1.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).
2.Change in the Recurrence Pattern and Predictors over Time after Complete Cure of Hepatocellular Carcinoma
Han Ah LEE ; Young-Sun LEE ; Beom Kyung KIM ; Young Kul JUNG ; Seung Up KIM ; Jun Yong PARK ; Ji Hoon KIM ; Hyunggin AN ; Do Young KIM ; Hyung Joon YIM ; Sang Hoon AHN ; Jong Eun YEON ; Kwan Soo BYUN ; Kwang-Hyub HAN ; Soon Ho UM ; Yeon Seok SEO
Gut and Liver 2021;15(3):420-429
Background/Aims:
We investigated changes in recurrence rates and significant recurrence predictors over time after complete cure of hepatocellular carcinoma (HCC).
Methods:
A total of 1,491 patients with first-time diagnosis of Barcelona Clinic Liver Cancer stage A HCC, completely cured by treatment between 2007 and 2016, were recruited from two Korean tertiary institutes.
Results:
The mean age of the population (1,144 men and 347 women) was 58.6 years. Of the total population, 914 patients (61.3%) had liver cirrhosis. Nine-hundred and forty-one (63.1%) and 550 (36.9%) patients were treated with surgical resection and radiofrequency ablation (RFA), respectively. One-year cumulative incidences of HCC recurrence were 14.3%, 9.9%, and 5.1% from the time of treatment, 3 years after treatment, and 5 years after treatment, respectively. Upon multivariate analysis, multiple tumors, maximal tumor size ≥3 cm, and high Model for End-Stage Liver Disease scores were independently associated with increased HCC recurrence risk from the time of treatment and 1 and 2 years after curative treatment (all p<0.05, except for maxi-mal tumor size ≥3 cm for recurrence 2 years after treatment). Meanwhile, liver cirrhosis and RFA were independently associated with the increased HCC recurrence risk for almost all time points (liver cirrhosis: all p<0.05; RFA: all p<0.005 except for recurrence from 5 years after treatment).
Conclusions
The recurrence rate of HCC after curative treatment gradually decreased over time. Two years after treatment, when tumor-related factors lose their prognostic implications, may be used as a cutoff to define the boundary between early and late recurrence of HCC.
3.Change in the Recurrence Pattern and Predictors over Time after Complete Cure of Hepatocellular Carcinoma
Han Ah LEE ; Young-Sun LEE ; Beom Kyung KIM ; Young Kul JUNG ; Seung Up KIM ; Jun Yong PARK ; Ji Hoon KIM ; Hyunggin AN ; Do Young KIM ; Hyung Joon YIM ; Sang Hoon AHN ; Jong Eun YEON ; Kwan Soo BYUN ; Kwang-Hyub HAN ; Soon Ho UM ; Yeon Seok SEO
Gut and Liver 2021;15(3):420-429
Background/Aims:
We investigated changes in recurrence rates and significant recurrence predictors over time after complete cure of hepatocellular carcinoma (HCC).
Methods:
A total of 1,491 patients with first-time diagnosis of Barcelona Clinic Liver Cancer stage A HCC, completely cured by treatment between 2007 and 2016, were recruited from two Korean tertiary institutes.
Results:
The mean age of the population (1,144 men and 347 women) was 58.6 years. Of the total population, 914 patients (61.3%) had liver cirrhosis. Nine-hundred and forty-one (63.1%) and 550 (36.9%) patients were treated with surgical resection and radiofrequency ablation (RFA), respectively. One-year cumulative incidences of HCC recurrence were 14.3%, 9.9%, and 5.1% from the time of treatment, 3 years after treatment, and 5 years after treatment, respectively. Upon multivariate analysis, multiple tumors, maximal tumor size ≥3 cm, and high Model for End-Stage Liver Disease scores were independently associated with increased HCC recurrence risk from the time of treatment and 1 and 2 years after curative treatment (all p<0.05, except for maxi-mal tumor size ≥3 cm for recurrence 2 years after treatment). Meanwhile, liver cirrhosis and RFA were independently associated with the increased HCC recurrence risk for almost all time points (liver cirrhosis: all p<0.05; RFA: all p<0.005 except for recurrence from 5 years after treatment).
