Efficacy and safety of sofosbuvir plus ribavirin for Korean patients with hepatitis C virus genotype 2 infection: A retrospective multi-institutional study

BACKGROUND/AIMS: Sofosbuvir plus ribavirin is a standard treatment for patients infected with chronic hepatitis C virus (HCV) genotype 2 in Korea. The purpose of this study was to examine the efficacy and safety of this treatment in Korean patients with chronic HCV genotype 2 infection. METHODS: We retrospectively analyzed clinical data of patients treated with sofosbuvir plus ribavirin for chronic HCV genotype 2 from May 2016 to December 2017 at eight hospitals located in the Daejeon-Chungcheong area. RESULTS: A total of 172 patients were treated with sofosbuvir plus ribavirin. Of them, 163 patients completed the treatment, and 162 patients were tested for sustained virologic response 12 weeks after treatment discontinuation (SVR12). Mean age was 59.6±12.3 years (27–96), and 105 (64.4%) patients were female. Of the total patients, 49 (30.1%) were diagnosed with cirrhosis, and 31 of them were treated for 16 weeks. Sofosbuvir plus ribavirin was the first-line treatment for 144 (88.3%) patients. Eleven (6.7%) patients were intolerant to previous interferon-based treatment. Eight (5.0%) patients relapsed after interferon-based treatment. HCV RNA non-detection rate at 4, 8, and 12 weeks was 97.5%, 99.1%, and 99.3%, respectively, and SVR12 was 98.8% (161/163). During treatment, 18 (11.0%) patients had to reduce their administrated dose of ribavirin because of anemia. One patient stopped the treatment because of severe anemia. Other adverse events, including dizziness, indigestion, and headache, were found in 26 (16.0%) patients. CONCLUSIONS: A 12-16 week treatment with sofosbuvir plus ribavirin is remarkably effective and well tolerated in Korean patients with chronic HCV genotype 2 infection.

The Effect of Naïve Tenofovir Dipivoxil Fumarate Monotherapy in Patients with Chronic Hepatitis B: 2-Year Results of a Real-world Single-center Study / 대한내과학회지

BACKGROUND/AIMS: An incomplete virological response has been observed to tenofovir dipivoxil fumarate (TDF) in nucleos(t)ide analogue (NA)-experienced chronic hepatitis B (CHB) patients. This study investigated the efficacy of TDF in NA-naïve CHB patients 96 weeks after treatment. METHODS: CHB patients treated with TDF were enrolled retrospectively between November 2012 and January 2016. We assessed virological and biochemical parameters. RESULTS: The study enrolled 179 NA-naïve patients with a median follow-up duration of 59.6 weeks. The serum hepatitis B virus (HBV) DNA level decreased significantly during treatment. The complete virological response (CVR) rate was 83.21% at week 96. In univariate analyses, the predictors of a CVR at 96 weeks were the baseline HBV DNA level (CVR vs. no-CVR, HBV DNA log10 mean value 7.34 vs. 7.86, 95% confidential interval [CI]: -7.89 to -7.37; p < 0.001) and male sex (CVR vs. no-CVR, 49.1% vs. 81.3%, odds ratio [OR] 0.22, 95% CI: 0.06 to 0.87; p = 0.025). In the multivariate analysis, male sex predicted a CVR at week 96. The CVR was significantly lower in males than in females (OR 0.12, 95% CI: 0.02 to 0.96; p = 0.046). CONCLUSIONS: TDF was effective for treating CHB for more than 2 years in NA-naïve patients.

Efficacy and safety of daclatasvir plus asunaprevir for Korean patients with HCV genotype Ib infection: a retrospective multi-institutional study

