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1.
J Infect Dis ; 2021 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-34894128

RESUMO

BACKGROUND: This study investigated the incidence and predictors of hepatitis B virus (HBV) relapse in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) who discontinued entecavir or tenofovir disoproxil fumarate (TDF). METHODS: A total of 205 and 111 HBeAg-positive patients without cirrhosis who had stopped entecavir or TDF treatment, respectively, for at least 6 months were recruited. RESULTS: In the entire cohort, patients with HBeAg seroconversion during treatment and propensity score (PS)-matched patients, patients who discontinued TDF had significantly higher rates of virological and clinical relapse than patients who discontinued entecavir therapy. Multivariate analysis identified TDF were independently associated with virological and clinical relapse in the entire cohort and subgroups analysis. Patients with HBeAg loss without anti-HBe antibody formation during treatment had significantly higher rates of off-therapy HBV relapse and HBeAg seroreversion than patients with HBeAg seroconversion during treatment. The HBcrAg level at end of treatment (EOT) was independently associated with HBV relapse and HBeAg seroreversion in all patients and patients with HBeAg seroconversion during treatment. CONCLUSIONS: TDF therapy, HBeAg loss without seroconversion during treatment and higher HBcrAg levels at EOT are significant predictors of HBV relapse in HBeAg-positive patients who discontinued entecavir or TDF.

3.
Biomedicines ; 9(12)2021 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-34944636

RESUMO

Unexpected high risk of synchronous/metachronous hepatocellular carcinoma (HCC) and transitional cell carcinoma (TCC) co-occurrence has been discovered previously. Here, we searched for genetic variation contributing to the co-occurrence of this double primary cancer (DPC). Using targeted exome sequencing, a panel of variants associated with concurrent DPC was identified. However, only a nonsynonymous variant within the Spectrin Repeat Containing Nuclear Envelope Protein 1 (SYNE1) gene was associated with DPC occurrence (p = 0.002), compared with that in the healthy population. Further independent cohort verification analysis revealed that the SYNE1-rs9479297-TT genotype (versus TC + CC genotypes) was enriched in patients with DPC, compared with that in those with TCC alone (p = 0.039), those with HCC alone (p = 0.006), those with non-HCC/non-TCC (p < 0.001), and healthy population (p < 0.001). SYNE1 mRNA expression reduced in both patients with HCC and TCC, and its lower expression in HCC was associated with shorter recurrence-free (p = 0.0314) and metastasis-free (p = 0.0479) survival. SYNE1-rs9479297 genotypes were correlated with tissue SYNE1 levels and clinical outcomes in HCC patients. Finally, SYNE1 silencing enhanced the cell proliferation and migration of HCC/TCC cells. In conclusion, SYNE1-rs9479297 genotypes were associated with HCC/TCC DPC co-occurrence and correlated with SYNE1 expression, which in turn contributed to HCC/TCC cell proliferation and migration, thereby affecting clinical outcomes.

4.
Glob Health Med ; 3(5): 293-300, 2021 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-34782872

RESUMO

The estimated prevalence of anti-HCV was 3.3% (1.8-5.5%) in the general population in Taiwan with several regional disparities. The reactive anti-HCV in different regions may vary between 0% and 65%. The National Hepatitis C Program (NHCP) office estimated approximately 623,323 persons reactive with anti-HCV based on several extensive region- and cohort-wide studies. Taiwan has accelerated its efforts to eliminate hepatitis C since 2018 by committing to achieve World Health Organization (WHO)'s 2030 goal of treating 80% of eligible patients by 2025. Many aggressive measures by the Ministry of Health and Welfare (MOHW) have been ongoing including several key success factors such as political commitment by the MOHW to finance this national program and improve National Health Insurance (NHI) reimbursement restrictions for treatment. Meanwhile, the Taiwan Centers for Disease Control (CDC) instituted harm reduction programs and the Health Promotion Administration (HPA) started to improve awareness and perform national screening programs. The NHCP office instituted monitoring, evaluation, micro-elimination and funding to linkage to care programs. In addition to sustainable financing, it is imperative to scale-up screening coverage through a precision public health approach to fill the gap of under-diagnosis. Hopefully, we can achieve early elimination by announcing the treatment target of 250000 CHC patients by 2025.

