Acute pancreatitis in Turkey: Results of a nationwide multicenter study.

BACKGROUND: Acute pancreatitis (AP) is the most common gastrointestinal disease requiring hospitalization, with significant mortality and morbidity. We aimed to evaluate the clinical characteristics of AP and physicians' compliance with international guidelines during its management. METHODS: All patients with AP who were hospitalized at 17 tertiary centers in Turkey between April and October 2022 were evaluated in a prospective cohort study. Patients with insufficient data, COVID-19 and those aged below 18 years were excluded. The definitions were based on the 2012 revised Atlanta criteria. RESULTS: The study included 2144 patients (median age:58, 52 % female). The most common etiologies were biliary (n = 1438, 67.1 %), idiopathic (n = 259, 12 %), hypertriglyceridemia (n = 128, 6 %) and alcohol (n = 90, 4.2 %). Disease severity was mild in 1567 (73.1 %), moderate in 521 (24.3 %), and severe in 58 (2.6 %) patients. Morphology was necrotizing in 4.7 % of the patients. The overall mortality rate was 1.6 %. PASS and BISAP had the highest accuracy in predicting severe pancreatitis on admission (AUC:0.85 and 0.81, respectively). CT was performed in 61 % of the patients, with the majority (90 %) being within 72 h after admission. Prophylactic NSAIDs were not administered in 44 % of the patients with post-ERCP pancreatitis (n = 86). Antibiotics were administered to 53.7 % of the patients, and 38 % of those received them prophylactically. CONCLUSIONS: This prospective study provides an extensive report on clinical characteristics, management and outcomes of AP in real-world practice. Mortality remains high in severe cases and physicians' adherence to guidelines during management of the disease needs improvement in some aspects.

Validation of the Revised Atlanta Criteria in determining the severity of acute pancreatitis.

BACKGROUND/AIM: Determining the severity of acute pancreatitis (AP) is crucial for patient management. The aim of our study was to assess the accuracy and limitations of the Revised Atlanta Criteria (RAC) in determining the severity of AP. MATERIALS AND METHODS: The study was retrospectively conducted on AP patients admitted to the Gastroenterology Department of Sakarya University Faculty of Medicine. The severity, morphology and local complications of AP were evaluated according to the RAC. Laboratory parameters, clinical scores predicting disease severity and Computer Tomography Severity Index scores were assessed. RESULTS: The study group included 113 patients. Ninety-eight (86.7%) had interstitial edematous, and 15 (13.3%) had necrotizing pancreatitis. AP pancreatitis was mild in 69 (61.1%), moderate in 33 (29.2%), and severe in 11 (9.7%). Compared to the moderate group, patients in the severe group had a higher hematocrit, creatinine, SIRS and BISAP scores at admission and more length of hospital stay, more ICU requirements, and higher mortality rates ( P  < 0.05). Eleven patients had single or multiple persistent organ failure (POF). The mortality rate of patients who developed early POF (n = 6) was higher compared to the group of patients who developed late POF (n = 2) (83.3% and 40%, respectively). CONCLUSION: Severity assessment using the RAC in patients with AP is consistent with laboratory parameters and scoring systems predicting severity. Severe pancreatitis cases who develop early POF may be classified separately.

Electronic Alert System Significantly Increases HBV Screening Rates Before Immunosuppressive Treatments.