Conclusions
The recurrence rate of HCC after curative treatment gradually decreased over time. Two years after treatment, when tumor-related factors lose their prognostic implications, may be used as a cutoff to define the boundary between early and late recurrence of HCC.
4.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).
5.Efficacy of a Complex of 5-Aminolevulinic Acid and Glycyl-Histidyl-Lysine Peptide on Hair Growth.
Weon Ju LEE ; Hyun Bo SIM ; Yong Hyun JANG ; Seok Jong LEE ; Do Won KIM ; Soon Ho YIM
Annals of Dermatology 2016;28(4):438-443
BACKGROUND: Pattern hair loss is a very common problem. Although effective therapeutics for the treatment of pattern hair loss have been used, novel therapeutic modalities are still required to enhance hair growth. OBJECTIVE: We investigated the efficacy and safety of a complex (ALAVAX) of 5-aminolevulinic acid (5-ALA) and glycyl-histidyl-lysine (GHK) peptide for the treatment of pattern hair loss. METHODS: Forty-five patients with male pattern hair loss were treated with ALAVAX 100 mg/ml (group A), ALAVAX 50 mg/ml (group B) or placebo (group C) once a day for 6 months. Total hair count, hair length, hair thickness, patient's assessment and adverse events were evaluated at month 1, 3, and 6. RESULTS: An increase in hair count for 6 months was 52.6 (p<0.05) in group A, 71.5 (p<0.05) in group B, and 9.6 in group C. The ratio of changes in hair count between group B (2.38) and group C (1.21) at 6 months showed a statistically significant difference (p<0.05). The proportion above good satisfaction was higher in group A (26.7%) than in the other groups (group B: 14.3%, group C: 7.1%). There was no statistically significant difference in hair length and hair thickness among 3 groups at 6 months. There was no adverse event in 3 groups. CONCLUSION: Our study showed that a complex of 5-ALA and GHK peptide may be considered as one of the complementary agents for the treatment of male pattern hair loss.
Hair*
;
Humans
;
Male
6.Gastrectomy for the treatment of refractory gastric ulceration after radioembolization with 90Y microspheres.
Sun Young YIM ; Jin Dong KIM ; Jin Yong JUNG ; Chang Ha KIM ; Yeon Seok SEO ; Hyung Joon YIM ; Soon Ho UM ; Ho Sang RYU ; Yun Hwan KIM ; Chong Suk KIM ; Eun SHIN
Clinical and Molecular Hepatology 2014;20(3):300-305
Transcatheter arterial radioembolization (TARE) with Yttrium-90 (90Y)-labeled microspheres has an emerging role in treatment of patients with unresectable hepatocellular carcinoma. Although complication of TARE can be minimized by aggressive pre-evaluation angiography and preventive coiling of aberrant vessels, radioembolization-induced gastroduodenal ulcer can be irreversible and can be life-threatening. Treatment of radioembolization-induced gastric ulcer is challenging because there is a few reported cases and no consensus for management. We report a case of severe gastric ulceration with bleeding that eventually required surgery due to aberrant deposition of microspheres after TARE.
Aged
;
Carcinoma, Hepatocellular/*diagnosis/radiotherapy
;
Embolization, Therapeutic/*adverse effects
;
Gastrectomy
;
Gastrointestinal Hemorrhage/etiology
;
Gastroscopy
;
Humans
;
Liver Neoplasms/*diagnosis/radiotherapy
;
Magnetic Resonance Imaging
;
Male
;
*Microspheres
;
Radiopharmaceuticals/therapeutic use
;
Stomach/pathology
;
Stomach Ulcer/*etiology/surgery
;
Yttrium Radioisotopes/chemistry
7.Serum Magnesium Level Is Associated with Type 2 Diabetes in Women with a History of Gestational Diabetes Mellitus: The Korea National Diabetes Program Study.
