studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 317A
Baseline Values
† When compared respective variables between groups, P >
0.05 except HBeAg+ at birth (P < 0.001) and detectable HBV
DNA at birth (P = 0.002). *3 mothers withdrew before the baseline
visit.
Disclosures:
Calvin Q. Pan - Advisory Committees or Review Panels: Gilead; Consulting:
BMS, Gilead, Abbvie, Janssen ; Grant/Research Support: BMS, Gilead, Merck;
Speaking and Teaching: BMS, Gilead, Abbvie
The following authors have nothing to disclose: Zhong-Ping Duan, Erhei Dai,
Shuqin Zhang, Guo Rong Han, Yuming Wang, Huaihong Zhang, Huaibin Zou,
Bao Shen Zhu, Wen Jing Zhao, Hong Xiu Jiang
210
High Efficacy of Grazoprevir/Elbasvir (GZR/EBR) in HCV
Genotype 1, 4, and 6-infected Patients With HIV Coinfection:
SVR24 Data From the Phase 3 C-EDGE Coinfection
Study
Jürgen K. Rockstroh 1 , Mark Nelson 2 , Christine Katlama 3 , Jacob P.
Lalezari 4 , Josep Mallolas 5 , Mark Bloch 6 , Gail Matthews 7 , Michael
Saag 8 , Philippe J. Zamor 9 , Chloe Orkin 10 , Jacqueline Gress 11 ,
Melissa Shaughnessy 11 , Stephanie Klopfer 11 , Anita Y. Howe 11 ,
Janice Wahl 11 , Bach-Yen T. Nguyen 11 , Eliav Barr 11 , Heather L.
Platt 11 , Michael Robertson 11 , Mark S. Sulkowski 12 ; 1 Bonn Umiversity,
Bonn, Germany; 2 Chelsea and Westminster Hospital, London,
United Kingdom; 3 Université Pierre et Marie Curie, Paris VI and
Hôpital Pitié-Salpêtrière, Paris, France; 4 Quest Clinical Research,
San Francisco, CA; 5 Hospital Clinic-University of Barcelona, Barcelona,
Spain; 6 Holdsworth House Medical Practice, Darlinghurst,
NSW, Australia; 7 St Vincent’s Hospital, Sydney, NSW, Australia;
8 University of Alabama at Birmingham, Birmingham, AL; 9 Carolinas
Medical Center, Charlotte, NC; 10 Royal London Hospital,
London, United Kingdom; 11 Merck & Co., Inc., Kenilworth, NJ;
12 Johns Hopkins University School of Medicine, Baltimore, MD
BACKGROUND: The fixed-dose combination (FDC) of grazoprevir
(GZR, MK-5172; NS3/4 protease inhibitor) and elbasvir
(EBR, MK-8742; NS5A inhibitor), an interferon-free, ribavirin-free,
once-daily tablet has shown robust efficacy and safety
in diverse populations. C-EDGE Coinfection evaluated GZR/
EBR among treatment-naive, HIV/HCV coinfected patients with
GT1, 4 or 6. METHODS: All patients were on stable antiretroviral
(ARV) therapy (tenofovir or abacavir, and lamivudine or
emtricitabine; and either raltegravir, dolutegravir or rilpivirine)
with CD4 >200 cells/mm 3 and an HIV RNA 500 cells/mm 3 and
HIV RNA 5× resistance to EBR in vitro (L31M, Y93S). Adverse
events (AEs) were reported in 72% (157/218) of patients; serious
AEs occurred in 0.9% (2/218) of patients. Adherence was
>90% in the total population, including virologic failures. PK
parameters were similar in patients with, and without SVR24.
2 patients had transient HIV viremia; both were subsequently
undetectable without a change in ARV regimen. CONCLUSION:
A 12-week regimen of GZR/EBR FDC was highly effective with
a favorable safety profile among HIV/HCV coinfected patients
with GT1, 4 or 6 infection. SVR24 was high in all patient subgroups,
including African-Americans and those with cirrhosis.
Disclosures:
Jürgen K. Rockstroh - Advisory Committees or Review Panels: Abbvie, BI, BMS,
Merck, Roche, Tibotec, Abbvie, Bionor, Tobira, ViiV, Gilead, Janssen; Consulting:
Novartis; Grant/Research Support: Merck; Speaking and Teaching: Abbott,
BI, BMS, Merck, Roche, Tibotec, Gilead, Janssen, ViiV
Mark Nelson - Advisory Committees or Review Panels: Janssen, MSD, BMS,
ABBVIE, Viiv, Gilead; Consulting: Janssen, MSD, BMS, ABBVIE, Viiv, Gilead;
Grant/Research Support: Boehringer Ingelheim, Janssen, MSD, BMS, ABBVIE,
Viiv, Gilead, Roche; Speaking and Teaching: GSK, Janssen, MSD, BMS, Abbott,
Viiv, Gilead
Josep Mallolas - Board Membership: Boehringer, Merck, Abbvie, Gilead, Janssen
Michael Saag - Grant/Research Support: BMS, Gilead, Abbvie, Merck, ViiV,
Janssen
Philippe J. Zamor - Grant/Research Support: AbbVie, Bristol Myers Squibb,
Gilead, Merck & Co. ; Speaking and Teaching: AbbVie, Bristol Myers Squibb,
Janssen
Chloe Orkin - Advisory Committees or Review Panels: Viiv, gilead, bms, boehringer
ingelgeim; Grant/Research Support: johnson and johnson, abbvie
Jacqueline Gress - Employment: Merck, Merck
Melissa Shaughnessy - Employment: Merck & Co., Inc.; Stock Shareholder:
Merck & Co., Inc.
Anita Y. Howe - Employment: Merck Research Laboratory
Janice Wahl - Employment: Merck & Co,
Bach-Yen T. Nguyen - Employment: Merck
Eliav Barr - Employment: Merck
Michael Robertson - Employment: Merck; Stock Shareholder: Merck
Mark S. Sulkowski - Advisory Committees or Review Panels: Merck, AbbVie,
Janssen, Gilead, BMS; Grant/Research Support: Merck, AbbVie, Janssen, Gilead,
BMS
The following authors have nothing to disclose: Christine Katlama, Jacob P.
Lalezari, Mark Bloch, Gail Matthews, Stephanie Klopfer, Heather L. Platt