Study of the management of viral hepatitis C

Abstract. Viral hepatitis C (VHC) is one of the leading causes of chronic liver disease and the overall prevalence of infection in 2019 has been estimated at approximately 1%. The aim of this study was to investigate the efficacy and tolerability of different antiviral drugs in the treatment of VHC. Data on the treatment of VHC in the National Programme for the Control of Viral Hepatitis were analysed. The clinical study was conducted in the Hospital for Infectious Diseases Toma Ciorbă during 2020-2021. The use of treatment with direct-acting antivirals is successful, with a failure rate of less than 0.5%, but also more than 6% among genotype 3. For patients resistant to the treatment regimens used in the National Programme, the use of genotype-specific treatment, as recommended by the European Association for the Study of the Liver (EASL), is required. Based on the study of disease records, the Declatasvir + Sofosbuvir and Sofosbuvir + Ribavirin regimens for chronic VHC show treatment efficacy of about 98% and 87.3 respectively for 12-24 weeks.Rezumat. Hepatita virală C (HVC) este una dintre principalele cauze ale bolilor hepatice cronice, iar prevalenţa generală a infecţiei în 2019 a fost estimată la aproximativ 1%. Scopul studiului este cercetarea eficienţei și tolerabilităţii diferitor preparate antivirale în tratamentul hepatitei virale C. Au fost analizate datele privind tratamentul hepatitei virale C în cadrul Programului Naţional pentru controlul hepatitelor virale. Studiul clinic a fost efectuat în Spitalul Clinic de Boli Infecţioase Toma Ciorbă pe parcursul anilor 2020-2021. Utilizarea tratamentului cu antivirale cu acţiune directă este de succes, rata eșecului fiind mai puţin de 0,5%, dar totodată mai mult de 6% în rândul genotipului 3. Pentru pacienţii rezistenţi la schemele de tratament utilizate în cadrul Programului Naţional este necesar tratamentul genotipic specific, conform recomandărilor Asociaţiei Europene pentru Studiul Ficatului (EASL). În baza studiului fișelor clinice de boală, schemele de terapie cu Declatasvir + Sofosbuvir şi Sofosbuvir + Ribavirină pentru HVC manifestă eficacitate de circa 98% și 87,3 respectiv, timp de 12-24 săptămâni

Wireless Capsule Endoscopy for Obscure Gastrointestinal Bleeding: Single Center, One Year Experience

BACKGROUND: Wireless capsule endoscopy (CE) is increasingly being used in the investigation of obscure gastrointestinal (GI) bleeding, but some studies have found that many of the bleeding lesions recognized by this technique are within the reach of conventional endoscopy

A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design.

International audienceCrohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required

A systematic review of the measurement of endoscopic healing in ulcerative colitis clinical trials: recommendations and implications for future research

Assessment of endoscopic disease activity, as measured by various endoscopic evaluative instruments, is an essential part of quantifying disease activity in clinical trials in patients with ulcerative colitis (UC). Evaluative instruments have specific definitions and operating properties that influence the interpretation of clinical trial results. Our objective was to systematically review all endoscopic evaluative instruments that measure endoscopic disease activity in UC and to describe their definitions and operating characteristics (reliability, responsiveness, and predictive validity). We performed a systematic review of evaluative instruments assessing endoscopic disease activity in UC. MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and Digestive Disease Week abstracts of clinical trials were searched from inception to January 2013. In total, 5885 studies were identified and screened for inclusion criteria. Four hundred twenty-two studies involving 31 evaluative instruments were identified. Two types of indices were found, numerical scoring systems and stepwise grading scales. Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for UC. Currently, the sigmoidoscopic component of the Mayo Score and the ulcerative colitis endoscopic index of severity show the most promise as reliable evaluative instruments of endoscopic disease activity. However, further validation is require

Assessment of histologic disease activity in Crohn's disease: a systematic review

Crohn's disease (CD) is an idiopathic, chronic, transmural inflammatory disorder of the gastrointestinal tract. Because mucosal involvement is near-universal, endoscopic healing has emerged as an important aspect in improving outcome. However, resolution of histologic disease activity has potential to convey additional benefit beyond that attained with endoscopic healing alone. Validated scoring systems of histologic disease activity are required to further assess this possibility. The aim of this study was to systematically review the existing histologic disease activity indices (HDAI) for CD and to assess their operating properties and potential use as outcome measures in clinical trials. MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and Digestive Disease Week (DDW) abstracts were searched from 1981 to April 2013 for applicable studies to identify relevant studies for review and analysis. In total, 3732 citations were screened to obtain 89 articles for inclusion. Sixty-six HDAIs were characterized as either stepwise or numerical instruments. These HDAIs were used for either assessment of response to medical therapy or for comparison with biomarkers or imaging tests. None of the HDAIs identified was developed according to currently accepted methods for developing evaluative instruments, and none have been formally validated. Measurement of histologic disease activity has potential value in CD; however, no validated measures are available. Additional research is needed to develop a methodologically rigorous instrument for use in clinical investigation and potentially for clinical practic

Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease

The Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn's Disease (SES-CD) are commonly used to assess Crohn's disease (CD) activity; however, neither instrument has been fully validated. We assessed intra-rater and inter-rater reliability of these indices. Video recordings of colonoscopies obtained from 50 patients with CD who participated in an induction trial of a biological therapy were triplicated and reviewed in random order by four central readers. Data were used to assess intra-rater and inter-rater reliability for CDEIS, SES-CD and a global evaluation of lesion severity (GELS). Subsequently, readers participated in a consensus process that identified common sources of disagreement. Intraclass correlation coefficients (ICCs) for intra-rater reliability for CDEIS, SES-CD and GELS (95% CIs) were 0.89 (0.86 to 0.93), 0.91 (0.89 to 0.95) and 0.81 (0.77 to 0.89), respectively, with standard error of measurement (SEM) of 2.10, 2.42 and 1.15. The corresponding ICCs for inter-rater reliability were 0.71 (0.63 to 0.76), 0.83 (0.75 to 0.88) and 0.62 (0.52 to 0.70), with SEM of 3.42, 3.07 and 1.63, respectively. Correlation between CDEIS and GELS was 0.75, between SES-CD and GELS was 0.74 and between CDEIS and SES-CD was 0.92. The most common sources of disagreement were interpretation of superficial ulceration, definition of disease site at the ileocolonic anastomosis, assessment of anorectal lesions and grading severity of stenosis. Central reading of CDEIS and SES-CD had 'substantial' to 'almost perfect' intra-rater and inter-rater reliability; however, the responsiveness of these instruments is yet to be determined. Clinicaltrials.gov NCT0146637