Sae Jeong YANG ; Soon Young HWANG ; Sei Hyun BAIK ; Kwan Woo LEE ; Moon Suk NAM ; Yong Soo PARK ; Jeong Taek WOO ; Young Seol KIM ; Sunmin PARK ; So Young PARK ; Chang Hoon YIM ; Hyun Koo YOON ; Sung Hoon KIM
Journal of Korean Medical Science 2014;29(1):84-89
Gestational diabetes mellitus (GDM) is a strong predictor of postpartum prediabetes and transition to overt type 2 diabetes (T2DM). Although many reports indicate that low magnesium is correlated with deteriorated glucose tolerance, the association between postpartum serum magnesium level and the risk for T2DM in women with a history of GDM has not been evaluated. We analyzed postpartum serum magnesium levels and development of prediabetes and T2DM in women with prior GDM according to American Diabetes Association (ADA) criteria using the Korean National Diabetes Program (KNDP) GDM cohort. During a mean follow-up of 15.6+/-2.0 months after screening, 116 women were divided into three groups according to glucose tolerance status. Ultimately, eight patients (6.9%) were diagnosed with T2DM, 59 patients (50.9%) with prediabetes, and 49 patients (42.2%) with normal glucose tolerance (NGT) after follow-up. The T2DM group had the lowest serum magnesium level (0.65 [0.63-0.68] mM/L) in the postpartum period, but there was no significant difference between the prediabetes group (0.70 [0.65-0.70] mM/L) and the NGT group (0.70 [0.65-0.70] mM/L) (P=0.073) Multiple logistic regression analysis showed that postpartum HOMA-IR was a significant predictor of both prediabetes and T2DM. Moreover, we found that postpartum serum magnesium level was also a possible predictor for T2DM development. Serum magnesium level in the postpartum period may be a possible predictor for T2DM development in women with a history of GDM.
Adult
;
Blood Glucose
;
Cohort Studies
;
Diabetes Mellitus, Type 2/*blood/diagnosis
;
Diabetes, Gestational/*blood
;
Female
;
Glucose Intolerance/*blood
;
Glucose Tolerance Test
;
Humans
;
Insulin Resistance
;
Magnesium/*blood
;
Postpartum Period/*blood
;
Prediabetic State/diagnosis
;
Pregnancy
;
Prospective Studies
;
Republic of Korea
;
Risk Factors
8.A Field Study of the Conditions of the Elderly in Rural Community ; The Correlation between of Sleep Quality and Quality of Life.
Soon Mo KWON ; Jeong Seok SEO ; Sang Kuk YANG ; Jin Yong CHOI ; Hyeon Woo YIM ; Sun Jin JO ; Hyun Suk JEONG ; Kun Ho YOON ; Beomwoo NAM
Journal of Korean Neuropsychiatric Association 2012;51(3):119-126
OBJECTIVES: This study aimed to investigate how sleep quality affects quality of life in the elderly of rural communities. METHODS: 877 elderly people aged 60 or over living in C towns participated in the study. They responded to the Pittsburgh Sleep Quality Index, EuroQol-5 dimension, Korean version of the short from of Geriatric Depression Scale, Mini-Mental State Examination for Dementia Screening and the presence of urinary incontinence. RESULTS: Most scores of the items of the quality of life index, except self-management, showed significant correlations with the total score of the sleep quality test. Statistically significant differences were found between the positives and the negatives of the sleep quality test in the scores of all the detailed items of the quality of life index. Among the detailed items of quality of sleep, subjective quality of sleep showed the highest correlation. CONCLUSION: The present study found that the subjective indicators such as subjective sleep quality and sleep disturbance affected quality of life in the rural lives of elderly people more than the objective indicators such as sleep durations or sleep latency periods. Based on the results of these studies, we concluded that a methodological approach and a management model to treating insomnia to improve the quality of life of the elderly would need to be developed and applied.
Aged
;
Dementia
;
Depression
;
Humans
;
Latency Period (Psychology)
;
Mass Screening
;
Quality of Life
;
Rural Population
;
Self Care
;
Sleep Initiation and Maintenance Disorders
9.Spinal cord injury after conducting transcatheter arterial chemoembolization for costal metastasis of hepatocellular carcinoma.
