Catherine K. Heitman

Research Triangle Park Foundation

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Cynthia L. Innes

National Institute of Environmental Health Sciences

Lawrence R. Boone

Centre for Human Genetics

Anton M. Jetten

National Institute of Environmental Health Sciences

Scott E. Justus

GlaxoSmithKline (Netherlands)

Terri Warren

Westover Heights Clinic

Kenneth H. Fife

Indiana University – Purdue University Indianapolis

Nigel Mercer

At Bristol

LL Lantieri

Université Paris-Est Créteil

Anthony Romania

Eye Center

René R. W. J. van der Hulst

Maastricht University

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Research Triangle Park Foundation

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GlaxoSmithKline (United States)

The University of Texas MD Anderson Cancer Center

Burroughs Wellcome Fund

Creative Commons

Indiana University – Purdue University Indianapolis

Sapienza University of Rome

Brigham and Women's Hospital

GlaxoSmithKline (Netherlands)

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Pharmacokinetics and Safety of Extemporaneously Compounded Valacyclovir Oral Suspension in Pediatric Patients from 1 Month through 11 Years of Age

Clinical Infectious Diseases (2009)

David W. Kimberlin Richard F. Jacobs S Weller Jan‐Stefan van der Walt Catherine K. Heitman

Valacyclovir provides enhanced acyclovir bioavailability in adults, but limited data are available in children. Children 1 month through 5 years of age with or at risk for herpesvirus infection received a single 25 mg/kg dose of extemporaneously compounded valacyclovir oral suspension (n = 57), whereaschildren1through 11 years of age received 10 mg/kg valacyclovir oral suspension twice daily for 3–5 days (herpes simplex virus infection) (n = 28) or 20 mg/kg 3 times daily for 5 days (varicella-zoster virus infection) (n = 27). Blood samples for pharmacokinetic analysis were collected during the 6 h after the first dose. Safety was monitored throughout the studies. Dose proportionality in the maximum observed concentration (Cmax) of acyclovir and the area under the concentration-time curve from time zero extrapolated to infinity (AUC0−∞) existed across the 10 to 20 mg/kg valacyclovir dose range. For children 2 through 5 years of age, an increase in dose from 20 to 25 mg/kg resulted in near doubling of the Cmax and AUC0−∞. Among infants 1 through 2 months of age receiving 25 mg/kg, the mean AUC0−∞ and Cmax were higher (∼60% and 30%, respectively) than those among older infants and children receiving the same dose. Valacyclovir oral suspension was well tolerated. No clinically significant trends were noted in clinical chemical, hematologic, or urinalysis values from screening to follow-up. Among children 3 months through 11 years of age, the 20 mg/kg dose of this formulation of valacyclovir oral suspension produces favorable acyclovir blood concentrations and is well tolerated. A dosing recommendation cannot be made for infants <3 months of age because of decreased clearance in this age group. ClinicalTrials.gov identifier: NCT00297206.

Suspension

10.1086/649212

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Citations (53)

An International, Randomized, Double-Blind, Placebo-Controlled, Study of Valacyclovir for the Suppression of Herpes Simplex Virus Type 2 Genital Herpes in Newly Diagnosed Patients

Sexually Transmitted Diseases (2008)

