Introduction: Ledipasvir/Sofosbuvir (LDV/SOF) single tablet regimen (STR) is approved for the treatment of chronic hepatitis C (CHC) patients. The ION-3 study showed that 8 weeks (8w) of LDV/SOF treatment was non-inferior to 12 weeks in previously untreated GT1 patients without cirrhosis with no additional benefit of adding ribavirin (RBV). According to the U.S label, 8w may be considered in this population who have a pre-treatment HCV RNA of < 6 million (M) IU/mL. The aim of this analysis is to characterise the population receiving 8w LDV/SOF and to describe outcomes in clinical practice. Methods: CHC patients treated with 8w LDV/SOF in a single centre in Germany, and for whom Sustained Virologic Response after 12 weeks of follow-up (SVR12) will be available in June, were included in the analysis. Baseline characteristics, prior treatment history, safety and effectiveness were investigated. The analysis was performed using descriptive statistics. Results: 46 patients met the inclusion criteria for this analysis. These patients initiated 8w treatment with LDV/SOF between 11/24/2014 to 01/27/2015. No patient had RBV added to the LDV/SOF STR. The mean (SD) age was 50.9 (12.4) years and 56.5% were males. The genotype distribution was 52%, 44% and 4% for GT1a, GT1b and GT4, respectively. At entry, 98% of patients had no cirrhosis, one patient had compensated cirrhosis. The METAVIR stage distribution of non-cirrhotic patients at baseline was 39.1%, 32.6%, 19.6% and 8.7% for F0, F1, F2 and F3, respectively. Median (range) HCV RNA at baseline was 5.86 (Q1-Q3 5.38-6.22; Min-Max 3.74-6.67) log10 IU/ml, no patient had HCV RNA ≥ 6M IU/mL. No patient was HIV co-infected and one patient was HBV co-infected. Overall, 98% of the patients were treatment-naïve. One patient had relapsed after previous IFN/RBV therapy. At baseline, co-morbidities were reported in 93% of patients, with depression (16%) and arterial hypertension (16%) being most common. To date, no discontinuations or relevant Adverse Drug Reactions have been observed. SVR4 was 100%, complete SVR12 results, adverse event and discontinuations data will be presented. Conclusion: 8w LDV/SOF was predominantly prescribed according to the U.S Prescribing Information for treatment-naïve, non-cirrhotic CHC patients with HCV RNA < 6M IU/mL at baseline. Preliminary results indicate that LDV/SOF is a safe, well tolerated treatment option with no adverse drug reactions or discontinuations reported so far.
ABSTRACT Background: Surgery plays an important role in the management of ulcerative colitis. Despite its curative intent, complications of the procedure are common and can have significant consequences to patients and care providers. We reviewed outcomes and rates of colectomy and its complications in ulcerative colitis (UC) patients in clinical practice. Materials and methods: MEDLINE, MEDLINE In-Process, Embase and Cochrane databases were searched for observational studies (January 2006–May 2017) reporting outcomes of surgery in moderate to severe UC in European countries. Studies were included if they reported colectomy rates, complications rate, predictors of colectomy and change in diagnosis in ulcerative colitis at the time of surgery. Results: 114 publications reporting either colectomy rates, postoperative complications or predictors of colectomy were identified. The overall rate of surgery from treatment initiation was reported in 20 articles and varied from 6% to 56% (follow-up time from 0.5 to 9 years). Early complications (≤30 days post-operatively) occurred in 0%–53% of patients undergoing surgery and late complications (>30 days post-operatively) occurred in 3.20%–58%. The common complications reported after colectomy (proctocolectomy or ileal pouch-anal anastomosis) were bowel obstruction, infectious complications and pouch-related complications (pouchitis, pouch failure). Three factors were found to be significant predictors of colectomy: a severe disease at baseline, being resistant to steroids and being frequently hospitalised. Conclusion: Colectomy rates vary widely among ulcerative colitis patients depending on type of patients (moderate, severe, refractory) and to patient's previous medical therapies. Surgery is still associated with a range of short and long term complications which might represent a source of burden in terms of cost and quality of life. Highlights:
