Safety and efficacy of CMX001 as salvage therapy for severe adenovirus infections in immunocompromised patients.

dc.contributor.author

Florescu, Diana F

dc.contributor.author

Pergam, Steven A

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Neely, Michael N

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Qiu, Fang

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Johnston, Christine

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Way, SingSing

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Sande, Jane

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Lewinsohn, Deborah A

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Guzman-Cottrill, Judith A

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Graham, Michael L

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Papanicolaou, Genovefa

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Kurtzberg, Joanne

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Rigdon, Joseph

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Painter, Wendy

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Mommeja-Marin, Herve

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Lanier, Randall

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Anderson, Maggie

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van der Horst, Charles

dc.date.accessioned

2022-03-23T20:02:48Z

dc.date.available

2022-03-23T20:02:48Z

dc.date.issued

2012-05

dc.date.updated

2022-03-23T20:02:48Z

dc.description.abstract

No therapeutic agent has yet been established as the definitive therapy for adenovirus infections. We describe the clinical experience of 13 immunocompromised patients who received CMX001 (hexadecyloxypropyl cidofovir), an orally bioavailable lipid conjugate of cidofovir, for adenovirus disease. We retrospectively analyzed 13 patients with adenovirus disease and viremia treated with CMX001; data were available for ≥ 4 weeks after initiation of CMX001 therapy. Virologic response (VR) was defined as a 99% drop from baseline or undetectable adenovirus DNA in serum. The median age of the group was 6 years (range, 0.92-66 years). One patient had severe combined immunodeficiency, 1 patient was a small bowel transplant recipient, and 11 were allogeneic stem cell transplant recipients. Adenovirus disease was diagnosed at a median of 75 days (range, 15-720 days) after transplantation. All patients received i.v. cidofovir for a median of 21 days (range, 5-90 days) before CMX001 therapy. The median absolute lymphocyte count at CMX001 initiation was 300 cells/μL (range, 7-1500 cells/μL). Eight patients (61.5%) had a ≥ 1 log10 drop in viral load after the first week of therapy. By week 8, 9 patients (69.2%) demonstrated a VR, with a median time to achieve VR of 7 days (range, 3-35 days). The change in absolute lymphocyte count was inversely correlated with the change in log10 viral load only at week 6 (r = -0.74; P = .03). Patients with VR had longer survival than those without VR (median 196 days versus 54.5 days; P = .04). No serious adverse events were attributed to CMX001 during therapy. CMX001 may be a promising therapeutic option for the treatment of severe adenovirus disease in immunocompromised patients.

dc.identifier

S1083-8791(11)00383-1

dc.identifier.issn

1083-8791

dc.identifier.issn

1523-6536

dc.identifier.uri

https://hdl.handle.net/10161/24674

dc.language

eng

dc.publisher

Elsevier BV

dc.relation.ispartof

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

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10.1016/j.bbmt.2011.09.007

dc.subject

Humans

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Adenoviridae

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Adenoviridae Infections

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Cytosine

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Antiviral Agents

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Treatment Outcome

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Salvage Therapy

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Stem Cell Transplantation

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Transplantation, Homologous

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Viral Load

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Severity of Illness Index

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Retrospective Studies

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Immunocompromised Host

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Adolescent

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Adult

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Aged

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Middle Aged

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Child

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Child, Preschool

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Infant

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Female

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Male

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Organophosphonates

dc.title

Safety and efficacy of CMX001 as salvage therapy for severe adenovirus infections in immunocompromised patients.

dc.type

Journal article

duke.contributor.orcid

Kurtzberg, Joanne|0000-0002-3370-0703

pubs.begin-page

731

pubs.end-page

738

pubs.issue

5

pubs.organisational-group

Duke

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School of Medicine

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Clinical Science Departments

pubs.organisational-group

Institutes and Centers

pubs.organisational-group

Pathology

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Pediatrics

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Duke Cancer Institute

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Institutes and Provost's Academic Units

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Initiatives

pubs.organisational-group

Duke Innovation & Entrepreneurship

pubs.organisational-group

Pediatrics, Transplant and Cellular Therapy

pubs.publication-status

Published

pubs.volume

18

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