studies

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 studies. GT1b-infected
patients without cirrhosis did not receive RBV as part of their
treatment regimen. SVR at post-treatment week 12 (SVR12;
HCV RNA