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788A AASLD ABSTRACTS HEPATOLOGY, October, 2015 Disclosures: Parvez S. Mantry - Consulting: Salix, Gilead, Janssen, Abbvie, BMS; Grant/ Research Support: Salix, Merck, Gilead, Boehringer-Ingelheim, Mass Biologics, Vital Therapies, Santaris, mass biologics, Bristol-Myers Squibb, Abbive, Bayer-Onyx, Shinogi, Tacere, Intercept; Speaking and Teaching: Gilead, Janssen, Salix Jeffrey S. Weinstein - Speaking and Teaching: Merck Hector E. Nazario - Advisory Committees or Review Panels: Gilead, Janssen; Speaking and Teaching: Gilead, Merck, Abbvie, Janssen Edward A. Dominguez - Advisory Committees or Review Panels: Gilead, Pfizer; Grant/Research Support: Cubist; Speaking and Teaching: Amgen, Astelleas The following authors have nothing to disclose: Carlos Fasola, Adil Habib, Maisha Barnes, Alejandro Mejia, Richard Dickerman, Stephen Cheng 1170 Treatment of Chronic HCV Genotype 1 (G1) Infection with Boceprevir: Frequency, Severity, Predictability and Management of Anemia in German Real-Life Gerlinde Teuber 1 , Peter Buggisch 2 , Hanns F. Loehr 3 , Hermann Steffens 4 , Michael R. R. Kraus 5 , Peter R. Geyer 6 , Bernd Weber 7 , Thomas Witthoeft 8 , Uwe Naumann 9 , Elmar Zehnter 10 , Dagmar Hartmann 11 , Bernd Dreher 11 , Manfred Bilzer 11 ; 1 Gastroenterological Practice, Frankfurt, Germany; 2 IFI Liver Center Hamburg, Hamburg, Germany; 3 Gastroenterological Practice, Wiesbaden, Germany; 4 Practice of Internal Medicine, Berlin, Germany; 5 Department II, Klinikum Burghausen, Burghausen, Germany; 6 Gastroenterological Practice, Fulda, Germany; 7 Competence Center Addiction, Kassel, Germany; 8 Gastroenterological Practice, Stade, Germany; 9 Center of Medicine, Berlin, Germany; 10 Gastroenterological Practice, Dortmund, Germany; 11 MSD Pharma GmbH, Haar, Germany Background: Anemia is a frequent complication in patients (pts) undergoing triple therapy with the HCV protease inhibitor boceprevir (BOC). Data regarding the frequency, severity, predictability and management of anemia caused by triple therapy in real-life are still scarce and were evaluated in the present interim analysis. Methods: From April 2012 until January 2014, 536 pts with HCV G1 infection were recruited in the ongoing NOVUS observational study by 97 practices and hospitals in Germany. Pts were treated with pegylated interferons (PegIFN) and ribavirin (RBV) together with BOC for 24 to 44 weeks after a 4 weeks lead-in period with PegIFN/RBV. The present interim analysis was restricted to 265 treatment-naïve and 132 previously treated pts with documented hemoglobin (Hb) levels at baseline and during therapy. Results: During BOC triple therapy anemia (Hb
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 789A past regimens in achieving SVR in this difficult to treat population. Table 1. Main demographic, baseline clinical, virological and laboratory (values expressed as mean ± standard deviation) characteristics of HCV-MC patients or ombitasvir/paritaprevir/ritonavir/dasabuvir for GT1 and sofosbuvir/ribavirin for GT 2/3. Data was included from 13 additional patients who are still awaiting medication approval for a total of 54 patients. Among these 54 patients, HCV medications were approved in 84% of patients with private insurance, 71% of Medicare and 50% of Medicaid patients (p=0.11). There was no difference in approval rate based on age, race, gender, genotype, treatment regimen or presence of cirrhosis. The median time spent per patient was 92.5 minutes (IQR 80.0-105.0). The median cost spent per patient was $60.54 (IQR 53.00-72.90). There was no difference in time spent acquiring HCV medications or cost per patient by genotype, insurance status, treatment regimen or presence of cirrhosis. Conclusion: In a Hepatology practice with experienced staff using a specialty pharmacy to improve efficiency, the median provider time needed to obtain DAAs was 90 minutes per patient. This relatively labor intensive process will need to be streamlined to encourage more clinicians to engage in HCV therapy for the large number of potential candidates in the United States. Disclosures: The following authors have nothing to disclose: Veronica Loy, Tamara Benyashvili, Megan OMahony, Douglas Pavkov, William Adams, Robin Todus, Michelle Watts, Natasha Von Roenn, Scott Cotler HCV:hepatitis c virus MC: mixed cryoglobulinemia Disclosures: T. Craig Cheetham - Grant/Research Support: Gilead, BMS The following authors have nothing to disclose: Rasham Mittal, Zoe Bider-Canfield, Amandeep K. Sahota 1172 The Time and Cost Investment Required to Obtain and Initiate Direct Acting Antiviral Therapy Veronica Loy, Tamara Benyashvili, Megan OMahony, Douglas Pavkov, William Adams, Robin Todus, Michelle Watts, Natasha Von Roenn, Scott Cotler; Hepatology, Loyola Medical Center, Chicago, IL The biggest barrier to direct-acting antiviral agent (DAA) therapy for hepatitis C (HCV) is cost. Initiating treatment with DAAs can be time intensive for the provider, including obtaining prior authorization. The purpose of this study was to assess the amount of unbillable time and cost needed to obtain DAAs for HCV. Methods: We prospectively enrolled patients for whom DAA therapy was planned from 9/30/2014- 3/19/2015. Providers recorded the amount of time spent in minutes to obtain medication and to initiate HCV therapy for each patient. The position of each provider (APN, RN, LPN) was noted. Data included age, gender, race, HCV genotype, type of insurance carrier, and presence of cirrhosis. Patients who subsequently defered therapy and those with incomplete time data were excluded from data analysis. In our practice, 2 LPNs and 6 RNs collect patient information and use a specialty pharmacy to obtain approval for DAAs. An APN reviews potential medication interactions and conducts a patient education session by phone. Time spent was converted to cost per patient based on average hourly medical wages in Illinois by Salary.com. Administrative time and cost per patient was compared by insurance carrier, HCV genotype, treatment regimen and presence of cirrhosis. Results: 79 patients consented to participate in the study. 25 were excluded due to incomplete time data (n=17) or subsequent deferral of therapy (n=8). 41 patients were started on therapy consisting of sofosbuvir/ledipasvir 1173 Health resource usage in peri-transplant patients during 12 weeks of therapy with sofosbuvir (SOF), with or without ribavirin (RBV) and an NS5A inhibitor Suman Verma 1 , Graham R. Foster 2 , William Irving 3 , John McLauchlan 5 , Michelle C. Cheung 2 , Benjamin E. Hudson 4 , Ivana Carey 1 , Kosh Agarwal 1 ; 1 Institute of liver <strong>studies</strong>, Kings College Hospital, London, United Kingdom; 2 The Blizard Institute, Queen Marys University of London, London, United Kingdom; 3 Virology, University of Nottingham, Nottingham, United Kingdom; 4 University of Nottingham, Nottingham, United Kingdom; 5 MRC University of Glasgow, London, United Kingdom Introduction Direct acting antiviral (DAA) therapy for HCV decompensated disease is a reality. However, health economic benefit in this advanced peritransplant population remains unclear. This study aims to assess healthcare resource utilization and quality returns from a clinical and cost perspective during 12 weeks (wks) of DAA therapy in this challenging population. Methods The UK NHS England Early Access Program (EAP) mandated antiviral therapy to HCV positive patients with advanced liver disease via 17 centres. Twelve weeks of therapy with SOF and an NS5A inhibitor (Ledipasvir or Daclatasvir), with or without RBV was administered to a cohort of ~500 decompensated cirrhostics, with 179 peritransplant (PT). PT was defined as meeting the NHSBT criteria for liver transplantation (LT) (n=56); on the national LT waiting list (n=50); or a previous LT with advanced HCV recurrence in graft and portal hypertension (n=45). Choice of therapy was clinician discretion. Data collection was prospective during the 12 wks of therapy via HCV Research UK on use of blood products; patient phone calls made to healthcare professionals including specialist hepatitis nurses (SHN) and consultants; unscheduled clinic appointments; and elective and emergency admissions into hospital and intensive care (ITU). Results Of the179 PT patients enrolled, 151 had completed 12 wks of therapy at the time of abstract submission. During this, 148 phone calls were made to SHN; 5 to hepatology consultants and 42 to other healthcare professionals (OHP) including GPs and clinical pharmacists, with a total duration of 993, 25, 280 minutes respectively. A total of 367 unscheduled clinic appointments
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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1366A CATEGORY INDEX HEPATOLOGY, Oc
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