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As one of the first Direct Acting Antivirals (DAA), the protease inhibitor Telaprevir (TVR) was available in the European Union from 9/2011 until 9/2016 as a new treatment option for chronic Hepatitis C.Aim. To assess the implementation of therapy stopping rules or shortening of the treatment and their impact on sustained virological response (SVR), as well as the safety and efficacy of the TVR-based therapy during routine daily treatment of patients in Germany.Materials and Methods. 802 patients were assessed (272 treatment naïve, 520 pre-treated) in the noninterventional, multi-center study.Results. 56.6 % of the patients achieved SVR. SVR rate was higher in patients with relapse after previous treatment (68.0 %) than in patients with a previous null-response (31.1 %) and in previously untreated patients (58.1 %). Stopping rule conditions were fulfilled by 3.2 % of patients and it was implemented in 65.4 % of these. 34.3 % of the patients fulfilled the conditions for a therapy shortening. This rule was adhered to in 48.4 % of these, in 34.5 % it was not adhered to. Thus recommendations were not always being followed. Therapy shortening was considered more frequently in previously untreated (54.8 %) than for previously treated patients (24.2 %). Stopping rule application but not shortened treatment reduced therapy costs.Conclusion. The TVR-based therapy represented a breakthrough at that time. Further DAAs have been added as therapeutic options since, increasing the complexity of treatment choice and correct implementation. They represent both an opportunity and a challenge for all those involved.As one of the first Direct Acting Antivirals (DAA), the protease inhibitor Telaprevir (TVR) was available in the European Union from 9/2011 until 9/2016 as a new treatment option for chronic Hepatitis C.Aim. To assess the implementation of therapy stopping rules or shortening of the treatment and their impact on sustained virological response (SVR), as well as the safety and efficacy of the TVR-based therapy during routine daily treatment of patients in Germany.Materials and Methods. 802 patients were assessed (272 treatment naïve, 520 pre-treated) in the noninterventional, multi-center study.Results. 56.6 % of the patients achieved SVR. SVR rate was higher in patients with relapse after previous treatment (68.0 %) than in patients with a previous null-response (31.1 %) and in previously untreated patients (58.1 %). Stopping rule conditions were fulfilled by 3.2 % of patients and it was implemented in 65.4 % of these. 34.3 % of the patients fulfilled the conditions for a therapy shortening. This rule was adhered to in 48.4 % of these, in 34.5 % it was not adhered to. Thus recommendations were not always being followed. Therapy shortening was considered more frequently in previously untreated (54.8 %) than for previously treated patients (24.2 %). Stopping rule application but not shortened treatment reduced therapy costs.Conclusion. The TVR-based therapy represented a breakthrough at that time. Further DAAs have been added as therapeutic options since, increasing the complexity of treatment choice and correct implementation. They represent both an opportunity and a challenge for all those involved. Ингибитор протеазы Телапревир (ТПВ) является одним из первых противовирусных препаратов прямого действия (ПППД) и применялся в странах Евросоюза при лечении хронического гепатита С в качестве нового метода с сентября 2011 года по сентябрь 2016 года. Цель: Оценить применение правил остановки (прекращения) или сокращения периода терапии и их влияние на устойчивый вирусологический ответ (УВО), а также безопасность и эффективность противовирусной терапии на основе ТПВ при рутинном применении в Германии. Материалы и методы. В неинтервенционном мультицентровом исследовании участвовали 802 пациента (272 пациента, ранее не получавшие, и 520 пациентов, ранее получавшие противовирусные препараты). Результаты. Устойчивый вирусологический ответ (УВО) был достигнут у 56,6 % пациентов. Доля пациентов с УВО среди пациентов с рецидивом после предыдущего лечения была выше (68,0 %), чем у пациентов с предыдущим нулевым ответом (31,1 %) и у пациентов, ранее не получавших противовирусные препараты (58,1 %). Критериям прекращения терапии соответствовали 3,2 % пациентов, из них у 65,4 % лечение было остановлено. Критериям сокращения терапии соответствовали 34,3 % пациентов. Это правило было применено в отношении 48,4 % из них, у 34,5 % оно не соблюдалось. Таким образом, не всегда соблюдались рекомендации по прекращению или сокращению терапии. Чаще терапию сокращали в группе пациентов, ранее не получавших лечения (54,8%), чем в группе пациентов, получавших противовирусную терапию в анамнезе (24,2%). Именно применение правил прекращения терапии, а не сокращение ее продолжительности, позволило снизить затраты на лечение. Заключение. Терапия на основе ТПВ в свое время стала прорывом в лечении гепатита С. Позже были предложены новые варианты ПППД для терапии, что усложнило выбор и точность применения препаратов. ПППД привнесли одновременно как новые возможности, так и новые сложности.

