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1.

Background

Diabetes is a risk factor of fibrosis progression in chronic hepatitis C (CHC). However, only one longitudinal study exploring whether diabetes is associated with progression from non-cirrhotic liver to cirrhosis in CHC patients has been conducted.

Aims

We investigated whether diabetes is associated with progression from non-cirrhotic liver to cirrhosis in non-genotype 3 CHC patients.

Methods

A cohort consisting of 976 non-genotype 3 patients histologically proven to have CHC was studied. After excluding patients with biopsy-proven or ultrasound-identified cirrhosis, there were 684 patients without cirrhosis. All 684 patients underwent hepatocellular carcinoma surveillance using ultrasound every 6 months, with a median duration of follow-up evaluation of 102.4 months. During the follow-up period, 60 patients developed cirrhosis according to ultrasound findings.

Results

For the subgroup of 684 patients without cirrhosis, Kaplan–Meier survival analyses showed no significantly different cumulative incidences of cirrhosis (log-rank test; P?=?0.71) among the patients with diabetes as compared to those without. However, after making adjustments for age, gender, fibrosis, steatosis, sustained virological response status, and obesity using Cox’s proportional hazard model, diabetes was found to be an independent predictor for cirrhosis (HR?=?1.9; 95% CI?=?1.05–3.43, P?=?0.03).

Conclusions

Diabetes is associated with progression from non-cirrhotic liver to cirrhosis in non-genotype 3 CHC patients.  相似文献   

2.

Background

Data about the outcomes after adalimumab dose de-escalation in inflammatory bowel disease (IBD) are scarce.

Objectives

To assess the outcomes after adalimumab dose de-escalation, and to identify potential factors associated with failure.

Methods

Retrospective, observational study including all IBD patients who had undergone adalimumab dose de-escalation to 40?mg every three weeks across seven GETAID centers, between June 2011 and September 2017. Failure of adalimumab dose de-escalation was defined as the need for treatment re-escalation, discontinuation of adalimumab, or clinical, biochemical and/or morphologic disease relapse.

Results

Fifty-six patients were identified (n?=?46 Crohn’s disease, n?=?10 ulcerative colitis). Median (IQR) duration of follow-up after adalimumab dose de-escalation was 15.9 (7.9–30.6) months. Adalimumab dose de-escalation was a failure in 21/56 (37.5%) patients and successful in 35/56 (62.5%) patients. Median (IQR) time until failure was 8.9 (4.6–15.6) months. At multivariate analysis, inactive disease at magnetic resonance imaging and/or endoscopy in the year before adalimumab dose de-escalation decreased the risk of failure with a factor five (P?=?0.02).

Conclusions

Adalimumab dose de-escalation to 40?mg every three weeks is possible in almost two thirds of IBD patients. Objective morphologic signs of active disease should be ruled out before considering a de-escalation strategy with adalimumab.  相似文献   

3.

Background

Chronic hepatitis B virus (HBV) infection remains a primary cause of morbidity and mortality worldwide.

Aim

The study is aimed at updating the clinical and epidemiological profile of chronic HBV infection in Italy.

Methods

A cross-sectional multicenter prospective study enrolled consecutive HBsAg positive patients seen in 73 Italian centers in the period 2012–2015. Individual patient data were collected using an electronic platform and analyzed using standard statistical methods.

Results

Among 2877 HBsAg positive individuals (median age 49.8?years, 68% males), 27% were non-Italian natives (NINs); 20% had chronic infection, 58.5% chronic hepatitis and 21.5% cirrhosis. Among NINs, age was younger, male gender was less prevalent and liver disease less advanced than in Italians (all p?<?0.0001). HBeAg positive cases were 23.6% among NINs vs 8.2% in Italians (p?<?0.0001); HDV coinfections 11.1% vs 7.3% (p?=?0.006) and HCV coinfections 2.3% vs 4.2% (p?=?0.017), respectively. Anti-HDV or anti-HCV antibodies were detected more frequently in patients with cirrhosis. Fifty percent of NINs with cirrhosis were aged below 45?years.

