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.

BACKGROUND: Hyperuricemia refers to an excess of uric acid in the blood and is associated with gouty arthritis, hypertension, metabolic syndrome, atrial fibrillation, kidney stones, insulin resistance (IR), and type 2 diabetes mellitus. Previous studies have used the homeostatic model assessment of IR (HOMA-IR), a well-known index of IR, to investigation the correlation between serum uric acid levels and IR. However, difficulty with measuring insulin levels limits the clinical applicability of the HOMA-IR index. This study investigated the correlation between hyperuricemia and the triglyceride glucose (TyG) index.METHODS: We used data from the Seventh Korea National Health and Nutrition Examination Survey, 2016. The study population included adults without diabetes aged >19 years. The TyG index, which serves as an indicator of IR, was calculated using fasting serum glucose and triglyceride levels to investigate the correlation between the TyG index and hyperuricemia. Pearson's correlation coefficient and analysis of covariance were used for statistical analysis, which was performed using IBM SPSS software.RESULTS: A statistically significant correlation was observed between serum uric acid levels and the TyG index. After adjustment for factors that may affect IR (age, body mass index, waist circumference, and systolic and diastolic blood pressures), we observed that the TyG index was significantly higher in the hyperuricemia than in the non-hyperuricemia group (8.96 vs. 8.54, P < 0.001).CONCLUSION: Serum uric acid levels were significantly correlated with IR assessed using the TyG index in adults without diabetes aged >19 years.
Adult ; Arthritis, Gouty ; Atrial Fibrillation ; Blood Glucose ; Body Mass Index ; Diabetes Mellitus, Type 2 ; Fasting ; Glucose ; Humans ; Hypertension ; Hyperuricemia ; Insulin ; Insulin Resistance ; Kidney Calculi ; Korea ; Nutrition Surveys ; Triglycerides ; Uric Acid ; Waist Circumference

BACKGROUND/AIMS: In addition to the globally endorsed Barcelona Clinic Liver Cancer (BCLC) staging system, other algorithms or staging systems have been developed, including the Hong Kong Liver Cancer (HKLC) staging system. This study aimed to validate the HKLC staging system relative to the BCLC staging system for predicting survival for hepatocellular carcinoma (HCC) patients in Korea. METHODS: From 2004 to 2013, 2,571 patients newly diagnosed with HCC were consecutively enrolled at three Korea University medical centers. RESULTS: Both staging systems differentiated survival well (p < 0.001). However, 1-year and 3-year survival were predicted better using the HKLC system than the BCLC system (area under the receiver operating characteristic curve: 0.869 vs 0.856 for 1 year, p=0.002; 0.841 vs 0.827 for 3 years, p=0.010). In hypothetical survival curves, the HKLC system exhibited better median overall survival than the BCLC system (33.1 months vs 19.2 months). In evaluations of prognosis according to either BCLC or HKLC treatment guidelines, risk of death was reduced in the group following only HKLC guidelines compared with the group following only BCLC guidelines (hazard ratio, 0.601; 95% confidence interval, 0.443 to 0.816; p=0.001). CONCLUSIONS: Although both staging systems predicted and discriminated HCC prognoses well, the HKLC system showed more encouraging survival benefits than the BCLC system.
Academic Medical Centers ; Carcinoma, Hepatocellular ; Hong Kong ; Humans ; Korea ; Liver Neoplasms ; Liver ; Neoplasm Staging ; Prognosis ; ROC Curve