5.
Artigo em Inglês | MEDLINE | ID: mdl-34825277

RESUMO

PURPOSE: To evaluate the prevalence and extension of macrovascular invasion (MaVI) in a large cohort of hepatocellular carcinoma (HCC) patients and analyze the association between MaVI and overall survival (OS). METHODS: From 2011 to 2018, 2540 patients with newly diagnosed HCC who were managed in our institution were enrolled in this retrospective study. Tumor invasion of the intrahepatic branches of the portal or hepatic veins was defined as peripheral MaVI. Tumor invasion of the main portal vein or inferior vena cava was defined as central MaVI. RESULTS: MaVI prevalence was 16.2% (n = 411). Among patients with Barcelona Clinic Liver Cancer (BCLC) stage C and Child-Pugh class A, 165 patients presented with peripheral MaVI and 89 patients with central MaVI. The median OS was 13.2 months (95% confidence interval [CI]: 11.4-15.4) in the peripheral MaVI group and 6.6 months (95% CI: 3.6-9.5) in the central MaVI group (p < 0.001). In patients with BCLC stage C and Child-Pugh class B or BCLC stage D, 68 patients presented with peripheral MaVI and 89 patients with central MaVI. The median OS was 3.6 months (95% CI: 3.1-4.2) in the peripheral MaVI group and 2.8 months (95% CI: 2.1-3.4) in the central MaVI group (p = 0.674). CONCLUSION: The extension of MaVI significantly affected patient survival only in those with BCLC stage C and Child-Pugh class A. In patients with BCLC stage C and Child-Pugh class B or BCLC stage D, survival was poor irrespective of MaVI status.

6.
Biomed J ; 2021 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-34801765

RESUMO

BACKGROUND: To evaluate the protective efficacy of a hepatitis B (HB) vaccination program in Taiwan among high-risk children. MATERIAL AND METHODS: Children born to HBeAg-positive mothers from 2001 to 2010 were invited back. Blood samples for hepatitis B virus (HBV) seromarkers were taken and the children underwent hepatobiliary ultrasonography. Perinatal factors including delivery mode and vaccination history were collected from their medical records. According to the results of HBV serological markers, the children were initially classified into five groups: HBV naïve, HB vaccine responder, HBsAg carrier, recovered from HBV infection, and anti-HBc-positive alone. Children in the HBV naïve and anti-HBc-positive alone groups who presented with an anamnestic response after a booster HB vaccine were re-assigned to the vaccine responder and recovered from infection groups, respectively. RESULTS: All of the 196 enrolled children received postnatal hepatitis B immunoglobulin (HBIG) and HB vaccinations, of whom one was HBV naïve (0.5%), 109 were vaccine responders (55.6%), 21 were carriers (10.7%), and 65 recovered from infection (33.2%). Among the 21 carriers, 14 (66.7%) presented in the immunotolerant phase. Cesarean section was the only significant perinatal factor between the carriers (5.3%) and those who recovered from infection (37.7%) (p=0.007). CONCLUSIONS: In this study, there was a 43.9% HBV infection rate and 10.7% HBsAg carrier rate in high-risk Taiwanese children even after receiving HBIG and HB vaccinations. Cesarean section may protect newborns from becoming HBsAg carriers, while HBV genotype and time of HBIG injection did not contribute to the HBV carrier rate.

7.
Front Oncol ; 11: 737767, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34760699

RESUMO

Background: Lenvatinib is approved for patients with advanced hepatocellular carcinoma (HCC) due to its non-inferiority to sorafenib of overall survival (OR) in clinical trials. This study was to compare the effectiveness and safety of lenvatinib and sorafenib in the real world. Methods: We retrospectively evaluated 338 patients with unresectable HCC who had undergone lenvatinib or sorafenib treatment between January 2018 and August 2020. Propensity-score matching analysis was performed with a 1:2 ratio to reduce the real-life baseline difference between the two groups. Results: A total of 210 patients (Male/Female: 150/60, mean age: 65.8 years) were recruited including 70 patients in the Lenvatinib group and 140 patients in the Sorafenib group. Compared with sorafenib, lenvatinib had significantly longer progression-free survival (PFS) (5.2 vs 3.3 months, p=0.019) but similar OR (13.3 vs 11.8 months, p=0.714). Additionally, lenvatinib had better disease control rates (62.3 vs 48.6%, p=0.029) and equivalent incidences of treatment-related adverse events over sorafenib. In multivariate analysis, lenvatinib was associated with better PFS over sorafenib (hazard ratio: 0.49, 95% confidence interval: 0.3-0.79, p=0.004) after adjustments of albumin-bilirubin grade and alpha-fetoprotein level; however, different agents using lenvatinib or sorafenib did not contribute to OS, whether in univariate or multivariate analysis. Patients who failed lenvatinib had a lower proportion of having sequential systemic therapies compared with the Sorafenib group (36.2 vs 47.8%, p=0.02). The most frequently used sequential therapy following lenvatinib and sorafenib was chemotherapy (n=9, 42.8%) and regorafenib (n=33, 50.8%), respectively. Conclusions: In clinical real-life practice, lenvatinib illustrated promising survival benefits and acceptable safety for patients with unresectable HCC, while reducing the risk of progression disease compared with sorafenib. Additionally, lack of approved post-lenvatinib systemic therapies is a serious issue in the real world.