Conclusion

The study offers an insight into the evolving burden of chronic hepatitis B virus infection in the near future and highlights new territories for public health interventions.  相似文献   

4.

Aims

To analyze the role of serum miR-125b-5p in reflecting liver damage and predicting outcomes in chronic hepatitis B (CHB) patients with acute-on-chronic liver failure (ACLF).

Methods

CHB patients with normal hepatic function (n?=?100), moderate-to-severe liver damage (n?=?90), and ACLF (n?=?136) were included. Among hepatitis B virus (HBV)-ACLF patients, 86 and 50 were in the training and validation cohorts, respectively. Serum miR-125b-5p level was measured by quantitative real-time PCR.

Results

Serum miR-125b-5p level increased with disease progression, and serum miR-125b-5p level was lower in surviving than in dead HBV-ACLF patients. Among HBV-ACLF patients, miR-125b-5p positively correlated with total bilirubin (TBil; r?=?0.214, p?<?0.05) and model for end-stage liver disease (MELD) score (r?=?0.382, p?<?0.001) and negatively correlated with prothrombin activity(PTA; r?=??0.215, p?<?0.05). MiR-122 showed a contrasting performance compared with miR-125b-5p. Cox regression analysis showed that miR-125b-5p, miR-122, and PTA were independent survival predictors for HBV-ACLF, and low miR-125b-5p and high miR-122 levels may predict a longer survival in HBV-ACLF. MiR-125b-5p (AUC?=?0.814) had a higher performance for survival prediction in HBV-ACLF compared with miR-122 (AUC?=?0.804), PTA (AUC?=?0.762), MELD score (AUC?=?0.799), and TBil (AUC?=?0.670) alone; predictive effectiveness of miR-125b-5p was increased by combination with miR-122 (AUC?=?0.898). MiR-125b-5p was an effective predictor of HBV-ACLF outcomes in the validation cohort.

Conclusions

MiR-125b-5p increase is associated with severity of liver damage; high serum miR-125b-5p may serve as a predictor for poor outcomes in HBV-ACLF cases.  相似文献   

5.

Background

Sigmoid volvulus is a common cause of colonic obstruction in old and frail patients. Its standard management includes the endoscopic detorsion of the colonic loop, followed by an elective sigmoidectomy to prevent recurrence. However, these patients are often poor candidates for surgery.

Aim

The aim of this study was to compare death rate between elective sigmoidectomy and conservative management following endoscopic detorsion for sigmoid volvulus.

Methods

The medical records of 83 patients undergoing endoscopic detorsion of a sigmoid volvulus from 2008 to 2014 were retrospectively reviewed. Patients were divided into two groups: ‘elective surgery’ and ‘no surgery’.

Results

Patients in the ‘no surgery’ group (n?=?42) were older and had more loss of autonomy than in the ‘elective surgery’ group. Volvulus endoscopic detorsion was successful in 96% of patients with no complications. The median follow-up was 13 months (1 day-67 months). The death rate was 62% in the ‘no surgery’ group versus 32% in the ‘elective surgery’ group (p?=?0.02). In the ‘no surgery’ group, 23/42 of patients had volvulus recurrence. No recurrence occurred after surgery.

Conclusion

Elective surgery must be planned as soon as possible after the first episode of sigmoid volvulus. In frail patients, other options must be developed.  相似文献   

6.

Backgound

A significant proportion of hepatitis B surface antigen (HBsAg) negative/anti-hepatitis B core antigen (anti-HBc) positive patients with non-Hodgkin lymphoma (NHL) undergoing rituximab-based chemotherapy (R-CT) may suffer hepatitis B virus (HBV) reactivation.

Aims

We wanted to assess efficacy and safety of lamivudine (LMV) prophylaxis to prevent this complication.

