studies

790A AASLD ABSTRACTS HEPATOLOGY, October, 2015
were required during the treatment period with 178 delivered
by consultants, 112 by SHN and 77 by OHP. Support for
anemia with erythropoietin, cosmofer or blood transfusion was
required equally across the PT cohorts (previous LT 7, fulfilling
NHSBT criteria 5, listed for LT 7). In addition there were
133 hospital admissions with 25% electively for ascites drainage,
and as an emergency 5% for variceal bleed and 9% for
encephalopathy. Furthermore, 21 patients underwent LT, with
complete inpatient stay data available for 13. This demonstrated
an average stay of 18.07 days, with 2.85 days on ITU
and 1.53 days ventilated. Further data will be presented at
AASLD specifically addressing financial costs. Conclusion This
preliminary analysis of health resource usage by PT patients
during SOF and NS5A inhibitor +/- RBV demonstrates that this
challenging advanced disease population still utilize significant
healthcare resource despite better tolerability of the new DAA
therapies.
Disclosures:
Graham R. Foster - Advisory Committees or Review Panels: GlaxoSmithKline,
Novartis, Boehringer Ingelheim, Tibotec, Chughai, Gilead, Janssen, Idenix,
GlaxoSmithKline, Novartis, Roche, Tibotec, Chughai, Gilead, Merck, Janssen,
Idenix, BMS; Board Membership: Boehringer Ingelheim; Grant/Research Support:
Chughai, Roche, Chughai; Speaking and Teaching: Roche, Gilead, Tibotec,
Merck, BMS, Boehringer Ingelheim, Gilead, Janssen
William Irving - Advisory Committees or Review Panels: Novartis, MSD, Janssen
Cilag, Bristol Myers Squibb; Grant/Research Support: GSK, Pfizer, Janssen
Cilag, Gilead Sciences; Speaking and Teaching: Janssen Cilag, Roche
Ivana Carey - Grant/Research Support: Gilead, Roche; Speaking and Teaching:
BMS
Kosh Agarwal - Advisory Committees or Review Panels: Gilead, Novartis,
Abbott; Grant/Research Support: Roche, MSD; Speaking and Teaching: BMS,
Astellas, Janssen
The following authors have nothing to disclose: Suman Verma, John McLauchlan,
Michelle C. Cheung, Benjamin E. Hudson
1174
Outcomes of ribavirin free regimens for treatment of
recurrent hepatitis C (genotype1) infection post liver
transplant
Mohamed G. Shoreibah 1 , DeAnn Jones 2 , Sarah Baggett 2 , Brendan
M. McGuire 1 , Omar Massoud 1 ; 1 GI and Hepatology, University
of Alabama at Birmingham, Birmingham, AL; 2 Pharmacy,
University of Alabama at Birmingham, Birmingham, AL
Background. The development of direct-acting antivirals in
the treatment of Hepatitis C Virus (HCV) is a rapidly evolving
field. Data on the use of the newer agent in the treatment
of recurrent HCV infection post liver transplant (LT) is scarce.
Methods. We performed a retrospective analysis comparing
two groups treated with RIBA free regimens for recurrent HCV
infection, genotype 1, post LT: Group A, treated with SIM/
SOF and Group B, treated with LDV/SOF (without RIBA).
