Real-life pilot study on the impact of the telemedicine platform EasyMICI-MaMICI® on quality of life and quality of care in patients with inflammatory bowel disease.

BACKGROUND: Telemedicine has shown promising results in the follow up of patients with inflammatory bowel disease. This study compared quality of life and disease activity in patients with inflammatory bowel disease monitored using a telemedicine platform versus standard care. METHODS: In this prospective multicenter study, patients with active inflammatory bowel disease were randomized to EasyMICI-MaMICI® telemedicine platform or standard care. The main objective was to assess the efficacy of the software platform, as measured by quality of life and quality of care. Secondary outcomes were changes in the use of healthcare resources, and patient satisfaction in the MaMICI group. RESULTS: Fifty-four patients were enrolled (November 2017-June 2018); 59.3% had Crohn's disease and 40.7% ulcerative colitis. Forty-two patients received biologics at inclusion. After 12 months, a significant improvement in quality of life was observed with MaMICI versus standard care, with mean (standard deviation) changes from baseline of 14.8 (11.8) vs 6.3 (9.7) in the SIBDQ scores and 18.5 (18.7) vs 2.4 (8.3) in the EuroQol 5 D-3L questionnaire scores (both p ≤ .02). Disease activity was similar in both treatment groups. Use of MaMICI slightly reduced healthcare utilization versus controls (mean gastroenterologist consultations 2.2 vs 4.1; p = .1308). Overall satisfaction with MaMICI was high (mean score 7/10), and 46.2% of remaining patients in the MaMICI group continued to use the platform until 12 months. CONCLUSION: Significant improvement in quality of life and overall satisfaction with this telemedicine platform, indicates that further evaluation of EasyMICI-MaMICI in larger numbers of patients with inflammatory bowel disease is warranted.

Evolution of Hepatitis C Virus Treatment During the Era of Sofosbuvir-Based Therapies: A Real-World Experience in France.

BACKGROUND: Treatment of hepatitis C virus (HCV) has been dramatically improved with the introduction of direct-acting antiviral agents (DAAs). Universal access to pangenotypic DAAs was provided in France from 2017, expanding the type of patients treated. Real-world studies are important to confirm effectiveness and safety in clinical practice, particularly in vulnerable populations. AIMS: To assess real-world effectiveness and safety of sofosbuvir-based therapy in adults with chronic HCV infection before and after universal access to DAAs in France. METHODS: This multicenter, non-interventional, prospective study assessed the effectiveness, safety, patient-reported outcomes and adherence with sofosbuvir-based regimens from October 2015 to July 2016 (Period 1: sofosbuvir-based therapy excluding sofosbuvir/velpatasvir) and from October 2017 to July 2018 (Period 2: pangenotypic sofosbuvir/velpatasvir-based therapy). RESULTS: Baseline data were documented for 1029 patients. Overall, 797 (77%) had sustained virologic response data available ≥ 9 weeks after treatment completion. Per protocol response was high (97%) irrespective of age, alcohol consumption, recreational drug use, or HIV/HCV coinfection. Adverse events occurred in approximately 25% of patients with the majority experiencing Grade 1 or 2 events. Sofosbuvir-based regimens improved health-related quality of life from baseline to end of treatment in patients with data at all timepoints. Overall, 99% of patients reported total or almost total adherence to therapy. CONCLUSIONS: Sofosbuvir-based therapy, including pangenotypic sofosbuvir/velpatasvir, is effective for the treatment of HCV in real-world clinical practice. This is an important step towards HCV elimination.

Endoscopic Kehr's T-Tube Placement to Treat Persistent Large Gastro-cutaneous Fistula After One Anastomosis Gastric Bypass: Video Demonstration.

BACKGROUND: We aim to show the endoscopic placement of a T-tube to treat a persistent large gastro-cutaneous fistula after OAGB. METHODS: We present the case of a 46-year-old woman with BMI of 48 kg/m2, who underwent OAGB and was re-operated on the 2nd postoperative day (POD) for leakage. Washing and drainage of the abdominal cavity was performed, and no fistulous orifice was identified. An upper gastrointestinal (GI) endoscopy was performed at POD 20 for the persistence of leakage of 150 ml/day by the drain and a gastric fistulous orifice of 2 cm was detected. RESULTS: At POD 22, under general anesthesia, upper GI endoscopy was performed and a T-tube was placed in the fistulous orifice with a "rendez-vous" technique (as demonstrated in the Video), placing the T branch in the digestive lumen pressed against the wall and the long part of the T exiting at the cutaneous orifice. The T-tube was clamped after 3 days and the patient could be gradually re-fed. The patient was discharged 8 days after the procedure, with perfect clinical tolerance and no complications. The ablation of the tube one was performed on POD 84. No relapse occurred during a follow-up of 48 months. CONCLUSION: Persistent large gastro-cutaneous fistulas with an orifice bigger than 1 cm in diameter are difficult to manage. The endoscopic placement of a T-tube seems a useful option, which may facilitate the healing of the fistula. Further studies are needed to better define the role of this procedure.

