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.Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial
Do Seon SONG ; Won KIM ; Sang Hoon AHN ; Hyung Joon YIM ; Jae Young JANG ; Young Oh KWEON ; Yong Kyun CHO ; Yoon Jun KIM ; Gun Young HONG ; Dong Joon KIM ; Young Kul JUNG ; Joo Hyun SOHN ; Jin-Woo LEE ; Sung Jae PARK ; Byung Seok LEE ; Ju Hyun KIM ; Hong Soo KIM ; Seung Kew YOON ; Moon Young KIM ; Kwan Sik LEE ; Young Suk LIM ; Wan Sik LEE ; Jin Mo YANG ; Kyun-Hwan KIM ; Kwang-Hyub HAN ; Soon Ho UM
Clinical and Molecular Hepatology 2021;27(2):346-359
Background/Aims:
Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.
Methods:
Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).
Results:
Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.
Conclusions
BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).
3.Diagnosis for Pheochromocytoma and Paraganglioma: A Joint Position Statement of the Korean Pheochromocytoma and Paraganglioma Task Force
Eu Jeong KU ; Kyoung Jin KIM ; Jung Hee KIM ; Mi Kyung KIM ; Chang Ho AHN ; Kyung Ae LEE ; Seung Hun LEE ; You-Bin LEE ; Kyeong Hye PARK ; Yun Mi CHOI ; Namki HONG ; A Ram HONG ; Sang-Wook KANG ; Byung Kwan PARK ; Moon-Woo SEONG ; Myungshin KIM ; Kyeong Cheon JUNG ; Chan Kwon JUNG ; Young Seok CHO ; Jin Chul PAENG ; Jae Hyeon KIM ; Ohk-Hyun RYU ; Yumie RHEE ; Chong Hwa KIM ; Eun Jig LEE
Endocrinology and Metabolism 2021;36(2):322-338
Pheochromocytoma and paraganglioma (PPGLs) are rare catecholamine-secreting neuroendocrine tumors but can be life-threatening. Although most PPGLs are benign, approximately 10% have metastatic potential. Approximately 40% cases are reported as harboring germline mutations. Therefore, timely and accurate diagnosis of PPGLs is crucial. For more than 130 years, clinical, molecular, biochemical, radiological, and pathological investigations have been rapidly advanced in the field of PPGLs. However, performing diagnostic studies to localize lesions and detect metastatic potential can be still challenging and complicated. Furthermore, great progress on genetics has shifted the paradigm of genetic testing of PPGLs. The Korean PPGL task force team consisting of the Korean Endocrine Society, the Korean Surgical Society, the Korean Society of Nuclear Medicine, the Korean Society of Pathologists, and the Korean Society of Laboratory Medicine has developed this position statement focusing on the comprehensive and updated diagnosis for PPGLs.
4.Diagnosis for Pheochromocytoma and Paraganglioma: A Joint Position Statement of the Korean Pheochromocytoma and Paraganglioma Task Force
Eu Jeong KU ; Kyoung Jin KIM ; Jung Hee KIM ; Mi Kyung KIM ; Chang Ho AHN ; Kyung Ae LEE ; Seung Hun LEE ; You-Bin LEE ; Kyeong Hye PARK ; Yun Mi CHOI ; Namki HONG ; A Ram HONG ; Sang-Wook KANG ; Byung Kwan PARK ; Moon-Woo SEONG ; Myungshin KIM ; Kyeong Cheon JUNG ; Chan Kwon JUNG ; Young Seok CHO ; Jin Chul PAENG ; Jae Hyeon KIM ; Ohk-Hyun RYU ; Yumie RHEE ; Chong Hwa KIM ; Eun Jig LEE
Endocrinology and Metabolism 2021;36(2):322-338
Pheochromocytoma and paraganglioma (PPGLs) are rare catecholamine-secreting neuroendocrine tumors but can be life-threatening. Although most PPGLs are benign, approximately 10% have metastatic potential. Approximately 40% cases are reported as harboring germline mutations. Therefore, timely and accurate diagnosis of PPGLs is crucial. For more than 130 years, clinical, molecular, biochemical, radiological, and pathological investigations have been rapidly advanced in the field of PPGLs. However, performing diagnostic studies to localize lesions and detect metastatic potential can be still challenging and complicated. Furthermore, great progress on genetics has shifted the paradigm of genetic testing of PPGLs. The Korean PPGL task force team consisting of the Korean Endocrine Society, the Korean Surgical Society, the Korean Society of Nuclear Medicine, the Korean Society of Pathologists, and the Korean Society of Laboratory Medicine has developed this position statement focusing on the comprehensive and updated diagnosis for PPGLs.
