METHODS: In this single-arm, open-label, phase 3 trial, we recruited patients from 38 sites across China, Thailand, Vietnam, Singapore, and Malaysia, who were chronically infected with HCV genotypes 1-6, and were HCV treatment-naive or treatment-experienced, either without cirrhosis or with compensated cirrhosis. Patients self-administered a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks. The primary efficacy endpoint was sustained virological response, defined as HCV RNA less than 15 IU/mL at 12 weeks after completion of treatment (SVR12), assessed in all patients who received at least one dose of study drug. The primary safety endpoint was the proportion of adverse events leading to premature discontinuation of study drug. This trial is registered with ClinicalTrials.gov, number NCT02671500, and is completed.
FINDINGS: Between April 14, 2016, and June 30, 2017, 375 patients were enrolled in the study, of whom 374 completed the full treatment course and one discontinued treatment. Overall, 362 (97% [95% CI 94-98]) of 375 patients achieved SVR12. Among 42 patients with HCV genotype 3b, all of whom had baseline resistance-associated substitutions in NS5A, 25 (89% [95% CI 72-98]) of 28 patients without cirrhosis and seven (50% [23-77]) of 14 patients with cirrhosis achieved SVR12. The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients). There were no discontinuations due to adverse events. Serious adverse events were reported in three (1%) patients, none of which was judged to be related to sofosbuvir-velpatasvir treatment.
INTERPRETATION: Consistent with data from other phase 3 studies, single-tablet sofosbuvir-velpatasvir for 12 weeks is an efficacious and safe treatment for Asian patients with chronic HCV infection, but might have lower efficacy in those infected with HCV genotype 3b and with cirrhosis.
FUNDING: Gilead Sciences.
METHODS: A sample of 837 Chinese students in elementary and middle school was collected for this study. The Perceived Stress Scale, the Social Support Scale, the Emotional Intelligence Scale, and the Post-Stress Growth Scale were employed to examine them. The data were analyzed using SPSS 25.0 software.
RESULTS: The results indicate a significant negative association between perceived stress and post-stress growth. Among perceived stress and social support, the former acted as a mediator, while the latter as a moderator. This study sheds light on the post-stress growth of Chinese left-behind children. The findings validated a model of moderated mediation that shows the relationship between perceived stress, emotional intelligence, social support, and post-stress growth.
CONCLUSION: This study confirmed that social support is one of the most important factors among left-behind children, from perceived stress to post-stress growth. Furthermore, the study reveals that emotional intelligence can adjust the relationship between perceived stress and social support to post-stress growth. Therefore, for both family education and school education, the result provides a new direction.