Background: Accurate assessment of hepatic fibrosis in patients with chronic HBeAg-negative Hepatitis B is of crucial importance not only to predict the long-term clinical course, but also to evaluate antiviral therapy indication. The aim of this study was to prospectively assess the utility of point shear wave elastography (pSWE) for longitudinal non-invasive fibrosis assessment in a large cohort of untreated patients with chronic HBeAg-negative hepatitis B virus (HBV) infection. Methods: 407 consecutive patients with HBeAg-negative HBV infection who underwent pSWE, transient elastography (TE) as well as laboratory fibrosis markers, including fibrosis index based on four factors (FIB-4), aspartate to platelet ratio index (APRI) and FibroTest, on the same day were prospectively followed up for six years. Patients were classified into one of the three groups: inactive carriers (IC, HBV-DNA &lt, 2000 IU/mL and ALT &lt, 40 U/L), grey zone group 1 (GZ-1, HBV DNA &lt, 2000 IU/mL and ALT &gt, grey zone group 2 (GZ-2, HBV-DNA &gt, 40 U/L). Results: pSWE results were significantly correlated with TE (r = 0.29, p &lt, 0.001) and APRI (r = 0.17, p = 0.005). Median pSWE values did not differ between IC, GZ-1 and GZ-2 patients (p = 0.82, p = 0.17, p = 0.34). During six years of follow-up, median pSWE and TE values did not differ significantly over time (TE: p = 0.27, pSWE: p = 0.05). Conclusion: Our data indicate that pSWE could be useful for non-invasive fibrosis assessment and follow-up in patients with HBeAg-negative chronic HBV infection.

Summary Background Ferric maltol was effective and well‐tolerated in iron deficiency anaemia patients with inflammatory bowel disease during a 12‐week placebo‐controlled trial. Aim To perform a Phase 3 extension study evaluating long‐term efficacy and safety with ferric maltol in inflammatory bowel disease patients in whom oral ferrous therapies had failed to correct iron deficiency anaemia. Methods After 12 weeks of randomised, double‐blind treatment, patients with iron deficiency anaemia and mild‐to‐moderate ulcerative colitis or Crohn's disease received open‐label ferric maltol 30 mg b.d. for 52 weeks. Results 111 patients completed randomised treatment and 97 entered the open‐label ferric maltol extension. In patients randomised to ferric maltol (‘continued’; n = 50), mean ± s.d. haemoglobin increased by 3.07 ± 1.46 g/dL between baseline and Week 64. In patients randomised to placebo (‘switch’; n = 47), haemoglobin increased by 2.19 ± 1.61 g/dL. Normal haemoglobin was achieved in high proportions of both continued and switch patients (89% and 83% at Week 64, respectively). Serum ferritin increased from 8.9 μg/L (baseline) to 26.0 μg/L (Week 12) in ferric maltol‐treated patients, and to 57.4 μg/L amongst all patients at Week 64. In total, 80% of patients reported ≥1 adverse event by Week 64. Adverse events considered related to ferric maltol were recorded in 27/111 (24%) patients: 8/18 discontinuations due to adverse events were treatment‐related. One patient was withdrawn due to increased ulcerative colitis activity. Conclusions Normal haemoglobin was observed in ≥80% of patients from weeks 20–64 of long‐term ferric maltol treatment, with concomitant increases in iron storage parameters. Ferric maltol was well‐tolerated throughout this 64‐week study.