5.Cilostazol and Probucol for Cognitive Decline after Stroke: A Cognitive Outcome Substudy of the PICASSO Trial
Jae-Sung LIM ; Sun U. KWON ; Kyung-Ho YU ; Sungwook YU ; Jong-Ho PARK ; Byung-Chul LEE ; Mi Sun OH ; Yong-Jae KIM ; Joung-Ho RHA ; Yang-Ha HWANG ; Ji Sung LEE ; Sung Hyuk HEO ; Seong Hwan AHN ; Woo-Keun SEO ; Jong-Moo PARK ; Ju-Hun LEE ; Jee-Hyun KWON ; Sung-Il SOHN ; Jin-Man JUNG ; Hahn Young KIM ; Eung-Gyu KIM ; Jae-Kwan CHA ; Man-Seok PARK ; Hyo Suk NAM ; Hee-Joon BAE ; Dong-Eog KIM ; Jaeseol PARK ; Yeonwook KANG ; Jimi CHOI ; Juneyoung LEE
Journal of Stroke 2021;23(1):128-131
6.Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial
Do Seon SONG ; Won KIM ; Sang Hoon AHN ; Hyung Joon YIM ; Jae Young JANG ; Young Oh KWEON ; Yong Kyun CHO ; Yoon Jun KIM ; Gun Young HONG ; Dong Joon KIM ; Young Kul JUNG ; Joo Hyun SOHN ; Jin-Woo LEE ; Sung Jae PARK ; Byung Seok LEE ; Ju Hyun KIM ; Hong Soo KIM ; Seung Kew YOON ; Moon Young KIM ; Kwan Sik LEE ; Young Suk LIM ; Wan Sik LEE ; Jin Mo YANG ; Kyun-Hwan KIM ; Kwang-Hyub HAN ; Soon Ho UM
Clinical and Molecular Hepatology 2021;27(2):346-359
Background/Aims:
Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.
Methods:
Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).
Results:
Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.
Conclusions
BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).
7.Carbon monoxide poisoning-induced type 1 Brugada electrocardiographic pattern
Youngmo CHO ; Seok Ran YEOM ; Suck Ju CHO ; Byung Kwan BAE ; Dae Sup LEE ; Tae Gyu HYUN ; Jinhee AHN ; Il Jae WANG
Journal of the Korean Society of Emergency Medicine 2021;32(5):480-484
Carbon monoxide (CO) can cause a variety of electrocardiogram (ECG) changes. The Brugada ECG patterns are very rare in CO poisoning cases. We detected a patient with a CO-induced type 1 Brugada ECG pattern with chest pain. The panel genetic test and echocardiogram revealed normal findings. The Brugada phenocopy gradually improved over 3 days. We reviewed the literature and suggested possible mechanisms.
8.Differences in Therapeutic Responses and Factors Affecting Post-Stroke Depression at a Later Stage According to Baseline Depression.
Eun Jae LEE ; Jong S KIM ; Dae Il CHANG ; Jong Ho PARK ; Seong Hwan AHN ; Jae Kwan CHA ; Ji Hoe HEO ; Sung Il SOHN ; Byung Chul LEE ; Dong Eog KIM ; Hahn Young KIM ; Seongheon KIM ; Do Young KWON ; Jei KIM ; Woo Keun SEO ; Jun LEE ; Sang Won PARK ; Seong Ho KOH ; Jin Young KIM ; Smi CHOI-KWON ; Min Sun KIM ; Ji Sung LEE
Journal of Stroke 2018;20(2):258-267
BACKGROUND AND PURPOSE: The pathophysiology of post-stroke depression (PSD) is complex and may differ according to an individual’s mood immediately after stroke. Here, we compared the therapeutic response and clinical characteristics of PSD at a later stage between patients with and without depression immediately after stroke. METHODS: This study involved a post hoc analysis of data from EMOTION (ClinicalTrials.gov NCT01278498), a placebo-controlled, double-blind trial that examined the efficacy of escitalopram (10 mg/day) on PSD and other emotional disturbances among 478 patients with acute stroke. Participants were classified into the Baseline-Blue (patients with baseline depression at the time of randomization, defined per the Montgomery-Asberg Depression Rating Scale [MADRS] ≥8) or the Baseline-Pink groups (patients without baseline depression). We compared the efficacy of escitalopram and predictors of 3-month PSD (MADRS ≥8) between these groups. RESULTS: There were 203 Baseline-Pink and 275 Baseline-Blue patients. The efficacy of escitalopram in reducing PSD risk was more pronounced in the Baseline-Pink than in the Baseline-Blue group (p for interaction=0.058). Several risk factors differentially affected PSD development based on the presence of baseline depression (p for interaction < 0.10). Cognitive dysfunction was an independent predictor of PSD in the Baseline-Blue, but not in the Baseline-Pink group, whereas the non-use of escitalopram and being female were more strongly associated with PSD in the Baseline-Pink group. CONCLUSIONS: Responses to escitalopram and predictors of PSD 3 months following stroke differed based on the presence of baseline depression. Our data suggest that PSD pathophysiology is heterogeneous; therefore, different therapeutic strategies may be needed to prevent PSD emergence following stroke.