Since sorafenib was introduced in 2007 for treating advanced hepatocellular carcinoma (HCC), 15 patients have achieved a complete response (CR) in advanced HCC. However, only four of these reports can be regarded as real CRs involving adequate assessments including imaging, serum tumor markers, and histologic examinations of completely resected specimens. A 54-year-old man with hepatitis C virus (HCV)-related liver cirrhosis (LC) presented to our unit. A CT scan demonstrated a 3.8-cm arterial hypervascular/portal-washout mass in the right lobe and invasion in the right portal vein. Twelve weeks after beginning sorafenib therapy, the AFP level was normalized and a CT scan showed a prominent decrease in the hepatic mass and a significant decrease in the volume of portal vein thrombosis (PVT). The patient received a right liver hemihepatectomy after 12 months. No viable tumor cells were found in the resected specimen, and there was no thrombotic obstruction of the portal vein. Twelve months later the patient showed no clinical evidence of HCC recurrence. This is the first case of CR in HCC treatment following sorafenib with histologically confirmed HCV-related HCC without LC evidence, HCC with PVT, and a follow-up of longer than 12 months. This case seems to be an extremely unusual clinical outcome in advanced HCC.
Biomarkers, Tumor ; Carcinoma, Hepatocellular* ; Follow-Up Studies ; Hepacivirus ; Hepatitis C ; Humans ; Liver ; Liver Cirrhosis ; Middle Aged ; Portal Vein ; Recurrence ; Response Evaluation Criteria in Solid Tumors ; Tomography, X-Ray Computed ; Venous Thrombosis

BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. METHODS: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. RESULTS: In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P < 0.0001), and week 240 (95.0% vs. 47.6%, P < 0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P < 0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P < 0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. CONCLUSIONS: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.
Alanine Transaminase ; DNA ; Hepatitis B virus ; Hepatitis B* ; Hepatitis B, Chronic* ; Hepatitis* ; Hepatitis, Chronic* ; Humans ; Incidence ; Lamivudine*

PURPOSE: Breast volume assessment is one of the most important steps during implant-based breast reconstruction because it is critical in selecting implant size. According to previous studies, there is a close relationship between the mastectomy specimen weight and resected breast volume. The aim of this study was to evaluate long-term patient satisfaction with implant-based breast reconstruction guided by the ratio of implant volume to mastectomy specimen weight. In doing so, we describe the ideal ratio for patient satisfaction. METHODS: A total of 84 patients who underwent implant-based breast reconstruction for breast cancer were included in this study. The patients were grouped by the ratio of implant size to mastectomy specimen weight (group 1, <65%; group 2, 65%–75%; and group 3, >75%). Outcome analysis was performed using a questionnaire of patient satisfaction and the desired implant size. RESULTS: Patient satisfaction scores concerning the postoperative body image, size, and position of the reconstructed breast were significantly higher in group 2. The average ratio of the ideal implant volume to mastectomy specimen weight for each group was 71.9% (range, 54.5%–96.7%), with the differences across the three groups being not significant (p=0.244). CONCLUSION: Since there is an increase in breast reconstruction, selecting the appropriate breast implant is undoubtedly important. Our novel technique using the ratio of implant volume to mastectomy specimen weight provides physicians a firm guide to intraoperative selection of the proper implant in reconstructive breast surgery.
Body Image ; Breast Implants ; Breast Neoplasms ; Breast* ; Female ; Humans ; Mammaplasty* ; Mastectomy* ; Patient Satisfaction*

BACKGROUND/AIMS: Distinction is vague between severe constipation and postoperative ileus (POI) in terms of pathogenesis, clinical features, and treatment options. However, no data are available regarding their associations. METHODS: After retrospective review of data from patients who underwent orthopedic surgery during the first 6 months of 2011, a total of 612 patients were included. Severe constipation was defined as symptoms of constipation requiring treatment using at least 2 laxatives from different classes for at least 6 months. POI was defined as paralytic ileus lasting more than 3 days post-surgery and associated with 2 or more of the following: (1) nausea/vomiting, (2) inability to tolerate an oral diet over a 24-hour period, and (3) absence of flatus over a 24-hour period. The subjects were divided into non-POI and POI groups, and we compared patient-, surgery-, and pharmaceutical-related factors. RESULTS: Thirteen (2.1%) out of 612 experienced POI. In comparisons between the non-POI and POI groups, univariate analysis showed significant differences in the mean age (51.4 vs 71.6 years), mean body mass index (24.1 vs 21.8 kg/m2), severe constipation (5.8% vs 76.9%), co-morbidities (33.2% vs 84.6%), type of orthopedic surgery (spine/hip/limb: 19.4/11.0/65.6% vs 23.1/61.5/15.4%), and estimated blood loss (50 vs 300 mL). Multivariate logistic regression analysis, after adjustment for age, body mass index, co-morbidities, type of orthopedic surgery, and estimated blood loss, showed that severe constipation was an independent risk factor for POI (OR, 35.23; 95% CI, 7.72-160.82; P < 0.001). CONCLUSIONS: Severe constipation is associated with POI after orthopedic surgery.
Body Mass Index ; Constipation* ; Diet ; Flatulence ; Humans ; Ileus* ; Intestinal Pseudo-Obstruction ; Laxatives ; Logistic Models ; Orthopedics* ; Retrospective Studies ; Risk Factors*

