Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study

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.

A Multi-Center, Double-Blind Randomized Controlled Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802 (Tenofovir Disoproxil Orotate) and Viread (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients

Background@#Tenofovir disoproxil fumarate (TDF, Viread® ) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF. @*Methods@#The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated. @*Results@#A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was −5.13 ± 1.40 in the DA-2802 group and −4.97 ± 1.40 log 10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity. @*Conclusion@#DA-2802 is considered an effective and safe treatment for patients with CHB.

Tenofovir alafenamide treatment may not worsen the lipid profile of chronic hepatitis B patients: A propensity score-matched analysis

Background/Aims@#Tenofovir alafenamide (TAF) has shown less favorable effect on lipids compared to tenofovir disoproxil fumarate (TDF) in clinical trials. However, data regarding these outcomes in patients with chronic hepatitis B (CHB) are scarce. Therefore, this study aimed to evaluate the effect of TAF on the lipid in patients with CHB. @*Methods@#A total of 237 TAF-treated CHB patients compared with TDF, inactive CHB, and non-hepatitis B virus (HBV)-infected control groups using propensity score matching (PSM). @*Results@#Following PSM, each analysis was conducted on cohorts via the matching of 70:140 (TAF:TDF), 89:89 (TAF:inactive CHB), 140:560 (TAF:non-HBV infected control), and 368:1,472 (TDF:non-HBV-infected control). A significant decrease in the total cholesterol (TC) level was noted at 48 weeks in the TDF group compared to the TAF group (176.3±32.9 vs. 156.7±27.7, P<0.001) and the non-HBV-infected control group (175.0±29.5 vs. 156.2±28.3, P<0.001). However, no significant change in TC was observed in the TAF group and inactive CHB or non-HBV-infected control groups at 48 weeks. For the subgroup analyses of TAF vs. non-HBV-infected control subjects and inactive CHB patients whose detailed lipid profile information were available, no between-group differences in TC, low-density lipoprotein (LDL)-cholesterol, highdensity lipoprotein (HDL)-cholesterol, TC/HDL ratio, and LDL/HDL ratio were observed at 48 weeks. @*Conclusions@#TDF seems to have a lipid-lowering effect compared to the non-HBV-infected control and TAF-treated groups. However, in real practice, TAF might not worsen the lipid profiles of subjects compared to non-HBV-infected controls and patients with inactive CHB.

Low-level viremia and cirrhotic complications in patients with chronic hepatitis B according to adherence to entecavir

Background/Aims@#Low-level viremia (LLV) after nucleos(t)ide analog treatment was presented as a possible cause of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). However, detailed information on patients’ adherence in the real world was lacking. This study aimed to evaluate the effects of LLV on HCC development, mortality, and cirrhotic complications among patients according to their adherence to entecavir (ETV) treatment. @*Methods@#We performed a retrospective observational analysis of data from 894 consecutive adult patients with treatment-naïve CHB undergoing ETV treatment. LLV was defined according to either persistent or intermittent episodes of <2,000 IU/mL detectable hepatitis B virus DNA during the follow-up period. Good adherence to medication was defined as a cumulative adherence ≥90% per study period. @*Results@#Without considering adherence in the entire cohort (n=894), multivariate analysis of the HCC incidence showed that LLV was an independent prognostic factor in addition to other traditional risk factors in the entire cohort (P=0.031). Good adherence group comprised 617 patients (69.0%). No significant difference was found between maintained virologic response and LLV groups in terms of the incidence of liver-related death or transplantation, HCC, and hepatic decompensation in good adherence group, according to multivariate analyses. @*Conclusions@#In patients with treatment-naïve CHB and good adherence to ETV treatment in the real world, LLV during treatment is not a predictive factor for HCC and cirrhotic complications. It may be unnecessary to adjust their antiviral agent for patients with good adherence who experience LLV during ETV treatment.