BACKGROUND: Hepatitis B Virus (HBV) screening rates before starting immunosuppressive treatments are suboptimal. The aim of the study was to evaluate the efficacy of a new electronic alert system in increasing HBV screening rates. METHODS: The electronic alert system, HBVision2, identifies patients at risk of HBV reactivation when a pre-determined International Classification of Diseases (ICD)-10 code is entered into the hospital's database or immunosuppressive treatment is prescribed. The system evaluates the prior Hepatitis B Surfage Antigen (HBsAg) and anti-Hepatitis B Core Immunglobulin G (HBc IgG) results and sends an alert code to the clinician for screening if serology is not completely available or consult a specialist in case of positive serology. The HBV screening and consultation rates of patients before (control group) and after HBVision2 were retrospectively compared. The clinical course of unscreened and/or unconsulted patients was determined, and the clinical efficacy of HBVision2 in preventing HBVr was predicted. RESULTS: Control group included 815 patients (52.6% male, mean age: 60 ± 12, 82.5% with oncologic malignancy) and study group included 504 patients (56% male, mean age: 60 ± 13, 91.4% with oncologic malignancy). Groups were similar with respect to gender, mean age, and HBVr risk profile of the immunosuppressive treatment protocols. Overall, both HBsAg (from 55.1% to 93.1%) and anti- HBc IgG screening rates significantly increased (from 4.3% to 79.4%) after the electronic alert system (P < .001, for both). Consultation rates of anti-HBc IgG-positive patients significantly increased from 40% to 72.7% (P = .012). HBVr developed in 2 patients (2.6%) who were not screened and/or consulted after the alert system. Alert program prevented the development of HBVr in 10 patients (1.9%) of the study group and decreased the development of HBVr by 80%. CONCLUSION: Electronic alert system significantly improved HBsAg and anti-HBc IgG screening rates before starting immunosuppressive treatment and prevented the development of HBVr to a great extent. However, screening rates are still below optimal and need to be improved.

Fully Covered Metal Stents Safely Facilitate Extraction of Difficult Bile Duct Stones.

BACKGROUND: Ten to 15% of the common bile duct (CBD) stones require advanced endoscopic extraction techniques during endoscopic retrograde cholangiopancreatography. The study aimed to evaluate the efficacy and safety of fully covered self-expandable metal stents (FC-SEMS) for facilitating the extraction of difficult bile duct stones. METHODS: Patients who received FC-SEMS for the extraction of difficult CBD stones were retrospectively reviewed. Group 1 included patients with extrahepatic stones above a distal CBD stricture, Group 2 included patients with intrahepatic stones above a hilar stricture, and Group 3 included patients with complex stone(s) and no biliary stricture. Complete stone clearance rate and complications of FC-SEMS treatment were evaluated. RESULTS: The study group included 33 procedures on 32 patients (mean age: 55±17, 56.3% male). FC-SEMS was placed as a primary treatment in 15 (45.5%) procedures. Complete stone clearance was achieved in 84.6% of the procedures in Group 1, 100% in Group 2, and 87.5% in Group 3 ( P =0.23). Overall, complete stone clearance was achieved in 30 of the 33 procedures (90.9%). None of the patients developed pancreatitis, cholecystitis, or cholangitis. Stent migration occurred in 4 procedures (12.1%), and all were clinically insignificant. CONCLUSION: FC-SEMS is effective and safe for facilitating treatment of difficult bile duct stones.

Benign biliary strictures associated with acute biliary pancreatitis.

BACKGROUND AND AIMS: There are limited data about the benign biliary strictures (BBS) which can develop during the clinical course of acute biliary pancreatitis (ABP) due to compression of the common bile duct (CBD) by edematous and inflamed pancreatic tissue. We aimed to determine the incidence of BBS due to ABP and its clinical course after endoscopic management. METHODS: The study was retrospectively conducted among patients with ABP who were admitted to a single tertiary reference center during 3 years. BBS-ABP was defined as distal narrowing of the CBD with proximal dilatation and delayed drainage of the contrast into the duodenum. Endoscopic treatment was performed by inserting a single 7F or 10F plastic stent which was exchanged every 3 months until stricture resolution. Patients were followed for 1 year after stricture resolution. RESULTS: Seven hundred and twenty-one patients had ABP during the study period. Among them, 257 (35.6%) patients underwent ERCP and 26 patients (3.6%) had CBD stricture due to ABP. A 7 Fr plastic stent was inserted in 18 patients and 10 Fr in 8 patients. The stricture was completely resolved at 3 months in 66.7%, at 6 months 23.8% and at 9 months (9.5%) of the patients. There was no procedure-related complications other than asymptomatic stent migration in 4 (19%) patients. None of the patients had recurrent biliary stricture during the 1 year stent-free follow-up period. CONCLUSION: BBS-ABP is a frequently seen clinical entity. In most patients, the stricture improves within 3 months and temporary endoscopic stenting prevents the patients from the consequences of the obstruction during this period.