BACKGROUND/AIMS: The combination of daclatasvir (DCV) and asunaprevir (ASV) has demonstrated a high sustained virologic response at 12 weeks (SVR12) and a low rate of adverse events in previous clinical studies. The purpose of this study was to clarify the results of treatment and side effects in Korean patients with chronic hepatitis C virus (HCV) genotype Ib infection. METHODS: We retrospectively analyzed clinical data from chronic HCV genotype Ib patients treated with DCV+ASV from August 2015 to September 2016 at five hospitals in the Daejeon-Chungcheong area. RESULTS: A total of 152 patients were examined for resistance associated variants (RAVs). Among them, 15 (9.9%) were positive for Y93 and one (0.7%) was positive for L31. Of 126 patients treated with DCV+ASV, 83 patients completed treatment and 76 patients were included in safety and efficacy analysis. Five (6.6%) were positive for Y93 and 12 (15.8%) exhibited cirrhotic change. DCV+ASV was the first-line treatment for 58 (76.3%) patients. Eleven (14.5%) patients relapsed after previous treatment that included interferon and seven (9.2%) of these patients were found to be intolerant of interferon. Adverse events occurred in 10 (13.2%) patients and two patients stopped the medication because of severe itching and skin rash. SVR12 was 89.5% (68/76) in all patients and 91.5% (65/71) in RAV-negative patients. CONCLUSIONS: DCV+ASV showed good efficacy in patients with HCV Ib infection in Korea. Close monitoring is needed for severe adverse events and treatment failure, which were uncommon.

Septic Shock in Pyogenic Liver Abscess: Clinical Considerations / 대한소화기학회지

BACKGROUND/AIMS: Pyogenic liver abscess (PLA) is a life-threatening condition, despite advances in diagnostic technology and strategies for treatment. A strong predictor of mortality in this condition is septic shock. This study describes clinical, biochemical, and radiologic features in patients with PLA with or without septic shock, with the intent of describing risk factors for septic shock. METHODS: Of 358 patients with PLA enrolled, 30 suffered septic shock and the remaining 328 did not. We reviewed the medical records including etiologies, underlying diseases, laboratory, radiologic and microbiologic findings, methods of treatment and treatment outcomes. RESULTS: The case fatality rate was 6.1%. In univariate analysis, the presence of general weakness, mental change, low platelet level, prolonged PT, high BUN level, high creatinine level, low albumin level, high AST level, high CRP level, abscess size >6 cm, the presence of gas-forming abscess, APACHE II score ≥20, and the presence of Klebsiella pneumoniae infection were significantly associated with septic shock. Multivariate analysis showed the presence of mental change (p=0.004), gas-forming abscess (p=0.012), and K. pneumoniae infection (p=0.027) were independent predictors for septic shock. CONCLUSIONS: The presence of mental change, gas-forming abscess, and K. pneumoniae infection were independent predictors for septic shock in patients with PLA.

Prevalence and Risk Factors of Gastroesophageal Reflux Disease in Patients with Type 2 Diabetes Mellitus

BACKGROUND: Gastrointestinal symptoms are common in patients with type 2 diabetes mellitus (T2DM). The prevalence of gastroesophageal reflux disease (GERD) in Korea appears to be increasing. Some studies have shown that T2DM is a risk factor for symptomatic GERD. However, this possibility is still debated, and the pathogenesis of GERD in T2DM is not yet fully understood. The aim of this study was to analyze the prevalence and risk factors (including autonomic neuropathy) of GERD in patients with T2DM. METHODS: This cross-sectional case-control study enrolled T2DM patients (n=258) and healthy controls (n=184). All participants underwent physical examinations and laboratory tests. We evaluated medical records and long-term diabetes complications, including peripheral and autonomic neuropathy in patients with T2DM. Esophagogastroduodenoscopy was performed in all patients. The Los Angeles (LA) classification was used to grade GERD. GERD was defined as LA grade A (or higher) or minimal change with GERD symptoms. GERD symptoms were examined using a frequency scale. Data were expressed as mean±standard error. Independent t-tests or chi-square tests were used to make comparisons between groups. RESULTS: The prevalence of GERD (32.6% vs. 35.9%, P=0.266) and GERD symptoms (58.8% vs. 59.2%, P=0.503) was not significantly different between T2DM patients and controls. We found no significant differences between T2DM patients with GERD and T2DM patients without GERD with respect to diabetic complications, including autonomic neuropathy, peripheral neuropathy, duration of DM, and glucose control. CONCLUSION: The prevalence of GERD in patients with T2DM showed no difference from that of controls. GERD was also not associated with peripheral and cardiovascular autonomic neuropathy, age, or duration of DM in patients with T2DM.

