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Reactivation of hepatitis B in the context of immunosuppressive therapy may be severe and potentially fatal. The US Food and Drug Administration has recently drawn attention to the potentially fatal risk of hepatitis B reactivation in patients receiving the anti-CD20 agents ofatumumab or rituximab. This action focuses attention on the broader issue of hepatitis B virus reactivation, which may occur with a wide variety of immunosuppressive therapies in benign or malignant disease. This article summarizes the data behind this issue. These data support the recommendation that all patients undergoing chemotherapy, immunosuppressive therapy, hematopoietic stem cell transplantation, or solid organ transplantation be screened for active or prior hepatitis B viral infection by testing for hepatitis B surface antigen and the antibody to hepatitis B core antigen in serum. Those who are found to be hepatitis B surface antigen-positive should start appropriate antiviral therapy to prevent reactivation. Additionally, even those who have recovered from hepatitis B will benefit from antiviral therapy in certain circumstances because of the risks associated with a form of hepatitis B virus reactivation referred to as "reverse seroconversion." There remain many uncertain areas that warrant further study, and further advances will benefit from close interactions between various medical specialties, regulatory agencies, and researchers.

Conclusions

There is good evidence to support routine screening of all patients for hepatitis B prior to undergoing chemotherapy or immunosuppressive treatment; use of prompt antiviral treatment appears to diminish the risk of severe or fatal reactivation of hepatitis B.

There is an increasing need to construct a risk-prediction scoring system for survival data and identify important risk factors (e.g., biomarkers) for patient screening and treatment recommendation. However, most existing methodologies either rely on strong model assumptions (e.g., proportional hazards) or only handle binary outcomes. In this article, we propose a flexible method that simultaneously selects important risk factors and identifies the optimal linear combination of risk factors by maximizing a pseudo-likelihood function based on the time-dependent area under the receiver operating characteristic curve. Our method is particularly useful for risk evaluation and recommendation of optimal subsequent treatments. We show that the proposed method has desirable theoretical properties, including asymptotic normality and the oracle property after variable selection. Numerical performance is evaluated on several simulation data sets and an application to hepatocellular carcinoma data.

Cirrhosis is morbid and increasingly prevalent, yet the U.S. health care system lacks enough physicians and specialists to adequately manage patients with cirrhosis. Although advanced practice providers (APPs) can expand access to cirrhosis-related care, their impact on the quality of care remains unknown. We sought to determine the effect on care quality and outcomes for patients managed by APPs using a retrospective analysis of a nationally representative American commercial claims database (Optum), which included 389,257 unique adults with cirrhosis. We evaluated a complication of process measures (i.e., rates of hepatocellular carcinoma [HCC] screening, endoscopic varices screening, and use of rifaximin after hospitalization for hepatic encephalopathy) and outcomes (30-day readmissions and survival). Compared with patients without APP care, patients with APP care had higher rates of HCC screening (adjusted odds ratio [OR] 1.23, 95% confidence interval 1.19, 1.27), varices screening (OR 1.20 [1.13, 1.27]), use of rifaximin after a discharge for hepatic encephalopathy (OR 2.09 [1.80, 2.43]), and reduced risk of 30-day readmission (OR 0.68 [0.66, 0.70]). Gastroenterology/hepatology consultation was also associated with improved quality metric performance compared with primary care; however, shared visits between gastroenterologists/hepatologists and APPs were associated with the best performance and lower 30-day readmissions compared with subspecialty consultation without an APP (OR 0.91 [0.87, 0.95]. Multivariate analysis adjusting for comorbidities, liver disease severity, and other factors including gastroenterology/hepatology consultation showed that patients seen by APPs were more likely to receive consistent HCC and varices screening over time, less likely to experience 30-day readmissions, and had lower mortality (adjusted hazard ratio 0.57, 95% confidence interval 0.55, 0.60). Conclusion: APPs, particularly when working with gastroenterologists/hepatologists, are associated with improved quality of care and outcomes for patients with cirrhosis.