New interferon (IFN)-free treatments for hepatitis C are more effective, safer but more expensive than current IFN-based therapies. Comparative data of these, versus current first generation protease inhibitors (PI) with regard to costs and treatment outcomes are needed. We investigated the real-world effectiveness, safety and cost per cure of 1st generation PI-based therapies in the UK.Medical records review of patients within the HCV Research UK database. Patients had received treatment with telaprevir or boceprevir and pegylated interferon and ribavirin (PR). Data on treatment outcome, healthcare utilisation and adverse events (AEs) requiring intervention were collected and analysed overall and by subgroups. Costs of visits, tests, therapies, adverse events and hospitalisations were estimated at the patient level. Total cost per cure was calculated as total median cost divided by SVR rate.154 patients from 35 centres were analysed. Overall median total cost per cure was £44,852 (subgroup range,: £35,492 to £107,288). Total treatment costs were accounted for by PI: 68.3 %, PR: 26.3 %, AE management: 5.4 %. Overall SVR was 62.3 % (range 25 % to 86.2 %). 36 % of patients experienced treatment-related AEs requiring intervention, 10 % required treatment-related hospitalisation.This is the first UK multicentre study of outcomes and costs of PI-based HCV treatments in clinical practice. There was substantial variation in total cost per cure among patient subgroups and high rates of treatment-related discontinuations, AEs and hospitalisations. Real world safety, effectiveness and total cost per cure for the new IFN free combinations should be compared against this baseline.
Abstract Background Sequential use of biologics in Inflammatory Bowel Disease (IBD) is often required in clinical practice to restore or maintain long-term remission. Health technology agencies are requiring treatment sequencing models which are more reflective of clinical practice. The accurate modelling of treatment sequences would help better understand expected patient benefit and make more informed decisions. The aim of our targeted literature review (TLR) was to identify real-world evidence (RWE) on the effectiveness of second-line or later treatments for Crohn’s disease (CD) or ulcerative colitis (UC) refractory to initial therapy and assess its suitability for treatment sequence modelling. Methods We identified observational studies from Europe, the United States (US), and Canada via EMBASE, MEDLINE, and MEDLINE-In-Process (searched from 01/01/2018 to 11/12/2023). Study selection was conducted by a senior researcher and quality was checked by a second one. Evidence was analysed to assess the availability of clinical remission and response, and steroid-free remission data by line of therapy and across various time points. We then conducted a gap analysis against the evidence needs of a treatment sequence model Results After screening a total of 145 publications were included for data extraction in the review: 61 in ulcerative colitis (UC), 50 in Crohn’s disease (CD), and 34 in combined IBD. Studies were predominantly conducted in Europe (n=95), followed by the US (n=26), and Canada (n=3). A total of 12 studies reported clinical remission for first line, four for second line, and two each for third and fourth lines of treatments of refractory patients with UC. Additionally, eight studies reported data for first line, seven for second line, eight for third line, three for fourth line, and two for fifth line treatments of refractory patients with CD. The remaining studies combined results for multiple lines of treatment. Clinical remission during maintenance for patients with CD ranged between 47% - 79%, 38% - 87%, 28% - 68%, and 16% - 63%, for first, second, third, and fourth line, respectively and 40%-67%, 35% - 77%, 41% - 47%, and 16% - 21% for patients with UC. Studies lacked granularity in the assessment of clinical remission and response specific to individual treatments, stratified by specific treatment failure history Conclusion Studies identified in our evidence review did not report sufficiently granular data on clinical response or remission to reliably inform a treatment sequence model. Addressing these data gaps is essential for enabling more reliable decision-making in clinical practice, supporting better resource allocation, and ultimately improving long-term outcomes for refractory patients with IBD.