PURPOSE: This study investigates morphologic change of the rectosigmoid colon using a belly board in prone position and distended bladder in patients with rectal cancer. We evaluate the possibility of excluding the proximal margin of anastomosis from the radiation field by straightening the rectosigmoid colon. MATERIALS AND METHODS: Nineteen patients who received preoperative radiotherapy between 2006 and 2009 underwent simulation in a prone position (group A). These patients were compared to 19 patients treated using a belly board in prone position and a distended bladder protocol (group B). Rectosigmoid colon in the pelvic cavity was delineated on planning computed tomography (CT) images. A total dose of 45 Gy was planned for the whole pelvic field with superior margin of the sacral promontory. The volume and redundancy of rectosigmoid colon was assessed. RESULTS: Patients in group B had straighter rectosigmoid colons than those in group A (no redundancy; group A vs. group B, 10% vs. 42%; p = 0.03). The volume of rectosigmoid colon in the radiation field was significantly larger in group A (56.7 vs. 49.1 mL; p = 0.009). In dose volume histogram analysis, the mean irradiated volume was lower in patients in group B (V45 27.2 vs. 18.2 mL; p = 0.004). In Pearson correlation coefficient analysis, the in-field volume of rectosigmoid colon was significantly correlated with the bladder volume (R = 0.86, p = 0.003). CONCLUSION: Use of a belly board and distended bladder protocol could contribute to exclusion of the proximal margin of anastomosis from the radiation field.
Anastomotic Leak ; Colon* ; Humans ; Prone Position ; Radiotherapy ; Rectal Neoplasms ; Urinary Bladder*

PURPOSE: This study investigates morphologic change of the rectosigmoid colon using a belly board in prone position and distended bladder in patients with rectal cancer. We evaluate the possibility of excluding the proximal margin of anastomosis from the radiation field by straightening the rectosigmoid colon. MATERIALS AND METHODS: Nineteen patients who received preoperative radiotherapy between 2006 and 2009 underwent simulation in a prone position (group A). These patients were compared to 19 patients treated using a belly board in prone position and a distended bladder protocol (group B). Rectosigmoid colon in the pelvic cavity was delineated on planning computed tomography (CT) images. A total dose of 45 Gy was planned for the whole pelvic field with superior margin of the sacral promontory. The volume and redundancy of rectosigmoid colon was assessed. RESULTS: Patients in group B had straighter rectosigmoid colons than those in group A (no redundancy; group A vs. group B, 10% vs. 42%; p = 0.03). The volume of rectosigmoid colon in the radiation field was significantly larger in group A (56.7 vs. 49.1 mL; p = 0.009). In dose volume histogram analysis, the mean irradiated volume was lower in patients in group B (V45 27.2 vs. 18.2 mL; p = 0.004). In Pearson correlation coefficient analysis, the in-field volume of rectosigmoid colon was significantly correlated with the bladder volume (R = 0.86, p = 0.003). CONCLUSION: Use of a belly board and distended bladder protocol could contribute to exclusion of the proximal margin of anastomosis from the radiation field.
Anastomotic Leak ; Colon* ; Humans ; Prone Position ; Radiotherapy ; Rectal Neoplasms ; Urinary Bladder*

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D3 (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.
Adult ; Aged ; Alendronate/adverse effects/*therapeutic use ; Cholecalciferol/adverse effects/deficiency/*therapeutic use ; Female ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal/*drug therapy ; Vitamin D Deficiency/*drug therapy