IntroductionBongkrekic acid (BA) is a potent mitochondrial toxin produced by Burkholderia gladioli pathovar cocovenenans, associated with foodborne outbreaks and a high mortality rate. By inhibiting adenine nucleotide translocase, BA causes energy failure and multiorgan dysfunction, particularly acute liver failure. In 2024, Taiwan reported its first BA outbreak. Among 35 confirmed cases, seven patients developed acute liver failure, of whom six died.Case reportA 49-year-old woman presented with vomiting, diarrhea, dizziness, abdominal pain, and jaundice after consuming contaminated flat rice noodles. Laboratory tests revealed significantly elevated AST, ALT, hyperbilirubinemia, and renal impairment. Her hepatic and renal dysfunction worsened. She received intensive care, including Stronger Neo-Minophagen C (SNMC), ursodeoxycholic acid, silymarin, lactulose, corticosteroids, antibiotics, vitamin K, and fresh frozen plasma. BA was confirmed in serum (111.75 mu g/mL), urine, and stool. With continued supportive therapy, her biochemical parameters gradually improved. She was discharged without sequelae on day 22.DiscussionThis case represents the only documented survival from BA-induced fulminant hepatic failure during the 2024 Taiwan outbreak. Prompt recognition, intensive care, and hepatoprotective therapy, including SNMC, probably contributed to a favorable outcome in this often-fatal intoxication. Increased awareness and public health measures are essential to prevent BA-related outbreaks and fatalities.
TPS607 Background: The combination of atezolizumab and bevacizumab (Atezo-Bev) has transformed the treatment landscape for unresectable hepatocellular carcinoma (HCC). With a response rate of approximately 30%, some patients become eligible for curative locoregional therapies (LRT) after successful systemic treatment. However, it remains unclear whether patients who achieve a partial response (PR) and are converted to a disease-free state with curative LRT have a similar prognosis to patients who achieve a complete response (CR) from Atezo-Bev alone. Additionally, it is unknown whether applying curative LRT improves survival outcomes for patients who achieve a PR. This study aims to address these critical questions. Methods: This multinational, retrospective study will enroll patients with clinically or histologically diagnosed HCC who received first-line Atezo-Bev and achieved a CR or PR according to RECIST v1.1. Patients must have started Atezo-Bev before September 30, 2024. Patients receiving concurrent anti-CTLA4 antibodies will be excluded. Curative LRT is defined as curative surgery, ablation, or definitive radiotherapy performed in patients who achieved a PR with Atezo-Bev treatment during their PR status. The primary endpoint is the recurrence-free survival (RFS) of patients who received curative LRT, compared to that of patients who obtained a CR solely from Atezo-Bev treatment. Secondary endpoints include the time to discontinuation of Atezo-Bev treatment after curative LRT, and the time from initiation of Atezo-Bev treatment to curative LRT; also, the overall survival and progression-free survival of patients who received curative LRT with be compared with those of patients who obtained CR solely from Atezo-Bev treatment and those of patients who obtained a PR after Atezo-Bev treatment but did not receive LRT. Disease-free status after curative surgery must be confirmed by imaging. Time from the best objective response to curative LRT will also be recorded. Data will be collected from up to 30 Asian sites, with an anticipated sample size of approximately 400 patients who received curative LRT and 1,200 patients who achieved a CR or PR without receiving curative LRT. Survival outcomes will be analyzed using Kaplan-Meier methods and compared with the log-rank test. They will be adjusted for baseline characteristics such as age, gender, HCC etiology, tumor extent, liver function reserve, alpha-fetoprotein level, and neutrophil/lymphocyte ratio using Cox proportional hazards models. The study is partially supported by Roche. Clinical trial information: NCT07091942 .
