Practical strategies for pruritus management in the obeticholic acid-treated patient with PBC: proceedings from the 2018 expert panel.

BACKGROUND AND AIMS: This article provides expert guidance on the management of pruritus symptoms in patients receiving obeticholic acid (OCA) as treatment for primary biliary cholangitis (PBC). PBC is a chronic, autoimmune cholestatic liver disease that affects intrahepatic bile ducts. If not adequately treated, PBC can lead to cholestasis and end-stage liver disease, which may require transplant. Timely treatment is therefore vital to patient health. Pruritus is a common symptom in patients with PBC. Additionally, the use of OCA to treat PBC can contribute to increased pruritus severity in some patients, adding to patient discomfort, decreasing patient quality of life (QoL), and potentially affecting patient adherence to OCA treatment. METHODS: In May 2018, a group of physician experts from the fields of gastroenterology, hepatology, and psychiatry met to discuss the management of pruritus in OCA-treated patients with PBC. Recognizing the importance of optimizing treatment for PBC, these experts developed recommendations for managing pruritus symptoms in the OCA-treated PBC patient based on their experience in clinical practice. RESULTS: These recommendations include a comprehensive list of management strategies (including over-the-counter, prescription, and alternative therapies), guidance on titration of OCA to minimize pruritus severity, and an algorithm that outlines a practical approach to follow up with patients receiving OCA, to better assess and manage pruritus symptoms. CONCLUSIONS: Pruritus associated with OCA therapy is dose dependent and often manageable, and with the proper education and tools, most pruritus cases can be effectively managed to minimize treatment discontinuation.

Is response guided therapy dead? Low cure rates in patients with detectable hepatitis C virus at week 4 of treatment.

BACKGROUND: Historically, chronic hepatitis C virus (HCV) treatment was response-guided. Clinical trials with sofosbuvir indicated on-treatment virologic response was not predictive of sustained virologic response (SVR) and hence response-guided therapy (RGT) was abandoned. The purpose of this study is to examine the association between on-treatment 4-week HCV RNA and SVR in patients treated in real-world practice. METHODS: The study is a retrospective analysis of consecutive patients started on treatment with a sofosbuvir-containing regimen, January 1, 2014 through August 20, 2014, for HCV genotype 1-6 infection. Patients were treated by HCV specialists at 6 centers in the Project ECHO (Extension for Community Healthcare Outcomes) HCV Collaborative or in the community by primary care clinicians mentored by HCV specialists through Project ECHO. Patients were included if they were over 18 years, had evidence of chronic HCV, and were started on a sofosbuvir-containing regimen. The aspartate aminotransferase:platelet ratio index (APRI) was used to estimate fibrosis. The main outcome measures were 4-week HCV RNA and SVR. RESULTS: Overall SVR was 82.5 %. At week 4, HCV RNA was detected in 27.4 % of patients. Stepwise multivariable logistic-regression analyses identified APRI > 1.0, male sex, genotype 3, and detectable on treatment 4-week HCV RNA as independent predictors of failure to achieve SVR. CONCLUSIONS: In a real-world setting, a significant proportion of sofosbuvir treated patients have detectable on-treatment 4-week HCV RNA. Detectable on-treatment 4-week HCV RNA is associated with virologic failure. More data are needed to formulate guidance for RGT with newly available HCV therapies.

Expanding primary care capacity to treat hepatitis C virus infection through an evidence-based care model--Arizona and Utah, 2012-2014.

Hepatitis C virus (HCV) infection is the leading reason for liver transplantation and a common cause of hepatocellular carcinoma, the most rapidly increasing cause of cancer-related deaths in the United States. Of the approximately 3 million persons living with HCV infection in the United States, an estimated 38% are linked to care, 11% are treated, and 6% achieve cure. Recent development of highly effective and well-tolerated medications, such as sofosbuvir and simeprevir, to treat chronic HCV infection shows promise in curbing rising HCV-related morbidity and mortality, with the potential to cure >90% of patients. To fully benefit from these new treatments, improvement in linkage to care and treatment is urgently needed.* Lack of provider expertise in HCV treatment and limited access to specialists are well-documented barriers to HCV treatment. In September 2012, CDC funded programs in Utah and Arizona to improve access to primary care providers with the capacity to manage and treat HCV infection. Both programs were modeled on the Extension for Community Healthcare Outcomes (Project ECHO), developed by the University of New Mexico's Health Sciences Center in 2003 to build primary care capacity to treat diseases among rural, underserved populations through videoconferencing and case-based learning in "teleECHO" clinics. To assess the effectiveness of these programs in improving primary care provider capacity and increasing the number of patients initiating treatment, process and patient outcome data for each state program were analyzed. In both states, Project ECHO was successfully implemented, training 66 primary care clinicians, predominantly from rural settings. Nearly all (93%) of the clinicians had no prior experience in care and treatment of HCV infection. In both states combined, 129 (46%) of HCV-infected patients seen in teleECHO clinics received antiviral treatment, more than doubling the proportion of patients expected to receive treatment. These findings demonstrate Project ECHO's ability to expand primary care capacity to treat HCV infection, notably among underserved populations.