Kenneth H. Fife Terri Warren Scott E. Justus Catherine K. Heitman

In Brief Background: Antiviral suppressive therapy of genital herpes is often initiated based on the established pattern of recurrences in an individual. Because most persons with first episode herpes simplex virus type 2 (HSV-2) infection experience recurrences and because viral shedding occurs frequently in the first year after infection, we examined the strategy of initiating suppressive therapy shortly after diagnosis of genital HSV-2 infection. Subjects and Methods: From June 16, 2004 to July 26, 2006, 384 subjects from 74 sites in the United States, Canada, Argentina, Brazil, and Chile who were newly diagnosed with a first recognized episode of genital herpes at the time of the screening visit or within 3 months before the screening visit were randomized (2:1) to receive valacyclovir 1 g once daily or placebo for 24 weeks. Subjects were instructed to return to clinic during suspected genital herpes outbreaks for clinician confirmation of recurrences. Results: Valacyclovir significantly prolonged the time to first recurrence of HSV-2 genital herpes in newly diagnosed subjects compared with placebo, with approximately 43% of subjects on placebo and 71% of subjects on valacyclovir recurrence-free at 24 weeks (P <0.001). Valacyclovir significantly reduced the mean number of genital HSV-2 recurrences per month occurring during the 24-week study period (0.11 for valacyclovir, 0.48 for placebo, P <0.001). Adverse events were comparable in the valacyclovir and placebo arms. Conclusion: Valacyclovir 1 g once daily administered for 24 weeks was well-tolerated and effective in suppressing genital herpes recurrences in immunocompetent newly diagnosed persons without an established recurrence pattern. Subjects with newly diagnosed herpes simplex virus type 2 genital herpes randomized to daily valacyclovir suppression had prolonged time to first recurrence and fewer recurrences over 24 weeks than subjects randomized to placebo.

Herpes Genitalis

Valaciclovir

Sex organ

Viral Shedding

Genital warts

10.1097/olq.0b013e31816d1f42

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Citations (29)

Treatment of active refractory rheumatoid arthritis with humanized monoclonal antibody campath‐1h administered by daily subcutaneous injection

Arthritis & Rheumatism (1995)

Eric L. Matteson David E. Yocum E. William St. Clair Antonio A. Achkar Michael S. Thakor

Abstract Objective. To investigate the dose tolerance and potential clinical activity of a humanized antilymphocyte monoclonal antibody, CAMPATH‐1H (C1H), in patients with active, refractory rheumatoid arthritis (RA). Methods . Thirty adult patients with active, refractory RA were treated in an open‐label, 3‐center, dose‐escalation study of subcutaneously injected C1H. Six patients were assigned to each of 5 dosage groups (0.3, 1.0, 3.0, 10.0 or 30.0 mg/day), and received 10 daily injections of C1H over a 12‐day period. Results . Side effects occurred primarily during the first 1–2 days of dosing, and included mild fever, chills, nausea, vomiting, headache, and, in a minority of patients, hypotension. All patients developed some discomfort at the injection site. Self‐limited infections occurred in 5 patients during the 6‐month study period. Peripheral blood lymphocyte counts fell promptly after initial dosing and recovered slowly, usually over 2–3 months. Serum antibodies to C1H developed in 54% of patients following treatment. Clinical improvement was observed in 56% of patients, based on the composite Paulus criteria, with a median time‐to‐response of 22 days and a median response duration of 32 days. Conclusion . C1H is a lymphocyte‐depleting antibody that exhibits biologic potency when administered subcutaneously to patients with refractory RA. Its use is associated with mild to moderate toxicity and short‐term amelioration of disease activity.

Chills

Refractory (planetary science)

10.1002/art.1780380903

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Citations (67)

Analysis of Fv-1 restriction in two murine embryonal carcinoma cell lines and a series of differentiated derivatives

Journal of General Virology (1991)

