studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 923A
Figure. Changes in fatigue and work productivity scores during
and after treatment with different anti-HCV regimens.
Disclosures:
Zobair M. Younossi - Advisory Committees or Review Panels: Salix, Janssen,
Vertex; Consulting: Gilead, Enterome, Coneatus
The following authors have nothing to disclose: Maria Stepanova, Linda Henry,
Fatema Nader, Sharon L. Hunt
1461
Cost-effectiveness of Daclatasvir in Combination with
Sofosbuvir for the Treatment of Subjects with Genotype
3 Chronic Hepatitis C Infection in the United States
Catherine St-Laurent Thibault 1 , Divya Moorjaney 1 , Michael Ganz 1 ,
Bruce E. Sill 2 , Shalini Hede 2 , Yong Yuan 2 , Anupama Kalsekar 2 ,
Boris Gorsh 2 ; 1 Modeling and Simulation, Evidera, St-Laurent, QC,
Canada; 2 Bristol-Myers Squibb Company, Plainsboro, NJ
BACKGROUND: An open label phase III trial evaluated the
efficacy and safety of daclatasvir (DCV) in combination with
sofosbuvir (SOF) for treatment of subjects with genotype (GT)
3 hepatitis C virus (HCV). This study evaluated the cost-effectiveness
of DCV+SOF versus SOF in combination with ribavirin
(RBV) over a time horizon of 20 years from the payer perspective
in the United States (US). METHODS: A published Markov
model was adapted to reflect US baseline demographic
characteristics, treatment patterns, costs of drug acquisition,
monitoring, disease management and adverse event management,
and mortality risks. Clinical inputs were based on the
ALLY3 trial for DCV+SOF and the VALENCE trial for SOF+RBV.
The primary cost-effectiveness outcome was the incremental
cost-utility ratio (ICUR). Life-years, incidence of complications
(compensated cirrhosis, decompensated cirrhosis, hepatocellular
carcinoma, liver transplant and liver-related death),
number of patients achieving sustained virological response
(SVR) and the total cost per SVR were used as the secondary
outcomes. Costs (2014 USD) and QALYs were discounted at
3% per year. An estimated cost was used for DCV based on
the current standard of care. Deterministic sensitivity analyses
(DSA) (varying SVR probabilities [+/-10%], health state and
therapy costs [+/-20%]), probabilistic sensitivity analyses (PSA)
(with probabilistic sampling of key inputs at each of the 1,000
iterations using their respective standard error) and scenario
analyses (evaluating the impact of various time horizons [5, 10
and 80 years] along with analyses for specific subpopulations
[treatment-naïve, treatment-experienced, cirrhotic or non-cirrhotic])
were conducted to assess the robustness of the results
to changes in inputs and assumptions. RESULTS: Compared
with SOF+RBV, DCV+SOF was a dominant treatment in the
base case as well as in almost all scenarios (i.e., treatment-experienced.
non-cirrhotic, lower DCV price, 5 and 10 year time
horizon). In the cirrhotic and treatment naïve population scenarios,
DCV+SOF was less costly but also slightly less effective
compared to SOF+R. DSA for the overall population showed
that ICURs were sensitive to variations in the probability of
achieving SVR for DCV+SOF and SOF+RBV. PSA for the overall
population indicated that DCV+SOF yielded an ICUR below
$50,000 per QALY gained in 78.7% of all iterations compared
to SOF+RBV. CONCLUSION: DCV+SOF is a dominant
option compared with SOF+RBV in the US for the overall GT3
HCV patient population. It may be important to understand the
real-world SVR rates, as variations in this efficacy parameter
can have a significant impact on the ICUR.
Disclosures:
Bruce E. Sill - Employment: Bristol-Myers Squibb; Stock Shareholder: Bristol-Myers
Squibb
Yong Yuan - Employment: Bristol Myers Squibb Company
Anupama Kalsekar - Employment: Bristol Myers Squibb
Boris Gorsh - Employment: Bristol-Myers Squibb; Stock Shareholder: Bristol-Myers
Squibb
The following authors have nothing to disclose: Catherine St-Laurent Thibault,
Divya Moorjaney, Michael Ganz, Shalini Hede
1462
The cost-effectiveness of ombitasvir/paritaprevir/ritonavir,
dasabuvir and ribavirin (3D+R) in patients with
liver transplantation after genotype 1 hepatitis C virus
infection
Sammy Saab 2 , Yuri Sanchez 3 , Caroline Huber 1 , Alice Wang 3 ,
Timothy R. Juday 3 ; 1 Precision Health Economics, Los Angeles, CA;
2 Pfleger Liver Institute, University of California, Los Angeles, Los
Angeles, CA; 3 AbbVie, Inc., North Chicago, IL
Background: Hepatitis C virus (HCV) is the most common indication
for liver transplantation, and HCV infection recurs in
over 90% of patients within a month of transplant. Liver fibrosis
progresses more rapidly after recurrence, and treatment
options historically have been limited in this population. New
interferon-free regimens have demonstrated safety and efficacy
in the post-transplant HCV population; we explore the cost-effectiveness
of regimens with FDA-approval or Phase III trial
results in the post-liver transplant setting from a US healthcare
system perspective. Methods: A cohort of post-liver transplant
patients with recurrent HCV genotype 1 and fibrosis stage
F0-F2 was modeled using a two-phase Markov model. In the
first phase, all patients underwent one of three treatment scenarios:
no treatment (NT), pegylated interferon and ribavirin
for 48 weeks (PR48), or ombitasvir/paritaprevir/ritonavir,