Infections

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Herpes Simplex

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Skin Diseases, Viral

Skin Diseases, Infectious

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Acyclovir

Valacyclovir

Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections

Patients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections

Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring

Pharmacokinetic analysis

Natalia Maximova, MD

Antonello Di Paolo, MD

* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality.
* Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals.
* Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection.
* Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection.
* Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children.
* Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

Herpesvirus infections may lead to severe disease with a high risk of complications and mortality in hematopoietic stem cell transplant (HSCT) recipients, or in patients receiving high-intensity chemotherapy for hematological malignancies. That risk is mainly associated with the worldwide prevalence of herpes simplex virus 1 (HSV-1) that increases consistently with age. In particular, the majority of adult leukemia patients are HSV seropositive, while allogeneic HSCT recipients had post-transplant HSV reactivation. It is worth noting that in the first post-transplant year, symptomatic varicella-zoster virus (VZV) reactivation has a rate of 13% - 55% in adult recipients. Similar percentages of children receiving HSCT had VZV reactivation, being also possible a disseminated infection in 10% of children. However, thanks to antiviral prophylaxis in seropositive HSCT recipients, the rate of infection has significantly dropped.

Among the drugs most used for treatment and prophylaxis of HSV/VZV infections among children who are HSCT recipients or undergo a high-intensity chemotherapy, acyclovir represents the drug of choice. Although its role in preventing and treating herpes virus infections, the pharmacokinetics of acyclovir is highly variable, especially in patients in intensive care units, in those who have organ dysfunction, or in children. In particular, information about the optimal use of acyclovir in children with malignancies is limited.

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy

Individual partecipant data will not be disclosed as per protocol and Ethics Committee requests. Protocol will be shared upon request, as well as the overall findings of the study

Percentage of patients who achieve an acyclovir minimum plasma concentration at steady state ≥0.5 mg/L, considered as an effective plasma concentration

IRCCS Burlo Garofolo

University of Pisa

Associate Professor of Pharmacology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients	NCT05198570	Herpesviridae I... Herpes Simplex ... Varicella Zoste... Transplantation... Oncology	Pharmacokinetic...	6 Months - 18 Years	University of Pisa
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients	NCT05198570	Herpesviridae I... Herpes Simplex ... Varicella Zoste... Transplantation... Oncology	Pharmacokinetic...	6 Months - 18 Years	University of Pisa
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients	NCT05198570	Herpesviridae I... Herpes Simplex ... Varicella Zoste... Transplantation... Oncology	Pharmacokinetic...	6 Months - 18 Years	University of Pisa

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