PURPOSE:This study investigated whether Fibrosis-4 (FIB-4) score and its change can serve as predictors of hepatocellular carcinoma (HCC) development in patients with chronic hepatitis C (CHC) infection receiving direct-acting antivirals (DAAs). METHODS:This study identified 9679 patients who completed DAA treatment and achieved sustained virologic response (SVR) from the Taiwan Nationwide Real-World HCV Registry Program, and their risk of HCC was analyzed. RESULTS:Multivariable Cox regression analyses identified diabetes mellitus (DM), alpha-fetoprotein (AFP) level, and FIB-4 score as independent predictors of HCC in both Model 1 (baseline) and Model 2 (SVR). Change in FIB-4 score (△FIB-4) of < -0.9086 from baseline to SVR achievement was a significant predictor of HCC only in Model 2 (SVR). In Model 2 (SVR), DM (hazard ratio [HR]: 1.53, 95% confidence interval [CI]: 1.04-2.26, p = 0.033), FIB-4 score (≥3.25 vs. <3.25; HR: 2.40, 95% CI: 1.63-3.53, p < 0.001), △FIB-4 (greater reduction: <-0.9086 vs. smaller reduction: ≥-0.9086; HR: 1.85, 95% CI: 1.25-2.74, p = 0.002), and AFP level (≥20 vs. <20 ng/mL; HR: 16.40, 95% CI: 9.16-29.36, p < 0.001) were significant predictors of HCC. At 3 years, the cumulative HCC incidence was 10.67% in patients with an FIB-4 score of ≥3.25 upon achieving SVR and △FIB-4 of < -0.9086 and 1.72% in those with an FIB-4 score of <3.25 upon achieving SVR and △FIB-4 of ≥ -0.9086. CONCLUSION:Posttreatment FIB-4 score and its change from baseline can be used to stratify HCC risk in patients with CHC receiving DAAs.
BACKGROUND/AIMS:The survival benefit of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection in patients with hepatocellular carcinoma (HCC), particularly in Barcelona Clinic Liver Cancer (BCLC) stages B/C, remains largely uncertain. We aimed to explore the impact of DAA therapy on overall survival (OS) in HCC patients using a nationwide cohort study. METHODS:We utilized the nationwide Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) database to include all adults receiving a DAA therapy for HCV, excluding those with other viral infections, liver transplantation, non-HCC malignancies, and terminal-staged HCC. We respectively analyzed the adjusted odds ratio (aOR) for sustained virological response (SVR) and adjusted hazard ratio (aHR) for OS. RESULTS:Between December 2013 and December 2020, 2,205 (9.3%) patients with HCC and 21,569 (90.7%) patients without HCC were include. The SVR rates were 96.6% in the HCC group and 98.8% in the non-HCC group (P<0.001), with HCC being an independent risk factor affecting SVR (aOR 0.41; 95% CI 0.31-0.54; P<0.001). In the whole patient cohort, SVR was independently associated with improved OS (aHR 0.46; 95% CI 0.35-0.60; P<0.001). Among patients with baseline HCC, SVR remained an independent factor related to OS (aHR 0.41; 95% CI 0.28-0.59; P<0.001). The impact of SVR on OS persisted significantly across BCLC stages 0/A and stages B/C. CONCLUSION:High SVR rates among HCC patients underscore the importance of DAA therapy in enhancing OS, reaffirming its efficacy across various HCC stages.
An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-na & iuml;ve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-na & iuml;ve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m(2) or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR >= 45 mL/min/1.73 m(2)) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m(2)). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m(2). Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-na & iuml;ve CHC patients with both early CKD and pre-ESRD.
Background/Aims: Treatment indications for patients with chronic hepatitis B (CHB) remain contentious, particularly for patients with mild alanine aminotransferase (ALT) elevation. We aimed to evaluate treatment effects in this patient population.Methods: This rollover study extended a placebo-controlled trial that enrolled non-cirrhotic patients with CHB and ALT levels below two times the upper limit of normal. Following 3 years of randomized intervention with either tenofovir disoproxil fumarate (TDF) or placebo, participants were rolled over to open-label TDF for 3 years. Liver biopsies were performed before and after the treatment to evaluate histopathological changes. Virological, biochemical, and serological outcomes were also assessed (NCT02463019).Results: Of 146 enrolled patients (median age 47 years, 80.8% male), 123 completed the study with paired biopsies. Overall, the Ishak fibrosis score decreased in 74 (60.2%), remained unchanged in 32 (26.0%), and increased in 17 (13.8%) patients (p<0.0001). The Knodell necroinflammation score decreased in 58 (47.2%), remained unchanged in 29 (23.6%), and increased in 36 (29.3%) patients (p=0.0038). The proportion of patients with an Ishak score ≥ 3 significantly decreased from 26.8% (n=33) to 9.8% (n=12) (p=0.0002). Histological improvements were more pronounced in patients switching from placebo. Virological and biochemical outcomes also improved in placebo switchers and remained stable in patients who continued TDF. However, serum HBsAg levels did not change and no patient cleared HBsAg.Conclusions: In CHB patients with minimally raised ALT, favorable histopathological, biochemical, and virological outcomes were observed following 3-year TDF treatment, for both treatment-naïve patients and those already on therapy.
