Hepatitis C virus infection is causing chronic liver disease, cirrhosis, and hepatocellular carcinoma. By combining direct-acting antivirals (DAAs), high sustained virologic response rates (SVRs) can be achieved. Resistance-associated substitutions (RASs) are commonly observed after DAA failure, and especially nonstructural protein 5A (NS5A) RASs may impact retreatment options.1-3 Data on retreatment of DAA failure patients using first-generation DAAs are limited.4-7 Recently, a second-generation protease- and NS5A-inhibitor plus sofosbuvir (voxilaprevir/velpatasvir/sofosbuvir [VOX/VEL/SOF]) was approved for retreatment after DAA failure.8 However, this and other second-generation regimens are not available in many resource-limited countries or are not reimbursed by regular insurance, and recommendations regarding the selection of retreatment regimens using first-generation DAAs are very important. This study aimed to analyze patients who were re-treated with first-generation DAAs after failure of a DAA combination therapy.

SummaryBackgroundGlecaprevir/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.AimTo evaluate the effectiveness and safety of glecaprevir/pibrentasvir under real‐world conditions in the German Hepatitis C‐Registry (DHC‐R).MethodsThe 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.ResultsAs 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.ConclusionGlecaprevir/pibrentasvir was highly effective and well tolerated under real‐world conditions. Clinical trial number: DRKS00009717 (German Clinical Trials Register, DRKS).

Einleitung Die Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) erhöht das Risiko für eine spätere stoffgebundene Abhängigkeitserkrankung und beeinflusst den Verlauf beider Erkrankungen negativ. Darüber hinaus erhöhen sowohl ADHS als auch Suchterkrankungen das Risiko für traumatische Erfahrungen.

Die koformulierten direkt antiviral wirksamen Substanzen Glecaprevir (NS3/4A-Inhibitor) und Pibrentasvir (NS5-Inhibitor) (G/P) sind zur Behandlung der chronischen Hepatitis C Virus (HCV)-Infektion mit den Genotypen (GT) 1 – 6 zugelassen. Klinische Studien zeigten Heilungsraten (SVR) von über 98%; Real-Life-Daten zu dieser Therapie sind jedoch bisher nur begrenzt vorhanden.

Während die Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) im Erwachsenenalter 2,5% der Allgemeinbevölkerung betrifft, ist sie weitaus häufiger bei Patienten mit einer Alkoholabhängigkeit, jedoch sind die Prävalenzraten aus bisherigen Studien uneinheitlich und schwanken zwischen 6 und 21%. ADHS in der Kindheit erhöht die Wahrscheinlichkeit, früher Substanzen zu konsumieren und eine Abhängigkeit zu entwickeln, erschwert die Behandlung und beeinträchtigt den Behandlungserfolg der Abhängigkeitserkrankung, jedoch ist das Erwachsenen-ADHS bei Suchtkranken unterdiagnostiziert. Ziel der Studie war die Erwachsenen-ADHS-Prävalenz bei abstinenten, alkoholabhängigen Patienten in der MEDIAN Klinik Wilhelmsheim während einer stationären Entwöhnungsbehandlung (8 – 16 Wochen) zu ermitteln.