Simeprevir and sofosbuvir with or without ribavirin to treat recurrent genotype 1 hepatitis C virus infection after orthotopic liver transplantation.

Although combination simeprevir (SIM) plus sofosbuvir (SOF) is an approved regimen for genotype 1 chronic hepatitis C virus (HCV), data regarding its safety and efficacy in liver transplant recipients remain limited. A multicenter retrospective study was performed to determine the efficacy and tolerability of a 12-week regimen of SIM/SOF with or without ribavirin (RBV) in 56 consecutive liver transplant recipients in 2014; 79% of patients had genotype 1a, 14% had cirrhosis, and 73% were treatment experienced. Sustained virological response at 12 weeks (SVR12) was 88% by intention to treat analysis (95% confidence interval, 84%-90%). Four patients relapsed, but no on-treatment virological failures occurred. The Q80K polymorphism did not impact SVR12, but there was a trend toward decreased sustained virological response with advanced fibrosis (P = 0.18). HCV RNA was detectable at treatment week 4 in 21% of patients, and those who had detectable levels were less likely to achieve SVR12 (58% versus 95%; P = 0.003). Five patients had baseline Child-Pugh class B cirrhosis, and 2 of them died (1 following early discontinuation of therapy). An additional discontinuation resulted from a severe photosensitivity reaction in a patient on concomitant cyclosporine. Seven patients receiving RBV developed progressive anemia requiring intervention. Immunosuppression dose modifications were minimal. SIM/SOF for 12 weeks was effective and well tolerated by compensated liver transplant recipients especially when administered without concomitant RBV or cyclosporine. SIM/SOF appears to have a niche as the only 12-week RBV-free treatment regimen currently recommended by guidelines for compensated transplant recipients. However, 12 weeks may not be the optimal duration of therapy for those with detectable virus at week 4 or possibly for those with cirrhosis. These data require confirmation by prospective randomized clinical trials. Liver Transplantation 22 635-643 2016 AASLD.

Aligning an emergency department hepatitis C and human immunodeficiency virus testing quality improvement initiative with universal screening recommendations.

Objective: The interactions among hepatitis C virus (HCV), human immunodeficiency virus (HIV), and the ongoing injection drug epidemic have created a syndemic that significantly affects the Appalachian region of the United States. The purpose of this work is to describe a successful Kentucky program that aimed to increase HCV and HIV testing for people visiting an urban emergency department (ED) who were screened, diagnosed, and linked to care after diagnosis with special consideration for substance use disorder. Methods: The Plan-Do-Study-Act model for quality improvement was used to create a streamlined process for testing, reporting results, and linking people to care. The program was refined and expanded across 3 phases. Results: Across all phases, a total of 25,685 patients were eligible for testing and did not opt out. Of those, 17,090 had HCV antibody (Ab) testing; 3460 (20.2%) had HCV Ab; 1750 (50.8%) had HCV RNA, and an average of 31% of patients were linked to care within 30 days. The program found 54 new cases of HIV infection. Conclusions: Universal HCV and HIV testing and linkage to care is possible within an ED. In areas affected by the syndemic, EDs may serve as a public health safety net to identify affected individuals and ensure they receive follow-up care. Testing in this center uncovered an exceptionally high prevalence of HCV infection and new HIV case identification.

Non-targeted hepatitis C virus screening in acute care healthcare settings in the Southern Appalachian region.

Objectives: The objective of this study was to evaluate the performance of non-targeted hepatitis C virus (HCV) screening in emergency departments (EDs) and other healthcare settings in terms of patients identified with HCV infection and linked to HCV care. Methods: In the Southern Appalachian region of the United States, we developed non-targeted HCV screening and linkage-to-care programs in 10 institutions at different healthcare settings, including EDs, outpatient clinics, and inpatient units. Serum samples were tested for HCV antibodies, and if positive, reflexed to HCV ribonucleic acid (RNA) testing as a confirmatory test for active infection. Patients with positive RNA tests were contacted to link them to HCV care. Results: Between 2017 and 2019, among 195,152 patients screened for HCV infection, 16,529 (8.5%) were positive by antibody testing, 10,139 (5.2% of screened patients and 61.3% of patients positive by antibody test) were positive by RNA testing, and 5778 (3.0% of screened patients and 57.0% of patients positive by RNA test) were successfully linked to HCV care. Among 83,645 patients screened in EDs, 9060 (10.8%) were positive by HCV antibody, and 5243 (6.3%) were positive by RNA test. Among patients positive by RNA testing, linkage to care was lower for patients screened in the ED (44.1%) compared with outpatient clinics (67.6%) (P < 0.01) and inpatient units (50.9%) (P < 0.01). Conclusions: Non-targeted HCV screening in acute care settings can identify large numbers of people with HCV infection. To optimize the utility of these screening programs, future work is needed to develop best practices that consistently link these patients to HCV care.

Differences in Referral Access to Care Between Gastrointestinal Subspecialty Patients: Barriers and Opportunities.

Purpose: Referral access to subspecialty care for patients with gastrointestinal (GI) diseases is not well defined, but has significant importance to patients. We hypothesized that patients experience barriers to care in two common gastroenterology subspecialties, Hepatology and Motility, in a university medical center. Methods: Two hundred thirteen clinic patients (mean age 46.5 years; 66.5% female; 85.6% Caucasians) completed a formatted questionnaire on access to care. Hepatology patients were older (49.7 years, p=0.008); motility patients predominantly female (76.8%, p<0.001). Gender distribution was even for hepatology (51.2% female). Both groups were overweight (mean body mass index 28.4). Results: Patients waited a mean 89.5 days to be seen by a subspecialist. There were differences by subspecialty (107.6 days for motility vs. 64.3 days for hepatology, p=0.022). A larger percentage of motility patients were told nothing was wrong with them (16.8%, p<0.01) and could not be helped (42.1%, p=0.000). Conclusions: Access to care for subspecialty gastroenterology patients in a university center appears to be impacted by a number of variables. While there are similarities, differences exist between these two subspecialties. Motility patients were more likely to have been told they have nothing wrong with them, suffer setbacks financially, and suffer mood problems. Their wait time for appointments was also greater than hepatology patients. Further investigations of referral access for gastroenterology patients may yield additional insights into disease-specific barriers to accessing subspecialty care.