This study examines the impact of hepatitis C virus (HCV) eradication through sofosbuvir/velpatasvir (SOF/VEL) treatment on glycated hemoglobin (HbA1c) levels in patients with chronic hepatitis C and type 2 diabetes mellitus (T2DM). Utilizing data from the Taiwan HCV Registry, a retrospective analysis was conducted on 2180 patients who met the inclusion criteria, 695 of whom had T2DM. HbA1c levels significantly decreased in the diabetes group from 7.32% ± 1.72% at baseline to 6.87% ± 1.34% after achieving sustained virological response (SVR12). Patients with higher baseline HbA1c levels and cirrhosis experienced more pronounced HbA1c reductions. Among diabetic patients with HbA1c levels ≥ 6.5, 24.6% achieved levels < 6.5 following HCV elimination, while 24.4% of prediabetic patients observed HbA1c reductions < 5.7. Multivariate analysis identified fasting glucose levels and diabetes status as significant factors associated with HbA1c decline. These findings suggest that successful HCV treatment can improve glycemic control, highlighting the need for collaboration between hepatology and non-hepatology specialists in patient care.
Background/purpose The risk of hepatocellular carcinoma (HCC) is increased in patients with chronic hepatitis C (CHC) and elevated alanine transaminase (ALT) levels. The association between HCC and ALT levels after interferon (IFN) or direct-acting antivirals (DAA) therapy is unclear. Methods Patients with CHC receiving antiviral therapy were included in two large-scale cohorts in Taiwan (T-COACH and TACR). Posttreatment ALT levels were assessed at 24-weeks/12-weeks after the end-of-treatment with IFN/DAA. HCC risk after antiviral therapy were identified for evaluation. Results Of 29,926 CHC patients enrolled in the study, 64%, 22.5%, and 13.5% had posttreatment healthy-normal (female, ≤19 U/L; male ≤30 U/L), high-normal (female, 19–40 U/L; male, 30–40 U/L), and abnormal (>40 U/L) ALT levels, respectively. During a median follow-up of 2.4 years, 1245 patients developed HCC. The 5-year cumulative HCC incidence was 11.2% and 5.2% in the abnormal and high-normal ALT groups, respectively, compared to 2.7% in the healthy ALT group. In Cox regression analysis, factors associated with a higher HCC risk were advanced fibrosis, abnormal and high-normal posttreatment ALT levels, cirrhosis, and old age; whereas a sustained virological response (SVR) was associated with a lower HCC risk. The aforementioned impacts of abnormal and high-normal posttreatment ALT levels were observed across the SVR, non-SVR, and non-cirrhotic subgroups. Conclusion Patients with CHC with high-normal and abnormal posttreatment ALT levels have an increased risk of HCC; thus, HCC surveillance is still necessary in this population.
BACKGROUND:The survival benefit of direct-acting antiviral (DAA) in hepatitis C virus (HCV)-infected patients with or without active hepatocellular carcinoma (HCC) remains debated. This study aimed to clarify this issue. METHODS:This retrospective nationwide cohort study utilized data from the Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) to identify adults with HCC who received DAA therapy for HCV between December 2013 and December 2020. Patients with other viral infections, prior liver transplantation, non-HCC malignancies, or terminal-stage HCC were excluded. The primary outcome was overall survival (OS). The adjusted odds ratio (aOR) for sustained virological response (SVR) and the adjusted hazard ratio (aHR) for OS were calculated. FINDINGS:A total of 2205 patients were included: 1771 (80.3 %) without active HCC and 434 (19.7 %) with active HCC. SVR was independently associated with improved OS (aHR 0.45, 95 % CI: 0.31-0.66; p < 0.001). In Barcelona Clinic Liver Cancer (BCLC) stage 0/A, the 3-year OS rate was significantly higher in the SVR group amongst patients with active HCC (71.7 %, 95 % CI 64.6-77.7 % vs. 39.9 %, 95 % CI 15.6-63.5 %; p = 0.007) but non-significantly higher amongst those without active HCC (84.2 %, 95 % CI 81.7-86.4 % vs. 70.0 %, 95 % CI 44.2-85.6 %; p = 0.181). In BCLC stage B/C, the 3-year OS rate was significantly higher in the SVR group amongst patients without active HCC (76.2 %, 95 % CI 70.2-81.2 % vs. 24.7 %, 95 % CI 5.3-51.3 %; p < 0.001) but not amongst those with active HCC (58.6 %, 95 % CI 47.9-67.7 % vs. 57.1 %, 95 % CI 17.2-83.7 %; p = 0.922). CONCLUSION:For BCLC stage 0/A HCC, early DAA initiation is recommended, even with active HCC. In BCLC stage B/C, DAA therapy appears most beneficial after tumor control.
