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Do A.,Yale University | Mittal Y.,Yale University | Liapakis A.,Yale University | Liapakis A.,Yale Liver Center | And 11 more authors.
PLoS ONE | Year: 2015

Background: New treatments for hepatitis C (HCV) infection hold great promise for cure, but numerous challenges to diagnosing, establishing care, and receiving therapy exist. There are limited data on insurance authorization for these medications. Materials and Methods We performed a retrospective chart review of patients receiving sofosbuvir/ledipasvir (SOF/ LED) from October 11-December 31, 2014 to determine rates and timing of drug authorization. We also determined predictors of approval, and those factors associated with faster decision and approval times. Results Of 174 patients prescribed HCV therapy during this period, 129 requests were made for SOF/LED, of whom 100 (77.5%) received initial approval, and an additional 17 patients (13.9%) ultimately received approval through the appeals process. Faster approval times were seen in patients with Child-Pugh Class B disease (14.4 vs. 24.7 days, p = 0.048). A higher proportion of patients were initially approved in those with Medicare/Medicaid coverage (92.2% vs. 71.4%, p = 0.002) and those with baseline viral load ≥6 million IU/mL (84.1% vs. 62.5%, p = 0.040). Linear regression modeling identified advanced fibrosis, high Model of End Stage Liver Disease (MELD) score, and female gender as significant predictors of shorter decision and approval times. On logistic regression, Medicare/Medicaid coverage (OR 5.96, 95% CI 1.66-21.48) and high viral load (OR 4.52, 95% CI 1.08-19.08) were significant predictors for initial approval. Conclusions Early analysis of real-world drug authorization outcomes between October-December 2014 reveals that nearly one in four patients are initially denied access to SOF/LED upon initial prescription, although most patients are eventually approved through appeal, which delays treatment initiation. Having Medicare/Medicaid and advanced liver disease resulted in a higher likelihood of approval as well as earlier decision and approval times. More studies are needed to determine factors resulting in higher likelihood of denial and to evaluate approval rates and times after implementation of restrictive prior authorization guidelines. © 2015 Do et al.

Lin C.-H.,Kaohsiung Chang Gung Memorial Hospital | Chen C.-L.,Liver Transplantation Program | Chen C.-L.,Chang Gung University | Lin T.-K.,Kaohsiung Chang Gung Memorial Hospital | And 6 more authors.
Medicine (United States) | Year: 2015

After liver transplantation, patients may develop seizures or epilepsy due to a variety of etiologies. The ideal antiepileptic drugs for these patients are those with fewer drug interactions and less hepatic toxicity. In this study, we present patients using levetiracetam to control seizures after liver transplantation. We retrospectively enrolled patients who received levetiracetam for seizure control after liver transplantation. We analyzed the etiology of liver failure that required liver transplantation, etiology of the seizures, outcomes of seizure control, and the condition of the patient after follow-up at the outpatient department. Hematological and biochemical data before and after the use of levetiracetam were also collected. Fifteen patients who received intravenous or oral levetiracetam monotherapy for seizure control after liver transplantation were enrolled into this study. All of the patients remained seizure-free during levetiracetam treatment. Two patients died during the follow-up, and the other 13 patients were alive at the end of the study period and all were seizurefree without neurological sequelae that interfered with their daily activities. No patients experienced liver failure or rejection of the donor liver due to ineffective immunosuppressant medications. The dosage of immunosuppressants did not change before and after levetiracetam treatment, and there were no changes in hematological and biochemical data before and after treatment. Levetiracetam may be a suitable antiepileptic drug for patients who undergo liver transplantation due to fewer drug interactions and a favorable safety profile. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Flamm S.L.,Liver Transplantation Program
Clinics in Liver Disease | Year: 2015

Covert hepatic encephalopathy is a common problem in cirrhosis, affecting up to 80% of patients. It is defined as test-dependent brain dysfunction with clinical consequences in the setting of cirrhosis in patients who are not disoriented. Because it is not apparent clinically, and diagnostic testing has not been standardized, the issue has often been ignored in clinical practice. Yet, the clinical consequences are notable, including impaired quality of life, diminished work productivity, and poor driving skills. © 2015 Elsevier Inc.