Hepatitis B Reactivation in Patients Treated with Direct-Acting Antivirals for Hepatitis C.

INTRODUCTION: There is limited research about HBV reactivation (HBVr) due to direct-acting antivirals (DAA) for HCV and most are limited by short duration of follow-up, small sample size, and absence of baseline HBV DNA. We aimed to determine the incidence and clinical course of HBVr in HBsAg and/or anti-HBcIgG positive patients treated with DAA for HCV. METHODS: Seven centers retrospectively analyzed their database on HCV patients treated with DAA between 2015 and 2019. Patients with HBV coinfection or resolved HBV infection were enrolled. Serum transaminases, HBsAg, HBeAg, and HBV DNA were followed every 4 weeks during DAA treatment and every 12 weeks 1 year after treatment. Entecavir or tenofovir disoproxil fumarate was started in case of HBVr. The development of HBVr, HBV flare, liver failure, and mortality were determined. RESULTS: 852 patients received DAA treatment for HCV. Among them, 35 (4.1%) had HBV coinfection and 246 (28.9%) had resolved HBV infection. 257 patients (53.3% male, mean age: 63 ± 9) constituted the study group (29 with coinfection and 228 with resolved infection). Three patients with coinfection were HBV DNA positive. HBVr developed in 10 (34.5%) HBsAg positive patients, either during (n = 3) or 12-48 weeks after finishing DAA treatment. HBV flare and acute liver failure developed in 1 patient (3.4%), each. Two patients with resolved infection developed HBVr (0.87%) and one (0.44%) had HBV flare. Overall, none of the patients died or underwent liver transplantation due to HBVr. CONCLUSION: Patients with HBV/HCV coinfection have a high risk of HBVr after DAA treatment and should receive antiviral prophylaxis. Patients with resolved infection have a low risk of HBVr and can be monitored by serial ALT measurements.

Hepatitis B reactivation after oral capecitabine treatment in a rectum cancer patient with isolated anti-HBc IgG positivity.

INTRODUCTION: Hepatitis B virus (HBV) reactivation in the setting of chemotherapy and immunosuppressive therapy is associated with significant morbidity and mortality. Herein we present a case of HBV reactivation after oral capecitabine treatment in a patient with rectum cancer and isolated anti-HBc IgG positivity. CASE REPORT: A 57-year-old man was consulted from the oncology clinic because of increased serum liver tests after chemotherapy. He underwent surgery for early-stage rectal cancer and received adjuvant chemotherapy with oral capecitabine. After cessation of chemotherapy, his laboratory tests revealed severe liver dysfunction. HBV markers showed positivity for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc). HBV DNA level was markedly elevated. MANAGEMENT AND OUTCOME: A review of medical records revealed that, before chemotherapy, the patient was positive for anti-HBc IgG but negative for HBsAg, and serum aminotransferases were within the normal limits. A diagnosis of HBV-related hepatitis due to capecitabine use was made, and the patient was put on tenofovir treatment. Six months later, HBV DNA decreased, and liver function tests were normalized. DISCUSSION: To the best of our knowledge, this is the first case report describing HBV reactivation after chemotherapy with capecitabine for rectal cancer in a patient with isolated anti-HBc IgG positivity. Our case shows that HBV reactivation may develop in a low-risk patient with a low degree of immunosuppression.