Treatment of Persistent Large Gastrocutaneous Fistulas After Bariatric Surgery: Preliminary Experience with Endoscopic Kehr's T-Tube Placement.

PURPOSE: Post-bariatric surgery gastrocutaneous fistula is a chronic leak with an incidence of 1.7 to 4.0% and no standardized management. A large gastrocutaneous fistula (LGCF) is not indicated for treatment with pigtail drains. We aimed to evaluate results of a novel treatment using endoscopic Kehr's T-tube placement. METHODS: Only patients with a postoperative LGCF duration of > 10 days and a flow rate of > 50 cc by external drainage after revisional surgery for sepsis were included. Endoscopic placement of Kehr's T-tube was performed. Patients had been reoperated with wash and drainage for severe sepsis after initial bariatric surgery in which no fistula had been discovered. Patients not reoperated, or with a fistula requiring intraoperative Kehr's T-tube placement, or a pigtail drain were excluded. Primary outcomes were endoscopic characteristics and results (LGCF closure rate, Kehr T-tube retention time, etc.). RESULTS: The study group included 12 women, 2 men; body mass index 43.1 ± 4.5 kg/m2. Interventions were SG (7), RYGB (2), OAGB (4), and SADI-S (1). Endoscopic assessment was carried out after a mean of 33.2 ± 44.3 days after the bariatric procedure. The mean fistula orifice diameter was 2.0 ± 0.9 cm. Kehr's T-tube was positioned at a mean 51.5 ± 54.8 days after the bariatric procedure. T-tube tolerance was excellent. Mean additional days: hospitalization, 34.4 ± 27.0; T-tube retention, 86.4 ± 73.1; fistula healing, 139.9 ± 111.5, LGCF closure rate, 92.9%. COMPLICATIONS: 1 pulmonary embolism, 2 T-tube migrations,1 drain-path bleed, 1 skin abscess. No mortality. CONCLUSIONS: Endoscopic Kehr's T-tube placement was successful in closing persistent post-bariatric surgery LGCF in 92.9% of patients.

Safety and efficacy of combination therapy with peginterferon alfa-2a (40kD) and ribavirin in the outpatient setting: prospective analysis of 197 patients with chronic hepatitis C viral infection.

OBJECTIVES: Combination therapy using peginterferon alfa-2a (40 kD) plus ribavirin achieves viral eradication in nearly 60% of patients with chronic hepatitis C viral infection. However, because of the numerous side effects, use of the combination regimen might be restricted for patients consulting private practitioners specialized in hepatogastroenterology. PATIENTS AND METHOD: Conducted in this specific context, this prospective clinical trial investigated the safety and efficacy of combination therapy in 197 patients. Therapy was given in compliance with the recommendations of the French consensus conference on hepatitis C treatment. RESULTS: Commonly reported adverse effects were noted in 90% of patients, most occurring during the first three months, with a stable prevalence thereafter and resolution after treatment end. The most frequent adverse events were asthenia (35 to 37.5% according to the treatment group pruritus (25 to 26.3%) and flu-like syndrome (19 to 21.7%). A depressive syndrome was reported in 20 to 21% of patients. Grade 4 neutropenia was exceptional and never led to severe infections. At intent-to-treat analysis, the rate of sustained virological response was 54.8% for the entire population. It was 71.1% for patients with genotypes 2 or 3 (mainly treated for 24 weeks) and 44.6% for patients with genotype 1 (all treated 48 weeks). CONCLUSION: The characteristic features of combination therapy observed in the context of private hepatogastroenterology consultations are similar to those observed in randomized clinical trials.

[Assessment of quality of life in chronic hepatitis C: effect of treatment]. / Evaluation de la qualité de vie au cours de l'hépatite chronique C: influence du traitement.

