studies

716A AASLD ABSTRACTS HEPATOLOGY, October, 2015
nosed between 1998-2014) with SCD in remission (with sickle
cell history > 30 years) All patients were placed LDV 90 mg
+ SOF 400 mg a day; with food for 12 weeks Patient characteristics:
the table will be included in the oral presentation
(slide) or poster Medications allowed: Hydroxyurea, Tylenol,
MS Contin, Methadone, Antibiotics (Levofloxacin, Doxycycline,
Colchicine, Metronidazole), epoetin alpha Exclusion: Decompensated
cirrhotics, HIV, HBV, Sepsis, brittle SCD with frequent
flares, uncontrolled DM, cardiomyopathy, CHF NYHA class
III-IV, CKD, chronic osteomyelitis, active IVDU, Daily alcohol >
30 grams, Deferoxamine for 12 weeks. Side events: Nausea-
9/24, constipation 6/24, diarrhea 2/24, headache 6/24,
abdominal pain 3/24, renal colic 1/24, insomnia 8/24, anemia
2/24, hyperbilirubinemia 4/24, UTI 3/24 Conclusion:
This study demonstrates that LDV and SOF combination in SCD
patients with CHC is safe and well tolerated; with an SVR12 of
91.67% (22/24) with 8.3% (2/24) viral failure (in concomitant
genotypes; 1a/4c and 1a/3c).
Results
(range 2-8 weeks) and remained negative thereafter. One
patient who was RBV-ineligible and received SOF/LDV without
RBV for only 12 weeks due to insurance issues developed virological
relapse between 4 and 8 weeks after treatment discontinuation.
Conclusions: Treatment with SOF/LDV with or without
RBV for 12-24 weeks was very well tolerated and resulted in
an excellent on-treatment virological response in HCV GT1
relapsers to SMV+SOF treatment. SVR12 data will be reported
when available.
On-Treatment Virological Response Rates
Disclosures:
Surakit Pungpapong - Grant/Research Support: BMS, Gilead
The following authors have nothing to disclose: Michael D. Leise, Kymberly D.
Watt, Hugo E. Vargas, Andrew P. Keaveny, Bashar A. Aqel
Disclosures:
The following authors have nothing to disclose: Patrick Basu, Niraj J. Shah, Nimy
John, M. Aloysius, Robert Brown
1038
Multicenter Experience using Sofosbuvir/Ledipasvir with
or without Ribavirin to Treat Hepatitis C Genotype 1
Relapsers after Simeprevir and Sofosbuvir Treatment
Surakit Pungpapong 1,2 , Michael D. Leise 3 , Kymberly D. Watt 3 ,
Hugo E. Vargas 4 , Andrew P. Keaveny 1,2 , Bashar A. Aqel 4 ;
1 Transplant, Mayo Clinic, Jacksonville, FL; 2 Gastroenterology &
Hepatology, Mayo Clinic, Jacksonville, FL; 3 Gastroenterology &
Hepatology, Mayo Clinic, Rochester, MN; 4 Gastroenterology &
Hepatology, Mayo Clinic, Scottsdale, AZ
Background: Approximately 10-15% of patients with hepatitis
C genotype 1 (HCV GT1) experience virological relapse after
all-oral antiviral regimen using simeprevir (SMV) and sofosbuvir
(SOF). The efficacy and safety of treating such relapsers using
sofosbuvir/ledipasvir fixed-dose combination (SOF/LDV) with/
without ribavirin (RBV) has not been described to date. Objective:
To report the virological response and safety of SOF/
LDV with or without RBV for 12-24 weeks in treating HCV
GT1 relapsers after SMV+SOF treatment. Results: To date, 42
patients (26% post-LT, 79% male, 17% non-white, 80% subtype
1a, 86% IL28B CT/TT, 76% F3-4) started SOF/LDV with
or without RBV at a median of 20 weeks (range 7-55 weeks)
after the last dose of SMV+SOF treatment. Five and 25 patients
started SOF/LDV with RBV (dose adjusted for renal function) for
12 and 24 weeks, respectively; while 12 patients who were
RBV-ineligible received SOF/LDV without RBV for 24 weeks.
Minimal adverse events were reported in those without RBV;
48% patients who received RBV developed significant anemia
requiring RBV dose reduction and/or discontinuation. In
LT recipients, minimal immunosuppression dose adjustments
were required and no biopsy-proven acute rejection occurred.
On-treatment virological response rates are shown in the Table.
Of 39 patients who received treatment at least 4 weeks, all
achieved undetectable HCV RNA at a median of 4 weeks
1039
RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir
+/- Ribavirin in Non-cirrhotic HCV Genotype 1-infected
Patients With Severe Renal Impairment or End-Stage
Renal Disease
Paul J. Pockros 1 , K. Rajender Reddy 2 , Parvez S. Mantry 3 , Eric
Cohen 4 , Michael Bennett 5 , Mark S. Sulkowski 6 , David Bernstein 7 ,
Thomas Podsadecki 4 , Daniel E. Cohen 4 , Nancy Shulman 4 , Deli
Wang 4 , Amit Khatri 4 , Manal Abunimeh 4 , Eric Lawitz 8 ; 1 Scripps
Clinic, La Jolla, CA; 2 University of Pennsylvania, Philadelphia,
PA; 3 The Liver Institute at Methodist Dallas, Dallas, TX; 4 AbbVie
Inc., North Chicago, IL; 5 Medical Associates Research Group,
San Diego, CA; 6 Johns Hopkins University, Baltimore, MD; 7 North
Shore University Hospital, Manhasset, NY; 8 The Texas Liver Institute,
University of Texas Health Science Center, San Antonio, TX
Background: HCV is common among patients (pts) with endstage
renal disease. Co-formulated ombitasvir/paritaprevir/r
(paritaprevir identified by AbbVie and Enanta, co-dosed with
ritonavir [r]) and dasabuvir (3D) do not require dose adjustment
in pts with renal insufficiency. In Phase 3 trials, 3D+/- RBV
showed high SVR rates and low rates of discontinuation due to
adverse events in HCV genotype 1 (GT1)-infected pts. RUBY-I is
an ongoing open-label study evaluating 3D+/-RBV in pts with
stage 4 or 5 chronic kidney disease (CKD) and GT1 infection.
Methods: Cohort 1 of RUBY-I enrolled treatment-naïve, non-cirrhotic
adults with GT1 infection and CKD stage 4 (estimated
GFR 15-30 mL/min/1.73m 2 ) or 5 (eGFR