Children with chronic hepatitis B (CHB) represent an area of unmet medical need, attributed to increased lifetime risk of CHB sequelae and limited therapeutic options compared with adult CHB patients. The PEG-B-ACTIVE (NCT01519960) phase III study evaluated peginterferon (PegIFN) alfa-2a treatment in children aged 3 to <18 years with CHB. A total of 161 hepatitis B e antigen (HBeAg)-positive immune-active patients without advanced fibrosis (AF)/cirrhosis were randomized (2:1) to PegIFN alfa-2a (Group A, n = 101) or no treatment (Group B, n = 50); patients with AF were assigned to PegIFN alfa-2a (Group C, n = 10). PegIFN alfa-2a was administered for 48 weeks by body surface area (BSA) category, based on 180 μg/1.73 m . HBeAg seroconversion rates at 24 weeks posttreatment were significantly higher in Group A (25.7% vs. 6%; P = 0.0043), as were the rates of hepatitis B surface antigen (HBsAg) clearance (8.9% vs. 0%; P = 0.03), hepatitis B virus (HBV) DNA <2,000 IU/mL (28.7% vs. 2.0%; P < 0.001) or undetectable (16.8% vs. 2.0%; P = 0.0069), and alanine aminotransferase (ALT) normalization (51.5% vs. 12%; P < 0.001). Safety, including incidence of ALT flares and neutropenia, was comparable to the established PegIFN alfa-2a profile in HBV-infected adults or hepatitis C virus-infected children. Changes in growth parameters were minimal during treatment and comparable to those in untreated patients. Safety and efficacy outcomes in Group C were in line with Group A. Conclusion: PegIFN alfa-2a treatment of children in the immune-active phase of CHB was efficacious and well tolerated, and associated with higher incidence of HBsAg clearance than in adults. This represents an important advance to the treatment options for children with CHB.
Background: The causes of chronic cough in elderly patients have not been specifically investigated. Therefore, it remains to be determined whether chronic cough differs between elderly and non-elderly patients. Objectives: To investigate the distribution of causes of chronic cough in elderly patients in comparison with etiologies of chronic cough observed in non-elderly patients. Methods: From 2,989 new patients presenting consecutively to the Department of Respiratory Medicine of the Tongji Hospital over a 1.5-year period, 287 patients with chronic cough were enrolled in the study. Patients aged ≥60 years were assigned to the elderly group. The elderly group comprised 104 patients and the non-elderly group the remaining 183 patients. The causes of cough were primarily evaluated according to a modification of Irwin’s anatomic diagnostic protocol which included induced sputum cytology, verified by the specific therapy. Results: Cough-variant asthma (34.6 vs. 41.5%) and upper airway cough syndrome (19.3 vs. 23.5%) were the most common causes of chronic cough both in the elderly and non-elderly groups. The distribution of causes and frequency were significantly different between elderly and non-elderly groups: angiotensin-converting enzyme inhibitor (ACEI)-induced cough (16.3 vs. 1.7%, χ2 value = 22.12, p < 0.001) and gastroesophageal reflux disease (GERD; 10.6 vs. 3.7%, χ2 value = 5.14, p = 0.02) were more common in the elderly group. Conclusions: A more frequent incidence of ACEI-induced cough and GERD is the distinctive feature in the cause distribution between elderly and non-elderly patients with chronic cough.
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