RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 α1 and α2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study.

Introduction: A unique anti-interleukin (IL)-13 monoclonal antibody, RPC4046, was generated on the basis of differential IL-13 receptor (R) blockade as assessed in a murine asthma model; the safety, tolerability, pharmacokinetics, and pharmacodynamics of RPC4046 were evaluated in a first-in-human study.

Methods: Anti-IL-13 antibodies with varying receptor blocking specificity were evaluated in the ovalbumin-induced murine asthma model. A randomized, double-blind, placebo-controlled, dose-escalation first-in-human study (NCT00986037) was conducted with RPC4046 in healthy adults and patients with mild to moderate controlled asthma.

Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial.

Importance: Patients co-infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are at high risk for liver disease progression. However, interferon-based treatments for HCV infection have significant toxicities, limiting treatment uptake.

Objective: To assess the all-oral 3 direct-acting antiviral (3D) regimen of ombitasvir, paritaprevir (co-dosed with ritonavir [paritaprevir/r]), dasabuvir, and ribavirin in HCV genotype 1-infected adults with HIV-1 co-infection, including patients with cirrhosis.

ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis.

Background: Interferon-containing regimens for the treatment of hepatitis C virus (HCV) infection are associated with increased toxic effects in patients who also have cirrhosis. We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r), the NS5A inhibitor ombitasvir (ABT-267), the nonnucleoside polymerase inhibitor dasabuvir (ABT-333), and ribavirin in an open-label phase 3 trial involving previously untreated and previously treated adults with HCV genotype 1 infection and compensated cirrhosis.

Methods: We randomly assigned 380 patients with Child-Pugh class A cirrhosis to receive either 12 or 24 weeks of treatment with ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), dasabuvir (250 mg twice daily), and ribavirin administered according to body weight.

Compliance with RSV prophylaxis: Global physicians' perspectives.

Respiratory syncytial virus (RSV) is a significant cause of morbidity in high-risk infants. Palivizumab is proven to prevent serious RSV disease, but compliance with prophylaxis (monthly doses during the RSV season) is essential to ensure protection. We invited 453 pediatricians to participate in a survey to identify their perspectives of barriers to compliance and interventions to improve compliance with palivizumab prophylaxis schedules.

A hybrid strategy for the prevention of cytomegalovirus-related complications in pediatric liver transplantation recipients.

Background: This single center, retrospective study describes experience with a hybrid prevention strategy combining short-course antiviral prophylaxis and preemptive cytomegalovirus (CMV) polymerase chain reaction (PCR) monitoring.

Methods: One hundred twenty-two pediatric liver transplantation recipients were followed up for a median of 2.3 years posttransplantation.

First case of toxoplasmosis following small bowel transplantation and systematic review of tissue-invasive toxoplasmosis following noncardiac solid organ transplantation.

Background: Toxoplasmosis prophylaxis is standard following heart and heart lung transplantation, when an increased risk of allograft transmitted Toxoplasma is well-recognized. In contrast, prophylaxis and routine serologic evaluation of donors and recipients for Toxoplasma in noncardiac solid organ transplantation (SOT) is not recommended. We report the first case of disseminated toxoplasmosis following small bowel transplantation, presumably transmitted via the transplanted intestine and systematically review reported cases of toxoplasmosis in noncardiac SOT recipients to determine if current guidelines should be reconsidered.

Immunization of pediatric solid-organ transplantation candidates: immunizations in transplant candidates.

Many children who receive solid-organ transplants have not completed their primary immunizations prior to transplantation. This leaves pediatric transplant recipients susceptible to the vaccine preventable illness of childhood, which if acquired post-transplantation are associated with increased rates of complications, hospitalization, graft rejection and mortality. The administration of vaccines to transplant candidates earlier and more rapidly than in the healthy child will improve vaccination rates among transplant recipients while not compromising immunogenicity.

Strategies for the prevention of cytomegalovirus infection and disease in pediatric liver transplantation recipients.

Cytomegalovirus (CMV) is the most common opportunistic infection following solid organ transplantation. Prevention and management of CMV infection has assumed a higher priority as transplantation has become a frequent treatment for many congenital and acquired disorders, as more potent immunosuppressive agents have become available, new molecular and virologic assays to detect CMV have made their way from research to clinical laboratories and new antiviral medications and biologics have been developed. Management strategies are diverse; however, there are little or no data from large controlled pediatric trials demonstrating the superiority of any particular approach.

Epidemiology of methicillin-resistant Staphylococcus aureus at a children's hospital.

Objective: To describe the relative contribution of and risk factors for both community-acquired and nosocomial methicillin-resistant Staphylococcus aureus (MRSA) infections.

Design: Retrospective cohort study.

Setting: 270-bed, tertiary-care children's hospital.