Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study / 中华医学杂志(英文版)

BACKGROUND@#Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.@*METHODS@#We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.@*RESULTS@#At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.@*CONCLUSIONS@#The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.@*TRIAL REGISTRATION@#ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.

Morphological change analysis based on cone beam CT of the upper airway for obstructive sleep apnea syndrome patients treated with oral appliance in skeletal class Ⅱ malocclusion with different vertical patterns / 华西口腔医学杂志

OBJECTIVE@#To analyze the morphological changes in the upper airway of obstructive sleep apnea syndrome (OSAS) patients treated with oral appliance in skeletal class Ⅱ malocclusion with different vertical features by using cone beam CT (CBCT).@*METHODS@#Thirty-six patients diagnosed with OSAS by polysomnography and daytime sleepiness scale and skeletal class Ⅱ malocclusion were treated with oral appliance for 4 months. The changes based on CBCT in the morphology of glossopharyngeal and palatopharyngeal before and after treatment in OSAS patients with different vertical features were compared.@*RESULTS@#After treatment with oral appliance, the glossopharyngeal and palatopharyngeal morphologies of patients with mild OSAS showed significant changes. After treatment with oral appliance, the glossopharyngeal morphology of all patients showed significant changes (P<0.05). The palatopharyngeal morphology of patients in the lower and average groups also exhibited significant changes (P<0.05). Sagittal changes in the glossopharyngeal measurements of high-angle patients demonstrated significant difference, whereas the other measured values showed no significant difference.@*CONCLUSIONS@#The morphological changes in the upper airway were significant in OSAS patients with lower and average vertical patterns when treated with oral appliance, but the changes in high vertical patterns were not significant.