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Antimicrobial Agents and Chemotherapy, May 1998, p. 1139-1145, Vol. 42, No. 5
0066-4804/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Sorivudine versus Acyclovir for Treatment of Dermatomal Herpes Zoster in Human Immunodeficiency Virus-Infected Patients: Results from a Randomized, Controlled Clinical Trial

John W. Gnann Jr.,1,* Clyde S. Crumpacker,2 Jacob P. Lalezari,3,dagger Jean A. Smith,4 Stephen K. Tyring,5 Kenneth F. Baum,6 Michael J. Borucki,7 W. Patrick Joseph,8 Gregory J. Mertz,9 Roy T. Steigbigel,10 Gretchen A. Cloud,11 Seng-jaw Soong,12 Lanette C. Sherrill,11 Deborah A. DeHertogh,13 Richard J. Whitley, and the Collaborative Antiviral Study Group (Casg)/aids Clinical Trials Group (Actg) Herpes Zoster Study GroupDagger

Division of Infectious Diseases,1 Comprehensive Cancer Center,11 and Department of Pediatrics, Children's Hospital,12 University of Alabama at Birmingham, Birmingham, Alabama; Beth Israel Deaconess Medical Center, Boston, Massachusetts2; Mount Zion Medical Center, San Francisco, California3; Division of Infectious Diseases, Department of Medicine, University of Texas Health Sciences Center, San Antonio, Texas4; Department of Microbiology/Immunology, University of Texas Medical Branch,5 and University of Texas Medical Branch,7 Galveston, Texas; Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver, Colorado6; Infectious Diseases Medical Group, Oakland, California8; Department of Medicine, Division of Infectious Diseases, University of New Mexico School of Medicine, Albuquerque, New Mexico9; Division of Infectious Diseases, State University of New York, Stony Brook, New York10; and Bristol-Myers Squibb, Princeton, New Jersey13

Received 15 September 1997/Returned for modification 18 December 1997/Accepted 17 February 1998

The present randomized, double-blind, placebo-controlled, multicenter clinical trial was designed to compare the efficacy and tolerability of sorivudine [1-beta -D-arabinofuranosyl-E-(2-bromovinyl)uracil] and acyclovir for the treatment of dermatomal herpes zoster in human immunodeficiency virus (HIV)-seropositive patients. A total of 170 HIV-seropositive adults presenting with herpes zoster (confirmed by direct fluorescent-antigen testing and/or viral culture) were enrolled and randomized to receive a 10-day course of orally administered sorivudine (40 mg once daily plus acyclovir placebos) or acyclovir (800 mg five times daily plus sorivudine placebo). Patients were monitored daily to document the events of cutaneous healing, pain, zoster-related complications, and drug-related adverse events. Patients were reassessed on days 21 and 28 and then once monthly for 1 year. The primary efficacy endpoint was time to the cessation of new vesicle formation. Secondary efficacy endpoints included times to other events of cutaneous healing, resolution of pain, and frequency of dissemination and zoster recurrence. In a multivariate analysis, sorivudine was superior to acyclovir for reducing the times to the cessation of new vesicle formation (relative risk [RR] = 1.54, 95% confidence interval [CI] = 1.00 to 2.36; P = 0.049) and total lesion crusting (RR = 1.48, 95% CI = 1.07 to 2.04; P = 0.017). In a univariate analysis, there was a trend favoring sorivudine for the cessation of new vesicle formation (median of 3 versus 4 days; P = 0.07) and a significant advantage for time to total lesion crusting (median of 7 versus 8 days; P = 0.02). The time to the resolution of zoster-associated pain, the frequency of dissemination, and the frequency of zoster recurrence were not different between the two treatment groups. Both drugs were well tolerated. Sorivudine is an effective drug for the treatment of herpes zoster in HIV-infected patients and results in accelerated cutaneous healing when compared with acyclovir therapy.

* Corresponding author. Mailing address: Division of Infectious Diseases, University of Alabama at Birmingham, 845 19th St. South, Birmingham, AL 35294-2170. Phone: (205) 934-2366. Fax: (205) 975-5718. E-mail: jgnann{at}uabid.dom.uab.edu.

dagger Present address: Quest Clinical Research, San Francisco, CA 94115.

Dagger Investigators in the CASG/ACTG Herpes Zoster Study Group are listed in the Appendix.

Antimicrobial Agents and Chemotherapy, May 1998, p. 1139-1145, Vol. 42, No. 5
0066-4804/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


This article has been cited by other articles:

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  • Gnann, J. W. Jr., Whitley, R. J. (2002). Herpes Zoster. NEJM 347: 340-346 [Full Text]  
  • Li, L., Dutschman, G. E., Gullen, E. A., Tsujii, E., Grill, S. P., Choi, Y., Chu, C. K., Cheng, Y.-c. (2000). Metabolism and Mode of Inhibition of Varicella-Zoster Virus by L-beta -5-Bromovinyl-(2-hydroxymethyl)-(1,3-dioxolanyl)uracil Is Dependent on Viral Thymidine Kinase. Mol. Pharmacol. 58: 1109-1114 [Abstract] [Full Text]  


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