8.
Kaohsiung J Med Sci ; 2021 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-34687140

RESUMO

To determine whether liver stiffness (LS) and fibrosis-4 (Fib-4) index were useful in assessing the occurrence of liver-related complications (LRC) in chronic hepatitis C (CHC) patients after direct-acting antivirals (DAAs) had been administered. This retrospective study enrolled CHC patients achieving sustained virological response (SVR) after DAA. A total of 697 (male/female: 294/403, mean age: 63.8 year) patients with measured LS and complete lab data at SVR were enrolled, followed, and analyzed. In a median follow-up of 21.4 months after SVR, 39 patients developed LRC including 28 with hepatocellular carcinoma (HCC), with the 30-month cumulative incidence of LRC and HCC being 7.7% and 5.1%, respectively. Predictions of occurrence of LRC and HCC were 0.820 and 0.774 for LS, and 0.775 and 0.737 for Fib-4, with optimal cutoffs of LS and Fib-4 being 14.5 kPa and 2.9 for LRC prediction. In multivariate analysis, LS was associated with the occurrence of LRC (hazard ratio: 3.97, 95% confidence interval [1.866, 8.446], p < 0.001) after adjustment for Fib-4 and diabetes. A risk-score system combining LS, Fib-4, and diabetes was developed for LRC risk assessment. Patients were stratified into low- (score 0-1), intermediate- (score 2-3), and high-risk (score 4) groups with LRC cumulative incidences of 1.7%, 14.9%, and 36.4%, respectively (p < 0.001). For patients with CHC after DAA, the risk scoring system based on LS, Fib-4, and diabetes was useful to assess the risk of LRC development during follow-up; accordingly, it would be advantageous for clinicians to set up more personalized and cost-effective strategies of surveillance.

9.
J Phys Chem Lett ; 12(37): 9011-9019, 2021 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-34515494

RESUMO

The cubic-phase antimony trioxide (α-Sb2O3) is a room-temperature stable molecular crystal, composed of cage-like tetraantimony hexoxide (Sb4O6) molecules. Despite its versatile functionality, the van der Waals (vdW) bond-dominated nanomechanics is still unclear. Here, the bending plate-like linear behaviors of high-quality α-Sb2O3 nanoflakes were observed using the nanoindentation method. It is found that the cage-molecular crystal owns a very low in-plane Young's modulus of 14.9 ± 0.8 GPa and a remarkable maximum tensile strain of 6.0-8.8%, corresponding to a rupture strength of 0.89-1.31 GPa. Elucidated by the atomistic simulations, the compliant elastic modulus and the unexpectedly strong rupture strain are associated with the high-symmetry vdW bonding structure. The vdW nanomechanics is of fundamental and technological relevance to nanoelectronics.

