1.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
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.
2.Prognostic Value of Alpha-Fetoprotein in Patients Who Achieve a Complete Response to Transarterial Chemoembolization for Hepatocellular Carcinoma
Jae Seung LEE ; Young Eun CHON ; Beom Kyung KIM ; Jun Yong PARK ; Do Young KIM ; Sang Hoon AHN ; Kwang-Hyub HAN ; Wonseok KANG ; Moon Seok CHOI ; Geum-Youn GWAK ; Yong-Han PAIK ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK ; Hwi Young KIM ; Tae Hun KIM ; Kwon YOO ; Yeonjung HA ; Mi Na KIM ; Joo Ho LEE ; Seong Gyu HWANG ; Soon Sun KIM ; Hyo Jung CHO ; Jae Youn CHEONG ; Sung Won CHO ; Seung Ha PARK ; Nae-Yun HEO ; Young Mi HONG ; Ki Tae YOON ; Mong CHO ; Jung Gil PARK ; Min Kyu KANG ; Soo Young PARK ; Young Oh KWEON ; Won Young TAK ; Se Young JANG ; Dong Hyun SINN ; Seung Up KIM ;
Yonsei Medical Journal 2021;62(1):12-20
Purpose:
Alpha-fetoprotein (AFP) is a prognostic marker for hepatocellular carcinoma (HCC). We investigated the prognostic value of AFP levels in patients who achieved complete response (CR) to transarterial chemoembolization (TACE) for HCC.
Materials and Methods:
Between 2005 and 2018, 890 patients with HCC who achieved a CR to TACE were recruited. An AFP responder was defined as a patient who showed elevated levels of AFP (>10 ng/mL) during TACE, but showed normalization or a >50% reduction in AFP levels after achieving a CR.
Results:
Among the recruited patients, 569 (63.9%) with naïve HCC and 321 (36.1%) with recurrent HCC after complete resection were treated. Before TACE, 305 (34.3%) patients had multiple tumors, 219 (24.6%) had a maximal tumor size >3 cm, and 22 (2.5%) had portal vein tumor thrombosis. The median AFP level after achieving a CR was 6.36 ng/mL. After a CR, 473 (53.1%) patients experienced recurrence, and 417 (46.9%) died [median progression-free survival (PFS) and overall survival (OS) of 16.3 and 62.8 months, respectively]. High AFP levels at CR (>20 ng/mL) were independently associated with a shorter PFS [hazard ratio (HR)=1.403] and OS (HR=1.284), together with tumor multiplicity at TACE (HR=1.518 and 1.666, respectively). AFP non-responders at CR (76.2%, n=359 of 471) showed a shorter PFS (median 10.5 months vs. 15.5 months, HR=1.375) and OS (median 41.4 months vs. 61.8 months, HR=1.424) than AFP responders (all p=0.001).
Conclusion
High AFP levels and AFP non-responders were independently associated with poor outcomes after TACE. AFP holds clinical implications for detailed risk stratification upon achieving a CR after TACE.
3.Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials
Jeong HEO ; Yoon Jun KIM ; Jin-Woo LEE ; Ji Hoon KIM ; Young-Suk LIM ; Kwang-Hyub HAN ; Sook-Hyang JEONG ; Mong CHO ; Ki Tae YOON ; Si Hyun BAE ; Eric D. CROWN ; Linda M. FREDRICK ; Negar Niki ALAMI ; Armen ASATRYAN ; Do Hyun KIM ; Seung Woon PAIK ; Youn-Jae LEE
Gut and Liver 2021;15(6):895-903
Background/Aims:
Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral combination therapy approved in Korea. An integrated analysis of five phase II and III trials was conducted to evaluate the efficacy and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) infection.
Methods:
The study analyzed pooled data on Korean patients with HCV infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P treatment. The patients were either treatment-naïve or had received sofosbuvir or interferon-based treatment. Efficacy was evaluated by assessing the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Safety was evaluated by monitoring adverse events (AEs) and laboratory assessments.
Results:
The analysis included 265 patients; 179 (67.5%) were HCV treatment-naïve, and most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three patients did not achieve SVR12: one had virologic failure and two had non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) expe-rienced at least one grade ≥3 AE. No serious AEs related to G/P treatment were reported, and grade ≥3 hepatic laboratory abnormalities were rare (0.8%).
