studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 773A
1142
Treatment Outcomes of Veterans with Decompensated
Cirrhosis Receiving All Oral Direct Acting Antiviral Hepatitis
C Therapy
Abigail Rabatin 1 , Mohamed Hashem 1 , Mary L. Townsend 1 , William
E. Bryan 1 , Cynthia A. Moylan 1,2 , Steve S. Choi 1,2 , Susanna
Naggie 1,2 ; 1 Durham VA Medical Center, Raleigh, NC; 2 Duke University
Medical Center, Durham, NC
Purpose Patients infected with hepatitis C virus (HCV) and decompensated
cirrhosis are a therapeutic challenge. The purpose of
this study was to evaluate the effectiveness and safety of oral
sofosbuvir-based regimens in Veterans with decompensated cirrhosis.
Design This is a multicenter, retrospective, cohort study
utilizing the national Veterans Affairs (VA) electronic medical
record. Veterans with decompensated cirrhosis who received
a sofosbuvir-based HCV regimen at a VA between 12/06/13
and 12/31/14 were included. Veterans who received interferon-containing
regimens were excluded. Possible decompensation
was identified using VA outpatient prescription data for
either lactulose, rifaximin or sorafenib. Manual chart review
was conducted confirming decompensating event (bleeding
esophageal varices, hepatic encephalopathy, ascites, spontaneous
bacterial peritonitis or hepatocellular carcinoma). The
primary objective was sustained virologic response defined as
an undetectable HCV RNA 12 weeks post-treatment (SVR12).
This study was approved by the Durham VA IRB. Results A total
of 7,622 Veterans received sofosbuvir during the study period
and 517 met criteria based on prescription data for possible
decompensation. A convenience sample of 250 was assessed
by manual chart review, of which 150 met inclusion criteria.
84% (N=126) completed treatment and 16% (N=24) discontinued
treatment early. The majority of Veterans were male
(97%), Caucasian (70%), with genotype 1-infection (84%) and
a mean age of 61 years. Median platelet count was 78 and
median albumin 3.1. There were 5 patients co-infected with
HBV and 5 with HIV. SVR12 is provided in Table 1. Relapse
was the only reason for virologic failure in Veterans completing
therapy. A majority of Veterans (69%) experienced at least one
adverse event (AE), most commonly fatigue (26%) and nausea
(11%). Severe AEs were uncommon (8%, N=12) and included
3 deaths that were not treatment related. Four patients died
after end of treatment. Conclusion All oral direct acting antiviral
regimens containing sofosbuvir are safe in Veterans with
decompensated cirrhosis; however, relapse rates were high
in this cohort. Patients with decompensated cirrhosis remain a
special population with unmet medical need and a high mortality
regardless of therapy.
Table 1
1143
Cost-effectiveness of ombitasvir/paritaprevir/ritonavir,
dasabuvir +/- ribavirin (3D±R) in patients with genotype
(GT) 1 chronic hepatitis C virus (HCV) and human
immunodeficiency virus (HIV) coinfection compared with
other standards of care in the US
Suchin Virabhak 2 , Scott J. Johnson 2 , Hélène Parisé 2 , Timothy R.
Juday 1 , Alice Wang 1 , Yuri Sanchez 1 , Sammy Saab 3 ; 1 HEOR,
AbbVie, Mettawa, ID; 2 Medicus Economics Inc., Boston, MA;
3 Pfleger Liver Institute, UCLA, Los Angeles, CA
BACKGROUND 3D±R has demonstrated safety and efficacy
in patients with GT1 HCV and HIV coinfection. Its cost-effectiveness
has not been evaluated vs no treatment (NT) or other
standards of care in the US, including sofosbuvir plus ledipasvir
(SOF+LDV), sofosbuvir plus pegylated-interferon and ribavirin
(SOF+PR), and SOF+R. METHODS A cost-effectiveness Markov
model was developed based on a natural HCV history with 13
health states: 8 disease progression states (F0-F4, decompensated
cirrhosis, hepatocellular carcinoma, and liver transplant),
3 sustained virologic response states, a spontaneous clearance
state, and a mortality state. Transition rates were obtained
from published literature. Adverse event rates, treatment-related
disutilities, treatment durations and efficacy rates were based
on the following clinical trials: TURQUOISE I (3D±R), ERADI-
CATE (SOF+LDV), PHOTON-1 and PHOTON-2 (SOF+R), and
P7977-1910 (SOF+PR). Baseline patient characteristics were
based on TURQUOISE I. Direct medical costs, including HIV
antiretroviral therapy, were extracted from a systematic literature
review and drug costs were based on the December 2014
Red Book. The model had a lifetime horizon with an annual
discount rate of 3%. Outcomes were measured in quality-adjusted
life-years (QALYs), lifetime costs, and incremental cost
effectiveness ratios (ICERs) in the overall coinfected population
and the treatment-naïve non-cirrhotic subpopulation, where
data were available. Probabilistic sensitivity analyses (PSA)
were conducted by varying all parameters simultaneously.
RESULTS In the overall coinfected population, 3D±R was “dominant”
over SOF+R (i.e., was less costly and more effective)
and was cost-effective at a threshold of $50,000 per QALY
gained compared to NT and SOF+PR. In naïve non-cirrhotic
coinfected patients, 3D±R was cost-effective compared to NT
at a $50,000 threshold per QALY gained. Compared with
SOF+LDV, 3D±R offers 0.1 less QALYs and $11,895 lower
lifetime costs. 3D±R was the preferred regimen in the majority
of PSA simulations when QALYs were valued at $50,000 or
$100,000 each. CONCLUSIONS 3D±R is a cost-effective treatment
option for GT1 HCV and HIV coinfected patients, both in
the overall and naïve non-cirrhotic populations, compared to
NT and other standards of care in the US.
Disclosures:
Susanna Naggie - Advisory Committees or Review Panels: BMS, Gilead, Abb-
Vie, Merck; Grant/Research Support: Gilead, AbbVie, BMS, Jenssen, Merck,
Achillion
The following authors have nothing to disclose: Abigail Rabatin, Mohamed
Hashem, Mary L. Townsend, William E. Bryan, Cynthia A. Moylan, Steve S. Choi
NA: No clinical trial data available
Disclosures:
Suchin Virabhak - Consulting: AbbVie
Scott J. Johnson - Consulting: AbbVie; Employment: Medicus Economics
Hélène Parisé - Consulting: MedicusEconomics LLC, AbbVie ; Employment: Statlog
Consulting Inc
Timothy R. Juday - Employment: AbbVie; Stock Shareholder: AbbVie
Yuri Sanchez - Employment: AbbVie; Stock Shareholder: AbbVie