Chronic hepatitis C (CHC) increases the risk of liver cirrhosis (LC) and hepatocellular carcinoma (HCC). This nationwide cohort study assessed the effectiveness of viral eradication of CHC. The Taiwanese chronic hepatitis C cohort and Taiwan hepatitis C virus (HCV) registry are nationwide HCV registry cohorts incorporating data from 23 and 53 hospitals in Taiwan, respectively. This study included 27,577 individuals from these cohorts that were given a diagnosis of CHC and with data linked to the Taiwan National Health Insurance Research Database. Patients received either pegylated interferon and ribavirin or direct-acting antiviral agent therapy for > 4 weeks for new-onset LC and liver-related events. Among the 27,577 analyzed patients, 25,461 (92.3
Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR). The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed. A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9
This study aimed to compare the effect of long-term continuous entecavir (ETV) compared with tenofovir disoproxil fumarate (TDF) on the reduction of hepatocellular carcinoma (HCC) development in patients with chronic hepatitis B (CHB) related liver cirrhosis. This study recruited patients who had CHB-related liver cirrhosis and received ETV or TDF treatment for more than 6 months. Regular assessments of ultrasonography and alpha-fetoprotein test were arranged every 3 months for HCC detection. Five-year cumulative incidence of HCC and risk factors for HCC development were analyzed. A total of 286 consecutive cirrhotic patients were included, 198 in the ETV group and 88 in the TDF group. During a median follow-up of 57.5 months, 25 (12.6%) patients in the ETV group and 12 (13.6%) patients in the TDF group developed HCC. The 5-year cumulative incidence of HCC was comparable between the ETV and TDF groups (6.57% vs. 9.09%, log-rank p = .242). Multivariate Cox proportional hazard analysis revealed that male, old age, diabetes, and low platelet count were independent risk factors for HCC development. This study observed that long-term ETV or TDF provided comparable preventive effects on HCC development in patients with CHB-related liver cirrhosis.
Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens’ safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists. 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data. Overall, 92.8
Hepatitis C virus (HCV) infection is an important public health problem, causing significant morbidity and mortality worldwide. The prevalence of HCV infections is especially high among people who inject drugs (PWID). The efficacy of direct‐acting antiviral (DAA) therapy was evaluated herein. During 2019‐2021, a total of 321 cases who received a full course of DAA therapy and completed a 12‐week follow‐up observation were studied. The most frequent genotype (GT) was GT6 (34.9%), followed by GT1a (23.4%), GT1b (14.6%), GT2 (12.1%), and GT3 (11.8%). Increase was observed in GT6 (from 29.8% in 2019 to 44.9% in 2021) and GT3 (from 9.9% in 2019 to 16.3% in 2021) over the study years. GT2 was more likely found in patients >50 years old, while GT3 was more in younger patients (both P < .05). GT3 was also more frequently associated with moderate scores of fibrosis‐4 index (FIB‐4) (1.45 ≤ FIB‐4 ≤ 3.25, 13/38 vs 49/283; P < .05). High viral loads (>1 500 000 IU/mL) were found in 65.7% of the patients, including 21.5% showing a very high level (>6 000 000 IU/mL). Compared to other genotypes, viral loads were significantly higher in GT6 ( P < .005) and lower in GT1b ( P < .01). The end of treatment virologic response rate and the sustained virologic response rate at 12 weeks (SVR12) post‐treatment were both 100%. Two recurrent infections with GT6 and GT2 were noted at 16‐month and 3‐month, respectively, after achieving SVR12. The present report provides a solid evidence for the effectiveness of DAA therapy in the treatment of hepatitis C among incarcerated PWID. We believe that appropriate DAA therapy, when incorporated with active universal screening, can achieve micro‐elimination of chronic hepatitis C in incarcerated persons. Hence, the strategies should be applied to all custodial settings, especially for PWID, as an important step to eliminate hepatitis C by 2025, a goal set by the Taiwan government.
Background/Aims: Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy.Methods: We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. Results: The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset.Conclusions: Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.
Enteroscopy offered the opportunity for the treatment of various small bowel diseases. In this chapter, we presented interesting cases with enteroscopic therapy in different conditions, especially in patients with altered gastric anatomy. Authors demonstrated double-balloon enteroscopy for difficult colon insertion, jejunal ulcer bleeding treated by argon plasma coagulation, lymphangioma bleeding treated by argon plasma coagulation, double-balloon enteroscopy using in a Roux-en-Y anastomosis for migrated metallic stent removal, and double-balloon enteroscopy for endoscopic retrograde cholangiopancreatography in a patient with Billroth II gastrojejunostomy.