Patients received treatment between October 2014 and April
2015. Patients were identified through hepatology department
records. Data collection included genotype, prior HCV therapies,
cirrhosis, and virologic response at 4 and 12 weeks on
treatment. A one sided t-test was used to determine statistical
significance. Results. A total of 78 patients met inclusion criteria
with mean time from LT of 61 months. Descriptive statistics
were: Group A (N:36, mean age: 58 years, 69% male, 58%
treatment experienced, 73% GT1a, 11% cirrhotics, 1 patient
with fibrosing cholestatic HCV) and Group B (N:42, mean
age: 60 years, 69% male, 55% treatment experienced, 77%
GT1a, 7% SOF failure, 10% cirrhotics, ). Group A patients
were treated for 12 weeks compared to planned 12 weeks in
76% and 24 weeks in 24% of patients in Group B. In group A,
100% completed treatment. End of treatment response (EOTR)
was 94% and available sustained virologic response (SVR12)
rate was 91%. One patient with fibrosing cholestatic HCV
achieved SVR12. All three patients who experienced relapse in
group A are currently enrolled in Group B with a planned 24
week treatment duration. A total of 50% of patients in Group B
have completed treatment. Available EOTR is 100 (N:20) and
available SVR12 is 100% (N:4). A total of 22% of patients
had renal insufficiency with a mean glomerular filtration rate
of 45 ml/min at the start of treatment. The mean albumin was
3.64 gm/dL at the start of treatment and 3.9 gm/dL at SVR12
(P=0.013), which suggests improved synthetic liver function.
No discontinuation of treatment due to adverse events occurred
in either group. Data collection is ongoing. Conclusion. The
combination of SIM/SOF showed a high efficacy of 91% in the
treatment of recurrent HCV post LT with excellent tolerability.
The use of LDV/SOF in this group of patients (without RIBA) is
being evaluated in our institution and appears to have excellent
virologic response and tolerability. Additional SVR12 data will
be reported at the time of the meeting.
Disclosures:
Mohamed G. Shoreibah - Advisory Committees or Review Panels: Gilead
Brendan M. McGuire - Grant/Research Support: bayer healthcare, salix
The following authors have nothing to disclose: DeAnn Jones, Sarah Baggett,
Omar Massoud
1175
Predictors of Treatment Adherence and Discontinuation
in Department of Defense (DoD) Health Care Beneficiaries
Treated for Chronic Hepatitis C 2004-2013
Dana Y. Teltsch 2 , David R. Walker 1 , Beth L. Nordstrom 2 , Kathy
Fraeman 2 , Karl Kronmann 3 , Kristina St Clair 3 ; 1 HEOR, Abbvie,
North Chicago, IL; 2 Retrospective Observational Studies, Evidera,
Lexington, MA; 3 Naval Medical Center Portsmouth, Portsmouth,
VA
Background and objective: New treatments for chronic hepatitis
C virus (HCV) promise excellent sustained virologic response
and cure rate. Treatment effectiveness, however, depends on
regimen compliance. Our goal was to identify predictors of
adherence and discontinuation in a veteran, dependent and
active duty military population receiving chronic HCV treatment.
Methods: We conducted a retrospective cohort study
of chronic HCV patients covered by the DoD health system
who initiated HCV treatments during 2004-2013. The defined
regimens included: peg-interferon (peg)+ribavirin (rib) alone
or in combination with boceprevir (boc)/telaprevir (tel)/simeprevir
(sim); or sofosbuvir (sof) in combination with rib/sim/
rib+sim/peg+rib; all regimens were studied for 12 weeks after
initiation. The time to regimen discontinuation was calculated
allowing up to a 60 (peg and rib) or 15 (other drugs) day gap,
and predictors of time to discontinuation identified using multivariate
Cox models. Adherence was measured by proportion
of days covered (PDC), with PDC > 80% considered adherent.
Multivariate logistic regression models sought predictors of
adherence. Potential predictors included patient demographics,
liver disease status, comorbidities, and baseline resource
utilization. Results: 6,196 patients initiated treatment with a
regimen of interest (4,756 peg+rib; 212 peg+rib+boc; 631
peg+rib+tel; 238 sof+sim; 24 sof+sim+rib; 178 sof+rib+peg;
157 sof+rib; 0 sim+peg+rib ). Mean age was 49.9 years, and
47.3% were female. 71.9% of patients had non-cirrhotic HCV;
26.5% compensated or decompensated cirrhosis; 1.6% were
post liver transplant. There was a small but consistent association
between increased time from diagnosis in years and
both earlier treatment discontinuation (hazard ratio (HR) 1.03;
95% confidence interval (CI) 1.00-1.06) and lower adherence
(odds ratio (OR) 0.96; (0.93-0.99)). Predictors of discontinua-