The Classification of Biliary Strictures in Patients With Right-Lobe Liver Transplant Recipients and Its Relation to Traversing the Stricture With a Guidewire.

BACKGROUND: Traversing the stricture with a guidewire is a prerequisite for the endoscopic treatment of biliary strictures after living donor liver transplantation. We aimed to evaluate the effect of variations in the biliary anastomosis and strictures on the success of endoscopic treatment and suggest a cholangiographic classification. METHODS: The 125 strictures among the 104 patients with right-lobe living donor liver transplantation were reviewed. The strictures were classified by the anastomosis pattern according to the number (1, 2, or >2), location (common bile, hepatic, or cystic duct), the angle between the proximal and distal sites of the anastomosis, and the contrast enhancement pattern. The relationship between the success rate of traversing the anastomosis and the classification was evaluated. RESULTS: Of the 125 biliary strictures, 86 (68.8%) could be passed via endoscopically. Thirty-three strictures were managed either percutaneously (n = 13) or by magnetic compression anastomosis (n = 20). Compared with the round, the triangular (odds ratio [OR], 6.5), the intermediate form (OR, 17.7), and the end-to-side anastomosis (OR, 5.1) were associated with an increased chance of traversing. The contrast enhancement pattern of the strictures and the bile ducts was also related to the successful rate of the endoscopic treatment (P < 0.001). The success rate was higher in the patients with the angle between the proximal and distal sites of the anastomosis approximated was small (0°-30° = 74%, 30°-60° = 69%, 60°-90° = 63%, >90° = 41%). CONCLUSIONS: The type of biliary anastomoses and stricture affect the success rate of endoscopic treatment. These data may play role in making decision about the type of anastomosis during the surgery.

Pancreaticobiliary maljunction in Turkish patients: a multicenter case series.

BACKGROUND AND AIMS: Pancreaticobiliary maljunction (PBM) is a malformation in which the pancreatic and bile ducts join outside the duodenal wall. It is associated with various biliary and pancreatic diseases. In addition, patients with PBM carry a substantial lifetime risk of developing biliary or gallbladder carcinoma. We aimed to present a multicenter case series of PBM from Turkey. METHODS: This study was conducted in adult and pediatric PBM patients who were referred to three tertiary reference centers of Turkey for endoscopic retrograde cholangiopancreatography (ERCP) between July 2007 and May 2020. The clinical presentations, types of PBM, ERCP findings, surgical histories, and the postoperative courses, including the development of biliary malignancies, were retrospectively reviewed. RESULTS: The study group included 47 (31 adult and 16 children) patients. Type D PBM was more frequent (13/41: 27.7%) than that reported in Eastern studies. Type A PBM was more common in the adults (51.6% vs. 12.5%, p < 0.05), whereas type C was more common in pediatric patients (31.3% vs. 13.2%, p < 0.05). Although fusiform anatomy was predominant in both of the groups, cystic dilatation was more common (25.8% vs. 12.5%) in adults and the common bile duct diameter was greater [22 mm (range 11-58) vs. 12 mm (range 5-33)] in adult patients compared to pediatric patients. Resective surgeries were more frequently done in pediatric patients (73.3% vs. 53.6%), whereas cholecystectomy was more frequently performed in adult patients (21.4% vs. 6.7%). CONCLUSION: Although our findings were compatible with Eastern studies, type D PBM (associated with pancreas divisum) was more frequent in our study population.

A Simple Method for Endoscopic Treatment of Large Gastric Phytobezoars: "Hand-Made Bezoaratome".

