studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 723A
MELD Change from Baseline to Follow-up Week 12
Didier Samuel - Consulting: Astellas, MSD, BMS, Roche, Novartis, Gilead, LFB,
Janssen-Cilag, Biotest, Abbvie
Gregory T. Everson - Advisory Committees or Review Panels: Roche/Genentech,
Abbvie, Galectin, Boehringer-Ingelheim, Eisai, Bristol-Myers Squibb, HepC
Connection, BioTest, Gilead, Merck; Board Membership: HepQuant LLC, PSC
Partners, HepQuant LLC; Consulting: Abbvie, BMS, Gilead, Bristol-Myers Squibb;
Grant/Research Support: Roche/Genentech, Pharmassett, Vertex, Abbvie, Bristol-Myers
Squibb, Merck, Eisai, Conatus, PSC Partners, Vertex, Tibotec, GlobeImmune,
Pfizer, Gilead; Management Position: HepQuant LLC, HepQuant LLC;
Patent Held/Filed: Univ of Colorado; Speaking and Teaching: Abbvie, Gilead
Xavier Forns - Consulting: Jansen, Abbvie; Grant/Research Support: Jansen,
Gilead
The following authors have nothing to disclose: Hans Van Vlierberghe, Robert
Brown
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
Michael P. Manns - Consulting: Roche, BMS, Gilead, Boehringer Ingelheim,
Novartis, Idenix, Achillion, GSK, Merck/MSD, Janssen, Medgenics; Grant/
Research Support: Merck/MSD, Roche, Gilead, Novartis, Boehringer Ingelheim,
BMS; Speaking and Teaching: Merck/MSD, Roche, BMS, Gilead, Janssen, GSK,
Novartis
Geoff McCaughan - Advisory Committees or Review Panels: Gilead
Michael P. Curry - Advisory Committees or Review Panels: Bristol Meyers Squib,
Abbvie; Grant/Research Support: Gilead Sciences, Mass Biologics, Merck,
Salix, Conatus; Stock Shareholder: Achilion
Markus Peck-Radosavljevic - Advisory Committees or Review Panels: Bayer, Gilead,
Janssen, BMS, AbbVie; Consulting: Bayer, Boehringer-Ingelheim, Jennerex,
Eli Lilly, AbbVie; Grant/Research Support: Bayer, Roche, Gilead, MSD, AbbVie;
Speaking and Teaching: Bayer, Roche, Gilead, MSD, Eli Lilly, AbbVie, Bayer
Jill M. Denning - Employment: Gilead Sciences, Inc.
Sarah Arterburn - Employment: Gilead Sciences Inc.; Stock Shareholder: Gilead
Sciences Inc.
Phillip S. Pang - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences
Diana M. Brainard - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
John G. McHutchison - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
Princy N. Kumar - Consulting: Janssen, ViiV Healthcare; Grant/Research Support:
Janssen, Merck, GSK, Gilead; Stock Shareholder: Merck, Phizer, Johnson&-
Johnson, GSK, Gilead
Eric M. Yoshida - Advisory Committees or Review Panels: Hoffman LaRoche, Gilead
Sciences Inc, Abbvie; Grant/Research Support: Abbvie, Hoffman LaRoche,
Merck Inc, Vertex Inc, Jannsen Inc, Gilead Sciences Inc, Boeringher Ingleheim
Inc, Astellas; Speaking and Teaching: Gilead Sciences Inc, Merck Inc
Massimo Colombo - Advisory Committees or Review Panels: BRISTOL-MEY-
ERS-SQUIBB, SCHERING-PLOUGH, ROCHE, GILEAD, BRISTOL-MEYERS-SQUIBB,
SCHERING-PLOUGH, ROCHE, GILEAD, Janssen Cilag, Achillion; Grant/
Research Support: BRISTOL-MEYERS-SQUIBB, ROCHE, GILEAD, BRISTOL-MEY-
ERS-SQUIBB, ROCHE, GILEAD; Speaking and Teaching: Glaxo Smith-Kline,
BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH, ROCHE, NOVARTIS, GILEAD,
VERTEX, Glaxo Smith-Kline, BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH,
ROCHE, NOVARTIS, GILEAD, VERTEX, Sanofi
Bart van Hoek - Advisory Committees or Review Panels: Janssen-Cilag, Bristol
Meyers Squib, Gilead, Merck, Abbvie
Jean-Francois Dufour - Advisory Committees or Review Panels: Bayer, BMS, Gilead,
AbbVie, Novartis, Sillagen, Genfit
Charles S. Landis - Grant/Research Support: Gilead, Abbvie, BMS
