studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 791A
tion included age >60 years at index date (1.18; 1.00-1.38,
compared to age 51-60); chronic kidney disease (1.51; 1.13-
2.02), diabetes (1.28; 1.09-1.50), HIV status (1.86; 1.24-
2.79), and psychiatric disorders (1.14; 1.02-1.28). Predictors
of adherence included decompensated cirrhosis (0.75; 0.61-
0.94 compared to non-cirrhotic HCV); chronic kidney disease
(0.70; 0.50-0.99); diabetes (0.80; 0.68-0.95); and HIV status
(0.59; 0.36-0.96). Conclusions: Later treatment time from diagnosis,
patient comorbidities, and older age were associated
with poor adherence and with discontinuation prior to the recommended
regimen duration. Results suggest that delaying
treatment for many years after HCV diagnosis may adversely
impact treatment compliance.
Disclosures:
Dana Y. Teltsch - Consulting: AbbVie; Employment: Evidera
David R. Walker - Employment: Abbvie; Stock Shareholder: Abbvie, Baxter
Healthcare
The following authors have nothing to disclose: Beth L. Nordstrom, Kathy Fraeman,
Karl Kronmann, Kristina St Clair
study suggests as a result of a good tolerability profile, monitoring
and AE related costs are minimal in LDV/SOF regimens.
This study also suggests that, when the 8w regimen is used,
the cost per SVR is significantly lower in naïve and NC when
compared to TE and cirrhotic patients, indicating an economic
benefit of selecting high effectiveness and well tolerated first
line therapies and early treatment.
Disclosures:
Peter Buggisch - Advisory Committees or Review Panels: Janssen, AbbVie, BMS;
Speaking and Teaching: Roche, MSD, Gilead, Merz Pharma
Karsten Wursthorn - Grant/Research Support: BMS
Albrecht Stoehr - Board Membership: MSD, Böhringer Ingelheim; Speaking
and Teaching: Janssen, MSD, Gilead, Abbvie, Böhringer Ingelheim, BMS, VIIV
Aline Gauthier - Consulting: Gilead
Petar K. Atanasov - Consulting: Gilead
Joerg Petersen - Advisory Committees or Review Panels: Bristol-Myers Squibb,
Gilead, Novartis, Merck, Bristol-Myers Squibb, Gilead, Novartis, Merck; Grant/
Research Support: Roche, GlaxoSmithKline, Roche, GlaxoSmithKline; Speaking
and Teaching: Abbott, Tibotec, Merck, Abbott, Tibotec, Merck
1176
Real-world effectiveness and cost per SVR of ledipasvir/
sofosbuvir chronic hepatitis C treatment
Peter Buggisch 1 , Karsten Wursthorn 1 , Albrecht Stoehr 1 , Aline
Gauthier 2 , Petar K. Atanasov 2 , Joerg Petersen 1 ; 1 Asklepios Klinik
St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg,
Germany; 2 Amaris Consulting, London, United Kingdom
Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) single
tablet regimen (STR) is approved in Europe and the US for
the treatment of chronic hepatitis C (CHC) patients. With the
emergence of novel, highly effective, and safe therapies and
the expected demand for them, the need for optimal resource
allocation is high. The cost per sustained viral response (SVR)
is a measure which provides insights into the amount spent for
the achievement of success in CHC therapy. This study aims
to assess the safety, effectiveness, and the cost per SVR associated
with LDV/SOF therapy in clinical practice in Germany.
Methods: The first CHC patients treated with LDV/SOF in a
single centre (and for whom SVR after 12 weeks of follow-up
(SVR12) will be available in November 2015) were included
in the analysis. Baseline characteristics, prior treatment history,
safety, effectiveness and cost per SVR were investigated
using descriptive statistics. Results: 115 patients met the inclusion
criteria for this analysis. 8w (51.3%), 12w (44.3%) or
24w (4.4%) treatment with LDV/SOF was initiated between
21/11/2014 - 03/03/2015. 21% of patients had ribavirin
(RBV) added to the STR (79% of which F4). The mean (SD) age
was 52 (12.2) years, 60% were male, 89.6% had at least one
comorbidity. Genotype (GT) distribution: 57%, 32%, 6% and
4% for 1a, 1b, 3 and 4, respectively. METAVIR stage distribution:
34%, 19%, 13%, 11% and 23% for F0, F1, F2, F3 and
F4, respectively. Median (IQR) HCV RNA at baseline was 0.97
(0.28-1.90) million IU/ml. 6% (2%) of patients were HIV (HBV)
co-infected. In patients with available outcome data, the SVR4
was 99% (n=92/93) and SVR12 was 100% (n=13/13). One
treatment experienced (TE) F4 patient on 12w STR+RBV did not
achieve SVR4. 6.9% (n=8) experienced grade 3 or 4 adverse
events (AE) and 5.2% (n=6) were assessed as treatment-related.
No AE lead to discontinuation. 1.0% of costs were
non-therapy costs. The median cost per SVR4 was €53,025 (PP
like approach). 73% of naïve patients and 66% of non-cirrhotic
(NC) were on 8w duration; median cost per SVR4 was 59%
lower in NC (€46,775) than in F4 patients and 58% lower in
naïve (€46,272) versus TE patients. SVR12 and cost per SVR12
will be available at the time of presentation. Conclusion: This
1177
Hope and Hopelessness in HCV patients in the era of
DAA therapy
Sophie K. Afdhal 1 , Michael Penn 1 , Zobair M. Younossi 2 , Michael
P. Curry 3 ; 1 Psychology, Franklin & Marshall College, Charlestown,
MA; 2 Inova Fairfax Hospital, Falls Church, VA; 3 Beth Israel Deaconess
Medical Center, Boston, MA
Hope and hopelessness are important patient responses to
chronic illness and can influence recovery from disease and
effect patient reported outcomes (PRO’s). In the era of Direct
Acting Antiviral (DAA) therapy with high SVR rates greater
than 90% and good tolerability we hypothesized that treatment
expectations might alter the hope of patients with HCV. AIMS:
To evaluate hope and hopelessness in a HCV population and
to correlate it with disease variables and PRO’s such as fatigue,
depression and QOL. PATIENTS and METHODS: Consecutive
adult patients with chronic HCV were enrolled from the
Liver Center at BIDMC and underwent education about the
new DAA therapies and then completed the Beck Hopelessness
survey (BHS), Beck Depression index (BDI), fatigue questionnaire
(FACIT-F) and the SF-36 health survey. Demographic,
social, educational and disease state data was collected. Data
was analyzed by Chi square for comparison between groups,
regression analysis and ANOVA. RESULTS: 158 patients were
enrolled over June to August 2014 and were predominantly
male (63%), Caucasian (75%) with over 56% having at least
some college level education. 52% of patients believed that
HCV was responsible for causing or worsening health related
issues, 40% had a history of depression, 30% had a history of
chronic pain, 17% had PTSD, 21% had current drug use and
35% current alcohol use. Mode of acquisition of HCV was drug
use in 38%. RESULTS: Mean hopelessness score (range 0 – 20)
was 4.25 + 4.5 and 25 patients had severe hopelessness with
a score > 10. BDI mean score 12.6 + 10.6 and 39 patients
had moderate to severe depression. Patients with a history of
depression or active depression were strongly correlated with
hopelessness; P < 0.0001. Patients with PTSD were more likely
to suffer from hopelessness (p