BACKGROUND: Large gastric phytobezoars are generally resistant to standard chemical or endoscopic treatments. We presented our experience of an alternative endoscopic method using a hand-made tool called a "hand-made bezoaratome" for the treatment of large gastric phytobezoars. METHODS: Patients who consulted or who were diagnosed with gastric bezoars at an education and research hospital between January 2015 and December 2018 were prospectively included in the study. Patients with phytobezoars of 50 mm and larger were included in the study. Patients with trichobezoars, lactobezoars, pharmacobezoars, under 18 years of age, and pregnant women were excluded. A 0.25 mm diameter guidewire and a mechanical lithotripter sheath were used to prepare the "hand-made bezoaratome." After the first procedure, patients were advised to consume 2500 mL of Coca Cola® or the same amount of pineapple juice per day, until the next procedure. Endoscopic procedures were performed at 5-day intervals until complete reabsorption of the bezoar was achieved. Patients were followed up for 6 weeks. RESULTS: The study group included 37 (21 males, mean age: 57.6 ± 12.5 years) patients. The median size of the phytobezoars was 71 mm (50-90). The median endoscopic procedure time was 853 s (380-1940 s). The success rate for endoscopic fragmentation was found to be 100%. No major complications occurred during the endoscopic procedures, but 1 patient (2.7%) required surgery for ileus due to an obstruction at the distal part of the jejunum, 61 h after the second endoscopic session. The overall success rate of the endoscopic treatment was 97.3%. CONCLUSION: Using a "hand-made bezoaratome" is effective and reliable for the endoscopic treatment of large gastric bezoars.

Comparison of Tenofovir Disoproxil Fumarate and Entecavir in the Prophylaxis of HBV Reactivation.

INTRODUCTION: Current guidelines recommend starting antiviral prophylaxis to prevent hepatitis B virus (HBV) reactivation in patients receiving immunosuppressive treatments (IST). The aim of this study was to compare the efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) for prophylaxis. METHODS: Patients, who were HBsAg and/or anti-HBc IgG positive and scheduled to receive IST for oncologic and hematologic diseases, were enrolled into the study. Those who were already receiving an antiviral treatment for HBV or had an associated HIV, hepatitis C, D were excluded. The remaining patients with a prophylaxis indication according to the AGA guideline were randomized to receive either ETV (0.5 mg/day) or TDF (245 mg/day). Prophylaxis was continued for 6-12 months after completion of IST. Patients were followed up for 1 year after completion of prophylaxis. The HBV reactivation rates and side effects of the drugs were compared. RESULTS: The study group included 120 patients. There was no significant difference between the demographic data, viral serologic parameters and reactivation risk profiles of the ETV (n = 60) and TDF (n = 60) groups. Forty-one patients in the ETV and 36 in the TDF group completed the antiviral prophylaxis, and no HBV reactivation was observed. HBV reactivation was observed in 4 of 37 patients (10.8%) in the ETV group and 5 of 35 (14.3%) patients in the TDF group (including one with flare) during the follow-up after completion of prophylaxis. Ten patients in the ETV group (16.7%) and 14 patients (23.3%) in the TDF group experienced side effects (p = 0.77). One patient in the TDF group had to switch to ETV due to severe itchy, maculopapular rash-like lesions. CONCLUSIONS: ETV and TDF had a similar efficacy in the prophylaxis of HBV reactivation in patients undergoing IST, with none of the patients experiencing reactivation.

The Importance of Eosinopenia for Predicting Treatment Response in Patients with Cholangitis.

