studies

798A AASLD ABSTRACTS HEPATOLOGY, October, 2015
234 consecutive patients were identified, of which 36 were
excluded due to prior SOF-based or current IFN-based Rx or
pending SVR12 (n=25), yielding 198 for study inclusion: 50 LT
and 148 non-LT. Results: Mean age was ~60 and the majority
(80%) in both groups were Caucasian or Hispanic. In non-LT,
10% had liver cancer, 71% cirrhosis (84% had decompensation
with clinical symptoms or MELD≥10 or CPT≥7), while only
8% of LT group had cirrhosis. In LT group, SVR12 was similar
for both GT 1a (88%) and 1b (87%), and in cirhrosis (87%)
but lower in those with prior-Rx (73%) (Fig 1). In non-LT group,
SVR12 was higher for GT 1b, noncirrhosis, Rx-naïve compared
to 1a, cirrhosis, and prior-Rx, though none of these differences
were statistically significant (Fig 1). Rx was well tolerated in
all groups with 6 Rx-unrelated SAEs. On multivariate analysis,
also inclusive of sex and age, the presence of at least 2 difficult-to-treat
features (prior Rx, cirrhosis, or GT 1a) was a significant
negative predictor for SVR12 (HR=0.06, CI 0.01-0.73,
p=0.027), but not the presence of just one of such factors or LT.
Conclusions: SMV+SOF Rx (no RBV) was safe and effective for
both LT and non-LT patients with SVR12 of ~80% for those with
difficult-to-treat features and 90% for those without. Significant
predictor for lower SVR12 was presence of 2 or more of such
features.
Disclosures:
Aijaz Ahmed - Consulting: Bristol-Myers Squibb, Gilead Sciences Inc., Roche,
AbbVie, Salix Pharmaceuticals, Janssen pharmaceuticals, Vertex Pharmaceuticals,
Three Rivers Pharmaceuticals; Grant/Research Support: Gilead Sciences
Inc.
Gabriel Garcia - Board Membership: Health Metrics Systems
W. Ray Kim - Advisory Committees or Review Panels: Bristol Myers Squibb,
Gilead Sciences, Abbvie, Merck
Dilesh Doshi - Employment: Janssen
Mindie H. Nguyen - Advisory Committees or Review Panels: Bristol-Myers
Squibb, Bayer AG, Gilead, Novartis, Onyx; Consulting: Gilead Sciences, Inc.;
Grant/Research Support: Gilead Sciences, Inc., Bristol-Myers Squibb, Novartis
Pharmaceuticals, Roche Pharma AG, Idenix, Hologic, ISIS
The following authors have nothing to disclose: Glen A. Lutchman, Nghia H.
Nguyen, Christine Y. Chang, Tami Daugherty, Radhka Kumari, Soumi Gupta
1190
Virological and Clinical Response in Patients with
HCV-Related Mixed Cryoglobulinemia Treated with
Interferon-Free Regimens: Preliminary Results of a Prospective
Pilot Study.
Laura Gragnani, Alessia Piluso, Teresa Urraro, Alessio Fabbrizzi,
Elisa Fognani, Luisa Petraccia, Monica Monti, Anna Linda Zignego;
Dept. Experimental and Clinical Medicine, University of
Florence, Firenze, Italy
Background: Hepatitis C virus (HCV) infection is often associated
with extrahepatic manifestations: the most frequent is
represented by mixed cryoglobulinemia (MC). MC is an autoimmune/B-cell
lymphoproliferative disorder, characterized by
the presence of circulating immune complexes, called cryoglobulins.
In 5–30% of cases, MC patients showed symptoms due
to a systemic vasculitis of small/medium size vessels (mixed
cryoglobulinemia syndrome, MCS). The etiologic therapy was
considered the first-line option in MCS patients. However, interferon
(IFN)-based therapy is frequently not tolerated. Recently,
the introduction of direct acting antivirals (DAAs) substantially
changed the treatment of HCV infection, allowing IFN-free
regimens. No data at present exist about the use of IFN-free
regimens in MC patients. Our aim was to analyze the efficacy
and safety of new generation DAAs in IFN-free regimens in MC
patients. Methods: Pilot prospective study, including 17 patients
with HCV-associated MC with or without symptoms treated
with new generation DAAs in IFN-free regimens. Patients were
treated, for 12 or 24 weeks, with different all-oral antiviral
regimen: ombitasvir, paritaprevir+ritonavir and dasabuvir ±
ribavirin; sofosbuvir plus daclatasvir and sofosbuvir plus ribavirin.
Results: Patients were divided in two different cohorts as follows:
(a) 10 patients (3 [27.3%] males, mean age 64.73±6.6
yrs) in the MCS-HCV group; (b) 7 patients (4 [57.1%] males,
mean age 55.57±10.52 yrs) in the MC-HCV group. The main
clinical baseline manifestation of MCS included purpura (80%),
arthralgia (80%), asthenia (100%), peripheral neuropathy
(90%), renal involvement (40%) and cutaneous ulcers (30%).
Regarding previous anti-HCV treatment, 7 (41%) patients were
naïve, 6 (35%) were partial or non responders, 1 (6%) patient
was virological relapser and 3 (18%) discontinued previous
treatment for severe adverse events. At week 8 of treatment, all
patients were HCV RNA negative. Furthermore, a reduction of
the cryocrit values was evident in all cases (p