Tenofovir disoproxil fumarate (DF) is highly effective for the suppression of hepatitis B virus (HBV) in chronically infected adults. This study evaluated the safety and efficacy of tenofovir DF in adolescents with chronic hepatitis B (CHB). In this double-blind, placebo-controlled trial, adolescents 12 to <18 years of age with CHB were randomized to tenofovir DF 300 mg (n 5 52) or placebo (n 5 54) once daily for 72 weeks. The primary endpoint was virologic response (HBV DNA <400 copies/mL) at week 72. One hundred six patients were enrolled; 101 patients completed 72 weeks of treatment. At baseline, 91% of patients were hepatitis B e antigen-positive and 85% had prior exposure to HBV therapy. A virologic response was observed in 89% (46/52) of patients who received tenofovir DF and 0% (0/54) of patients who received placebo (P < 0.001). Treatment response was not affected by prior HBV treatment. Furthermore, no resistance to tenofovir DF developed through week 72. Among patients with an alanine aminotransferase (ALT) level greater than the upper limit of normal at baseline, normalization of ALT occurred in 74% of patients receiving tenofovir DF and 31% of patients receiving placebo (P < 0.001). The rate of grade 3/4 adverse events was higher among patients treated with placebo (24%) than patients treated with tenofovir DF (10%). No patients met the safety endpoint of a 6% decrease in spine bone mineral density at week 72. Conclusion: Tenofovir DF therapy in HBV-infected adolescents was well tolerated and highly effective at suppressing HBV DNA and normalizing ALT values in both treatment-naïve adolescents and those with prior exposure to HBV therapy. (HEPATOLOGY 2012;56:2018-2026 See Editorial on Page 2016 D espite the success of recent vaccination efforts, chronic hepatitis B (CHB) remains a serious global health care problem and is a major cause of serious liver disease. 1 It is estimated that approximately 350 million people live with CHB infection and approximately 600,000 die each year due to the acute or chronic consequences of hepatitis B. 1 Mathematical modeling suggests that over 80% of these deaths are from infections contracted during childhood. 2 This is most likely because approximately 90% of those infected as infants and 30%-50% of those infected from 1 to 4 years of age develop chronic infection. 1 These chronically infected children are at high risk of developing severe liver disease and dying from hepatitis B virus (HBV)-related sequelae. Approximately 25% of individuals who become chronically infected in childhood later develop cirrhosis or cancer of the liver. 1 Studies in adults with CHB have shown that the risk of developing liver complications is correlated with serum HBV DNA levels, which can be mitigated by effective viral suppression. 3,4 It is not yet known Abbreviations: ALT, alanine aminotransferase; BMD, bone mineral density; CHB, chronic hepatitis B; DF, disoproxil fumarate; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; LLOQ, lower limit ...

No abstract

PHiD-CV was immunogenic against each of the 10 pneumococcal vaccine serotypes when coadministered with DTPw-HBV/Hib and poliovirus vaccines.

Coadministration of PHiD-CV with commonly used childhood vaccines induced high levels of seroprotection/seropositivity against all targeted diseases. No evidence of negative interference on the immune response to any of the coadministered vaccine antigens was observed when compared with the current routine practice of 7vCRM coadministration.

Multisystem Inflammatory Syndrome in Children (MIS-C) is a new clinical entity occurring in children and young adults, which is associated with the SARS-CoV-2 infection. The first cases of MIS-C were diagnosed in Poland in May 2020. Since October 2020, a significant increase in the incidence of this new disease has been observed in Poland, reflecting the increased incidence of COVID-19 in the paediatric population. MIS-C develops as a result of dysregulation of the immune system occurring 4 weeks after the SARS-CoV-2 infection. Diagnosis is based on the following criteria: a set of clinical features (including fever and signs of multiple organ damage) and elevated inflammatory markers, with exclusion of other causes. The most common complications involve the cardiovascular system: acute myocardial damage with reduced left ventricular ejection fraction, shock, and coronary artery abnormalities and arrhythmias. Mortality in Western Europe and the United States is around 1-2%. Appropriate management, including vital function support and immunomodulatory treatment, allows for a quick recovery in the vast majority of patients. This document is an updated guideline for the diagnostic and therapeutic management of children with suspected MIS-C in Poland. The most important changes concern treatment, steroid therapy, and antiplatelet therapy in particular.

No abstract

Individuals with a history of allergy are potentially at risk of suffering from adverse effects after COVID-19 vaccination. We sought to assess the tolerance towards the Pfizer-BioNTech vaccine in allergic patients. To address this issue, we used a questionnaire conducted on-line in a group of medical professionals who were vaccinated with the Pfizer-BioNTech vaccine. A total of 1808 respondents, out of whom 1707 received two doses of the vaccine, returned the questionnaire. Local reactions after injection were more frequent in allergic individuals after both doses (swelling p = 0.0003). Systemic adverse events (AE-SYS) occurred more often after the second than the first dose in both groups (allergic persons: 77.29% vs 41.06%); vomiting and arthralgia occurred more often in allergic subjects (p = 0.0009). AE-SYS in allergic individuals lasted longer than in non-allergic ones after the first (p = 0.01) and the second dose (p = 0.0009). Allergic reactions after vaccination were reported more frequently in allergic subjects: after the first dose (p = 0.00001) and after the second dose (p = 0.001). Rhinitis was the most frequent symptom observed more often in allergic patients. No severe allergic reactions occurred during the full cycle of vaccination. Although the Pfizer-BioNTech vaccine is tolerated worse by allergic than non-allergic individuals, the occurring adverse symptoms are mild and do not preclude a successful completion of the vaccination cycle. The presence of symptoms suggestive of allergy does not constitute a condition of increased risk of developing clinically significant adverse events following Pfizer COVID-19 vaccination.

Two doses of RIX4414 were immunogenic and well-tolerated in European preterm infants.