Only partial improvement in health-related quality of life after treatment of chronic hepatitis C virus infection with direct acting antivirals in a real-world setting-results from the German Hepatitis C-Registry (DHC-R).

Improvement of health-related quality of life (HRQoL) is frequently reported as a benefit when treating hepatitis C virus infection (HCV) with direct acting antivirals (DAA). As most of the available data were obtained from clinical trials, limited generalizability to the real-world population might exist. This study aimed to investigate the impact of DAA therapy on changes in HRQoL in a real-world setting. HRQoL of 1180 participants of the German Hepatitis C-Registry was assessed by Short-Form 36 (SF-36) questionnaires. Scores at post-treatment weeks 12-24 (FU12/24) were compared to baseline (BL). Changes of ≥2.5 in mental and physical component summary scores (MCS and PCS) were defined as a minimal clinical important difference (MCID). Potential predictors of HRQoL changes were analysed. Overall, a statistically significant increase in HRQoL after DAA therapy was observed, that was robust among various subgroups. However, roughly half of all patients failed to achieve a clinically important improvement in MCS and PCS. Low MCS (p < .001, OR = 0.925) and PCS (p < .001, OR = 0.899) BL levels were identified as predictors for achieving a clinically important improvement. In contrast, presence of fatigue (p = .023, OR = 1.518), increased GPT levels (p = .005, OR = 0.626) and RBV containing therapy regimens (p = .001, OR = 1.692) were associated with a clinically important decline in HRQoL after DAA therapy. In conclusion, DAA treatment is associated with an overall increase of HRQoL in HCV-infected patients. Nevertheless, roughly half of the patients fail to achieve a clinically important improvement. Especially patients with a low HRQoL seem to benefit most from the modern therapeutic options.

[Screening gastroscopy in Germany - first results of the pilot phase of the Prä-GIT study]. / Vorsorgegastroskopie in Deutschland ­ erste Ergebnisse der Pilotphase der Prä-GIT-Studie.

The primary aim of the Prä-GIT study is to collect information on the prevalence and course of precancerous and early malignant lesions in the upper GIT (uGIT) as well as risk factors associated with these lesions in asymptomatic individuals. Study participants presenting for a screening colonoscopy will undergo an additional endoscopic examination of the uGIT in the same session. 5000 participants in 30 endoscopy clinics in Bayern will be included. The pilot study presented here was performed to test the main study protocol as well as the acceptance of an additional uGIT endoscopic examination. METHODS: Three endoscopy clinics in Bayern took part in the three-month pilot study between October and December 2018. Patients presenting for a screening colonoscopy in these clinics were offered an additional endoscopic examination of the uGIT which was performed according to a standard operating procedure (SOP). Furthermore, data on dietary habits and lifestyle, as well as biological samples, were collected. RESULTS: 52 participants were included in three clinics in Altötting, Augsburg and Regensburg. The average age was 63.4 years. The average time spent per uGIT endoscopy was 11 minutes. No complications occurred. One participant showed a polyp of the recessus piriformis. Refluxesophagitis was seen in 21 participants, four participants had Barrett's esophagus with histological evidence of low-grade dysplasia in one patient, and an esophageal polyp with low-grade dysplasia was seen in one participant. Helicobacter-pylori gastritis was documented in 12 participants. Corpus-dominant atrophy was described in one participant, while a duodenal adenoma with low-grade dysplasia was seen in two participants. 100 % and 89 % of study participants gave a blood or a stool sample, respectively. All participants answered the questionnaire on dietary and lifestyle habits. CONCLUSION: The Prä-GIT study was designed to generate a database for premalignant and early cancerous lesions of the uGIT in Germany in asymptomatic individuals presenting for a regular screening colonoscopy. The current pilot study has delivered important insights into the feasibility of the main study protocol. Additionally, the pilot study has shown a high rate of acceptance of an additional uGIT examination in this study population.

Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C-Registry.

BACKGROUND: Glecaprevir/pibrentasvir is a pangenotypic direct-acting antiviral regimen approved for treating adults chronically infected with hepatitis C virus (HCV). There are limited real-world data on glecaprevir/pibrentasvir to date. AIM: To evaluate the effectiveness and safety of glecaprevir/pibrentasvir under real-world conditions in the German Hepatitis C-Registry (DHC-R). METHODS: The DHC-R is an ongoing, non-interventional, multicentre, prospective, observational cohort study that monitors patients with chronic HCV infection. Data were collected from patients who initiated glecaprevir/pibrentasvir and completed a screening visit on or after 2 August 2017. The primary effectiveness endpoint was sustained virological response at post-treatment Week 12 (SVR12). Safety and tolerability were also assessed. RESULTS: As of 15 July 2018, 586 patients received glecaprevir/pibrentasvir and had documented SVR12 data, treatment discontinuation, loss to follow-up or HCV reinfection. Five hundred and fifty-two patients (94%) received on-label treatment. At baseline, most on-label patients were infected with HCV genotype 1 (53%) or 3 (33%), HCV treatment-naïve (90%), without cirrhosis (94%), and treated for 8 weeks (93%). Five hundred and thirty-four patients (96.7%) achieved SVR12 (intention-to-treat [ITT] analysis). By modified ITT analysis (excluding patients who discontinued and did not achieve SVR12 or patients lost to follow-up), the SVR12 rate was 99.4% (n/N = 534/537). There was one documented virological failure (relapse) and two documented HCV reinfections. One hundred and forty-two (26%) adverse events (AEs) and 9 (2%) serious AEs occurred; 2 (<1%) AEs led to treatment discontinuation. All patients treated off-label (N = 34) achieved SVR12. CONCLUSION: Glecaprevir/pibrentasvir was highly effective and well tolerated under real-world conditions. Clinical trial number: DRKS00009717 (German Clinical Trials Register, DRKS).