Malignant neoplasms are very rare disease regardless of primary or secondary. The diagnosis of small intestine malignant tumor is challenging. In this chapter, the authors presented various malignant diseases from clinical history, pictures of enteroscopy or capsule endoscopy, finding of pathology, and key features of radiology study. These diseases were angiosarcoma, myxofibrosarcoma, primary adenocarcinoma in jejunum, metastatic renal cell carcinoma, gastrointestinal stromal tumor, appendiceal adenocarcinoma with duodenal metastasis, lymphoma, mucosa-associated lymphoid tissue in jejunum, metastatic melanoma, retroperitoneal malignant tumor with ileal-vesical fistula, and sarcomatoid metastatic tumor.
Background Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naïve patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce. Methods The TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naïve HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated. Results Of the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/µl, and FibroScan > 20 kPa and platelet < 150,000/µl, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related. Conclusions In this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naïve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.
The relationship between hormone replacement therapy (HRT) and hepatocellular carcinoma (HCC) was discussed for several decades. However, the long-term effects of HRT on female patients with hepatitis C during nature postmenopausal periods are unclear. This study aimed at investigating the effect of HRT on HCC risk and overall survival. We conducted a retrospective population-based cohort study using data from Taiwan's National Health Insurance Research Database from January 1, 2000 to December 31, 2013. The treated cohort, consisting of 1022 patients with hepatitis C who received hormone analog therapy for at least 90 days (treated cohort), was matched with the control cohort, consisting of 1022 untreated patients with hepatitis C (controls) who had never received a hormone prescription, through propensity score adjustment; furthermore, cumulative incidence was calculated, and multivariable analyses were performed. The treated and control cohorts were followed up for mean periods of 7.47 and 6.64 years, respectively. The treated cohort had a significantly lower crude hazard ratio (HR) of HCC of 0.43 (95% confidence interval [CI]: 0.30-0.61, P < .001), with an adjusted HR of 0.49 (95% CI 0.31-0.76, P = .001). After adjustment for other confounders and comorbidities, the hormone analog treatment was associated with a reduced risk of HCC. Subgroup analyses provided estimates of the strength of the associations between HRT and reduced HCC risk in different age categories. Our retrospective population study in Taiwan revealed that using hormone analog reduces the risk of HCC and mortality in patients with hepatitis C virus infection who are receiving HRT, such as menopausal women.
BACKGROUND & AIMS: Sofosbuvir is approved for chronic hepatitis C (CHC) patients with severe chronic kidney disease (CKD). The impact of sofosbuvir-based therapy on renal function augmentation on a real-world nationwide basis is elusive. METHODS: The 12,995 CHC patients treated with sofosbuvir-based (n = 6802) or non-sofosbuvir-based (n = 6193) regimens were retrieved from the Taiwan nationwide real-world HCV Registry Program. Serial estimated glomerular filtration rate (eGFR) levels were measured at baseline, end of treatment (EOT), and end of follow-up (EOF) (3 months after EOT). RESULTS: The eGFR decreased from baseline (91.4 mL/min/1.73 m(2)) to EOT (88.4 mL/min/1.73 m(2); P < .001) and substantially recovered at EOF (88.8 mL/min/1.73 m(2)) but did not return to pretreatment levels (P < .001). Notably, a significant decrease in eGFR was observed only in patients with baseline eGFR >= 90 mL/min/1.73 m(2) (from 112.9 to 106.4 mL/min/1.73 m(2); P < .001). In contrast, eGFR increased progressively in patients whose baseline eGFR was <90 mL/min/1.73 m(2) (from 70.0 to 71.5 mL/min/1.73 m(2); P < .001), and this increase was generalized across different stages of CKD. The trend of eGFR amelioration was consistent irrespective of sofosbuvir usage. Multivariate adjusted analysis demonstrated that baseline eGFR >90 mL/min/1.73 m(2) was the only factor independently associated with significant slope coefficient differences of eGFR (-1.98 mL/min/1.73 m(2); 95% confidence interval, -2.24 to -1.72; P < .001). The use of sofosbuvir was not an independent factor associated with eGFR change. CONCLUSIONS: Both sofosbuvir and non-sofosbuvir-based regimens restored renal function in CHC patients with CKD, especially in those with significant renal function impairment.