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Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
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Objective:To study the prognostic impact of prognostic nutritional index (PNI) before radiotherapy in clinical stage Ⅲ esophageal cancer patients.Methods:We retrospectively reviewed 125 esophageal cancer patients with clinical stage Ⅲ undergoing definitive radiotherapy in Fourth Hospital of Hebei Medical University from 2013 to 2017. The PNI and nutritional risk index (NRI) were calculated before radiotherapy. The optimal cutoff value of PNI was determined by time-dependent receiver operating characteristics (ROC) at 49.925.The patients were divided into low PNI group(PNI<49.925) and high PNI group (PNI≥49.925). Based on NRI, the patients were divided into normal NRI group (NRI≥100) and abnormal NRI group (NRI<100). Kaplan-Meier method was used to calculate the overall survival (OS) and progression-free survival (PFS) and to perform univariate analysis. The mutlivariate analysis was performed by Cox regression model.Results:PNI was positively correlated with hemoglobin ( r=0.505, P<0.001) and NRI ( r=0.594, P<0.001). The 1-, 3- and 5-year OS rates in the low PNI group were significantly lower than those of the high PNI group (67.5%, 27.3%, 11.4% vs. 85.4%, 45.8%, 27.4%, respectively, χ2=8.569, P<0.05). Moreover, the 1-, 3- and 5-year PFS rates in the low PNI group were obviously higher than those in the high PNI group (59.7%, 23.2%, 4.9% vs. 79.2%, 35.4%, 24.9%, respectively, χ2=6.715, P<0.05). Univariate analysis showed that GTV, radiotherapy dose, chemotherapy, albumin, NRI and PNI were significantly correlated with OS and PFS (OS: χ2=6.822, 4.326, 4.474, 13.123, 8.846, 8.569, P<0.05: PFS: χ2=7.869, 4.636, 5.874, 10.911, 8.544, 6.715, P<0.05). Multivariate analysis showed that GTV, radiotherapy dose and PNI were independent prognostic factors for OS ( P<0.05). And GTV, radiotherapy dose, chemotherapy and PNI were independent prognostic factors for PFS ( P<0.05). Conclusions:The PNI before radiotherapy is a significant and independent predictor for survival of clinical stage Ⅲ esophageal cancer patients. Based on simple and inexpensive standard laboratory measurements, PNI could be a promising prognostic biomarker for esophageal cancer patients.
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Objective To explore the relationship between body composition and β-cell function in obese females with normal glucose metabolism. Methods Seventy-five obese women with normal blood glucose and without family history of diabetes were investigated. They were assigned to 4 groups based on body mass index (BMI). Body fat content was measured by dual-energy X-ray absorptiometry (DEXA), and intravenous glucose tolerance test (IVGTT) was performed. The acute insulin response (AIR), the area under the curve (AUC) of insulin (AUCins) and homeostasis model assessment (HOMA) for β-cell function (HOMA2-% B) were calculated. Insulin resistance index(HOMA2-IR) and the ratio of AUCins to AUC of glucose (AUCins/AUCglu) were calculated to assess insulin resistance. Results Women with higher BMI appeared to have more total body fat content and trunk fat content. The similar distribution was also found in other parameters, including the plasma glucose levels at 0 and 10 min, AUCins, AIR, AUCins/AUCglu and the difference of insulin level between 0 and 10 min [INS (10-0)] during IVGTF. AUCins, AIR, AUCins/AUCglu and [INS (10-0)] were positively correlated with the age, BMI,total body fat content and trunk fat content. After adjustment of age, the trunk fat content was independently associated with the AIR in a good linear manner. Conclusion The obese females show change in body composition with more trunk fat content. They show significant insulin resistance with compensated elevation of insulin secretion. Body composition assessment is a valid and more accurate method than BMI and waist circumference in predicting early damaged β-cell function in obese patients.