This year we attended the American Association for the Study of Liver Disease in San Francisco. It was a great opportunity to meet with PBC specialists from across Canada. At the meeting we had the opportunity to see updates on clinical trials taking place around the world as new drugs are developed to treat PBC.
From Cymabay Therapeutics we heard the results of the Phase 2 trial for a new drug called Seladelpar. Based upon the positive results already seen in PBC patients enrolled in Phase 2, a phase 3 study will begin in November. This 52 week study will involve 240 patients with the following sites already established in Canada and more to come on board in the near future. Currently locations in Canada include: Calgary, Toronto, Montreal and Winnipeg
Last year, Glaxo Smith Kline, began a Phase 2b clinical trial for their product GSK2330672; enrollment completion is expected by September, 2019, with Canadian sites in: Montreal, Winnipeg, Calgary, Edmonton, and London. The study involves 7 site visits and recording of itch daily using a specially designed personal hand held device.
Several interesting studies were highlighted during the conference including the following presentations:
Brain changes found in people with PBC – Conclusions: “Our findings suggest that oxygen delivery may play an important role in brain changes associated with chronic cholestatic liver disease. NIRS markers of oxygenation and cerebrovascular activity were altered in patients with PBC, and normalized with effective UDCA treatment. These findings support the use of partable and non-invasive near-infrared spectroscopy (NIRS) as a useful neuroimaging tool to study brain changes in patients with liver disease.”
Benefits of Telehealth in Liver Transplantation in serving remote communities – Conclusions: “No statistically significant difference was noted between the two group in terms of distance from transplant center. Patients seen by telehealth experienced no delay in the time from referral to initial evaluation or listing decision. Therefore, telehealth can reliably be used to triage patients for liver transplantation without impacting the time to evaluation or listing. Telehealth may reduce travel burden, overcome geographic disparities and increase access to specialized services by connecting patients needing transplantation earlier in their disease course (lower MELD-Na) comparable to those evaluated by standard of care. Further study on the impact of telehealth on transplantation access, outcomes and cost for the Veterans Health Administration are warranted.”
Increasing Prevalence of PBC in Canada: looking at years 2005- 2015 this University of Calgary study finds increased prevalence of PBC in Canada. Presentation also highlighted better transplant free survival for those taking UDCA (Urso).
Mindfulness to improve PBC – Based upon the success of a study using mindfulness to improve quality of life and blood work for patients with Autoimmune Hepatitis, this 8 week study will begin for PBC in January 2019. We look forward to the results.
Dr. Gideon Hirschfield introduced PBC Patient Care Pathways, for PBC diagnosis, treatment and management. See full presentation here.