Pyogenic Liver Abscess: Changes in Clinical Features over the Last 10 Years / 대한내과학회지

BACKGROUND/AIMS: A pyogenic liver abscess is an acute bacterial infection that can potentially lead to life-threatening sepsis. This study examined the clinical features and changing trends of pyogenic liver abscess over the last 10 years. METHODS: We investigated patient characteristics, laboratory findings, blood and abscess culture results, location and characteristics of the abscess, and treatment modality in the medical records of 146 patients. We divided them into three groups by period: period 1, 23 patients in 2002-2003; period 2, 46 patients in 2007-2008; and period 3, 77 patients in 2012-2013. RESULTS: The mean patient age was 64.3 +/- 15.1 years and 87 of the 146 patients were male (59.6%). Period 2 had a higher prevalence of chronic alcoholics (30.4% vs. 10.4%) and lower prevalence of fever and chills (73.9% vs. 92.2%) compared with period 3. Klebsiella pneumoniae was the most commonly cultured bacteria and the microbiological findings did not differ among the three periods. Pyogenic liver abscesses were more common in the right liver. The lengths of hospital stay and treatment modalities were similar in all three periods. CONCLUSIONS: Although there were slight differences in symptoms among the periods, there were no changes in the liver abscess characteristics, i.e., location, size, and culture results. As there were no changes, the treatment strategy also did not change. We should continue to investigate the clinical features of liver abscess.

Cryptococcal meningitis in a patient with chronic hepatitis C treated with pegylated-interferon and ribavirin

Various adverse events have been reported during combination therapy with pegylated (PEG)-interferon-alpha and ribavirin, although opportunistic infections, especially cryptococcal meningitis, are very rare. A 61-year-old woman complained of headaches and a fever during treatment of a chronic hepatitis C virus (HCV) infection. She had been treated for 7 months. Her headaches were refractory to analgesics, and she developed subtle nuchal rigidity. The cerebral spinal fluid (CSF) revealed a white blood cell count of 205/mm3, 51 mg/dL protein, 35 mg/dL glucose, and negative Cryptococcus antigen. The CSF culture resulted in no growth. Five days later, the CSF was positive for Cryptococcus antigen. We administered amphotericin B and flucytosine, followed by fluconazole. Approximately 2 months later, she was discharged. For the first time, we report a case of cryptococcal meningitis during the treatment of chronic HCV with PEG-interferon-alpha and ribavirin.

Comparison of Malnutrition Risk between Patients with Liver Cirrhosis and Viral Hepatitis Carrier: A Single Center Study / 대한소화기학회지

BACKGROUND/AIMS: It is well-known that patients with chronic liver disease commonly have nutritional deficiency. In the present study, we investigated the differences in malnutrition risk between patients with liver cirrhosis and viral hepatitis carrier. METHODS: Patients with chronic liver disease who have been hospitalized at Konyang University Hospital from May 2012 to April 2013 were analyzed retrospectively. The malnutrition risk was divided into three categories (low, intermediate, and high) according to Konyang University Hospital Malnutrition Screening, which include BMI, serum albumin, total lymphocyte count (TLC), hemoglobin, weight change, appetite, and dysphagia, within 24 hours of hospitalization. RESULTS: Among a total of 460 patients, 313 had liver cirrhosis (LC), and 147 were viral hepatitis carriers. Age (p<0.001), serum albumin level (p<0.001), TLC (p=0.011), hemoglobin (p<0.001) and serum cholesterol level (p=0.005) were significant different between the two groups. However, there were no difference in height, weight, and BMI. The malnutrition risk of the patients with viral hepatitis carrier was significantly lower than that of the patients with LC (p<0.001). In addition, among 313 patients with LC, malnutrition risk of the patients with Child-Pugh class A (n=150) was significantly lower than that of the patients with class B (n=90) or C (n=73) (p<0.001). CONCLUSIONS: Viral hepatitis carrier group had significantly lower malnutrition risk than LC group. The risk of malnutrition in Child-Pugh class A group was significantly lower than that in class B or C group.