OBJECTIVE: To compare recovery of eosinopenia, C-reactive protein (CRP) and procalcitonin levels in predicting the response to treatment in patients with cholangitis. STUDY DESIGN: Descriptive, analytical study. PLACE AND DURATION OF STUDY: Department of Gastroenterology, Sakarya Training and Research Hospital, Turkey between September 2018 and February 2019. METHODOLOGY:  Patients with cholangitis, who underwent endoscopic retrograde cholangiopancreatography (ERCP), were inducted. Those with choledocholic thiasis alone were considered controls. Eosinophil count above 100.5 cells/µL was the limit value accepted as improvement. ERCP repeat was decided according to eosinophil count below 100.5 and not clinically improving. Relationship between inflammatory markers such as CRP, procalcitonin and eosinopenia values in patients with stone-associated cholangitis was investigated. RESULTS: The cholangitis group was comprised of 62 patients [mean age 67±14.57 years; 26 (41.9%) female], while control group was comprised  of 57 patients [mean age 57.4±18.10 years; 39 (68.4%) females, p=0.004]. At time of admission, median eosinophils was significantly lower in cholangitis group at 17.50 [9.82-84] ×103/µL compared to control group at 168 [100.11-270] ×103/µL (p=0.001). ERCP were repeated on two patients as their clinical conditions and unremitting eosinophil counts worsened. Eosinophil and CRP markers and clinical improvement were observed after  second ERCP procedure. CONCLUSION: Eosinopenia may be used as inflammatory marker in  evaluation of response to treatment and for predicting the need to repeat ERCP during clinical follow-up of patients who undergo cholangitis treatment. Key Words: Cholangitis, C-reactive protein, Endoscopic retrograde cholangiopancreatography, Eosinopenia, Procalcitonin.

HBV flare associated with immunosuppressive treatments: it is still dangerous in the third-generation antivirals era.

BACKGROUND: There are limited data about the mortality and morbidity of patients with HBV flare related to immunosuppressive treatments (IST) in the third-generation antivirals era. Herein, we performed a multi-centric study in patients treated with entecavir (ETV) or tenofovir disoproxil fumarate (TDF) and evaluated their clinical course. METHODS: The study group included patients who were referred to gastroenterology or infectious disease specialists at eight different hospitals in Turkey. HBV flare was defined as at least a threefold elevation in alanine aminotransferase (ALT) levels above the upper limit of normal range. The demographic data, IST protocol, virological markers, liver tests, international normalized ratio (INR), HBV DNA, reactivation risk profile according to AGA guideline, MELD and MELD-Na scores were retrospectively evaluated. The primary aim of the study was to determine the liver-related mortality, including transplantation, at 12 weeks and factors predicting it. Secondary aims were to compare ETV and TDF with respect to mortality and time to ALT, bilirubin normalization and HBV DNA undetectability. RESULTS: The study group included 40 patients (29 males, mean age: 57 ±12 years). Twenty-five patients (62.5%) had a high risk of reactivation. Twenty-six patients received TDF and 14 patients received ETV treatment. Eight (20%) patients developed acute liver failure and one patient (2.5%) underwent living donor liver transplantation. Seven patients died due to liver-related complications, revealing a mortality rate of 17.5%. In multivariate analysis, total bilirubin levels at the onset, ALT levels and delta-MELD score at the first week were the independent risk factors for liver related mortality (HR: 1.222, 1.003, 1.253 and 95% CI: 1.096, 1.362; 1.001, 1.004 and 1.065, 1.470, respectively). There was no significant difference between the TDF and ETV groups with respect to time to normalize ALT and bilirubin levels, HBV DNA undetectability and mortality rates (16% and 21.4%, respectively). CONCLUSIONS: HBV flare associated with IST has a high mortality in the third-generation antivirals era. High total bilirubin at the onset and high ALT and delta-MELD score at the first week predict poor prognosis.

Fully Covered Self-Expandable Metal Stens eliminate surgical repair requirement in both endoscopic sphincterotomy and precut sphincterotomy-related perforation (with video).