Introduction : Intraductal papillary mucinous neoplasia (IPMN) is a benign cystic neoplasm that has the potential to transform into pancreatic cancer over time. These lesions are usually asymptomatic. A main pancreatic duct IPMN is usually symptomatic and may present as an emergency when occlusion of the common bile duct with thick mucinous secretion and jaundice develop. This complication is hard to manage pharmacotherapeutically or by endoscopic procedure and may require surgical treatment. Purpose : This is a case report of a complicated main pancreatic duct IPMN that required an urgent, two-stage operation. A review of the literature on the topic was carried out. Case description : A 67-year-old male patient with symptoms of jaundice was diagnosed with acute cholangitis, cholecystitis, and pancreatitis as complications of the mucinous obstruction of the main pancreatic duct and of the common bile duct (CBD) caused by IPMN. The condition was confirmed by cholangio-pancreatoscopy and biopsy. Stenting of CBD was attempted, but the procedure turned out unsuccessful, and we proceeded to an emergency two-stage operation. The first operation consisted of the clearance of the bile ducts from infected mucinous secretion, cholecystectomy, and hepatico-jejunostomy. A Whipple procedure was performed as a second-stage operation. Discussion : Cases of emergency are not common in patients with IPMN. However, obstructive jaundice by mucinous secretion due to the disease is hard to treat only by endoscopy because of the high risk of obstruction of the endoprosthesis. On the other hand, emergency pancreatic resections are associated with a high risk of perioperative complications. Conclusion : Sometimes, the complicated main pancreatic duct IPMNs can pose a challenge for the interdisciplinary team of invasive gastroenterologists and surgeons, and the key to a successful outcome is surgical interventions in two- or three stages that include complications management as the first stage, followed by surgical resection as a second stage operation. Biliary drainage improvement is usually only temporarily successful with the insertion of biliary stents because of the rapid mucinous occlusion and the remaining risk of cholangitis and cholecystitis.
Background: Biologics used to treat ulcerative colitis (UC) may lose their effect over time, requiring patients to undergo dose escalation or treatment switching, and systematic literature reviews of real-world evidence on these topics are lacking. Aim: To summarize the occurrence and outcomes of dose escalation and treatment switching in UC patients in real-world evidence. Methods: Studies were searched through MEDLINE, MEDLINE IN PROCESS, Embase and Cochrane (2006-2017) as well as proceedings from three major scientific meetings. Results: In total, 41 studies were included in the review among which 35 covered dose escalation and 12 covered treatment switching of biologics. Tumor necrosis factor antagonist (anti-TNF) escalation for all patients included at induction ranged from 5% (6 months) to 50% (median 0.67 years) and 15.2% to 70.8% (8 weeks) for anti-TNF induction responders. Mean/median time to dose escalation on anti-TNF ranged from 1.84 to 11 months. The most common switching pattern, infliximab → adalimumab, occurred in 3.8% (median 5.6 years) to 25.5% (mean 3.3 years) of patients. Conclusions: Dose escalation and treatment switching of biologics may be considered as indicators of suboptimal therapy suggesting a lack of long-term remission and response under current therapies.
Hip arthrosis is the main cause of disability of all degenerative joint diseases and therefore it is considered to be of social significance. The presented clinical case aims to confirm the efficacy of the applied kinesitherapeutic program in conservative treatment of 62-year-old patient with right-sided coxarthrosis. The kinesitherapeutic methods included right lower limb massage, suspension therapy, tractions and manual movements of the right hip joint, positional treatment, active exercisesinan openkinetic chain, postisometric relaxation and stretching for shortened muscles.The pain symptoms were reduced, the volume of movement in the right hip increased, the strength of the right hip joint stabilizer musclespartially improved.
The cytokine storm has been identified as one of the leading causes of the severe course and, in some cases, the fatal outcome of COVID-19 infection. Other factors aggravating the course of the disease are accompanying disorders such as cardiovascular diseases, diabetes mellitus, diseases of the respiratory system, and oncological diseases. In this article, we present the course of the coronavirus infection in patients with an accompanying malignant disease, chronic lymphocytic leukemia (CLL), namely. The study included 8 patients with proven PCR-positive tests for SARS-CoV2 and confirmed chronic lymphocytic leukemia as a comorbidity. The course of the coronavirus infection in the CLL group was compared with that in the control group of 100 patients. In both groups, we compared subjective complaints such as tiredness, fatigue, and joint and muscle pain with objective criteria such as temperature, laboratory markers of inflammation, X-ray imaging, and frequency of necessary intubation. Despite the expected poor prognosis in patients with concomitant oncological disease, in the case of chronic lymphocytic leukemia, our results showed a quite different milder coronavirus infection course. Obviously, patients with CLL cannot develop a pronounced cytokine storm, most probably due to certain immunosuppression related to the pathogenesis and drug treatment options for the comorbidity of CLL.
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