Necessity of Upper Gastrointestinal Endoscopy in Patients with Noncardiac Chest Pain / 대한내과학회지

BACKGROUND/AIMS: Gastroesophageal reflux disease (GERD) is the most frequent cause of noncardiac chest pain (NCCP) in Western countries. Gastroduodenal disease has a high prevalence in Korea; thus, it is important to evaluate the stomach/duodenum. We retrospectively reviewed the findings in patients with chest pain who were diagnosed by coronary angiography (CAG) to be normal or who had minimal coronary lesions to evaluate the necessity of performing esophagogastroduodenoscopy (EGD) in patients with NCCP. METHODS: A total of 565 patients with chest pain underwent CAG followed by EGD from February 2000 to March 2011 at Konyang University Hospital. We excluded patients who underwent EGD more than 3 days after CAG or had significant coronary lesions. We retrospectively reviewed the EGD findings of the remaining 349 patients. RESULTS: Of the 349 patients, 151 were male, and the average age of the patients was 57.7+/-11.44 years. After performing EGD, GERD was diagnosed in 35 patients (10.0%; LA [Los Angeles classification]-A, 30; LA-B, three; LA-C, two) and peptic ulcer was diagnosed in 48 patients (13.8%; gastric ulcer, 34; duodenal ulcer, 10; gastric and duodenal ulcer, four). Gastritis was diagnosed in 253 patients (72.5%; erosive, 89; erythematous, 90; hemorrhagic, 10; mixed, 64). Duodenitis, esophagitis, Barrett's esophagus, hiatus hernia, and gastric cancer was diagnosed in 36 (10.3%), three (0.9%), two (0.6%), three (0.9%), and one patient, respectively. CONCLUSIONS: Unlike the situation in the west, stomach/duodenal lesions other than GERD are common causes of NCCP in Korea, Therefore, prior to proton pump inhibitor testing or empirical therapy, EGD is necessary to evaluate NCCP and to rule out gastroduodenal lesions.

Is There a Difference in the Prevalence of Gastroesophageal Reflux Disease between Peritoneal Dialysis and Hemodialysis Patients? / 대한소화기학회지

BACKGROUND/AIMS: Gastroesophageal reflux disease (GERD) is a common upper gastrointestinal disorder in patients with chronic kidney disease (CKD). However, little is known about the prevalence of GERD in dialysis patients. The aim of the present study was to investigate the difference in the prevalence of GERD in peritoneal dialysis and hemodialysis patients. METHODS: From July 2010 to August 2011, peritoneal dialysis patients (n=30) and hemodialysis patients (n=38) were enrolled. The prevalences of GERD were assessed at a single center with endoscopic findings and interviews using a questionnaire. Also, risk factors of GERD were evaluated. RESULTS: The prevalences of GERD in peritoneal dialysis and hemodialysis patients were 33.3% and 39.5% (p=0.748), respectively. The prevalences of erosive reflux esophagitis (ERD) in peritoneal dialysis and hemodialysis patients were 16.7% and 23.7% (p=0.477), respectively. The prevalences of nonerosive reflux disease (NERD) in peritoneal dialysis and hemodialysis patients were 16.7% and 13.2% (p=0.685), respectively. The prevalences of GERD, ERD and NERD were higher than those of the general population. The risk factor for GERD was age in hemodialysis patients. CONCLUSIONS: The prevalence of GERD in dialysis patients was higher than that in the general population. However, there was no significant difference between peritoneal dialysis and hemodialysis patients.

A Case of Splenic Pseudocyst Complicated by Acute Pancreatitis / 대한소화기학회지

Splenic pseudocyst is a rare disease associated with chronic and acute pancreatitis splenic pseudocyst is treated by distal pancreatectomy and splenectomy. A 47-year old woman with a 10-year history of alcohol abuse presented with epigastric and left upper quadrant pain of 3 days duration. Abdominal CT showed a 4.0x4.5 cm sized cystic lesion in the tail of the pancreas. Analgesics was administrated for the relief of abdominal pain. On the 4th hospital day, the patient complained more of left upper quadrant pain, so we took follow up CT scans. On follow up CT, one large splenic pseudocyst with size of 9.5x4.5x10.0 cm was noted. The patient was treated conservatively by percutaneous catheter drainage and discharged on the 13th hospital day. This case is the first case report of splenic pseudocyst treated conservatively, not by surgery in Korea.

Hepatocolic Fistula after Radiofrequency Ablation for Hepatocellular Carcinoma / 대한내과학회지

Radiofrequency ablation (RFA) is a relatively safe therapy for patients with hepatocellular carcinoma (HCC); however, complications are not unknown. A hepatocolic fistula is a rare complication after RFA. We report a case of a hepatocolic fistula following a liver abscess after RFA for HCC in a 58-year-old male. The patient was diagnosed with HCC and liver cirrhosis from hepatitis B infection 3 years prior to admission. The HCC was in segment 6 of the liver and was treated with transarterial chemoembolization and RFA. One month after the second RFA, he was diagnosed with a liver abscess, for which he was treated with antibiotics for 2 months, but continued to have intermittent fever and chills. We made a diagnosis of hepatocolic fistula using colonoscopy, fluoroscopy, and liver dynamic computed tomography. The patient underwent a surgical procedure after antibiotic therapy. Although a hepatocolic fistula is a rare complication following RFA, clinicians should be aware of its existence.