Methods

Eighty-five consecutive HBsAg negative/anti-HBc positive NHL patients (71 years, 100% serum HBV DNA undetectable, 74% anti-HBs positive) received LMV coadministered with R-CT and for 18 months after the end of R-CT. Serum ALT, HBsAg, anti-HBs and HBV DNA were assessed every 4 months during and after end of LMV.

Results

During 39 (2–108) months of study period, including 21 months of LMV and 27 additional months after LMV discontinuation, one patient (2%) had HBV reactivation, 31 months after stopping LMV and during administration of new immunosuppressive regimens, without LMV prophylaxis, owing to incomplete oncological response. A 50% decline of anti-HBs titers occurred in 22/63 (35%) patients, including 12 who became anti-HBs seronegative. Five (6%) patients had ALT increase during R-CT but none required R-CT discontinuation. Seventeen (20%) patients died, all for tumour progression.

Conclusion

LMV prophylaxis is safe and effective in preventing HBV reactivation in HBsAg negative/anti-HBc positive NHL patients receiving R-CT.  相似文献   

7.

Background

Autoimmune liver disease (AILD) includes autoimmune hepatitis (AIH) and autoimmune sclerosing cholangitis (ASC). AILD is often associated with other extra-hepatic immune-mediated disorders (EDs), but there are few pediatric studies available to date. In this study we evaluated the association between AILD and EDs in our pediatric series.

Methods

In this single centre retrospective study 48 patients (39 AIH and 9 ASC children) were evaluated. Thirty-six children were primarily referred to our Centre for liver disease suspicion, while the remaining twelve had a previous diagnosis of EDs. All the patients were screened for various EDs at AILD diagnosis and yearly during the follow-up.

Results

Mean duration of follow-up was 9?years and 1 month. Twenty-two (46%) patients had a diagnosis of EDs. Ulcerative colitis (UC) was the most frequent EDs (9 patients), followed by autoimmune thyroid disease (5 patients) and celiac disease (5 patients). In 7 out of 9 UC patients, ASC was present.

Conclusions

Our study showed a high association (46%) between AILD and EDs. In particular, in 8 out of 9 ASC patients UC was diagnosed (p-value 0.007). It is important to look for EDs in AILD children and, conversely, AILD in EDs children with abnormal liver function tests.  相似文献   

8.

Background

Although very common in Western countries, poor epidemiological data on diverticular disease (DD) is available from the family practice.

Aims

To evaluate the behavior of Italian General Practitioners (GPs) on approaching DD.

Methods

Health Search Database was analyzed retrospectively.

Results

On a population of 975,523 individuals, 33,597 patients had a registered diagnosis of DD (“lifetime” prevalence?=?3.4%, M?=?3.2%, F?=?3.7%; higher values are found in females over-65?years old; low rates of complications: diverticulitis?=?0.3%, bleeding?=?0.002%). As risk factors, NSAIDs and ASA were taken by 14.8% and 26.5% respectively, opioids by 7.5%, corticosteroids by 5.2%; as protective factors, 30.4% were under statins and 17.7% under calcium-antagonists. Approximately 13% of patients were referred to specialists. Colonoscopy and abdominal CT were prescribed to 48.5% and to 13% of already diagnosed patients. Among DD sufferers, 27% experienced hospitalization, but only 3.4% of cases were for a DD-linked problem. Treatment included rifaximin (61%), mesalazine (14.7%), probiotics (12.4%), ciprofloxacin (7.6%).

Conclusion

DD has a large impact in general practice with a higher prevalence in the elderly. GPs are required to pay particular attention to risk factors both for disease development and for its complications in order to reduce the costs deriving from diagnostic procedures, referral and hospitalization.  相似文献   

9.

Background

Despite the improvement of medical therapies, nearly half of patients with Crohn’s disease require surgery within 10?years after diagnosis. However, intestinal resection is not curative and recurrence may occur.

Aims

To evaluate post-surgical outcomes for patients with Crohn’s disease in a large monocentric cohort, and to identify variables associated with clinical and surgical relapse.

