Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study.

BACKGROUND: Interferon-free regimens are needed to treat hepatitis C virus (HCV) infections. We investigated the efficacy of combined simeprevir and sofosbuvir. METHODS: We enrolled patients with chronic HCV genotype 1 infections who had previously not responded to pegylated interferon (peginterferon) and ribavirin or were treatment naive. Patients were randomly assigned in a 2:1:2:1 ratio to receive 150 mg simeprevir and 400 mg sofosbuvir daily for 24 weeks with (group 1) or without (group 2) ribavirin or for 12 weeks with (group 3) or without (group 4) ribavirin, in two cohorts: previous non-responders with METAVIR scores F0-F2 (cohort 1) and previous non-responders and treatment-naive patients with METAVIR scores F3-F4 (cohort 2). The primary endpoint was sustained virological response 12 weeks after stopping treatment (SVR12). Analysis was done by intention to treat. Safety data from cohorts 1 and 2 were pooled for analysis. This study is registered with ClinicalTrials.gov, number NCT01466790. FINDINGS: 168 patients were enrolled and randomised, and 167 started treatment (n=80 in cohort 1 and n=87 in cohort 2). SVR12 was achieved in 154 (92%) patients (n=72 [90%, 95% CI 81-96] in cohort 1 and n=82 [94%, 87-98] in cohort 2). The most common adverse events in the pooled groups were fatigue (n=52 [31%]), headache (n=33 [20%]), and nausea (n=26 [16%]). Grade 4 adverse events were seen in one (2%) of 54 patients in each of groups 1 and 3 and in three (10%) of 31 patients in group 2, whereas grade 3-4 events were reported in less than 5% of all patients, except increased blood amylase concentration. Serious adverse events were seen in four (2%) patients, all in groups 1 and 2. Four (2%) patients discontinued all study treatment because of adverse events, three before week 12. INTERPRETATION: Combined simeprevir and sofosbuvir was efficacious and well tolerated. FUNDING: Janssen.

Modified technique to extract malpositioned or migrated self-expanding stents from the esophagus and stomach.

BACKGROUND AND AIM: Various methods have been used to remove self expandable stents (SES) because of either malposition or migration. The main difficulties encountered in such situations are the anatomic obstacle of the lower and upper esophageal sphincters as well as risk of mucosal injury during removal. METHODS: We describe a modified approach using an esophagogastroduodenoscope (EGD) in combination with a foreign body hood protector, rat tooth forceps and snare allowing for successful SES removal from the upper gastrointestinal tract in four cases. RESULTS: In all cases, the SES were successfully removed from upper gastrointestinal tract using this technique. No complications were noted after extraction. CONCLUSION: The foreign body hood protector combined with rat tooth forceps/snare technique is a safe and effective alternative to previously described methods for extraction of SES from the upper gastrointestinal tract. This method may be applicable for the removal of other such objects within the endoscope's reach.

Extraction of hollow gastric foreign bodies by flexible upper endoscopy assisted by a through-the-scope balloon catheter for anchoring.

BACKGROUND: Various methods have been used to remove foreign bodies; hollow foreign bodies deserve special consideration. The main difficulty encountered in such situations is the anatomic obstacle of the lower and upper esophageal sphincters along with a risk of perforation. OBJECTIVE: We describe a unique approach by using an esophageal balloon dilator to anchor a hollow foreign body onto an endoscope, which allows for the successful extraction of such objects with minimal risk. DESIGN: Case series. SETTING: Shands Jacksonville and University of Florida/Jacksonville, Jacksonville, Florida. PATIENTS: Two consecutive patients with hollow foreign bodies in the stomach that required removal. INTERVENTIONS: A combined approach by using an endoscope and a 20-mm by 8-cm esophageal balloon dilator to remove hollow foreign bodies from the stomach. MAIN OUTCOME MEASUREMENTS: Nonsurgical removal of hollow gastric foreign bodies. RESULTS: Both foreign bodies were successfully removed from the stomach and extracted by mouth with this technique. There were no complications after both procedures. CONCLUSIONS: The inflated esophageal balloon that anchors a hollow foreign body onto a flexible endoscopic technique is a safe and effective alternative to previously described methods for removal of such foreign bodies in the gastric cavity. This method may be applicable to the removal of other hollow objects within the gastric lumen.