Refractory and Resistant Herpes Simplex Virus Mucocutaneous Infections in Immunocompromised Patients: Literature Review and Proposed Definitions for Use in Clinical Trials

Author:

Chemaly Roy F1ORCID,Shafat Tali1ORCID,Wald Anna2ORCID,Kotton Camille N3ORCID,Papanicolaou Genovefa45ORCID,Yong Michelle K678,Miller Veronica9ORCID,Komatsu Takashi E10ORCID,Mullick Charu10,Hodowanec Aimee C10ORCID,Westman Gabriel1112,Khawaja Fareed1ORCID,Birkmann Alexander13ORCID,Ljungman Per1415ORCID

Affiliation:

1. Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center , Houston, Texas ,

2. Departments of Medicine, Laboratory Medicine and Pathology, and Epidemiology, University of Washington School of Medicine and Vaccine and Infectious Diseases Division, Fred Cancer Research Center , Seattle, Washington ,

3. Transplant Infectious Diseases, Massachusetts General Hospital , Boston, Massachusetts ,

4. Infectious Diseases Service, Department of Medicine, Memorial Sloan Kettering Cancer Center , New York, New York ,

5. Department of Medicine, Weill Cornell Medical College , New York, New York ,

6. Department of Infectious Diseases, Peter MacCallum Cancer Centre , Melbourne ,

7. Sir Peter MacCallum Department of Oncology, University of Melbourne , Melbourne ,

8. Department of Infectious Diseases, Royal Melbourne Hospital , Melbourne ,

9. Forum for Collaborative HIV Research, University of California , Berkeley, California ,

10. Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland ,

11. Swedish Medical Products Agency , Uppsala ,

12. Department of Medical Sciences, Section of Infectious Diseases, Uppsala University , Uppsala ,

13. AiCuris Anti-Infective Cures AG , Wuppertal ,

14. Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center , Stockholm ,

15. Department of Medicine Huddinge, Division of Hematology, Karolinska Institute , Stockholm ,

Abstract

Abstract Herpes simplex virus (HSV) infection is one of the most prevalent viral infections worldwide. In general, host immunity is sufficient to clear viral shedding and recurrences, although it is insufficient to prevent subsequent virologic reactivations. In immunocompromised patients, prolonged and difficult-to-treat HSV infections may develop. The diagnosis of refractory HSV infection is based on the lack of clinical response to nucleoside analogs. Antiviral resistance is confirmed via genotypic and/or phenotypic testing. To provide consensus definitions of refractory and/or resistant (R/R) HSV mucocutaneous infections for clinical trial use, the HSV Resistance Working Group of the Transplant Associated Viral Infections Forum, which includes international clinicians, scientists, industry representatives, and regulatory officials, conducted a literature review of previously published data related to R/R HSV infections in immunocompromised patients. We propose definitions of R/R HSV mucocutaneous infections, which will be subject to re-evaluation and revision based on forthcoming data and future studies.

Funder

Transplantation Associated Virus Infections

Publisher

Oxford University Press (OUP)

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