Methods

Patients with Crohn’s disease who had surgery for ileal and colonic Crohn’s disease between 2004 and 2016 and on at least one-year follow-up following surgery were included.

Results

One hundred ninety-three patients were included in the study. Crohn’s disease recurrence concerned 53% of patients after a median 56-month (6–158) follow-up and 29% of patients required a second surgical intervention. At logistic regression analysis, active smoking and young age at diagnosis were identified as independent risk factor for post-surgical relapse (p?=?0.01), while colonic or ileocolonic resection was recognized as a risk factor for surgical Crohn’s disease relapse (p?=?0.003).

Conclusions

Post-surgery recurrence is frequent for patients with Crohn’s disease. Active smoking and young age at diagnosis are risk factors for Crohn’s disease recurrence. As compared with patients undergoing small-bowel surgery, patients with colonic resection are proner to relapse requiring a second surgical intervention.  相似文献   

10.

Introduction and aim

The transitional process of young patients affected by inflammatory bowel disease from pediatric to adult care is a crucial step. Our study aimed to investigate the 1-year success outcome of this transitional process.

Methods

From 2013 to 2018, we evaluated the transitional process of patients with Crohn’s disease or ulcerative colitis. For each patient, the following parameters 12 months before and 12 months after the transition were evaluated: Body Mass Index, disease activity and smoker status, number of outpatient visits and the pharmacological therapy, the number of disease exacerbations, hospitalizations and surgical interventions.

Results

We enrolled 106 patients with IBD. No statistically significant difference was found between patients’ Body Mass Index before and after transition. There was a significant reduction in the number of exacerbations and hospitalizations in the 12 months post-transition (pre-transition exacerbations: 0.74?±?0.79, post-transition exacerbations: 0.35?±?0.57, p?<?0.001; pre-transition hospitalizations: 0.28?±?0.44, post-transition hospitalizations: 0.1?±?0.3, p?<?0.001). In contrast, there was no significant difference in the number of outpatient visits (3.40?±?1.4 vs 3.25?±?1.2; p?=?ns) and of patients undergoing surgery (0.9% vs 1.8%, p?=?ns).

Conclusion

The parameters used as success indicators of the transition program confirm the achievement of continuity of care from Pediatrics to adult Gastroenterology, in a critical phase of the natural history of IBD patients.  相似文献   

11.

Background

We aimed to identify the main determinants of long-term overall survival (OS), including virologic control, and recurrence after radiofrequency ablation (RFA) of hepatocellular carcinoma (HCC) on cirrhosis.

Methods

Cirrhotic patients treated by RFA for HCC within Milan criteria were included. Associations between patient features and events were estimated by the Kaplan–Meier method with the log rank test and using uni/multivariate Cox models.

Results

389 cirrhotic patients (Child–Pugh A 86.6%, 473 tumors) were included. OS was 79.8%, 42.4% and 16%, and overall tumor recurrence 45%, 78% and 88% at 2, 5 and 10 years, respectively. In multivariate analysis, age, Child–Pugh, GGT, HCC near major vessels, esophageal varices, alkaline phosphatase and HBV predicted OS. Gender, ALT, AFP and alcohol intake were associated with tumor recurrence. Multinodular HCC (19.5%) was associated with risk of tumor recurrence outside Milan criteria. HBV patients had longer OS than other patients (P?=?0.0059); negative HBV PCR at RFA was associated with decreased tumor recurrence (P?=?0.0157). Using time-dependent analysis in HCV patients, a sustained virologic response was associated with increased OS (124.5 months) compared to other patients (49.2 months, P?<?0.001).

Conclusion

Virologic response and severity of underlying liver disease were the main determinants of long-term OS after RFA for HCC developing on cirrhosis.  相似文献   

12.

Background

The current definitions and etiologies of acute-on-chronic liver failure (ACLF) are clearly very different between East and West.

Aims

This study aimed to develop an effective prognostic nomogram for acute-on-chronic hepatitis B liver failure (ACHBLF) as defined by the Asia Pacific Association for the Study of the Liver (APASL).