Chronic Hepatitis B Infection Is Significantly Associated with Chronic Kidney Disease: a Population-based, Matched Case-control Study

BACKGROUND: Hepatitis B virus (HBV) infection leads to hepatic and extrahepatic manifestations including chronic kidney disease (CKD). However, the association between HBV and CKD is not clear. This study investigated the association between chronic HBV infection and CKD in a nationwide multicenter study. METHODS: A total of 265,086 subjects who underwent health-check examinations in 33 hospitals from January 2015 to December 2015 were enrolled. HBV surface antigen (HBsAg) positive cases (n = 10,048), and age- and gender-matched HBsAg negative controls (n = 40,192) were identified. CKD was defined as a glomerular filtration rate (GFR) < 60 mL/min/1.73 m² or proteinuria as at least grade 2+ of urine protein. RESULTS: HBsAg positive cases showed a significantly higher prevalence of GFR < 60 mL/min/1.73 m² (3.3%), and proteinuria (18.9%) than that of the controls (2.6%, P < 0.001, and 14.1%, P < 0.001, respectively). In the multivariate analysis, HBsAg positivity was an independent factor associated with GFR < 60 mL/min/1.73 m² along with age, blood levels of albumin, bilirubin, anemia, and hemoglobin A1c (HbA1c). Likewise, HBsAg positivity was an independent factor for proteinuria along with age, male, blood levels of bilirubin, protein, albumin, and HbA1c. A subgroup analysis showed that HBsAg positive men but not women had a significantly increased risk for GFR < 60 mL/min/1.73 m². CONCLUSION: Chronic HBV infection was significantly associated with a GFR < 60 mL/min/1.73 m² and proteinuria (≥ 2+). Therefore, clinical concern about CKD in chronic HBV infected patients, especially in male, is warranted.

Efficacy of tenofovir-based rescue therapy for chronic hepatitis B patients with resistance to lamivudine and entecavir

BACKGROUND/AIMS: Tenofovir disoproxil fumarate (TDF) monotherapy for 48 weeks provided a virological response comparable to that of TDF and entecavir (ETV) combination therapy in patients infected with ETV-resistant hepatitis B virus (HBV). Little long-term data in routine clinical practice are available regarding the optimal treatment of patients with ETV-resistant HBV. METHODS: We investigated the long-term antiviral efficacy of combination therapy of TDF+lamivudine (LAM) or TDF+ETV compared to that of TDF monotherapy in 73 patients with resistance to both LAM and ETV. RESULTS: Patients were treated with TDF monotherapy (n=12), TDF+LAM (n=19), or TDF+ETV (n=42) for more than 6 months. The median duration of TDF-based rescue therapy was 37 months. Virologic response (VR) was found in 63 patients (86.3%). The rates of VR among the three groups (TDF monotherapy, TDF+LAM, and TDF+ETV) were not statistically different (log-rank P=0.200) at 12 months (59.3%, 78.9%, and 51.8%, respectively) or at 24 months (88.4%, 94.7%, and 84.2%). In addition, treatment efficacy of TDF-based combination or TDF monotherapy was not statistically different with ETV-resistant strains or exposure to other antiviral agents. In multivariate analysis, only lower baseline HBV DNA level was an independent predictor for VR (hazard ratio, 0.723; 95% confidence interval, 0.627-0.834; P<0.001). CONCLUSIONS: TDF monotherapy was as effective as combination therapy of TDF+LAM or TDF+ETV in maintaining long-term viral suppression in chronic hepatitis B patients with resistance to both LAM and ETV. HBV DNA level at the start of TDF rescue therapy was the only independent predictor of subsequent VR.

Comparison of tenofovir plus lamivudine versus tenofovir monotherapy in patients with lamivudine-resistant chronic hepatitis B