Affective Symptoms
;
Anger
;
Citalopram
;
Depression*
;
Female
;
Humans
;
Random Allocation
;
Risk Factors
;
Stroke
9.One Stage Posterior Minimal Laminectomy and Video-Assisted Thoracoscopic Surgery (VATS) for Removal of Thoracic Dumbbell Tumor.
Kyoung Hyup NAM ; Hyo Yeoung AHN ; Jeong Su CHO ; Yeoung Dae KIM ; Byung Kwan CHOI ; In Ho HAN
Journal of Korean Neurosurgical Society 2017;60(2):257-261
OBJECTIVE: This study was conducted to assess the surgical results of one-stage posterior minimal laminectomy and video-assisted thoracoscopic surgery (VATS) for the treatment of thoracic dumbbell tumor and to describe its precise technique. In addition, we investigated the technique's usefulness and limitations. METHODS: Seven cases of thoracic dumbbell tumor (two men and five women, mean age, 43 years) were analyzed retrospectively. Pathological findings included schwannoma in four patients, neurofibroma in two patients, and hemangioma in one patient. The location of tumors varied from T2/3 to T12/L1. Dumbbell tumors were resected by one-stage operation using posterior laminectomy followed by VATS without instrumentation. Clinical data were reviewed. RESULTS: The mean follow-up period was 25 months (range, 3–58 months), and the operative time ranged from 255 to 385 min (mean, 331 min), with estimated blood loss ranging from 110 to 930 mL (mean, 348 mL). The tumor was completely resected without instrumentation and postoperative instability in all cases. Postoperative complications included atelectasis and facial anhydrosis in one case each. CONCLUSION: One-stage posterior minimal laminectomy and VATS may be a safe and less invasive technique for removal of thoracic dumbbell tumor without instability. This method has the advantage of early ambulation and rapid recovery because it reduces blood loss and postoperative pain.
Early Ambulation
;
Female
;
Follow-Up Studies
;
Hemangioma
;
Humans
;
Laminectomy*
;
Male
;
Methods
;
Neurilemmoma
;
Neurofibroma
;
Operative Time
;
Pain, Postoperative
;
Postoperative Complications
;
Pulmonary Atelectasis
;
Retrospective Studies
;
Thoracic Surgery, Video-Assisted*
10.Acute toxicity and cytotoxicity evaluation of Dendrobium moniliforme aqueous extract in vivo and in vitro.
Mu Jin LEE ; Ho Kyung JUNG ; Min Suk KIM ; Ji Hun JANG ; Mi Ok SIM ; Tea Mook KIM ; Ho PARK ; Byung Kwan AHN ; Hyun Woo CHO ; Jung Hee CHO ; Won Seok JUNG ; Jong Choon KIM
Laboratory Animal Research 2016;32(3):144-150
Dendrobium moniliforme (L.) Sw., an herb of the Orchidaceae family, has long been used in traditional medicine to strengthen bones, nourish the stomach, and promote the production of bodily fluid. Recently, polysaccharides isolated from Dendrobium have been used in functional foods and nutraceutical products. A traditional method to process Dendrobium is to soak fresh stems in an ethanol solution, which is the most important factor to ensure high yields of aqueous-extractable polysaccharides. The present study was carried out to investigate the potential acute toxicity of D. moniliforme aqueous extract (DMAE), by a single oral dose in Sprague-Dawley rats. The test article was orally administered once by gavage to male and female rats at doses of 0, 2,500, and 5,000 mg/kg body weight (n=5 male and female rats for each dose). Throughout the study period, no treatment-related deaths were observed and no adverse effects were noted in clinical signs, body weight, food consumption, serum biochemistry, organ weight, or gross findings at any dose tested. The results show that a single oral administration of DMAE did not induce any toxic effects at a dose below 5,000 mg/kg in rats, and the minimal lethal dose was considered to be over 5,000 mg/kg body weight for both sexes. With respect to cytotoxicity, the cell viability of human embryonic kidney (HEK293) cells was less than 50% when the cells were treated with 10 mg/mL aqueous extract for 24 h.
Administration, Oral
;
Animals
;
Biochemistry
;
Body Weight
;
Cell Survival
;
Dendrobium*
;
Dietary Supplements
;
Ethanol
;
Female
;
Functional Food
;
Humans
;
In Vitro Techniques*
;
Kidney
;
Male
;
Medicine, Traditional
;
Methods
;
Orchidaceae
;
Organ Size
;
Polysaccharides
;
Rats
;
Rats, Sprague-Dawley
;
Stomach

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