Methods

The nomogram was based on a retrospective study of 573 patients with ACHBLF, defined according to the APASL, at the Beijing Ditan Hospital. The results were validated using a bootstrapped approach to correct for bias in two external cohorts, including an APASL ACHBLF cohort (10 hospitals, N?=?329) and an EASL-CLIF ACHBLF cohort (Renji Hospital, N?=?300).

Results

Multivariate analysis of the derivation cohort for survival analysis helped identify the independent factors as age, total bilirubin, albumin, international normalized ratio, and hepatic encephalopathy, which were included in the nomogram. The predictive value of nomogram was the strongest compared with CLIF-C ACLF, MELD and MELD-Na and similar to COSSH-ACLF in both the derivation and prospective validation cohorts with APASL ACHBLF, but the CLIF-C ACLF was better in the EASL-CLIF ACHBLF cohort.

Conclusions

The proposed nomogram could accurately estimate individualized risk for the short-term mortality of patients with ACHBLF as defined by APASL.  相似文献   

13.

Background

Symptomatic bradycardia has been reported in adults treated for chronic hepatitis C using sofosbuvir based regimens.

Aim

We studied the cardiac safety of sofosbuvir/ledipasvir in Egyptian children, treated for chronic hepatitis C.

Methods

The study included 40 hepatitis C virus infected children and adolescents 12–17 years old, using the combination of sofosbuvir (400?mg)/ledipasvir (90?mg) in a single oral tablet (Harvoni) taken daily for 12 weeks. All subjects underwent a baseline standard 12-lead surface Electrocardiography that was repeated at 4 and 12 weeks of therapy. Electrocardiography parameters (Heart Rate, RR interval, PR interval, QRS, QT interval, corrected QT interval, QT dispersion, JT interval, corrected JT interval, JT dispersion, Tpeak-Tend interval) were compared at the 3 different time points during antiviral therapy.

Results

No symptoms related to the cardiovascular system were reported during treatment. There were no cases of symptomatic bradycardia/syncope. Heart rate was noted to be significantly lower and RR and QT intervals were significantly longer in the baseline electrocardiography. Heart rate was significantly lower and RR interval was significantly longer in patients with higher viral load.

Conclusion

No adverse cardiovascular events were observed in this group of HCV infected children and adolescents treated with sofosbuvir/ledipasvir. None of the patients developed bradyarrhythmias during treatment.  相似文献   

14.

Background and aims

Lynch syndrome (LS) is associated with an increased risk of small bowel tumors but routine screening is not recommended in international guidelines. The aim of our study was to determinate the prevalence of duodenal tumors in a French cohort of LS patients.

Methods

Patients carrying a germline pathogenic variant in a MMR gene, supported by our local network, in which at least one upper endoscopy had been performed, were included. We registered the occurrence of duodenal lesions in those patients.

Results

154 LS patients were identified including respectively 85 MSH2 and 41 MLH1 mutated patients respectively. Seven out of 154 (4.5%) had at least one duodenal lesion. Median age at diagnosis was 58 years (range: 49–73). The twelve lesions locations were: descending duodenum (n?=?7), genu inferius (n?=?2), duodenal bulb (n?=?1), ampulla (n?=?1), fourth duodenum (n?=?1). Three lesions were invasive adenocarcinomas. The incidence rate of duodenal lesions in patients with MSH2 or MLH1 pathogenic variants was respectively 7.1% (6 out of 85) and 2.4% (1 out of 41) emphasizing a trend toward increased risk of developing duodenal lesion in MSH2 mutated patients: OR: 5.17, IC95% (0.8–60.07), p?=?0.1307.

Conclusion

Regarding this high prevalence rate, especially in MSH2 patients, regular duodenal screening during upper endoscopy should be considered in routine in LS patients.  相似文献   

15.

Background

The long-term management of perianal Crohn’s disease for patients on anti-TNF-α therapy remains challenging.

Aim

To evaluate the long-term course and complications of patients with perianal fistulas treated with anti-TNF-α based on their clinical remission and healing on MRI.