OBJECTIVES: To study Quality of Life during chronic hepatitis C infection in patients recruited by hospital-based- or private hepatologists and to assess the effect of antiviral therapy. METHODS: A self-administered quality of life questionnaire (SF36) was proposed before, during, and 6 months after the end of treatment. The quality of life scales were assessed according to treatment response. RESULTS: 599 patients filled in the questionnaire before treatment and 168 patients 6 months after the end of treatment. After 6 months of therapy, patients with treatment response (n=54) showed increased scores in all SF-36 scales, this increase reaching more than 25% for "Role Physical", "General Health Perception" and "Vitality" scores. Non-responders (n=70) had an impairment of physical scores but a general improvement of Mental Health. CONCLUSION: This study confirms that sustained virological response is associated with an improved quality of life in hepatitis C patients. However, non-responders still have a positive "General Health Perception". Together with the development of new therapies, these observations could help to convince reluctant patients to be treated.

Telaprevir- and boceprevir-based tritherapies in real practice for F3-F4 pretreated hepatitis C virus patients.

AIM: To assess, in a routine practice setting, the sustained virologic response (SVR) to telaprevir (TPV) or boceprevir (BOC) in hepatitis C virus (HCV) null-responders or relapsers with severe liver fibrosis. METHODS: One hundred twenty-five patients were treated prospectively for 48 wk with TPV or BOC + pegylated-interferon (peg-INF) α2a + ribavirin (PR) according to standard treatment schedules without randomization. These patients were treated in routine practice settings in 10 public or private health care centers, and the data were prospectively collected. Only patients with severe liver fibrosis (Metavir scores of F3 or F4 upon liver biopsy or liver stiffness assessed by elastography), genotype 1 HCV and who were null-responders or relapsers to prior PR combination therapy were included in this study. RESULTS: The Metavir fibrosis scores were F3 in 35 (28%) and F4 in 90 (72%) of the patients. In total, 62.9% of the patients were null-responders and 37.1% relapsers to the previous PR therapy. The overall SVR rate at 24 wk post-treatment withdrawal was 59.8%. The SVR was 65.9% in the TPV group and 44.1% in the BOC group. Independent predictive factors of an SVR included a response to previous treatment, relapsers vs null-responders [OR = 3.9; (1.4, 10.6), P = 0.0084], a rapid virological response (RVR) [OR 6.9 (2.6, 18.2), P = 0.001] and liver stiffness lower than 21.3 kPa [OR = 8.2 (2.3, 29.5), P = 0.001]. During treatment, 63 patients (50.8%) had at least one severe adverse event (SAE) of grade 3 or 4. A multivariate analysis identified two factors associated with SAEs: female gender [OR = 2.4 (1.1, 5.6), P = 0.037] and a platelet count below 150 × 10(3)/ mm(3) [OR = 5.3 (2.3, 12.4), P ≤ 0.001]. CONCLUSION: More than half of these difficult-to-treat patients achieved an SVR and had SAEs in an actual practice setting. The SVR rate was influenced by the response to previous PR treatment, the RVR and liver stiffness.

Longitudinal liver stiffness assessment in patients with chronic hepatitis C undergoing antiviral therapy.

BACKGROUND/AIMS: Liver stiffness (LS) measurement by means of transient elastography (TE) is accurate to predict fibrosis stage. The effect of antiviral treatment and virologic response on LS was assessed and compared with untreated patients with chronic hepatitis C (CHC). METHODS: TE was performed at baseline, and at weeks 24, 48, and 72 in 515 patients with CHC. RESULTS: 323 treated (62.7%) and 192 untreated patients (37.3%) were assessed. LS experienced a significant decline in treated patients and remained stable in untreated patients at the end of study (P<0.0001). The decline was significant for patients with baseline LS ≥ 7.1 kPa (P<0.0001 and P 0.03, for LS ≥ 9.5 and ≥ 7.1 kPa vs lower values, respectively). Sustained virological responders and relapsers had a significant LS improvement whereas a trend was observed in nonresponders (mean percent change -16%, -10% and -2%, for SVR, RR and NR, respectively, P 0.03 for SVR vs NR). In multivariate analysis, high baseline LS (P<0.0001) and ALT levels, antiviral therapy and non-1 genotype were independent predictors of LS improvement. CONCLUSIONS: LS decreases during and after antiviral treatment in patients with CHC. The decrease is significant in sustained responders and relapsers (particularly in those with high baseline LS) and suggests an improvement in liver damage.