BACKGROUND/AIMS: Tenofovir disoproxil fumarate (TDF) exhibits similar antiviral efficacy against treatment-naïve and lamivudine (LAM)-resistant chronic hepatitis B (CHB). However, there are few clinical reports on the antiviral effects of TDF-LAM combination therapy compared to TDF monotherapy in patients with LAM-resistant CHB. METHODS: We investigated the antiviral efficacy of TDF monotherapy vs. TDF-LAM combination therapy in 103 patients with LAM-resistant CHB. RESULTS: The study subjects were treated with TDF alone (n=40) or TDF-LAM combination therapy (n=63) for ≥6 months. The patients had previously been treated with TDF-based rescue therapy for a median of 30.0 months (range, 8-36 months). A virologic response (VR) was achieved in 99 patients (96.1%): 95.0% (38/40) of patients in the TDF monotherapy group and 96.8% (61/63) of patients in the TDF-LAM combination therapy group. The VR rates were not significantly different between the TDF monotherapy and TDF-LAM combination therapy groups (88.9 vs. 87.3% at month 12, and 94.4 vs. 93.7% at month 24, log-rank p=0.652). Univariate and multivariate analyses revealed that none of the pretreatment factors were significantly associated with VR. CONCLUSIONS: TDF monotherapy was as effective as TDF-LAM combination therapy for maintaining viral suppression in the vast majority of patients with LAM-resistant CHB, which suggests that TDF add-on therapy with LAM is unnecessary.

Clinical Application of Non-invasive Diagnostic Tests for Liver Fibrosis / 대한소화기학회지

The diagnostic assessment of liver fibrosis is an important step in the management of patients with chronic liver diseases. Liver biopsy is considered the gold standard to assess necroinflammation and fibrosis. However, recent technical advances have introduced numerous serum biomarkers and imaging tools using elastography as noninvasive alternatives to biopsy. Serum markers can be direct or indirect markers of the fibrosis process. The elastography-based studies include transient elastography, acoustic radiation force imaging, supersonic shear wave imaging and magnetic resonance elastography. As accumulation of clinical data shows that noninvasive tests provide prognostic information of clinical relevance, non-invasive diagnostic tools have been incorporated into clinical guidelines and practice. Here, the authors review noninvasive tests for the diagnosis of liver fibrosis.

Performance Evaluation of Immunoassay Detection of HBsAg Mutants and Their Clinical Significance in the High Risk Groups

BACKGROUND: False negative results have been reported in the immunodetection of hepatitis B virus (HBV) because of the existence of the various mutants of the virus, causing most suppliers to try to develop superior reagents by using highly sensitive and specific monoclonal or polyclonal antibodies. In this study, we evaluated the effectiveness of 3 newly developed reagents by major manufacturers by adopting automated methods with increased sensitivity and specificity in the detection and discrimination of native and recombinant mutant antigens. METHODS: We analyzed samples confirmed positive for hepatitis B surface antigen (HBsAg), high-risk samples from chronic hepatitis patients treated with antiviral agents, and samples from patients who had undergone liver transplantation and were treated with high-dose hepatitis B immunoglobulin (HBIG) by using reagents and systems newly developed by Abbott Laboratories (USA), Roche Diagnostics (Germany), and Siemens Healthcare Diagnostics (USA). Recombinant sample panels from these manufacturers with low and high concentrations were also analyzed for comparing the 3 reagents. RESULTS: There were no discrepant results among the various selected patient groups; however, for the recombinant mutant panels, all of the 3 reagents showed highly positive detection rates for their corresponding mutant panels, but showed relatively discrepant mutant detection rates when cross-tested with the other mutant panels. Detection rates of the HBsAg mutant panels were higher at a higher concentration of the mutant samples, but were lower for the same mutant receptor sites at a lower concentration. CONCLUSIONS: The 3 major detection methods seem to recognize the major native mutants commonly encountered in clinical practice. However, in the case of recombinant mutants, we believe that our data are not to be interpreted as a reference standard for any reagent, because the results can only be validated for the reagents' corresponding mutant panels; such results tend to be mutually exclusive, and the enough concentration of mutants was required to be adjusted for a comparative analysis.