Cecal Fecaloma Due to Intestinal Tuberculosis: Endoscopic Treatment

Colorectal fecaloma is a mass of accumulated feces that is much harder in consistency than a fecal impactation. The rectosigmoid area is the common site for fecalomas and the cecum is the most unusual site. Diagnosis is usually made by distinctive radiographic findings of a mobile intraluminal mass with a smooth outline and no mucosal attachment. Most of the fecalomas are successfully treated by conservative methods such as laxatives, enemas and rectal evacuation. When conservative treatments have failed, endoscopic procedures or a surgical intervention may be needed. We report here that a cecal fecaloma caused by intestinal tuberculosis scar was successfully removed by endoscopic procedures.

An Intraluminal Gallbladder and Bile Duct Hematoma after a Percutaneous Biopsy of Hepatic Adenoma / 대한내과학회지

Hepatocellular adenoma is a rare, but benign, tumor mostly found in women taking oral contraceptives. Hepatocellular adenoma must be treated when bleeding of the tumor, intraperitoneal hemorrhage, or malignant transformation occurs. A percutaneous liver biopsy is relatively safe and effective, but carries the risk of mild complications, such as pain, temporary hypotension, and bleeding, and severe complications, such as intraperitoneal bleeding, peritonitis, pneumothorax, hemothorax, other organ injury, and sepsis. We treated a 33-year-old woman with hemobilia and gallbladder hematoma following a sono-guided percutaneous liver biopsy. Complete quadrantectomy with anterior lobe resection was done after angiography and embolization of the hepatic artery.

Guidelines for the Treatment of Functional Dyspepsia / 대한소화기학회지

Functional dyspepsia (FD) is defined as the presence of symptoms thought to originate in the gastroduodenal area, in the absence of any organic, systemic, or metabolic disease that is likely to explain the symptoms. Based on the available evidence and consensus opinion, thirteen consensus statements for the treatment of FD were developed using the modified Delphi approach. Proton pump inhibitor, prokinetics, and histamine 2 receptor antagonists are effective for the treatment of FD. Mucosal protecting agents, fundus relaxant, and drugs for visceral hypersensitivity can improve symptoms in FD. Antacids and antidepressants may help improving symptoms in FD. Comparing endoscopy with 'test and treat' of Helicobacter pylori, endoscopy may be more effective initial strategy for managing patients with FD in Korea given high incidence of gastric cancer and low cost of endoscopy. Helicobacter pylori eradication can be one of the therapeutic options for patients with FD. Psychotherapy is effective for those who have severe symptoms and refractoriness. Further studies are strongly needed to develop better treatment strategies for Korean patients with FD.

Endoscopic Findings and Clinical Significance of Portal Hypertensive Colopathy / 대한소화기학회지

BACKGROUND/AIMS: The endoscopic findings and clinical relevance of portal hypertensive colopathy are not well described in Korea. We aimed to do a retrospective study of mucosal changes in the colon of patients with liver cirrhosis and to find their association with clinical characteristics. METHODS: We reviewed the clinical data and endoscopic findings of 48 patients with liver cirrhosis and 48 patients, matched for age and sex, with irritable bowel disease (IBS) who underwent colonoscopy over a 5 year span. RESULTS: Patients with liver cirrhosis were more likely to have colitis-like lesions and vascular abnormalities than IBS patients. Low platelet count (p=0.005) and severe esophageal varices (p=0.011) were associated with portal hypertensive colopathy, whereas the etiologies and severity of cirrhosis were not associated with these findings. CONCLUSIONS: Portal hypertensive colopathy can be defined with colitis-like lesions or vascular lesions. These lesions are more frequently present in patients with more severe esophageal varices and thrombocytopenia.