Conclusions
G/P therapy was highly efficacious and well tolerated in Korean patients with HCV infection, with most patients achieving SVR12. The safety profile was comparable to that observed in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P.
4.Feasibility and Safety of Single-Port Video-Assisted Thoracic Surgery for Primary Lung Cancer.
Woon HEO ; Do Kyun KANG ; Ho ki MIN ; Hee Jae JUN ; Youn Ho HWANG
The Korean Journal of Thoracic and Cardiovascular Surgery 2017;50(3):190-196
BACKGROUND: The feasibility of single-port video-assisted thoracic surgery (SPVATS) for primary lung cancer is not well understood. In this study, we compared SP and multi-port (MP) VATS for the surgical treatment of patients with primary lung cancer. METHODS: Surgical treatment was performed in 181 patients with primary lung cancer at Inje University Haeundae Paik Hospital between June 2012 and December 2015. A propensity-matched analysis was used to compare the postoperative outcomes and to evaluate the comparative feasibility and safety of SPVATS and MPVATS. RESULTS: There were 37 patients in the SPVATS group and 67 patients in the MPVATS group. Propensity matching produced 32 pairs. The operation time (210 minutes versus 200 minutes, p=0.11), volume of the estimated blood loss (170 mL versus 160 mL, p=0.19), duration of chest tube drainage (5 days versus 6 days, p=0.66), and length of hospital stay (9 days versus 10 days, p=0.89) were similar between the 2 groups. CONCLUSION: In our study, SPVATS for primary lung cancer was safe and feasible in well selected patients. A prospective, randomized study with a large group and long-term follow-up is necessary to evaluate the clinical feasibility and the advantages of SPVATS for primary lung cancer.
Chest Tubes
;
Drainage
;
Follow-Up Studies
;
Humans
;
Length of Stay
;
Lung Neoplasms*
;
Lung*
;
Prospective Studies
;
Thoracic Surgery, Video-Assisted*
5.A New Root-Strengthening Technique for Acute Aortic Dissection with a Weakened Aortic Root: The Neo-Adventitia Technique.
Ji Yong KIM ; In Ha KIM ; Woon HEO ; Ho Ki MIN ; Do Kyun KANG ; Youn Ho HWANG ; Hee Jae JUN
The Korean Journal of Thoracic and Cardiovascular Surgery 2017;50(6):436-442
BACKGROUND: Dissection flaps in acute type A aortic dissection typically extend into the root, most frequently into the non-coronary sinus (NCS). The weakened root can be susceptible not only to surgical trauma, but also to future dilatation because of its thinner layers. Herein, we describe a new technique that we named the “neo-adventitia” technique to strengthen the weakened aortic root. METHODS: From 2012 to 2016, 27 patients with acute type A aortic dissection underwent supracommissural graft replacement using our neo-adventitia technique. After we applied biologic glue between the dissected layers, we wrapped the entire NCS and the partial left and right coronary sinuses on the outside using a rectangular Dacron tube graft that served as neo-adventitia to reinforce the dissected weakened wall. Then, fixation with subannular stitches stabilized the annulus of the NCS. RESULTS: There were 4 cases of operative mortality, but all survivors were discharged with aortic regurgitation (AR) classified as mild or less. Follow-up echocardiograms were performed in 10 patients. Of these, 9 showed mild or less AR, and 1 had moderate AR without root dilatation. There were no significant differences in the size of the aortic annulus (p=0.57) or root (p=0.10) between before discharge and the last follow-up echocardiograms, and no reoperations on the aortic roots were required during the follow-up period. CONCLUSION: This technique is easy and efficient for reinforcing and stabilizing weakened roots. Furthermore, this technique may be an alternative for restoring and maintaining the geometry of the aortic root. An externally reinforced NCS could be expected to resist future dilatation.
Adhesives
;
Aorta
;
Aortic Valve Insufficiency
;
Cardiac Surgical Procedures
;
Coronary Sinus
;
Dilatation
;
Follow-Up Studies
;
Humans
;
Mortality
;
Polyethylene Terephthalates
;
Sinus of Valsalva
;
Survivors
;
Transplants
6.Acute Limb Ischemia and Coronary Artery Disease in a Case of Kimura's Disease.