Performance Evaluation of 3 Kinds of HBsAg Qualitative Assays and 2 Kinds of Quantitative Assays

BACKGROUND: Currently used techniques for quantitation of HBsAg often yield discordant results; therefore, development of quantitation techniques that can detect HBsAg with high accuracy has become very important. Recent advances have led to the development of several HBsAg detection systems. Here, we evaluated the performance of 3 newly developed detection systems, which can detect HBsAg both qualitatively and quantitavely, and determined the concordance among their results. METHODS: Four hundred and thirty two samples assigned to 4 groups-patient group, dilution group, weakly reactive group, and linearity group- were subjected to qualitative and quantitative detection of HBsAg by using the 3 systems developed by 3 major manufacturers; Abbott Architect, Roche E170 and Siemens Centaur XP. RESULTS: The results for the qualitative analyses were closely concordant among the three systems (98.3%) for all 432 samples. In 123 samples that were determined as HBsAg-negative, E170 (76%) distributed frequently at the upper half level (0.5-1.0) of negative reference range, compared with Architect (11%) and Centaur XP (22%). In particular, in 65 samples that were diluted from the strongly positive samples to obtain weakly positive samples, the average index values obtained using Architect (3.6 S/CO), E170 (4.2 COI) and Centaur XP (11.4 index value) differed significantly (P<0.0001). In the antiviral treatment group and the post-liver transplantation group, no inconsistency was observed among the results of the qualitative and quantitative assays. In the 18-fold serially diluted samples, no linearity was observed. CONCLUSIONS: Because of the possibility of false-positive detection in the HBsAg-negative samples, regular management of equipment and appropriate selection of reagents are very important. In weakly positive samples, quantitative assay has not to be replaced for qualitative assay. Therefore, the qualitative assays should be used for screening the samples, whereas the quantitative assays should be used for monitoring the Hepatitis B virus (HBV) load in the samples determined as HBsAg-positive. The qualitative index value should not be interpreted as a quantitative measure of HBV load.

Localized Uterine Recurrence of Hepatocellular Carcinoma 4 Years after Curative Resection / 대한내과학회지

Extrahepatic metastasis of hepatocellular carcinoma (HCC) can be found in various organs, but metastasis to the female genital tract is extremely rare. A 48-year-old woman who had undergone curative left lobectomy for small HCC 4 years earlier was admitted because of sequential alpha-fetoprotein elevation. Upon abdominal MRI and hepatic angiography, no evidence of HCC recurrence was found in the remnant liver. However, a positron emission tomography CT scan showed a hypermetabolic lesion in the uterine fundus, which was revealed as metastatic HCC after total hysterectomy. This is, to our knowledge, the first documented case of metastatic uterine tumor that originated from HCC without intrahepatic recurrence.

Localized Uterine Recurrence of Hepatocellular Carcinoma 4 Years after Curative Resection / 대한내과학회지

Extrahepatic metastasis of hepatocellular carcinoma (HCC) can be found in various organs, but metastasis to the female genital tract is extremely rare. A 48-year-old woman who had undergone curative left lobectomy for small HCC 4 years earlier was admitted because of sequential alpha-fetoprotein elevation. Upon abdominal MRI and hepatic angiography, no evidence of HCC recurrence was found in the remnant liver. However, a positron emission tomography CT scan showed a hypermetabolic lesion in the uterine fundus, which was revealed as metastatic HCC after total hysterectomy. This is, to our knowledge, the first documented case of metastatic uterine tumor that originated from HCC without intrahepatic recurrence.

Clinical Characteristics of Occult HBV Infection and Impact on Treatment Response in Patients with Chronic Hepatitis C / 대한내과학회지

BACKGROUND/AIMS: The prevalence of occult HBV infection (OBI) in patients with chronic hepatitis C (CHC) in Korea has not been reported. Additionally, it is unclear whether OBI influences treatment outcome in CHC patients. We investigated the prevalence of OBI and its impact on treatment outcome in patients with CHC. METHODS: Seventy-six patients with CHC were enrolled and treated with pegylated or conventional interferon and ribavirin. Hepatitis B virus (HBV) DNA was detected by nested polymerase chain reaction. RESULTS: Among the 68 patients who completed treatment and follow-up, HBV DNA was detected in serum from nine (13.2%) patients, liver tissue from 10 (14.7%), and serum or liver tissue from 15 (22.1%). OBI was diagnosed in nine (12.7%) control subjects. No difference in the prevalence of OBI between patients with CHC and controls was observed (13.2 vs. 12.0%; p = 0.92). No significant differences in age, sex, genotype 1 frequency, amount of hepatitis C virus RNA, anti-hepatitis B surface antigen/anti-hepatitis B core-IgG seropositivity, staging, or histology grading were observed in patients with or without HBV DNA. Sustained virological response was achieved in 73.3% of patients with OBI and 83.0% without OBI (p = 0.46). CONCLUSIONS: These results demonstrate that a significant proportion of patients with CHC have occult HBV infection and that OBI does not affect treatment outcome in patients with CHC.

