studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 761A
ties and anemia did not affect SRV-12. A sub-group of patients
over age 75, analyzed separately, showed SVR-12 of 100%,
10% reported fatigue and 5.2% had diarrhea, with no hospitalizations
during the treatment. Conclusion: Sofosbuvir based
regimen is safe and effective in patients over the age of 65
years including those with cirrhosis.
Genotype (GT)
Treatment naïve (TN)
Treatment experienced (TE)
Disclosures:
The following authors have nothing to disclose: Beshoy T. Yanny, Amandeep K.
Sahota
1120
Sofosbuvir and Ledipasvir/Sofosbuvir for the Treatment
of Patients with Chronic Genotype 6 Hepatitis C Virus
Infection: Integrated Analysis of Phase 2 and Phase 3
Studies
Edward J. Gane 1 , Wan-Long Chuang 2 , Tarek I. Hassanein 3 ,
Kris V. Kowdley 4 , Eric Lawitz 5 , Bing Gao 6 , Hongmei Mo 6 , Robert
H. Hyland 6 , Jenny C. Yang 6 , Shampa De-Oertel 6 , Diana M.
Brainard 6 , Steven J. Knox 6 , John G. McHutchison 6 , Ching-Lung
Lai 7 , Henry Lik-Yuen Chan 8 ; 1 New Zealand Liver Transplant Unit,
Auckland, New Zealand; 2 Kaohsiung Medical University, Kaohsiung,
Taiwan; 3 Southern California Liver Centers, Coronado, CA;
4 Swedish Medical Center, Seattle, WA; 5 The Texas Liver Institute,
San Antonio, TX; 6 Gilead Sciences, Inc, Foster City, CA; 7 Queen
Mary Hospital, Hong Kong, Hong Kong; 8 The Chinese University
of Hong Kong, Hong Kong, Hong Kong
Introduction: Chronic HCV infection is endemic in South East
Asia with HCV genotype 6 (GT6) accounting for 18-49% of
those infected. In the US and Canada, nearly one-third of immigrants
from Southeast Asia with HCV are infected with GT6.
Few studies have examined the efficacy and safety of direct
acting antiviral (DAA) regimens in GT6 infected patients. The
aim of this integrated analysis was to characterize the efficacy
and safety of sofosbuvir (SOF)-based regimens in patients with
chronic GT6 HCV infection. Methods: GT6 infected subjects
were identified in 5 studies (ATOMIC, NEUTRINO, GS-US-
334-0115, ELECTRON2, GS-US-337-0131) and are included
in this analysis. Treatment-naïve or treatment-experienced
patients received SOF+RBV±Peg-IFNα or ledipasvir (LDV)/SOF
for 12-24 weeks. The primary efficacy endpoint in all studies
was SVR12. Results: A total of 52 subjects with GT6 HCV infection
were identified. The majority were treatment-naïve (94%),
Asian (81%), male (58%), and had IL28B CC alleles (81%).
The mean age was 50 years (range 26-76) and 10% had cirrhosis.
GT6 subtypes included 6a, 6a/b, 6c-1, 6e, 6g, 6j, 6l,
6m, 6o, 6p, 6q, and 6r. The table below presents SVR12 by
regimen. One subject in ELECTRON2 withdrew consent after
receiving 8 weeks of LDV/SOF and relapsed with the emergent
NS5B RAV S282T. All remaining 51 patients achieved
SVR12, including 100% (3/3) experienced and 100% (5/5)
cirrhotics. Conclusions: SOF+RBV±Peg-IFNα and LDV/SOF
regimens are well-tolerated and highly effective in patients with
chronic GT6 HCV infection including those who are treatment
experienced and have compensated cirrhosis. These regimens
provide multiple therapeutic options for consideration when
evaluating optimal therapy for individual patients with chronic
GT6 HCV infection.