10.
JGH Open ; 5(8): 929-940, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34386602

RESUMO

Background and Aim: Ropeginterferon alfa-2b (P1101) is a novel long-acting mono-PEGylated recombinant proline interferon (IFN) conjugated to a 40 kDa branched polyethylene glycol (PEG) chain at its N-terminus, allowing every-two-week injection. It received European Medicines Agency and Taiwan marketing authorization for the treatment of polycythemia vera in 2019 and 2020, respectively. This phase 2 study aimed to evaluate the pharmacokinetics, safety, and preliminary efficacy of ropeginterferon alfa-2b as compared with PEG-IFN-α2a in patients with chronic hepatitis C virus genotype 1 infection. Methods: One hundred six treatment naive patients were enrolled in this phase 2 study and randomized to four treatment groups: subcutaneous weekly PEG-IFN-α2a 180 µg (group 1), weekly ropeginterferon alfa-2b 180 µg (group 2), weekly ropeginterferon alfa-2b 270 µg (group 3), or biweekly ropeginterferon alfa-2b 450 µg (group 4) plus ribavirin for 48 weeks. Results: After multiple weekly administration, serum exposure (AUC0-τ) in ropeginterferon alfa-2b 180 µg was approximately 41% greater and the accumulation ratio of 2-fold greater than PEG-IFN-α2a 180 µg. The incidences of flu-like symptoms were 66.7% (18/27), 53.3% (16/30), 55.0% (11/20), and 48.3% (14/29), anxiety were 14.8% (4/27), 6.7% (2/30), 0%, and 0%, and depression were 25.9% (7/27), 13.3% (4/30), 0%, and 3.4% (1/29), for groups 1-4, respectively. Two grade 2 of 3 depression were noted in PEG-IFN-α2a arm, but none in ropeginterferon arms. The SVR24 rates were 77.8% (21/27), 66.7% (20/30), 80% (16/20), and 69% (20/29), respectively. Conclusions: Ropeginterferon alfa-2b showed longer effective half-life and superior safety profile than PEG-IFN-α2a. Biweekly injection of ropeginterferon alfa-2b will be studied in larger viral hepatitis patient population.

11.
Am J Surg ; 2021 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-34399978

RESUMO

BACKGROUND: To assess preoperative image tumor characteristics and alpha-fetoprotein (AFP) levels to predict early recurrence after liver resection (LR) for hepatocellular carcinoma (HCC). METHODS: This retrospective study's enrolled patients underwent LR for newly diagnosed HCC between 2011 and 2018. Multivariate logistic regression analyses using the Akaike information criterion were adopted to construct a nomogram to predict early recurrence (i.e. recurrence within 1 year). The performance of this nomogram was evaluated using calibration plots with bootstrapping. RESULTS: Early recurrence was identified in 99 patients (11.2%). Four predictive factors, namely an AFP level of >400 ng/mL; image-diagnosed tumor characteristics, including a tumor size of > 5 cm; vascular invasion; and multiple tumors were adopted in the final model of the early recurrence nomogram, with a concordance index of 0.67. The calibration plots showed good agreement between the nomogram predictions and the actual observations of early recurrence. CONCLUSION: We have developed a simple nomogram with preoperative image tumor characteristics and AFP levels to predict the early recurrence of HCC after LR.

12.
Dig Dis Sci ; 2021 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-34241753

RESUMO

BACKGROUND: The predictors of persistent virological suppression after clinical relapse remain unclear. AIMS: To investigate the predictors of retreatment or persistent virological suppression after clinical relapse in chronic hepatitis B (CHB) patients who discontinued entecavir or tenofovir disoproxil fumarate (TDF). METHODS: A total of 243 hepatitis B e antigen-negative CHB patients without cirrhosis who experienced clinical relapse after entecavir or TDF cessation were enrolled. RESULTS: Of the 243 CHB patients, 192 received retreatment and 51 did not receive retreatment after clinical relapse. Of the 51 patients without retreatment, 23 achieved persistent virological suppression (persistent HBV DNA < 2000 IU/mL at least 2 years) and 10 experienced hepatitis B surface antigen (HBsAg) loss. The Cox regression analysis showed that short consolidation duration, short duration of the first clinical relapse from the end of treatment (EOT), and high bilirubin and HBV DNA levels at the first clinical relapse were independent predictors of retreatment. Long duration of the first clinical relapse from the EOT and low HBsAg levels at the first clinical relapse were independent factors of patients with persistent virological suppression. The rates of persistent virological suppression at the first clinical relapse among patients with HBsAg < 100 and ≥ 100 IU/mL were 44.4% (12/27) and 5.1% (11/216) (P < 0.001), respectively. Baseline HBsAg levels and no retreatment requirement were independent factors associated with HBsAg loss. CONCLUSIONS: The HBsAg of 100 IU/mL at the first clinical relapse could predict persistent virological suppression after clinical relapse in patients who discontinued entecavir or TDF therapy.