Clinical Aspects of Intraabdominal Cystic Lymphangioma in Korea / 대한소화기학회지

BACKGROUND/AIMS: Cystic lymphangioma is an uncommon disease, and rarely develops in the intraabdomen. The aim of this article was to discuss about clinical characteristics of intraabdominal cystic lymphangioma developed in Korea. METHODS: Age, sex, symptoms, locations and size of the lesions, diagnostic methods, treatments, complications and recurrence were analyzed in 13 pathologically confirmed cases of intraabdominal cystic lymphangioma and 18 cases of literature consideration reported in Korea. RESULTS: Intraabdominal cystic lymphangioma commonly developed in adults compared to the other lymphangioma, and frequently located in the mesentery. Abdominal pain was the most common symptom, but it was a non-specific finding. Tenderness and abdominal mass were not significantly associated. The size of mass was diverse. Abdominal ultrasonography and abdominal CT were diagnostic tools most commonly used, but preoperative diagnosis was possible only in 22.6%. All patients were discharged without any complications, and no recurrence was reported. CONCLUSIONS: Preoperative diagnosis of intraabdominal cystic lymphangioma is difficult and symptoms and signs are not specific. Intra-abdominal cystic lymphangioma should be suspected in patients with non specific abdominal pain and intraabdominal mass and active diagnostic evaluation is mandatory.

A Case of Neck Abscess Caused by Salmonella Serotype D in a Patient with Liver Cirrhosis

Non-typhoidal salmonellosis, which is increasing nowadays in Korea as well as in the developed countries, is manifested as enteritis in most cases, but it also encompasses bacteremia, intraabdominal infections, and bone, joint and soft tissue infections. These rare diseases are known to result from primary gastrointestinal infection and subsequent bacteremia with or without symptoms. We experienced a case of neck abscess caused by Salmonella serotype D, which is a rare but important differential diagnosis of neck abscess. We herein report it.

Clinical Features of Pyogenic Liver Abscess according to Age Group / 대한소화기학회지

BACKGROUND/AIMS: Pyogenic liver abscess remains a major diagnostic and therapeutic challenge, despite advances in diagnostic technology and new strategies for treatment. This study was conducted to compare the differences in clinical features and outcomes of pyogenic liver abscess according to age. METHODS: In total, 166 patients were enrolled and included 63 (75 years old, group III) patients in each group. We reviewed the medical records retrospectively including etiology, underlying diseases, characteristics of the liver abscess, laboratory and microbiologic findings, treatment, and outcome of the patients. RESULTS: Group I had higher prevalence rates of male patients and chronic alcoholics, but lower prevalence rates of biliary disease, hypertension, and malignancy. In laboratory findings, group II had higher incidence of thrombocytopenia, elevated blood urea nitrogen and creatinine. There were no differences in symptoms and microbiologic findings in blood and pus among the three groups. Liver abscesses were more common in right liver in Group I. The lengths of stay and the treatment modalities were similar in three groups. CONCLUSIONS: Although there were differences in sex ratio, etiology, underlying disease among the different age groups, they did not cause difference in treatment and clinical outcome of pyogenic liver abscess. Thus, we recommend active treatments in patients of all age.

Efficacy of Initial Treatment with Clevudine in Naive Patients with Chronic Hepatitis B

BACKGROUND/AIMS: Clevudine, a pyrimidine nucleoside analogue, has potent antiviral effects in patients with chronic viral hepatitis B (CHB). We report the efficacy of initial treatment with clevudine in naive patients with CHB living in Daejeon and Chungcheong Province, South Korea. METHODS: One hundred five adults with CHB were administered 30 mg of clevudine per day for an average of 51 weeks. We evaluated viral markers and liver biochemistry retrospectively every 3 months. RESULTS: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and hepatitis B virus (HBV) DNA before the treatment were 184 +/- 188 IU/L, 150 +/- 138 IU/L, and 7.1 +/- 1.2 log copies/mL, respectively. Undetectable rates (< 60 IU/mL) of DNA were 36.2%, 68.9%, 83.6%, 76.2%, and 75.8% at 12, 24, 36, 48, and 60 weeks, respectively. Seroconversion rates were 9.1%, 13.6%, 24.6%, 26.5%, and 26.1% and ALT normalization rates were 64.5%, 78.1%, 87.9%, 90.0% at 12, 24, 36, and 48 weeks, respectively. Six patients (5.7%) had a viral breakthrough. CONCLUSIONS: Clevudine is a useful drug in the initial treatment of patients with CHB, with a potent antiviral effect and low incidence of viral breakthrough.