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742A AASLD ABSTRACTS HEPATOLOGY, October, 2015 ever, efficacy was suboptimal. Further research is needed to determine whether more potent DAA regimens with or without RBV will allow treatment duration to be shortened in acute or recently acquired HCV infection. Disclosures: Edward J. Gane - Advisory Committees or Review Panels: Novira, AbbVie, Janssen, Gilead Sciences, Janssen Cilag, Achillion, Merck, Tekmira; Speaking and Teaching: AbbVie, Gilead Sciences, Merck Joe Sasadeusz - Grant/Research Support: Gilead Sciences, BMS, Roche, Janssen; Speaking and Teaching: Gilead Sciences, Roche, BMS Kathy Petoumenos - Grant/Research Support: Gilead Sciences Jason Grebely - Advisory Committees or Review Panels: Merck, Gilead; Grant/ Research Support: Merck, Gilead, Abbvie, BMS Gregory Dore - Board Membership: Gilead, Merck, Abbvie, Bristol-Myers Squibb; Grant/Research Support: Gilead, Merck, Abbvie, Bristol-Myers Squibb; Speaking and Teaching: Gilead, Merck, Abbvie, Bristol-Myers Squibb Gail Matthews - Advisory Committees or Review Panels: gilead; Consulting: Viiv; Grant/Research Support: Gilead Sciences, janssen; Speaking and Teaching: BMS, MSD The following authors have nothing to disclose: Marianne Martinello, Margaret Hellard, David Shaw, Tanya L. Applegate, Laurence Maire, Philippa Marks, David Cooper patients, including 6 with GT1b infection, received 3D+RBV for 24 weeks, and 13 GT1b patients received treatment without RBV for 24 weeks. SVR4 was achieved in 39/40 (98%) patients. The most common adverse events (AEs) were fatigue, nausea, headache, rash, anemia, and asthenia. Two serious AEs were reported, neither of which was attributed to study drugs. One patient with a history of prior LT rejection discontinued treatment on day 86 due to low grade rejection revealed by liver biopsy, but achieved SVR12. Hemoglobin declines
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 743A 1085 Utilizing claims data to understand the relationships between diagnosing, prescribing, and dispensing patterns for HCV patients in the pre and post sofosbivir eras Michel F. Denarie; Real world evidence Solutions, IMS Health, Yardley, PA UTILIZING CLAIMS DATA TO UNDERSTAND THE RELATION- SHIPS BETWEEN DIAGNOSING, PRESCRIBING, AND DIS- PENSING PATTERNS FOR HCV PATIENTS IN THE PRE AND POST SOFOSBUVIR ERAS BACKGROUND AND AIMS: The treatment of Hepatitis C (HCV) patients has undergone profound change since the introduction of sofosbuvir in late 2013. Many patients were warehoused until the launch of sofosbuvir because it was the first directly acting antiviral (DAA) to offer an interferon-free, short duration, highly tolerable and efficacious regimen. The study also determined the amount and duration of patient warehousing and the variations between ethnicities. The intent was to utilize claims data to demonstrate how HCV treatment dynamics have changed in the pre and post sofosbuvir era. DESIGN/METHODS: This 2 year retrospective study utilized US IMS claims data. Patients were selected for HCV diagnosis for a period of six months, then followed for a period of 12 months to determine the date of prescription, and then followed for an additional 6 months to ascertain whether they were actually dispensed the prescribed product(s). We limited the analysis to patients prescribed telaprevir, boceprevir, sofosbuvir and simeprevir; breaking into two patient cohorts: pre-sofosbuvir (Period 1/Jan 2012 - Nov 2013) and post-sofosbuvir (Period 2/Dec 2013 - Aug 2014) launch. Using these cohorts, we were able to determine an index diagnosis date, an index written date, and an index dispensed date. RESULTS: 11,256 newly diagnosed HCV patients (40% females and 60% males) were included in the study. Results demonstrate the amount and length of patient warehousing increased dramatically in the 12 months preceding the introduction of sofosbuvir and simeprevir (see Chart 1), most notably for patients prescribed sofosbuvir and simeprevir. During Period 1, 93% of simeprevir and 81% of sofosbuvir patients were dispensed their medication more than 12 months after the initial HCV diagnosis was recorded, while only 45% of simeprevir and 36% of sofosbuvir patients were dispensed their medication more than 12 months after initial diagnosis in Period 2. The time between the WRx (written scripts) to the DRx (dispensed script) did not materially change. Chart 1 CONCLUSIONS: This study displayed the drastic differences in patient warehousing between Periods 1 and 2, most notably for sofosbuvir and simeprevir treatments. Many newly diagnosed HCV patients waited for the new DAAs to be introduced to receive a prescription. Once prescribed, despite the high cost of treatment, the time between the WRx and the DRx did not materially increase, and remained mostly within one month indicating the benefits outweighed the cost. Disclosures: The following authors have nothing to disclose: Michel F. Denarie 1086 Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Patients With or Without Cirrhosis Stefan Zeuzem 2 , Ira M. Jacobson 3 , Jordan J. Feld 4 , Heiner Wedemeyer 5 , Xavier Forns 6 , Pietro Andreone 7 , Massimo Colombo 8 , David Bernstein 9 , Fred Poordad 10 , Christophe Hezode 11 , Thomas Podsadecki 1 , Wangang Xie 1 , Tami Pilot-Matias 1 , Regis A. Vilchez 1 , John M. Vierling 12 ; 1 AbbVie, North Chicago, IL; 2 J.W. Goethe University, Frankfurt, Germany; 3 Weill Cornell Medical College, New York, NY; 4 Toronto Centre for Liver Disease, University of Toronto, Toronto, ON, Canada; 5 Medizinische Hochschule Hannover, Hannover, Germany; 6 Liver Unit, Hospital Clinic, IDIBAPS and CIBEREHD, Barcelona, Spain; 7 Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna, Bologna, Italy; 8 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy; 9 North Shore University Hospital, Manhasset, NY; 10 The Texas Liver Institute/University of Texas Health Science Center, San Antonio, TX; 11 Henri Mondor University Hospital, AP-HP, Universite Paris-Est, Cr’eteil, France; 12 Baylor College of Medicine, St. Luke’s Advanced Liver Therapies, Houston, TX Introduction: Treatment with the 3 direct-acting antiviral (3D) regimen of ombitasvir (OBV), paritaprevir (PTV, boosted with ritonavir [r]; identified by AbbVie and Enanta) and dasabuvir (DSV), with or without ribavirin (RBV), achieved sustained virologic response (SVR) rates between 95% and 100% across a broad range of hepatitis C virus (HCV) genotype (GT) 1-infected patients. In this analysis, we examined the efficacy through post-treatment week 48 of the 3D regimen in HCV GT1-infected patients with or without cirrhosis. Methods: Treatment-naïve and -experienced HCV GT1a- or GT1b-infected patients with and without compensated cirrhosis received the recommended 3D regimen of co-formulated OBV/PTV/r (25mg/150mg/100mg once daily) and DSV (250mg twice daily), ± weightbased RBV, for 12 or 24 weeks in six phase 3 <strong>studies</strong>. GT1b-infected patients without cirrhosis did not receive RBV as part of their treatment regimen. SVR at post-treatment week 12 (SVR12; HCV RNA
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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1366A CATEGORY INDEX HEPATOLOGY, Oc
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