Coronavirus disease 2019 vaccine in pediatric post-kidney transplantation.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of persons worldwide. Many vaccines have been developed; however, their efficacy in pediatric solid organ transplant recipients is yet to be determined. METHODS: This is a prospective observational, non-interventional single-center study on the safety and efficacy of a COVID-19 vaccine (BNT162b2) in pediatric kidney transplant recipients. The primary aim of this study was to evaluate immunogenicity according to SARS-CoV-2-specific neutralizing antibody titer after two vaccine doses. The secondary aims were to investigate the safety of the vaccines, solicited local and systemic adverse reactions, incidence of COVID-19 post-vaccination, and effects on transplant graft function. Baseline investigations were conducted on pediatric renal transplant recipients, and recruited participants were advised to have the Comirnaty® mRNA vaccine according to protocol. RESULTS: A total of 48 patients (male, n = 31, 64.6%; female, n = 17, 35.4%), median age 14 [12-16] years were included, and all received two doses of the vaccine. The vaccine had a favorable safety and side-effect profile. The S-antibody titer of all patients ranged between .4 and 2,500 U/ml and was > 50 U/ml in 89% of the patients. No difference in the measured antibody immune response was noted between infected and uninfected children. No major side effects were reported. CONCLUSION: The vaccine had a favorable safety profile in 12- to 15-year-old kidney transplant recipients, producing a greater measured antibody response than that in older transplant recipients.

Comparison of the safety and immunogenicity of the BNT-162b2 vaccine and the ChAdOx1 vaccine for solid organ transplant recipients: a prospective study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its resulting disease, coronavirus disease 2019 (COVID-19), has spread to millions of people worldwide. Preliminary data from organ transplant recipients have shown reduced seroconversion rates after the administration of different SARS-CoV-2 vaccination platforms. However, it is unknown whether different vaccination platforms provide different levels of protection against SARS-CoV-2. To answer this question, we prospectively studied 431 kidney and liver transplant recipients (kidney: n = 230; liver: n = 201) who received either the ChAdOx1 vaccine (n = 148) or the BNT-162b2 vaccine (n = 283) and underwent an assessment of immunoglobulin M/immunoglobulin G spike antibody levels. The primary objective of the study is to directly compare the efficacy of two different vaccine platforms in solid organ transplant recipients by measuring of immunoglobulin G (IgG) antibodies against the RBD of the spike protein (anti-RBD) two weeks after first and second doses. Our secondary endpoints were solicited specific local or systemic adverse events within 7 days after the receipt of each dose of the vaccine. There was no difference in the primary outcome between the two vaccine platforms in patients who received two vaccine doses. Unresponsiveness was mainly linked to diabetes. The rate of response after the first dose among younger older patients was significantly larger; however, after the second dose this difference did not persist (p = 0.079). Side effects were similar to those that were observed during the pivotal trials.

Developing a multidisciplinary HCV direct-acting antivirals utilization management and assessment program.

BACKGROUND: The introduction of direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infections has revolutionized outcomes for patients with HCV. Cost-effective use of these antivirals in addition to ensuring patient adherence is of paramount importance. OBJECTIVES: The goal of this article is to describe the processes by which a tertiary care, multisite institution managed the complexities involved in administering DAA treatment and managing the increased cost of therapy. Specifically, the objectives of this article are to describe the development of a multidisciplinary HCV management program and the role of pharmacists in this program, including formulary management strategies and monitoring of DAAs use in our institution, development of guidelines, electronic prescribing protocols and order sets, and specific outcomes based on a concurrent medication use evaluation. PRACTICE DESCRIPTION: King Faisal Specialist Hospital and Research Centre is a tertiary care referral hospital. As a tertiary referral hospital, it offers primary and highly specialized inpatient and outpatient medical care. The process of selecting and developing institutional HCV management program is described. PRACTICE INNOVATION: This article provides key details regarding how a multidisciplinary HCV program using DAAs can be implemented successfully at a tertiary care facility. Key facets of our innovation include establishing formulary guidelines, setting up eligibility criteria for patients, and establishing an HCV taskforce and multidisciplinary HCV program clinic. EVALUATION: Medication use evaluations were regularly conducted to monitor sustained virologic response rates, adherence to guidelines, adverse reactions, and drug interactions. METHODS: Formulary guidelines, setting up an eligibility criterion for patients, and an HCV taskforce and multidisciplinary HCV program clinic were established. RESULTS: The involvement of pharmacists in a multidisciplinary HCV program in outpatient settings resulted in improved formulary decision making, reduction of costs, and improvement of adherence to institutional guidelines. PRACTICE IMPLICATIONS: The role of a pharmacist in the management of patients with HCV with DAAs is important. Pharmacists play an integral part in medication management and overall reduction in health care expenditure. Many disease management programs can be complemented with pharmacists to improve patient care and reduce cost. CONCLUSION: HCV treatment is challenging, and a multidisciplinary approach to treat HCV is critical. It is a rapidly evolving field; therefore, it requires dynamic formulary management and collaborative practice approaches to monitor pharmacotherapy carefully and efficiently. Clinical pharmacists play a pivotal role within the multidisciplinary team by providing support to both patients and health care providers with regard to the treatment of HCV.