Catherine K. Heitman Cynthia L. Innes Anton M. Jetten Lawrence R. Boone

We have used antibiotic-resistant retrovirus vectors rescued by Fv-1-sensitive murine leukaemia viruses (MuLV) to examine the Fv-1 phenotype of two undifferentiated embryonal carcinoma (EC) cell lines derived from teratocarcinomas of mouse strain 129. In addition, a set of EC cell-derived differentiated cell lines was analysed. Restriction of both B-tropic and endogenous N-tropic virus is characteristic of the Nr-type restriction reported in mouse strain 129. However, results indicate that Fv-1 restriction is not expressed in the PCC4.aza1R EC cell line. In contrast, the F9 EC cell line showed a strong restriction of the B-tropic pseudotyped vector but failed to restrict endogenous N-tropic pseudotypes. The Fv-1 gene thus seems to be differentially expressed in two EC cell lines derived from the same mouse strain. Furthermore, the selective restriction of B-tropic but not endogenous N-tropic MuLV in F9 cells suggests that these activities function independently of each other. Analysis of PCC4.aza1R-derived differentiated cell lines revealed that three fibroblast cell lines derived by retinoic acid-induced differentiation were also phenotypically silent for Fv-1. However, a pre-adipocyte line established following simultaneous exposure to retinoic acid and 5-azacytidine showed strong restriction of both B-tropic and endogenous N-tropic MuLV. Although additional data suggest that there is no correlation between the differentiated pre-adipocyte phenotype and Fv-1 expression, our results nonetheless show that Nr restriction can be observed in some derivatives of PCC4.aza1R cells, presumably by activating expression of the Fv-1 gene.

Embryonal carcinoma

10.1099/0022-1317-72-3-609

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Citations (1)

Abrogation of Fv-1 restriction by genome-deficient virions produced by a retrovirus packaging cell line

Journal of Virology (1990)

Lawrence R. Boone Cynthia L. Innes Catherine K. Heitman

The Fv-1b-mediated restriction of N-tropic retrovirus vector infection of BALB/3T3 cells was partially abrogated by prior infection with N-tropic murine leukemia virus. Likewise, abrogation of the Fv-1b restriction of N-tropic murine leukemia virus replication was accomplished by prior infection with genome-deficient virions produced by an N-tropic murine leukemia virus packaging cell line. The latter observation suggests that the Fv-1 target in genome-deficient virions abrogates Fv-1 restriction in the absence of any viral genome-directed processes.

3T3 cells

10.1128/jvi.64.7.3376-3381.1990

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Citations (31)

Effect of Valacyclovir on Viral Shedding in Immunocompetent Patients With Recurrent Herpes Simplex Virus 2 Genital Herpes: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Mayo Clinic Proceedings (2006)

Kenneth H. Fife Terri Warren René Ferrera Douglas Young Scott E. Justus

Viral Shedding

Subclinical infection

10.4065/81.10.1321

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Citations (30)

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): Review of Epidemiology and Prevalence Assessment in Europe

Aesthetic Surgery Journal (2020)

Fabio Santanelli di Pompeo Michail Sorotos Mark W. Clemens Guido Firmani Ηλίας Αθανασόπουλος

Abstract Background Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) epidemiologic studies focus on incidence and risk estimates. Objectives The aim of this study was to perform a thorough literature review, and to provide an accurate estimate of BIA-ALCL prevalence in Europe. Methods We searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications reporting BIA-ALCL epidemiology. Research was conducted between November 2019 and August 2020. European prevalence was assessed as the ratio between pathology-confirmed cases and breast implant–bearing individuals. The Committee on Device Safety and Development (CDSD) collected data from national plastic surgery societies, health authorities, and disease-specific registries to calculate the numerator. The denominator was estimated by combining European demographic data with scientific reports. Results Our research identified 507 articles: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 articles, we selected 35 that discussed epidemiology and 12 reviews. The CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the 28 member states of the European Union (EU-28). Countries where specific measures have been implemented to tackle BIA-ALCL account for 61% of the EU-28 population and actively reported 382 cases with an overall prevalence of 1:9121. Conclusion Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared with the European mean, suggesting that these countries have improved the detection of the condition and reduced underreporting, which affects the numerator value. Other nations should adopt projections based on these measures to avoid underestimating how widespread BIA-ALCL is. Level of Evidence: 4

Anaplastic large-cell lymphoma

Breast implant

10.1093/asj/sjaa285

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Citations (42)

Differential Expression of Fv‐1 in Fibroblasts Derived from Embryonal Carcinoma Cells

Annals of the New York Academy of Sciences (1989)

Catherine K. Heitman Cynthia L. Innes Anton M. Jetten Lawrence R. Boone

10.1111/j.1749-6632.1989.tb16480.x

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