Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results.

Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. This was a prospective single-center observational study in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study. A total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey-Bradshaw score showed a significant change at 12 months (P=0.007) but no significant change was observed in median CRP at this timepoint (P=0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P=0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients. Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months

Real-world evidence of sofosbuvir/velpatasvir as an effective and simple hepatitis C virus treatment and elimination tool in homeless populations

Lay abstract Reducing the prevalence of HCV in people experiencing homelessness is an important step toward elimination of viral hepatitis as a major public health threat. However, several patient and social factors can complicate treatment. Increasing treatment access and cure rates in this population requires treatment regimens to be simple, effective and well tolerated. In this real-world analysis of data collected from 15 clinical cohorts, a once daily 12-week regimen of sofosbuvir/velpatasvir, requiring minimal monitoring, achieved high cure rates across a broad range of HCV-infected people experiencing homelessness.Background: People experiencing homelessness are disproportionately affected by hepatitis C virus (HCV) and can face specific barriers to care. Simple treatment algorithms could increase linkage to care in this population. Methods: This retrospective real-world analysis pooling data from 15 clinical cohorts evaluated effectiveness of a once-daily sofosbuvir/velpatasvir (SOF/VEL) regimen in HCV-infected people experiencing homelessness. The primary outcome was sustained virological response (SVR) in the effectiveness population (patients with confirmed SVR status). Secondary outcomes included reasons for not achieving SVR, adherence and time between diagnosis and SOF/VEL treatment start. Results: Of 153 patients treated with SOF/VEL for 12 weeks without ribavirin, SVR was 100% in the effectiveness population (n = 122), irrespective of various baseline factors including active injecting drug use and presence of mental health disorders. Conclusion: HCV-infected people experiencing homelessness can successfully be treated with SOF/VEL. SOF/VEL enables implementation of simple treatment algorithms and can support test-and-treat strategies through rapid treatment starts and minimal monitoring

Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

Hepatitis C virus (HCV) is prevalent in people with mental health disorders, a priority population to diagnose and cure in order to achieve HCV elimination. This integrated analysis pooled data from 20 cohorts in seven countries to evaluate the real-world effectiveness of the pangenotypic direct-acting antiviral (DAA) sofosbuvir/velpatasvir (SOF/VEL) in people with mental health disorders. HCV-infected patients diagnosed with mental health disorders who were treated with SOF/VEL for 12 weeks without ribavirin as part of routine clinical practice were included. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with an available SVR assessment. Secondary outcomes were reasons for not achieving SVR, characteristics of patients with non-virological failures, adherence, and time from HCV RNA diagnosis to SOF/VEL treatment initiation. A total of 1209 patients were included; 142 did not achieve an SVR for non-virological reasons (n = 112; 83 lost to follow-up, 20 early treatment discontinuations) or unknown reasons (n = 30). Of the 1067 patients in the EP, 97.4% achieved SVR. SVR rates in the EP were ≥95% when stratified by type of mental health disorder and other complicating baseline characteristics, including active injection drug use and antipsychotic drug use. Of 461 patients with data available in the EP, only 2% had an adherence level < 90% and 1% had an adherence level < 80%; all achieved SVR. Patients with mental health disorders can be cured of HCV using a well-tolerated, pangenotypic, protease inhibitor-free SOF/VEL regimen. This DAA allows the implementation of a simple treatment algorithm, with minimal monitoring requirements and fewer interactions with central nervous system drugs compared with protease-inhibitor DAA regimens.Medicine, Faculty ofNon UBCMedicine, Department ofReviewedFacultyResearche