SVR12 Rates in GT6 HCV Patients
1ATOMIC (P7977-0724), NEUTRINO (GS-US-334-0110); 2GS-
US-334-0115; 3ELECTRON2 (GS-US-337-0122), GS-US-337-
0131
Disclosures:
Edward J. Gane - Advisory Committees or Review Panels: Novira, AbbVie, Janssen,
Gilead Sciences, Janssen Cilag, Achillion, Merck, Tekmira; Speaking and
Teaching: AbbVie, Gilead Sciences, Merck
Wan-Long Chuang - Advisory Committees or Review Panels: Gilead, Abbvie;
Speaking and Teaching: BMS, Roche, MSD
Tarek I. Hassanein - Advisory Committees or Review Panels: AbbVie, Bristol-Myers
Squibb; Grant/Research Support: AbbVie Pharmaceuticals, Obalon, Bristol-Myers
Squibb, Eiasi Pharmaceuticals, Gilead Sciences, Janssen R&D, Idenix
Pharmaceuticals, Ikaria Therapeutics, Merck Sharp & Dohme, NGM BioPharmaceuticals,
Ocera Therapeutics, Salix Pharmaceuticals, Sundise, TaiGen Biotechnology,
Takeda Pharmaceuticals, Vital Therapies, Tobria; Speaking and
Teaching: Baxter, Bristol-Myers Squibb, Gilead, Salix, AbbVie
Kris V. Kowdley - Advisory Committees or Review Panels: Achillion, BMS, Evidera,
Gilead, Merck, Novartis, Trio Health, Abbvie; Grant/Research Support:
Evidera, Gilead, Immuron, Intercept, Tobira; Speaking and Teaching: Abbvie,
Gilead
Eric Lawitz - Advisory Committees or Review Panels: AbbVie, Achillion Pharmaceuticals,
Regulus, Theravance, Enanta, Idenix Pharmaceuticals, Janssen, Merck
& Co, Novartis, Gilead; Grant/Research Support: AbbVie, Achillion Pharmaceuticals,
Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmith-
Kline, Idenix Pharmaceuticals, Intercept Pharmaceuticals, Janssen, Merck & Co,
Novartis, Nitto Denko, Theravance, Salix, Enanta; Speaking and Teaching: Gilead,
Janssen, AbbVie, Bristol Meyers Squibb
Bing Gao - Employment: Gilead; Stock Shareholder: Gilead
Hongmei Mo - Employment: Gilead Science Inc
Robert H. Hyland - Employment: Gilead Sciences, Inc; Stock Shareholder: Gilead
Sciences, Inc
Jenny C. Yang - Employment: Gilead Sciences, Inc
Shampa De-Oertel - Employment: Gilead Sciences, Inc; Stock Shareholder: Gilead
Sciences, Inc
Diana M. Brainard - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
Steven J. Knox - Employment: Gilead Sciences
John G. McHutchison - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
Ching-Lung Lai - Advisory Committees or Review Panels: Bristol-Myers Squibb,
Gilead Sciences Inc; Consulting: Bristol-Myers Squibb, Gilead Sciences, Inc;
Speaking and Teaching: Bristol-Myers Squibb, Gilead Sciences, Inc
Henry Lik-Yuen Chan - Advisory Committees or Review Panels: Gilead, MSD,
Bristol-Myers Squibb, Roche, Novartis Pharmaceutical, Abbvie; Speaking and
Teaching: Echosens
1121
Real Life Experience with Sofosbuvir and Ledipasvir
Fixed Dose Regimen in the Multiethnic Cohort of Patients
with Chronic Hepatitis C
Marina Roytman 2,1 , Alister L. Tang 1 , Christina Wu 1 , Joy I.
Piotrowski 1 , Leena K. Hong 2 , Ruby Trujillo 2 , Leslie Huddleston 2 ,
Isabel Hung Wan 2 , Peter Poerzgen 2 , Sumodh Kalathil 2 , Naoky
CS C. Tsai 2,1 ; 1 Medicine, University of Hawaii at Manoa, John A.
Burns School of Medicine, Honolulu, HI; 2 Queen’s Liver Center,
Honolulu, HI
Purpose/Background: ION-1-3 trials have demonstrated high
SVRs and favorable side effect profiles in the treatment of GT1
HCV patients. However, reports of regimen experiences in
the real life clinical setting are limited. This study investigates
the safety and efficacy of Ledipasvir (LDV)- Sofosbuvir (SOF)
regimen in the multiethnic patient cohort, including patients
with decompensated cirrhosis, in a real life clinical setting.
Methods: Retrospective review of 154 patients with genotype
1 (GT1) chronic hepatitis C (HCV) infection treated with a