Yu C.-Y.,Liver Transplantation Program | Ou H.-Y.,Liver Transplantation Program | Huang T.-L.,Liver Transplantation Program | Chen T.-Y.,Liver Transplantation Program | And 3 more authors.
Transplantation Proceedings | Year: 2012

Background: Hepatocellular carcinoma (HCC) is the leading malignant tumor in Taiwan. The majority of HCC patients are diagnosed in late stages and therefore in eligible for potentially curative treatments. Locoregional therapy has been advocated as an effective treatment for patients with advanced HCCs. Purpose: The aim of this study was to evaluate the outcomes of HCC downstaged patients after locoregional therapy to allow eligibility for liver transplantation. Methods and materials: From January 2004 to June 2010, 161 patients with HCCs underwent liver transplantation including 51 (31.6%) who exceeded the University of CaliforniaSan Francisco (UCSF) who had undergone successful locoregional therapy to be downstaged within these criteria. Among the downstaged patients, 48 (94.1%) underwent transarterial embolization; 7 (13.8%), percutaneous ethanol injection; 24 (47.1%), radiofrequency ablation; 15 (29.4%), surgical resection, and 34 (66.7%), combined treatment. Results: The overall 1- and 5-year survival rates of all HCC patients (n = 161) were 93.2% and 80.5%. The overall 1- and 5-year survival rates of downstaged (n = 51) versus non-downstaged (n = 110) subjects were 94.1% versus 83.7% and 92.7% versus 78.9%, respectively (P =.727). There are 15 (9.2%) HCC recurrences. The overall 1- and 5-year tumor-free rates of all HCC patients were 94.8% and 87.2%. The overall 1- and 5-year tumor-free rates between downstaged versus non-downstaged patients were 93.9% and 90.1% versus 95.2% and 86.0%, respectively (P =.812). Conclusion: Patients with advanced HCC exceeding the UCSF/Milan criteria can be downstaged to fit the criteria using locoregional therapy. Importantly, successfully downstaged patients who are transplanted show excellent tumor-free and overall survival rates, similar to fit-criteria group. © 2012 by Elsevier Inc. All rights reserved.

Chiang H.-J.,Liver Transplantation Program | Hsu H.-W.,Liver Transplantation Program | Chen P.-C.,Liver Transplantation Program | Chiang H.-W.,Liver Transplantation Program | And 4 more authors.
Transplantation Proceedings | Year: 2012

Objective: The purpose of this study was to evaluate the image quality and diagnostic accuracy of postgadolinium complex of diethylenetriaminepentaacetic acid (GD-DTPA)-enhanced magnetic resonance cholangiography (MRC) in donor selection. Materials and methods: Donors (n = 228) with both preoperative MRC and intraoperative cholangiography (IOC) were enrolled in this study. MRC pre- and post-GD-DTPA enhancement were performed using 1.5-T magnetic resonance imaging. The signal-to-noise ratio (SNR) of liver parenchyma and contrast-to-noise ratio of bile duct, as well as the contrast between bile duct and liver parenchyma, were calculated. The biliary anatomy correlation with the IOC during hepatectomy and patient prognosis were also evaluated. Results: Quantitative results of the SNR of the liver parenchyma post-GD-DTPA were statistically significantly lower than preenhanced MRC (2.69 times reduced from the preenhanced MRC). The contrast of the bile duct and liver parenchyma in post-GD-DTPA were significantly higher than the preenhancement MRC. The anatomic diagnostic accuracy rate of post-GD-DTPA MRC was 92.9%. The sensitivity and specificity of GD-PTPA MRC were 85% and 96%, respectively. GD-DTPA-enhanced MRC has higher accuracy than the preenhanced MRC (92.9% vs 75%). The concurrence between GD-DTPA-enhanced MRC and IOC were commendable (kappa = 0.9). The posttransplant biliary complication rate was 5.5%, and the 3-year survival rate was 91.2% in the recipients. Conclusion: GD-DTPA, a paramagnetic metal, can shorten the T1 and T2 relaxation values of surrounding protons. This decreases the signal of the liver parenchyma and brightens the biliary anatomy. It can improve the image quality of MRC and increase the diagnostic accuracy of the biliary tract classification. It is mandatory in the "donor and recipient surgery during the LDLT". © 2012 by Elsevier Inc. All rights reserved.

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