Cirrhosis is morbid and increasingly prevalent, yet the U.S. health care system lacks enough physicians and specialists to adequately manage patients with cirrhosis. Although advanced practice providers (APPs) can expand access to cirrhosis-related care, their impact on the quality of care remains unknown. We sought to determine the effect on care quality and outcomes for patients managed by APPs using a retrospective analysis of a nationally representative American commercial claims database (Optum), which included 389,257 unique adults with cirrhosis. We evaluated a complication of process measures (i.e., rates of hepatocellular carcinoma [HCC] screening, endoscopic varices screening, and use of rifaximin after hospitalization for hepatic encephalopathy) and outcomes (30-day readmissions and survival). Compared with patients without APP care, patients with APP care had higher rates of HCC screening (adjusted odds ratio [OR] 1.23, 95% confidence interval 1.19, 1.27), varices screening (OR 1.20 [1.13, 1.27]), use of rifaximin after a discharge for hepatic encephalopathy (OR 2.09 [1.80, 2.43]), and reduced risk of 30-day readmission (OR 0.68 [0.66, 0.70]). Gastroenterology/hepatology consultation was also associated with improved quality metric performance compared with primary care; however, shared visits between gastroenterologists/hepatologists and APPs were associated with the best performance and lower 30-day readmissions compared with subspecialty consultation without an APP (OR 0.91 [0.87, 0.95]. Multivariate analysis adjusting for comorbidities, liver disease severity, and other factors including gastroenterology/hepatology consultation showed that patients seen by APPs were more likely to receive consistent HCC and varices screening over time, less likely to experience 30-day readmissions, and had lower mortality (adjusted hazard ratio 0.57, 95% confidence interval 0.55, 0.60). Conclusion: APPs, particularly when working with gastroenterologists/hepatologists, are associated with improved quality of care and outcomes for patients with cirrhosis.

Background

A greater understanding of the determinants of health behavior among those with and at-risk of chronic hepatitis B virus (HBV) infection is needed for effective design and implementation of public health initiatives.

Aims

To determine factors associated with (1) willingness to accept HBV antiviral treatment and (2) satisfaction with provider communication regarding HBV care in a diverse cohort of HBV-infected patients.

Methods

Using a multifaceted model of health behavior, the Health Behavior Framework, we conducted a comprehensive assessment of knowledge, attitudes, beliefs, and barriers to HBV care.

Results

We enrolled 510 patients, with mean age 46 years; 53.1% men; and 71.6% Asian or Hawaiian/Pacific Islander. Patients were knowledgeable about HBV infection, but one-fifth did not think that HBV was a treatable disease; over a quarter felt it was so common among family and friends that it did not concern them, and less than half of patients believed they were likely to have liver problems or transmit HBV to others during their lifetime. Perceived susceptibility to disease risk was the only independent predictor of willingness to accept HBV treatment (β = 0.23, p = 0.0005), and contrary to expectations, having a doctor that speaks the same language was predictive of lower patient satisfaction with provider communication about their HBV care (β = - 0.65, p < 0.0001).

Conclusions

Patients with greater perceived susceptibility to the health consequences of HBV infection are more likely to accept treatment, and patient-provider language concordance impacts patient satisfaction with communication regarding HBV care in an unexpected direction.