13.
Case Rep Oncol ; 14(2): 906-911, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34267637

RESUMO

Liver abscess formation is one of the major complications following radiofrequency ablation (RFA) in patients with hepatocellular carcinoma (HCC). Clostridium perfringens is a rare but fatal (mortality rate: 70-100%) organism that could lead to severe sepsis. We presented a case where a 63-year-old woman with diabetes mellitus, hypertension, chronic hepatitis B-related cirrhosis in Child-Pugh class A and HCC with initial TNM stage II who had undergone 2 sessions of transarterial chemoembolization. RFA was performed for 4 small HCC due to poor effect of previous transarterial chemoembolization. However, all 4 treated tumors developed liver abscesses presenting with septic shock within 1 day. Aspirated abscesses and blood culture both yielded C. perfringens infection. After intensive care, optimal intravenous antibiotic, and abscesses aspiration, the patient recovered successfully. All tumors achieved complete response during the follow-up period without local recurrence. The clinical presentations and risk factors of C. perfringens-related liver abscess after RFA will be discussed in this manuscript.

14.
BMJ Open ; 11(7): e046115, 2021 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-34233977

RESUMO

OBJECTIVES: Community-based screening for hepatitis B virus (HBV) and hepatitis C virus (HCV) is essential for hepatitis elimination. This study attempted to increase screening accessibility and efficacy by using alternative tools. DESIGN: Population-based prospective cohort study. SETTING: Hepatitis elimination program at Yunlin County, Taiwan. PARTICIPANTS: All 4552 individuals participated in 60 screening sessions of a community-based HBV and HCV screening project in five rural townships with approximately 95 000 inhabitants in central-western Taiwan. INTERVENTIONS: To increase accessibility, 60 outreach screening sessions were conducted in 41 disseminative sites. Quantitative HBV surface antigen (qHBsAg) and anti-HCV testing with reflex HCV core antigen (HCV Ag) tests were employed as alternative screening tools. MAIN OUTCOME MEASURES: Calculate village-specific prevalence of HBsAg, anti-HCV and HCV Ag and establish patient allocation strategies according to levels of qHBsAg HCV Ag and alanine aminotransferase (ALT). RESULTS: Of 4552 participants, 553, 697 and 290 were positive for HBsAg, anti-HCV and HCV Ag, respectively; 75 of them had both HBsAg and anti-HCV positivity. The average (range) number of participants in each screening session was 98 (31-150). The prevalence rates (range) of HBsAg, anti-HCV and HCV Ag were 12.1% (4.3%-19.4%), 15.3% (2.6%-52.3%) and 6.4% (0%-30.2%), respectively. The HCV Ag positivity rate among anti-HCV-positive participants was 42% (0%-100%). Using cut-off values of >200 IU/mL for qHBsAg, >3 fmol/L for HCV Ag and >40 IU/mL for ALT as criteria for patient referral, we noted an 80.2% reduction in referral burden. Three villages had high anti-HCV prevalences of 52.3%, 53.8% and 63.4% with corresponding viraemic prevalences of 23.2%, 30.1% and 22% and thus constituted newly identified HCV-hyperendemic villages. CONCLUSION: Outreach hepatitis screening increases accessibility for residents in rural communities. Screening HBV and HCV through qHBsAg and HCV Ag tests provides information concerning viral activities, which might be conducive to precise patient allocation in remote communities.


Assuntos
Hepatite B , Hepatite C , Estudos de Coortes , Hepacivirus , Hepatite B/diagnóstico , Hepatite B/epidemiologia , Antígenos de Superfície da Hepatite B , Hepatite C/diagnóstico , Hepatite C/epidemiologia , Humanos , Estudos Prospectivos , Reflexo , Taiwan/epidemiologia
15.
J Formos Med Assoc ; 2021 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-34303584

RESUMO

BACKGROUND/PURPOSE: This study is to use albumin-bilirubin (ALBI) grade and up-to-7 (UT7) criteria to assess outcomes of patients with intermediate stage hepatocellular carcinoma (HCC) after transarterial (chemo)embolization (TA(C)E). METHODS: Between January 2012 and January 2019, newly diagnosed intermediate HCC patients underwent TA(C)E were enrolled and analyzed. The demographics, clinical characteristics and survival were obtained from medical chart reviews. RESULTS: A total of 359 patients were enrolled and 30.4% of them were within UT7 criteria (UT7 (-)). There were 36.5%, 59.3%, and 4.2% of the patients with ALBI grade I, II, and III, respectively. Beyond UT7 (UT7 (+)) and ALBI grade II/III were associated with overall mortality in multivariate analysis. Based on ALBI grade I/II/III and UT7 -/+, patients were classified into six groups as ALBI grade I plus UT7 (-), II plus UT7 (-), III plus UT7 (-), I plus UT7 (+), II plus UT7 (+), and III plus UT7(+). Distributions of median survival were 47.5, 32.9, 15, 34.3, 16.7 and 14.3 months, respectively. Patients with statistically insignificant survivals were further combined. Patients with ALBI grade I plus UT7 (-) were reclassified as ALBI-U class I, whereas ALBI grade II plus UT7 (-) and I plus UT7 (+) were ALBI-U class II, and the others were ALBI-U class III. There were 8.4%, 48.7%, and 42.9% of patients in ALBI-U class I, II, and III, respectively. The 5-year survival rate was 48.8%, 22.5%, and 13.7% in ALBI-U class I, II, and III, respectively (p < 0.01). CONCLUSION: ALBI-U classification was useful in predicting outcomes of patient with intermediate stage HCC after TA(C)E.