Woon HEO ; Hee Jae JUN ; Do Kyun KANG ; Ho Ki MIN ; Youn Ho HWANG ; Ji Yong KIM ; Kyung Han NAM
The Korean Journal of Thoracic and Cardiovascular Surgery 2017;50(2):114-118
Kimura disease (KD) is an immune-mediated chronic inflammatory disease of unknown etiology. KD has many complications associated with hypereosinophilia, including various forms of allergic reactions and eosinophilic lung disease. Additionally, hypereosinophilia is associated with hypercoagulability, which may lead to thromboembolic events. A 36-year-old man with KD presented with acute limb ischemia and coronary artery occlusion. He underwent thrombectomy, partial endarterectomy of both popliteal arteries, and coronary artery stent insertion. KD is a systemic disease that affects many organs and presents with thromboembolism and vasculitis. In a patient with KD, physicians should evaluate the vascular system, including the coronary arteries.
Adult
;
Angiolymphoid Hyperplasia with Eosinophilia
;
Coronary Artery Disease*
;
Coronary Stenosis
;
Coronary Vessels*
;
Endarterectomy
;
Eosinophils
;
Extremities*
;
Humans
;
Hypersensitivity
;
Ischemia*
;
Lung Diseases
;
Popliteal Artery
;
Stents
;
Thrombectomy
;
Thromboembolism
;
Thrombophilia
;
Vasculitis
7.Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016.
Deog Young KIM ; Yun Hee KIM ; Jongmin LEE ; Won Hyuk CHANG ; Min Wook KIM ; Sung Bom PYUN ; Woo Kyoung YOO ; Suk Hoon OHN ; Ki Deok PARK ; Byung Mo OH ; Seong Hoon LIM ; Kang Jae JUNG ; Byung Ju RYU ; Sun IM ; Sung Ju JEE ; Han Gil SEO ; Ueon Woo RAH ; Joo Hyun PARK ; Min Kyun SOHN ; Min Ho CHUN ; Hee Suk SHIN ; Seong Jae LEE ; Yang Soo LEE ; Si Woon PARK ; Yoon Ghil PARK ; Nam Jong PAIK ; Sam Gyu LEE ; Ju Kang LEE ; Seong Eun KOH ; Don Kyu KIM ; Geun Young PARK ; Yong Il SHIN ; Myoung Hwan KO ; Yong Wook KIM ; Seung Don YOO ; Eun Joo KIM ; Min Kyun OH ; Jae Hyeok CHANG ; Se Hee JUNG ; Tae Woo KIM ; Won Seok KIM ; Dae Hyun KIM ; Tai Hwan PARK ; Kwan Sung LEE ; Byong Yong HWANG ; Young Jin SONG
Brain & Neurorehabilitation 2017;10(Suppl 1):e11-
“Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016” is the 3rd edition of clinical practice guideline (CPG) for stroke rehabilitation in Korea, which updates the 2nd edition published in 2014. Forty-two specialists in stroke rehabilitation from 21 universities and 4 rehabilitation hospitals and 4 consultants participated in this update. The purpose of this CPG is to provide optimum practical guidelines for stroke rehabilitation teams to make a decision when they manage stroke patients and ultimately, to help stroke patients obtain maximal functional recovery and return to the society. The recent two CPGs from Canada (2015) and USA (2016) and articles that were published following the 2nd edition were used to develop this 3rd edition of CPG for stroke rehabilitation in Korea. The chosen articles' level of evidence and grade of recommendation were decided by the criteria of Scotland (2010) and the formal consensus was derived by the nominal group technique. The levels of evidence range from 1++ to 4 and the grades of recommendation range from A to D. Good Practice Point was recommended as best practice based on the clinical experience of the guideline developmental group. The draft of the developed CPG was reviewed by the experts group in the public hearings and then revised. “Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016” consists of ‘Chapter 1; Introduction of Stroke Rehabilitation’, ‘Chapter 2; Rehabilitation for Stroke Syndrome, ‘Chapter 3; Rehabilitation for Returning to the Society’, and ‘Chapter 4; Advanced Technique for Stroke Rehabilitation’. “Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016” will provide direction and standardization for acute, subacute and chronic stroke rehabilitation in Korea.
Canada
;
Consensus
;
Consultants
;
Humans
;
Korea*
;
Practice Guidelines as Topic
;
Rehabilitation*
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Scotland
;
Specialization
;
Stroke*
8.The role of scheduled second TACE in early-stage hepatocellular carcinoma with complete response to initial TACE.