Methods

Patients were evaluated clinically and by MRI. Deep remission was defined as clinical remission associated with the absence of contrast enhancement and T2 hyperintensity on MRI. Flare-free survival, surgery and hospitalizations were compared based on the presence or not of deep remission.

Results

Forty-eight consecutive patients were included with a median follow-up of 62?months after anti-TNF-α first administration. Deep remission was observed in 16 patients (33.4%). For patients in deep remission, the median time to any perianal event was 116?months (95–130) versus 42?months (8–72) in patients with pathological MRI (p?<?0.001). Sixteen patients (50%) with pathological MRI had perianal surgery versus 2 (12.5%) in the deep remission group (p?<?0.05). The mean duration of cumulative hospital stays was 0.75?±?0.52?days in the deep remission group versus 19.7?±?7.4 in the pathological group (p?<?0.05).

Conclusions

Higher flare-free survival and lower rates of surgery and hospitalization were found in patients achieving deep remission.  相似文献   

16.

Background

Gastric cancer is sometimes complicated by obstructive jaundice. However, ERCP may be challenging in patients who have advanced gastric cancer, or recurrent gastric cancer after surgical resection that is complicated by obstructive jaundice. In such cases, percutaneous transhepatic biliary drainage (PTBD) is considered. Recently, EUS-guided biliary drainage (EUS-BD) has been developed. We conducted a retrospective study to compare the efficacy of EUS-BD and PTBD in patients with obstructive jaundice due to gastric cancer.

Methods

Patients with gastric cancer complicated with obstructive jaundice who were contraindicated for standard ERCP were enrolled.

Results

A total of 47 consecutive patients were enrolled during the study period. The technical success rates of PTBD and EUS-BD were 88.9% (16/18) and 96.7% (29/30), respectively (P?=?0.64). The stent patency period, including patient death was equivalent between the two groups (EUS-BD vs. PTBD: 188.4?days vs. 200.9 days, P?=?0.974). Time to stent dysfunction in the EUS-BD group (391.1 days) was not significantly different as compared to that in the PTBD group (398.1?days) (P?=?0.78). Adverse events were relatively severe in the PTBD group.

Conclusions

Given the relative severity of adverse events in the PTBD group, EUS-BD might be the procedure of choice for gastric cancer patients with contraindications by inability to perform ERCP.  相似文献   

17.

Background

Despite the dramatic improvement in viral eradication rates that has been reached with direct antiviral agents (DAAs), the real benefit of viral eradication after DAAs on hepatocellular carcinoma (HCC) development is still controversial.

Aim

To prospectively assess the risk of HCC occurrence and early recurrence in a large cohort of DAA-treated HCV-cirrhotic patients and to identify potential predictors of HCC development.

Methods

We analyzed data prospectively collected from 1927 consecutive HCV-infected cirrhotic patients treated with DAA from January to December 2015 in 10 tertiary liver centers in Italy and followed-up for one year after therapy. 161 patients had a previous HCC.

Results

38/161 subjects developed tumor recurrence during the follow-up (recurrence rate?=?24.8 per 100-year), patients with SVR had a significantly lower rate of recurrence. Lack of SVR and alpha-fetoprotein (AFP) were independent predictors of HCC recurrence. 50/1766 patients without a previous HCC history developed HCC during follow-up (incidence rate?=?2.4 per 100-year). Lack of SVR was the strongest predictor of HCC development. Furthermore, patients with SVR and no stigmata of portal hypertension have a lower incidence rate of HCC (1.0 per 100-year).

Conclusions

SVR is associated with a significant decrease of recurrent or de novo HCC. Baseline AFP and signs of portal hypertension can help to stratify the risk of HCC.  相似文献   

18.

Background

Anti-TNF therapies infliximab (IFX), adalimumab (ADA), and golimumab (GOL) are approved for treating moderate to severe ulcerative colitis (UC). In UC, only the switch from IFX to ADA has been investigated, reaching no more than 10–43% remission rates at 12 months.