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Diabetes is associated with liver disease progression and increased hepatocellular carcinoma risk, but factors associated with diabetes in patients with chronic hepatitis B virus (HBV) infection in North America are unknown. We aimed to determine factors predictive of diabetes and impaired fasting glucose (IFG) in a large HBV-infected multiethnic cohort. Adults with chronic HBV not receiving antiviral therapy were enrolled from 21 centers in North America. Diabetes was defined by history/medication use or fasting glucose≥126 mg/dL and IFG as fasting glucose 100-125 mg/dL. Of 882 patients included, 47.2% were female, 71.3% Asian, 83.7% foreign born, median age was 44 years, and median body mass index BMI 24.3 kg/m2. In this cohort, 26.0% were hepatitis B envelope antigen (HBeAg) positive, 43.9% had HBV DNA≥20,000 IU/mL, and 26.7% alanine aminotransferase (ALT)≥2× upper limit of normal (≥40 U/L women, ≥60 U/L men). Overall, 12.5% had diabetes and 7.8% IFG. The combined prevalence of diabetes or IFG was highest among blacks (36.7%) and those either born in the United States/Canada or foreign born with migration>20 years ago (25.5%). Obesity (odds ratio [OR]: 2.13), hyperlipidemia (OR, 4.13), hypertension (OR, 3.67), high ALT level (OR, 1.86), and family history of diabetes (OR, 3.43) were associated with diabetes. Factors associated with IFG were obesity (OR, 4.13) and hypertension (OR, 3.27), but also HBeAg positivity (OR, 0.39). Recent migration was negatively associated with diabetes among non-Asians (OR, 0.30).

Conclusions

Diabetes is more prevalent in HBV-infected North American adults than the general population and is associated with known metabolic risk factors and liver damage, as determined by ALT levels. Among the foreign born, longer duration of North America residence predicted diabetes risk in non-Asians. These results highlight the opportunities for interventions to prevent diabetes especially among at-risk ethnic groups with HBV.

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Hepatitis C virus (HCV) infection recurs in liver recipients who are viremic at transplantation. We conducted a randomized, controlled trial to test the efficacy and safety of pretransplant pegylated interferon alpha-2b plus ribavirin (Peg-IFN-α2b/RBV) for prevention of post-transplant HCV recurrence. Enrollees had HCV and were listed for liver transplantation, with either potential living donors or Model for End-Stage Liver Disease upgrade for hepatocellular carcinoma. Patients with HCV genotypes (G) 1/4/6 (n = 44/2/1) were randomized 2:1 to treatment (n = 31) or untreated control (n = 16); HCV G2/3 (n=32) were assigned to treatment. Overall, 59 were treated and 20 were not. Peg-IFN-α2b, starting at 0.75 μg/kg/week, and RBV, starting at 600 mg/day, were escalated as tolerated. Patients assigned to treatment versus control had similar baseline characteristics. Combined virologic response (CVR) included pretransplant sustained virologic response and post-transplant virologic response (pTVR), defined as undetectable HCV RNA 12 weeks after end of treatment or transplant, respectively. In intent-to-treat analyses, 12 (19%) assigned to treatment and 1 (6%) assigned to control achieved CVR (P = 0.29); per-protocol values were 13 (22%) and 0 (0%) (P = 0.03). Among treated G1/4/6 patients, 23 of 30 received transplant, of whom 22% had pTVR; among treated G2/3 patients 21 of 29 received transplant, of whom 29% had pTVR. pTVR was 0%, 18%, and 50% in patients treated for <8, 8-16, and >16 weeks, respectively (P = 0.01). Serious adverse events (SAEs) occurred with similar frequency in treated versus untreated patients (68% versus 55%; P = 0.30), but the number of SAEs per patient was higher in the treated group (2.7 versus 1.3; P = 0.003).

Conclusion

Pretransplant treatment with Peg-IFN-α2b/RBV prevents post-transplant recurrence of HCV in selected patients. Efficacy is higher with >16 weeks of treatment, but treatment is associated with increased risk of potentially serious complications.

Patients with nonalcoholic fatty liver disease (NAFLD) are at an increased risk of cardiovascular disease. Hydoxy-3-methyglutaryl-coenzyme reductase inhibitors, statins, reduce the risk of cardiovascular events.¹ Studies have shown that statins are safe among patients with liver disease, including those with compensated cirrhosis,² and their use is associated with lower mortality, hepatic decompensation, and possibly hepatocellular carcinoma.^3,4 Despite these data, statins are under prescribed among patients with liver disease due to concerns about hepatotoxicity.⁵ This study aimed to assess prevalence and patient factors associated with indicated statin use in patients with NAFLD in a real-world cohort.