An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection

BACKGROUND/AIMS: In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.METHODS: This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or Child-Pugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).RESULTS: SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.CONCLUSIONS: In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.

Estimation of Gastrocnemius Muscle Volume Using Ultrasonography in Children with Spastic Cerebral Palsy

PURPOSE: This study aimed to investigate useful parameters for estimating gastrocnemius (GCM) muscle volume (MV) using ultrasonography (US) and anthropometry in children with spastic cerebral palsy (CP). MATERIALS AND METHODS: Eighteen legs from nine children with spastic CP aged 2 to 6 years were investigated in this study. Tibial length (TL) of each leg was measured and muscle thickness (MT) and anatomical cross-sectional area (aCSA) of GCM muscles were assessed using US. The volume of the GCM was measured by magnetic resonance imaging (MRI) scans. The relationship of TL, MT, and aCSA with MV measured by MRI was investigated. Simple and multiple regression analyses were performed to establish muscle volume prediction equations. RESULTS: Resting MT, aCSA, and TL were highly related to MV of both medial and lateral head of GCM determined by MRI. The MV prediction equation based on simple regression analysis resulted in r2 values ranging from 0.591 to 0.832 (p<0.05). The r2 values were higher using aCSA as independent variable than using MT. The MV prediction equation based on multiple regression analysis resulted in r2 values ranging from 0.779 to 0.903 (p<0.05). However, the relatively high standard error of the estimate values ranged from 18.0-33.6% on simple regression and 15.5-25.6% on multiple regression. The contribution of aCSA was higher than that of MT for predicting MV of GCM. CONCLUSION: Our study demonstrated the suitability of US assessment of aCSA and MT combined with TL for estimating MV of GCM in children with spastic CP and showed that aCSA is more useful parameter than MT.

Architectural Changes of the Gastrocnemius Muscle after Botulinum Toxin Type A Injection in Children with Cerebral Palsy

PURPOSE: This study used ultrasonography (US) to investigate the architectural changes in gastrocnemius muscles (GCM) after botulinum toxin injection (BoNT-A) in children with cerebral palsy (CP). MATERIALS AND METHODS: Thirteen children with CP who received a BoNT-A injection into their GCM to treat equinus were recruited (9 males and 4 females). Architectural changes in both the medial and lateral heads of the GCM from a total of 20 legs were assessed using B-mode, real-time US. Muscle thickness (MT), fascicle length (FL), and fascicle angle (FA) were measured over the middle of the muscle belly in both a resting and neutral ankle position. Measures at 1 and 3 months after the injection were compared with baseline data taken before the injection. RESULTS: The mean age of the subjects was 5.8 (+/-1.6) years. Spasticity was significantly reduced when measured by both the modified Tardieu scale and the modified Ashworth scale at 1 and 3 months after injection (p<0.05). The MT and FA of both the medial and lateral heads of the GCM were significantly reduced for both neutral and resting ankle positions at 1 and 3 months after the injection. The FL of both the medial and lateral heads of the GCM were significantly increased in a resting position (p<0.05), but not in a neutral position. CONCLUSION: Our results demonstrated muscle architectural changes induced by BoNT-A injection. The functional significances of these changes were discussed.