16.
Cancers (Basel) ; 13(14)2021 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-34298750

RESUMO

GI cancers are characterized by high recurrence rates and a dismal prognosis and there is an urgent need for new therapeutic approaches. This is a narrative review designed to provide a summary of the efficacy as measured by overall survival, progression free survival, and safety data from phase 3 randomized controlled GI clinical trials of ramucirumab including those from important pre-specified patient subgroups and evidence from real clinical practice worldwide. Quality of life (QOL) is discussed where data are available. Our aim was to summarize the efficacy and safety of ramucirumab in the treatment of GI cancers using these existing published data with a view to demonstrating how ramucirumab may help improve treatment outcome for patients with GI cancers. The data indicate that ramucirumab is efficacious, safe, and tolerable across the intent-to-treat patient populations as a whole and across several pre-specified subgroups, even those whose disease is traditionally more difficult to treat. Furthermore, survival outcomes observed in real-world clinical practice demonstrate similar data from phase 3 clinical trials even in patients with complications, suggesting that the benefits of ramucirumab translate in actual clinical practice.

17.
Sci Rep ; 11(1): 13543, 2021 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-34188161

RESUMO

Clinical trials showed pangenotypic direct-acting antivirals' (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. The primary endpoint was sustained virologic response 12 weeks after treatment cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4%), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon; only < 1% exhibited elevated total bilirubin or aminotransferase levels with both regimens. Five drug discontinuations occurred due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.


Assuntos
Antivirais/administração & dosagem , Hepacivirus/genética , Hepatite C Crônica , Resposta Viral Sustentada , Idoso , Feminino , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/epidemiologia , Hepatite C Crônica/genética , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Taiwan/epidemiologia
18.
Kaohsiung J Med Sci ; 37(10): 894-902, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34166565

RESUMO

Sorafenib is the recommended first-line treatment option for patients with advanced hepatocellular carcinoma (HCC). Hepatitis C virus (HCV)-related advanced HCC (HCV-HCC) seemed to have a better response than hepatitis B virus (HBV)-related HCC (HBV-HCC) in sorafenib use, but it was undetermined. Hence, we aimed to investigate the effect of sorafenib between HBV-HCC and HCV-HCC patients in Taiwan. From August 2012 to December 2016, 575 consecutive advanced HCC patients received sorafenib under the reimbursement of Taiwan national health insurance in our hospital. Radiologic assessment was performed at a 2-month interval. Those patients with tumor progression or liver function deterioration were disallowed for further sorafenib use. Patients with HBV or HCV infection were, retrospectively, enrolled and followed till December 2018. There were 277 (62.4%) HBV-HCC patients and 167 (37.6%) HCV-HCC patients. Before sorafenib, 192 (69.3%) HBV-HCC patients who had used nucleoside analogs (NAs) for HBV management, whereas only 5 (3%) HCV-HCC patients received interferon-based antiviral therapy. Overall survival (OS) of HCV-HCC patients was significantly superior to HBV-HCC patients without NAs (8.8 months vs. 4.9 months, p = 0.006), but was noninferior to HBV-HCC patients with NAs (8.8 months vs. 10.7 months, p = 0.54). Using propensity score matching, progression-free survival (2.0 months vs. 2.1 months, p = 0.374) and OS (10.5 months vs. 9.6 months, p = 0.746) between HBV-HCC and HCV-HCC groups were not different. Antiviral therapy might increase survival benefits of advanced HBV-HCC patients underwent sorafenib use, leading to a comparable OS to HCV-HCC patients in Taiwan.