OBJECTIVE: Endoscopic retrograde cholangiopancreatography (ERCP)-related perforations occur in 0.3-0.6% of patients. The treatment of retroperitoneal paravaterian perforations (type II), which develop during endoscopic sphincterotomy or precut sphincterotomy, remains a matter of debate. We aimed to evaluate the efficacy of fully covered self expandable metal stent (Fc-SEMS) placement in the treatment of type II perforations. METHODS: The study was conducted in a tertiary ERCP reference center of Turkey between December 2013 and June 2016. Patients with type II ERCP-related perforation constituted the study group. Type II perforations were treated by insertion of an Fc-SEMS (10 mm × 60 mm) during the ERCP procedure or intraoperatively by surgery-endoscopy rendezvous technique, if biliary cannulation could not be achieved. RESULTS: A total of 2689 ERCPs were performed. ERCP-related perforation was observed in 12 procedures (0.4%). Eight patients had Stapfer type II perforations, which developed during endoscopic sphincterotomy in seven patients and precut sphincterotomy in one patient. Fc-SEMSs were inserted during the ERCP procedure in seven patients and intraoperatively by surgery-endoscopy rendezvous technique in one patient. None of the patients developed fever, hemodynamic instability, or peritoneal signs. Stents were removed after a median duration of 9 (3-14) days. All of the patients were uneventfully discharged after an average hospital length of stay of median 5 (1-9) days. CONCLUSION: Fc-SEMSs are highly effective in the nonoperative treatment of type II perforations and their intraoperative insertion in patients with unsuccessful cannulation may facilitate surgery by eliminating the need for duodenum repair surgery.

Rheumatologists' awareness of hepatitis B reactivation before immunosuppressive therapy.

HBV reactivation (HBVr) is a well-known complication of immunosuppressive (IS) treatment. The aim of this study was to evaluate the awareness of rheumatologists about the risk of HBVr. A survey was sent via e-mail to 270 members of the Turkish Society for Rheumatology. It consisted of fourteen questions on their awareness of the major society guidelines, approach to hepatitis B virus (HBV) screening according to different IS regimens, decision process in screening patients for HBV, knowledge of antiviral treatments for HBV, follow-up strategies, experience and postgraduate training on HBVr. Forty-eight (17.8%) rheumatologists responded to the survey. Of the respondents, 93.8% reported that they screened all patients before IS treatment, while 6.2% screened patients with a high risk of HBV infection only. The screening rate was 95.8% (46/48) in patients undergoing high-risk IS treatment and 35.4% (17/48) in those undergoing low-risk treatment. All respondents screened for HBsAg, and 83.3% (40/48) screened for anti-HBc IgG and anti-HBs. Forty-four (91.7%) rheumatologists had previously initiated antiviral prophylaxis, and 14 (29.2%) had detected HBVr in at least one patient. Rheumatologists had a high awareness of the necessity for HBV screening before IS treatment. However, the screening rates were still lower than desired, especially in patients receiving IS treatments with moderate or low risk of reactivation.

Low recurrence rate of hepatocellular carcinoma following ledipasvir and sofosbuvir treatment in a real-world chronic hepatitis C patients cohort.

The aims of the present study were to evaluate the efficacy and tolerability of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin in the treatment of chronic hepatitis C (CHC) in patients with advanced liver disease and to analyse whether the use of LDV/SOF treatment is associated with a new occurrence of hepatocellular carcinoma (HCC) during and after LDV/SOF treatment. The Turkish Early Access Program provided LDV/SOF treatment to a total of 200 eligible CHC patients with advanced liver disease. The median follow-up period was 22 months. All patients were Caucasian, 84% were infected with genotype 1b, and 24% had a liver transplantation before treatment. The sustained virological response (SVR12) was 86.0% with ITT analysis. SVR12 was similar among patients with Child-Pugh classes A, B and C disease and transplant recipients. From baseline to SVR12, serum ALT level and MELD score were significantly improved (P < 0.001). LDV/SOF treatment was generally well tolerated. Only one patient developed a new diagnosed HCC. Seventeen of the 35 patients, who had a history of previous HCC, developed HCC recurrence during the LDV/SOF treatment or by a median follow-up of 6 months after treatment. HCC recurrence was less commonly observed in patients who received curative treatment for HCC compared with those patients who received noncurative treatment (P = 0.007). In conclusion, LDV/SOF with or without ribavirin is an effective and tolerable treatment in CHC patients with advanced liver disease. Eradication is associated with improvements in liver function and a reduced risk of developing a new occurrence of HCC.