David J. Mutimer - Advisory Committees or Review Panels: Gilead Sciences,
AbbVie, Janssen, MSD, BMS; Speaking and Teaching: Gilead Sciences, AbbVie,
Janssen, BMS
Steven L. Flamm - Advisory Committees or Review Panels: Gilead, Bristol Myers
Squibb, AbbVie, Janssen, Salix; Consulting: Merck, Janssen, Bristol Myers
Squibb, AbbVie, Salix, Gilead; Grant/Research Support: Janssen, Bristol Myers
Squibb, Gilead, AbbVie; Speaking and Teaching: Salix
Michael R. Charlton - Grant/Research Support: GIlead Sciences, Merck, Janssen,
AbbVie, Novartis
K. Rajender Reddy - Advisory Committees or Review Panels: Merck, Janssen,
Vertex, Gilead, BMS, Abbvie; Grant/Research Support: Merck, BMS, Ikaria,
Gilead, Janssen, AbbVie
1050
Adherence and Discontinuation Rates of Sofosbuvir-Based
Regimens: Modeling Real World Experience in
a Large Managed Care Organization
Pravin S. Kamble 2 , David R. Walker 1 , Steven Marx 1 , Ray Harvey 2 ,
Claudia L. Uribe 2 , Suvapun Bunniran 2 , Jenna Collins 2 ; 1 HEOR,
Abbvie, North Chicago, IL; 2 Outcomes, Comprehensive Health
Insights, Louisville, KY
BACKGROUND Discontinuation (DC) rates of sofosbuvir (SOF)
based medications are generally very low in clinical trials (<
1%). Adherence (ADH) rates on the other hand are rarely
reported in clinical trials. Only a handful of studies have examined
this issue outside of clinical trials, however, those studies
did not comprehensively attempt to adjust for factors that may
impact DC and ADH rates. OBJECTIVES The objective was to
assess medication ADH and DC rates in SOF-based regimens
and identify factors potentially associated with poor ADH and
DC rates in patients with the hepatitis C virus (HCV). METH-
ODS A retrospective cohort study using administrative claims
data from a large managed care organization from May 2013
to Sept 2014. Plan types included Medicare Advantage Prescription
Drug (MAPD) and commercial (COM) which provide
medical and pharmacy benefits. The study cohort included
patients initiating 12 or 24-week treatment on SOF. The index
date was defined as the first prescription fill date for SOF from
Nov 2013 to March or May 2014 with a follow up period of
12 or 24 weeks. Continuous enrollment for 6 months pre-index
and 4 or 6 months post index date was required. ADH was calculated
using proportion of days covered (PDC). Patients with
at least 85% PDC were categorized as adherent. Patients were
deemed discontinued if a gap of >14 days exists between
fills. Regression analyses were conducted to identify baseline
covariates associated with ADH or DC among plan members.
Covariates included age, gender, risk score, plan type, geographic
region, treatment co-pay, prior treatment experience,
use of interferon, treatment duration and baseline healthcare
use and costs. RESULTS In total, 514 MAPD and 63 COM
members initiated HCV treatment with DAA. Patients were 63%
male, mean age of 60 years, 84% on 12-week treatment,
and 36% of SOF members were also on peginteferon. The
discontinuation rate was 18% and the percent of members
considered non-adherent was 14%. Based on the regression
analysis, only older age, higher comorbidity risk score and
use of peginterferon were significantly positively associated
with non-adherence after controlling for other covariates. For
12-week treatment patients, being in a non-HMO plan or in
Medicare were predictors of being at lower risk of medication
discontinuation. CONCLUSIONS In a real world setting, 14%
of members on a new DAA are not adherent and 18% had
fill gaps greater than 14 days. Sicker, older members are less
likely to be adherent, whereas non-HMO and MAPD members