19.
Front Oncol ; 11: 683341, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34136408

RESUMO

Background: Nivolumab and regorafenib are approved second-line therapies for patients with hepatocellular carcinoma (HCC) after sorafenib failure. This study compared the effectiveness of nivolumab and regorafenib following sorafenib. Methods: We retrospectively enrolled HCC patients who had undergone nivolumab or regorafenib after sorafenib failure. Treatment response, treatment-related adverse events (TRAE) and clinical outcomes of study patients were recorded and analyzed. Results: A total of 90 patients (male/female: 67/23, mean age: 63 years) were enrolled, including 32 patients in the Nivolumab group and 58 patients in the Regorafenib group. The Nivolumab group had better objective response rates (16% vs 6.4%) and disease control rates (44% vs 31.9%) than the Regorafenib group, but there was no statistical difference. The comparison of time to progression (3.0 months vs 2.6 months, p=0.786) and overall survival (OS) (14 months vs 11 months, p = 0.763) between Nivolumab and Regorafenib groups were also insignificant. Regarding number of TRAE incidences, the Nivolumab group was significantly lower than the Regorafenib group (37.5% vs 68%). After cession of nivolumab/regorafenib, 34 patients (37.8%) (Nivolumab group/Regorafenib group: 11/23) could afford the following therapies. Concerning sequential systemic therapies, 17 patients (18.9%) received third-line therapy, whereas six patients (6.7%) could move to fourth-line therapy. In multivariable analysis, patients who achieved disease control were associated with improved OS (hazard ratio, 0.18; 95% confidence interval, 0.07-0.46; p<0.001) after adjusting Child-Pugh class and post-treatment. Conclusions: After sorafenib failure, using nivolumab or regorafenib both illustrated promising treatment outcomes.

20.
BMC Gastroenterol ; 21(1): 259, 2021 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-34118889

RESUMO

INTRODUCTION: Real-world data regarding the impact of hepatic fibrosis on the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) treatment is limited in the Asian population. METHODS: We analyzed data for all 823 patients with hepatitis C virus treated with SOF/VEL from June 2019 to September 2020 at Chang Gung Memorial Hospital in Chiayi, Taiwan. The degree of fibrosis was determined using the fibrosis-4 (FIB-4) index, with advanced fibrosis or cirrhosis defined as a FIB-4 score of > 3.25. The primary treatment outcome was the rate of sustained virologic response 12 weeks after treatment cessation (SVR). Adverse events (AEs) were also evaluated. RESULTS: SVR rates did not significantly differ (p > 0.05) between patients with FIB-4 scores of ≤ 3.25 and those with scores of > 3.25. In the per protocol analysis, 99.2% (593/598) of the FIB-4 ≤ 3.25 group and 100% (172/172) of the FIB-4 > 3.25 group achieved SVR; in the evaluable population analysis, 93.4% (593/635) of the FIB-4 ≤ 3.25 group and 91.5% (172/188) of the FIB-4 > 3.25 group achieved SVR. Five patients with FIB-4 scores of ≤ 3.25 did not attain SVR: two relapsed and three had no response. The most common AEs were comparable (p > 0.05) for the FIB-4 ≤ 3.25 group and the FIB-4 > 3.25 group and included abdominal discomfort (4.4% vs. 5.9%), fatigue (4.1% vs. 5.9%), and skin itching (3.6% vs. 3.2%). Laboratory abnormalities were more common in the FIB-4 > 3.25 group (p < 0.001). Six patients with FIB-4 scores of > 3.25 had total bilirubin elevation > 3 × the upper normal limit (UNL). Alanine transaminase elevation > 5 × the UNL was observed in two patients with FIB-4 scores of ≤ 3.25 and one patient with a FIB-4 score of > 3.25. No AEs resulted in treatment discontinuation. CONCLUSIONS: SOF/VEL treatment is well tolerated and achieves high SVR rates for patients of Taiwanese ethnicity with HCV, regardless of cirrhosis status.


Assuntos
Hepatite C Crônica , Hepatite C , Antivirais/efeitos adversos , Carbamatos , Hepacivirus/genética , Hepatite C/complicações , Hepatite C/tratamento farmacológico , Hepatite C Crônica/complicações , Hepatite C Crônica/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis , Humanos , Cirrose Hepática/complicações , Cirrose Hepática/tratamento farmacológico , Sofosbuvir/efeitos adversos , Resposta Viral Sustentada , Taiwan , Resultado do Tratamento
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