Overexpression of bone morphogenetic protein 4 in STO fibroblast feeder cells represses the proliferation of mouse embryonic stem cells in vitro

Embryonic stem cells (ESCs) can be propagated in vitro on feeder layers of mouse STO fibroblast cells. The STO cells secrete several cytokines that are essential for ESCs to maintain their undifferentiated state. In this study, we found significant growth inhibition of mouse ESCs (mESCs) cultured on STO cells infected with adenovirus containing a dominant-negative mutant form of IkappaB (rAd-dnIkappaB). This blockage of the NF-kappaB signal pathway in STO cells led to a significant decrease in [3H]thymidine incorporation and colony formation of mESCs. Expression profile of cytokines secreted from the STO cells revealed an increase in the bone morphogenetic protein4 (BMP4) transcript level in the STO cells infected with adenoviral vector encoding dominant negative IkappaB (rAd-dnIkappaB). These results suggested that the NF-kappaB signaling pathway represses expression of BMP4 in STO feeder cells. Conditioned medium from the rAd-dnIkappaB-infected STO cells also significantly reduced the colony size of mESCs. Addition of BMP4 prevented colony formation of mESCs cultured in the conditioned medium. Our finding suggested that an excess of BMP4 in the conditioned medium also inhibits proliferation of mESCs.

The presence of high level soluble herpes virus entry mediator in sera of gastric cancer patients

The development of gastric cancer (GC) is closely related to chronic inflammation caused by Helicobacter pylori infection, and herpes virus entry mediator (HVEM) is a receptor expressed on the surface of leukocytes that mediates potent inflammatory responses in animal models. However, the role of HVEM in human GC has not been studied. Previously, we showed that the interaction of HVEM on human leukocytes with its ligand LIGHT induces intracellular calcium mobilization, which results in inflammatory responses including induction of proinflammatory cytokine production and anti-bacterial activities. In this study, we report that leukocytes from GC patients express lower levels of membrane HVEM (mHVEM) and have lower LIGHT-induced bactericidal activities than those from healthy controls (HC). In contrast, levels of soluble HVEM (sHVEM) in the sera of GC patients were significantly higher than in those of HC. We found that monocyte membrane-bound HVEM is released into the medium when cells are activated by proinflammatory cytokines such as TNF-alpha and IL-8, which are elevated in the sera of GC patients. mHVEM level dropped in parallel with the release of sHVEM, and release was completely blocked by the metalloprotease inhibitor, GM6001. We also found that the low level of mHVEM on GC patient leukocytes was correlated with low LIGHT-induced bactericidal activities against H. pylori and S. aureus and production of reactive oxygen species. Our results indicate that mHVEM on leukocytes and sHVEM in sera may contribute to the development and/or progression of GC.

Liver Resection Versus Transplantation for Hepatocellular Carcinoma within Milan Criteria: An Intention-to-treat Analysis

PURPOSE: Postoperative as well as intention-to-treat outcomes of deceased donor liver transplantation (DDLT) for patients with hepatocellular carcinoma (HCC) within the Milan criteria were compared to outcomes for patients who underwent liver resection. The goal was to select the optimal therapeutic option for these patients. METHODS: Among 1363 patients diagnosed with HCC between Jan 2001 and Sep 2008, 57 underwent liver resection for HCC within the Milan criteria (LRX group) and 47 registered for DDLT (WAIT group). Thirteen patients underwent DDLT (LTX group), including 2 salvage DDLT for recurrent HCC after resection. The outcomes for the LRX group were compared with those for the LTX and WAIT groups. RESULTS: Child class B or C patients accounted for 5% in the LRX group and 81% in the WAIT group (p=0.000). Among 47 registrants in the WAIT group, 11 underwent DDLT after a mean waiting time of 282 days (LTX group). Tweleve patients were dropped from the waitlist due to death or disease progression after a mean time of 317 days after registration. There was 1 operative death in the LTX group 14 days after DDLT due to primary graft nonfunction. The 3-year overall and disease-free survival rates were comparable between the LRX and LTX groups. On the other hand, the LRX group showed a significantly better intention-to-treat outcome than the WAIT group. The 3-year survival rates were 80.4% for the LRX group and 52.0% for the WAIT group (p=0.002). CONCLUSION: For HCC patients within the Milan criteria, liver resection should be considered as their primary option of treatment in Korea, where the DDLT rate is below 6%.