Sang Jung PARK ; Chang Ha KIM ; Jin Dong KIM ; Soon Ho UM ; Sun Young YIM ; Min Ho SEO ; Dae In LEE ; Jun Hyuk KANG ; Bora KEUM ; Yong Sik KIM
Clinical and Molecular Hepatology 2012;18(3):316-320
Transcatheter arterial chemoembolization (TACE) has been used widely to treat patients with unresectable hepatocellular carcinoma. However, this method can induce various adverse events caused by necrosis of the tumor itself or damage to nontumor tissues. In particular, neurologic side effects such as cerebral infarction and paraplegia, although rare, may cause severe sequelae and permanent disability. Detailed information regarding the treatment process and prognosis associated with this procedure is not yet available. We experienced a case of paraplegia that occurred after conducting TACE through the intercostal artery to treat hepatocellular carcinoma that had metastasized to the rib. In this case, TACE was attempted to relieve severe bone pain, which had persisted even after palliative radiotherapy. A sudden impairment of sensory and motor functions after TACE developed in the trunk below the level of the sternum and in both lower extremities. The patient subsequently received steroid pulse therapy along with supportive care and continuous rehabilitation. At the time of discharge the patient had recovered sufficiently to enable him to walk by himself, although some paresthesia and spasticity remained.
Antiviral Agents/therapeutic use
;
Bone Neoplasms/radiography/secondary
;
Carcinoma, Hepatocellular/diagnosis/pathology/*therapy
;
Catheter Ablation
;
Chemoembolization, Therapeutic/*adverse effects
;
Hepatitis B/complications/drug therapy
;
Humans
;
Liver Cirrhosis/etiology
;
Liver Neoplasms/diagnosis/pathology/*therapy
;
Male
;
Middle Aged
;
Positron-Emission Tomography
;
Soft Tissue Neoplasms/secondary
;
Spinal Cord Injuries/*etiology
;
Tomography, X-Ray Computed
10.Optimal time for repeating the IgM anti-hepatitis A virus antibody test in acute hepatitis A patients with a negative initial test.
Jong Jin HYUN ; Yeon Seok SEO ; Hyonggin AN ; Sun Young YIM ; Min Ho SEO ; Hye Sook KIM ; Chang Ha KIM ; Ji Hoon KIM ; Bora KEUM ; Yong Sik KIM ; Hyung Joon YIM ; Hong Sik LEE ; Soon Ho UM ; Chang Duck KIM ; Ho Sang RYU
The Korean Journal of Hepatology 2012;18(1):56-62
BACKGROUND/AIMS: The nonspecific clinical presentation of acute hepatitis A (AHA) mandates the detection of anti-hepatitis A virus IgM antibodies (IgM anti-HAV) in the serum for obtaining a definitive diagnosis. However, IgM anti-HAV might not be present during the early phase of the disease. The aim of this study was to determine the optimal time for repeating the IgM anti-HAV test (HAV test) in AHA patients with a negative initial test. METHODS: In total, 261 patients hospitalized with AHA were enrolled for this retrospective study. AHA was diagnosed when the test for IgM anti-HAV was positive and the serum alanine aminotransferase (ALT) level was > or =400 IU/L. Repeat HAV test was conducted after 1-2 weeks if the initial HAV test was negative but AHA was still clinically suspected. RESULTS: The results of the initial HAV test were negative in 28 (10.7%) patients. The intervals from symptom onset to the initial-HAV-test day and from the peak-ALT day to the initial-HAV-test day were significantly shorter in the negative-initial-HAV-test group, but on multivariate analysis only the latter was significantly associated with negative results for the initial HAV test (beta=-0.978; odds ratio [95% confidence interval]=0.376 [0.189-0.747]; P=0.005). The HAV test was positive in all patients when it was performed at least 2 days after the peak-ALT day. CONCLUSIONS: The results of HAV tests were significantly associated with the interval from the peak-ALT day to the HAV-test day. The optimal time for repeating the HAV test in clinically suspicious AHA patients with a negative initial HAV test appears to be at least 2 days after the peak-ALT day.
Acute Disease
;
Adult
;
Alanine Transaminase/blood
;
Female
;
Hepatitis A/*diagnosis
;
Hepatitis A Antibodies/*blood
;
Hepatitis A virus/*immunology
;
Humans
;
Immunoglobulin M/*blood
;
Male
;
Odds Ratio
;
Retrospective Studies
;
Time Factors

Result Analysis
Print
Save
E-mail