studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 803A
pharmacokinetics studies,H2-blocker famotidine (40 mg q12
hours) & PPI omeprazole (20 mg single dose) decreased LDV
Cmax by 17-20% & 4-11% respectively but had no effect on
AUC 1 . In the ION trials, which evaluated the effect of SOF/
LDV in genotype 1 patients, patients were not allowed to be
on any acid-suppressing agents for 28 days before initiation of
therapy. Hence, currently there is no clinical data on the effect
of acid suppressing agents on SVR in patients treated with
SOF/LDV. Aim: To evaluate the effect of co-administration of
PPI (at doses recommended in the package insert) with LDV/
SOF on SVR12 in hepatitis C genotype 1 patients. Methods:
Data from a combined treatment cohort of three Hepatology
referral centers were obtained on all hepatitis C genotype1
patients on PPI treated with SOF/LDV with or without ribavirin
(RBV). Treatment duration (8-24 weeks) & addition of RBV was
at the discretion of the treating hepatologist Results: Of the 50
patients in this cohort,30 (60%) were male, 35 (70%)had genotype
1a, 29 (58%) were Caucasians, & 68% had cirrhosis.
Mean age was 58 years, with a mean BMI of 31 kg/m 2 . 25
(50%) were treatment naïve & the remaining were treatment
experienced with peg-interferon (peg-IFN) + RBV with or without
Telaprevir/Bocepravir, peg-IFN + RBV + SOF, Simeprevir
+SOF with or without RBV, SOF+RBV. PPI was co-administered
at the recommended package insert dosing primarily
for GERD (86%). 22/43 had undetectable viral load after 4
weeks of treatment initiation, & 92% (22/24) who completed
treatment achieved end-of treatment (EOT) response defined by
undetectable viral load. Treatment was very well tolerated with
treatment discontinuation in only one patient due to intractable
nausea & vomiting requiring hospitalization. SVR12 results to
follow Conclusion: The co-administration of a PPI with LDV/
SOF at recommended doses does not seem to effect EOT
response. Symptoms of GERD are also generally well tolerated
at the package insert PPI dosing while on treatment 1 German
P, et al. Effect of food & acid reducing agents on the relative
bioavailability & pharmacokinetics of ledipasvir/sofosbuvir
fixed dose combination tablet.15th International Workshop on
Clinical Pharmacology of HIV & Hepatitis Therapy; Washington,
D.C. 2014
Disclosures:
Hector E. Nazario - Advisory Committees or Review Panels: Gilead, Janssen;
Speaking and Teaching: Gilead, Merck, Abbvie, Janssen
Manjushree Gautam - Speaking and Teaching: Gilead
Stevan A. Gonzalez - Consulting: AbbVie; Speaking and Teaching: Gilead,
Salix, AbbVie
Ruben Ramirez-Vega - Speaking and Teaching: Gilead
Apurva A. Modi - Speaking and Teaching: Salix, Merck, Gilead, Abbvie, Janssen
The following authors have nothing to disclose: Jamil S. Alsahhar, Mohammad
Ashfaq, Milka Ndungu, Olga Teachenor, Gabriel R. Gonzales
1200
Pre-Existing Co-Morbidities and Co-Medications of
Patients Undergoing Treatment of Chronic HCV G1
Infection in German Real-Life
Peter Buggisch 1 , Hanns F. Loehr 2 , Gerlinde Teuber 3 , Hermann
Steffens 4 , Michael R. R. Kraus 5 , Peter R. Geyer 6 , Bernd Weber 7 ,
Thomas Witthoeft 8 , Uwe Naumann 9 , Elmar Zehnter 10 , Dagmar
Hartmann 11 , Bernd Dreher 11 , Manfred Bilzer 11 ; 1 IFI Liver Center
Hamburg, Hamburg, Germany; 2 Gastroenterological Practice,
Wiesbaden, Germany; 3 Gastroenterological Practice, Frankfurt,
Germany; 4 Practice of Internal Medicine, Berlin, Germany;
5 Department II, Klinikum Burghausen, Burghausen, Germany;
6 Gastroenterological Practice, Fulda, Germany; 7 Competence
Center Addiction, Kassel, Germany; 8 Gastroenterological Practice,
Stade, Germany; 9 Center of Medicine, Berlin, Germany; 10 Gastroenterological
Practice, Dortmund, Germany; 11 MSD Pharma
GmbH, Haar, Germany
Background: Information about co-morbidities of patients (pts)
currently treated for chronic HCV genotype 1 (G1) infection in
real-life is scarce. The present interim analysis of the NOVUS
observational study was therefore aimed to investigate the
frequency of pre-existing and ongoing co-morbidities of pts
treated for chronic HCV G1 infection in German real-life and
to determine the frequency of co-medications. Methods: From
April 2012 until January 2014, 536 pts with HCV G1 infection
were recruited in the ongoing NOVUS study by 97 practices
and hospitals in Germany. Until now, pre-existing co-morbidities
before triple therapy of HCV G1 infection with boceprevir
(BOC) were documented for 469 pts. Results: Ongoing
co-morbidities were reported for 329 of 469 pts (70%) before
treatment of HCV G1 infection. Overall, 599 ongoing co-morbidities
(multiple answers allowed) were documented. The most
frequently reported co-morbidities were obesity (BMI >30 kg/
m 2 ) (19%), cardiovascular diseases (18%), psychiatric disorders
(14%), opiate substitution (13%), gastrointestinal diseases
(11%), metabolic disorders (8%), thyroid gland diseases (7%),
bone and joint diseases (6%), skin diseases (5%), HIV- co-infection
(4%) and kidney diseases (2%). When co-morbidities
were analyzed by gender (female vs. male), thyroid diseases
occurred more frequently in females (13% vs. 3%, P