Aim

Of the present study was to investigate disease outcome after a switch from subcutaneous (SC) agents to the intravenous (IV) agent (IFX).

Methods

In this retrospective multicentre study, we analysed the charts of UC patients unresponsive/intolerant or with secondary loss of response (LOR) to ADA or GOL who were switched to IFX. We evaluated clinical response and remission together with adverse events at 3, 6, and 12 months follow-up.

Results

Seventy-six patients were included; 38 patients started ADA and 38 started GOL for a mean therapy duration of 6?±?6 months. Indications for switch were adverse events in 3%, primary failure in 79%, and LOR in 18% of patients. Clinical remission was reached by 47%, 50%, and 77% of patients, respectively. Patients that switched for LOR did numerically, but not statistically, better than patients who switched for primary failure.

Conclusions

Our data show a superior remission rate in SC to IV anti-TNF switch in UC compared to the IV to SC switch reported in literature.  相似文献   

19.

Background

Till now, pooled data about the safety and efficacy of different direct-acting antiviral (DAAs) regimens in different renal situations are still under evaluation.

Aim

To evaluate a real-life experience of the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus ribavirin (OBV/PTV/r plus RIB) in patients with end-stage kidney disease (ESKD).

Patients and methods

Between January 2017 and January 2018, an open-label multicenter prospective study was designed to enroll all consecutive patients with proven CHC genotype 4 infections and concomitant ESKD based on estimated glomerular filtration rate (eGFR) with (HD group) or without hemodialysis (non-HD group). Patients were given a co-formula of OBV/PTV/r (25/150/100?mg) once-daily plus RIB was given for 12?weeks. Sustained virologic response (SVR 12) was the primary endpoint.

Results

A total of 110 patients were enrolled. An overall SVR 12 was reported in 104 (94.5%) patients, and treatment failure were reported in 6 patients [2 patients (1.8%) were relapsed, and 4 patients (3.6%) patients were non-responders]. SVR12 was 96% in HD and 91.4% in non-HD patients (P?=?0.286).There were no reported serious adverse events. Anemia was reported in 66.6% (n?=?50) in HD group and in 31.4% (n?=?11) in non-HD group.

Conclusion

Although it is still challenging, achievement of SVR12 in patients with chronic HCV and concomitant end-stage kidney disease in the era of DAAs became possible with a 12?weeks course of a co-formula of ombitasvir/paritaprevir /ritonavir plus ribavirin.

ClinicalTrials.gov ID

NCT03341988.  相似文献   

20.

Introduction

Combination of cisplatine and Gemcitabine (CisGem) is the reference 1st line Chemotherapy in patients with advanced biliary cancer. FOLFIRINOX demonstrated an overall survival superiority when compared to gemcitabine in 1st line for patients with metastatic pancreatic adenocarcinoma. Because of similarities between pancreatic and biliary cancers, we proposed a randomized trial comparing mFOLFIRINOX and CisGEm.

Aim

PRODIGE38-AMEBICA is a phase II/III trial evaluating efficacy of modifed FOLFIRINOX (D1 bolus removed) or CisGEm on patients with locally advanced non resectable or metastatic biliary tract cancer.

Patients and methods

Main inclusion criteria are histologically or cytologically proven biliary tract tumor (intra or extra hepatic or hilar or gallbladder carcinoma), measurable disease (metastases and/or primary tumor), Bilirubin <1,5?N and transaminases <5?N. The randomization (ratio 1:1) will be stratified on center, stage of the disease, tumor localization and previous adjuvant treatment. The Phase II trial has an objective of 73% patients alive and without progression at 6?months for Folfirinox (versus 59% for Gemcis). 128 additional patients should be added in the phase III trial with an objective of overall survival improvement of 4?months in favor of mFOLFIRINOX.

Conclusion

The study is opened in France (EudraCT no.: 2015-002282-35). All the patients (188) of the phase II part are currently randomized.  相似文献   

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