Jung Hee KIM ; Dong Hyun SINN ; Sung Wook SHIN ; Sung Ki CHO ; Wonseok KANG ; Geum Youn GWAK ; Yong Han PAIK ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK ; Moon Seok CHOI
Clinical and Molecular Hepatology 2017;23(1):42-50
BACKGROUND/AIMS: We investigated the outcomes of early-stage hepatocellular carcinoma (HCC) patients who showed a complete response (CR) to initial transarterial chemoembolization (TACE), with a focus on the role of scheduled TACE repetition. METHODS: A total of 178 patients with early-stage HCC who were initially treated with TACE and showed a CR based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria on one month follow-up computed tomography (CT) were analyzed. Among them, 90 patients underwent scheduled repetition of TACE in the absence of viable tumor on CT. RESULTS: During a median follow-up period of 4.6 years (range: 0.4-8.8 years), mortality was observed in 71 patients (39.9%). The overall recurrence-free and local recurrence-free survival rates at 1 year were 44.4% and 56.2%. In the multivariable model, scheduled repetition of TACE was an independent factor associated with survival (hazard ratio [95% confidence interval]: 0.56 [0.34-0.93], P=0.025). When stratified using Barcelona clinic liver cancer (BCLC) stage, scheduled repetition of TACE was associated with a favorable survival rate in BCLC stage A patients, but not in BCLC 0 patients. CONCLUSIONS: Scheduled repetition of TACE was associated with better survival for early-stage HCC patients showing a CR after initial TACE, especially in BCLC stage A patients.
Carcinoma, Hepatocellular*
;
Follow-Up Studies
;
Humans
;
Liver Neoplasms
;
Mortality
;
Response Evaluation Criteria in Solid Tumors
;
Survival Rate
9.Response to: Comparison of Posterior Lumbar Interbody Fusion and Posterolateral Lumbar Fusion in Monosegmental Vacuum Phenomenon within an Intervertebral Disc.
Ki Chan AN ; Gyu Min KONG ; Dae Hyun PARK ; Jong Min BAIK ; Ji Hong YOUN ; Woon Seong LEE
Asian Spine Journal 2016;10(5):984-984
No abstract available.
Intervertebral Disc*
;
Vacuum*
10.Comparison of Posterior Lumbar Interbody Fusion and Posterolateral Lumbar Fusion in Monosegmental Vacuum Phenomenon within an Intervertebral Disc.
Ki Chan AN ; Gyu Min KONG ; Dae Hyun PARK ; Jong Min BAIK ; Ji Hong YOUN ; Woon Seong LEE
Asian Spine Journal 2016;10(1):93-98
STUDY DESIGN: Retrospective. PURPOSE: To compare the clinical and radiological outcomes of posterolateral lumbar interbody fusion (PLIF) and posterolateral lumbar fusion (PLF) in monosegmental vacuum phenomenon within an intervertebral disc. OVERVIEW OF LITERATURE: The vacuum phenomenon within an intervertebral disc is a serious form of degenerative disease that destabilizes the intervertebral body. Outcomes of PLIF and PLF in monosegmental vacuum phenomenon are unclear. METHODS: Monosegmental instrumented PLIF and PLF was performed on 84 degenerative lumbar disease patients with monosegmental vacuum phenomenon (PLIF, n=38; PLF, n=46). Minimum follow-up was 24 months. Clinical outcomes of leg and back pain were assessed using visual analogue scales for leg pain (LVAS) and back pain (BVAS), and the Oswestry disability index (ODI). The radiographic outcome was the estimated bony union rate. RESULTS: LVAS, BVAS, and ODI improved in both groups. There was no significant difference in the degree of these improvements between PLIF and PLF patients (p>0.05). Radiological union rate was 91.1% in PLIF group and 89.4% in PLF group at postoperative 24 months (p>0.05). CONCLUSIONS: No significant differences in clinical results and union rates were found between PLIF and PLF patients. Selection of the operation technique will reflect the surgeon's preferences and patient condition.
Back Pain
;
Follow-Up Studies
;
Humans
;
Intervertebral Disc*
;
Leg
;
Retrospective Studies
;
Vacuum*
;
Weights and Measures

Result Analysis
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