A Case of Colonic Duplication Cyst Mimicking Gastrointestinal Stromal Tumor

Duplications of the gastrointestinal tract are rare congenital malformations that are usually present during the first decade of life. However, a smaller number of cases may remain occult until adulthood. Overall, the colon is the least common site of congenital gastrointestinal duplications. Colonic duplications can present with symptoms of diverticulitis and can be confused with acquired giant cysts or masses. We present a rare case of a duplication cyst of the colon in a female adult. Although the preoperative evaluations, including an abdominal CT scan and colonoscopy, were suggestive of a gastrointestinal tumor of the colon, the final diagnosis was a colonic duplication cyst based on the histopathologic examination of the resected specimen. Even if intestinal duplication cysts are uncommon, they should be considered in the differential diagnosis of intestinal masses.

Treatment of chronic hepatitis B / 대한내과학회지

Despite the introduction of hepatitis B virus (HBV) vaccine for over 20 years now, HBV infection remains an important health problem. Antiviral treatment of chronic hepatitis B has dramatically changed over the last decade. A variety of therapeutic options are now available for the treatment of chronic hepatitis B infection, including four nucleos (t) ide analogues (i.e lamivudine, adefovir, entecavir and clevudine), along with standard and pegylated interferon. Newer oral nucleos (t) ide analogues that include tenofovir, emtricitabine and telbivudine are soon likely to be approved in Korea. Given the wide array of choices and the complex nature of chronic hepatitis B (CHB) infection, selection of the appropriate therapeutic agent can be challenging for clinicians. To help guide clinicians in treating patients with CHB, the Korean Association for the Study of the Liver published a guideline in 2004, which was subsequently revised in 2007 on the basis of new developments in the field. This review includes the range of treatment options and criteria for determining when and how to most effectively intervene with antiviral therapy for chronically infected patients with HBV.

Treatment recommendations for chronic hepatitis B: an evaluation of current guidelines based on a natural history study in the United States / 대한간학회지

No abstract available.

Risk Factors for Lymph Node Metastasis after Endoscopic Resection for Early Colorectal Cancer

BACKGROUND/AIMS: Although endoscopic resection is widely used for the treatment of early colorectal cancer, the risk factors for lymph node metastasis are not clear. This study was designed to determine the risk factors for lymph node metastasis in patients with colorectal cancer who are treated by endoscopic resection. METHODS: The medical records of patients with histologically-proven early colorectal cancers who were treated by endoscopic resection between January 2002 and September 2008 were retrospectively reviewed. Information regarding the demographic data of patients and the clinicopathologic characteristics were recorded and analyzed. RESULTS: Twenty-nine patients who underwent subsequent surgical treatment after endoscopic resection for early colorectal cancer were enrolled in this study. Six patients (20.7%) had lymph node metastases on surgical pathologic examination. The predictive factors for lymph node metastasis were tumor morphology (non-polypoid flat tumors [p=0.019]), absence of background adenomas (p=0.033), and deep submucosal invasion > or = 2,000 um (p=0.012). Unexpectedly, the presence of vascular invasion was not associated with lymph node metastasis. CONCLUSIONS: The presence of vascular invasion might not be an absolute indication for additional surgical treatment of early colorectal cancer; however, deep submucosal invasion, accompanied by a gross tumor with a non-polypoid flat morphology, and the absence of background adenomas are potential risk factors for lymph node metastasis.