet (n=107) or ganciclovir (n=127). Medical histories, laboratory tests, and drug treatment histories during the first 6 months of treatment were analyzed. Results: Neutropenia was more common in patients assigned to ganciclovir than to foscarnet (34% vs 14%;P=.001). Patients assigned to foscarnet reported more infusion-related symptoms (58% vs 24%;P .001); they also experienced a trend toward more nephrotoxic effects (13% vs 6%;P=.082) and electrolyte abnormalities. The incidence of seizures was similar in both groups (foscarnet, 12%; ganciclovir, 9%;P=.511). Patients assigned to foscarnet were more likely to be switched to the alternative treatment (foscarnet to ganciclovir, 46%; ganciclovir to foscarnet, 11%;P Conclusions: Compared with ganciclovir, the use of foscarnet was more frequently limited by the occurrence of toxic reactions. However, these toxic reactions rarely had long-term sequelae. In light of the previously reported survival benefit seen in patients treated with foscarnet, these data support the use of foscarnet for the initial treatment of cytomegalovirus retinitis. (Arch Intern Med. 1995;155:65-74)
- Published
- 1995