1671. Ledipasvir/Sofosbuvir is Safe and Effective for the Treatment of Patients with Genotype 1 Chronic HCV Infection in Both HCV Mono-and HCV/HIV Co-infected Patients
Session: Poster Abstract Session: HIV: HIV/HCV Co-Infection Treatment and Complications
Saturday, October 10, 2015
Room: Poster Hall
Posters
  • Naggie LDV SOF HCV1 ID Wk 2015 Poster 1671 FINAL.pdf (417.7 kB)
  • Background: The current AASLD/IDSA Hepatitis C Guidance states that HIV/HCV-coinfected persons should be treated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications. We compared the safety and efficacy of the single tablet regimen of ledipasvir/sofosbuvir (LDV/SOF) in HCV genotype (GT) 1 patients co-infected with HIV-1 in the Phase III ION-4 study with HCV mono-infected GT 1 patients in the Phase III ION 1-3 studies. 

    Methods: In the ION-4 study, 327 GT 1 HCV/HIV co-infected patients (126 treatment-naïve, non-cirrhotic, 134 treatment-experienced, non-cirrhotic, 20 treatment-naïve, cirrhotic, 47 treatment-experienced cirrhotic) received LDV/SOF 90/400 mg daily for 12 weeks.  In the ION 1-3 studies, 538 GT 1 HCV mono-infected patients (395 treatment-naïve, non-cirrhotic, 87 treatment-experienced, non-cirrhotic, 34 treatment-naïve, cirrhotic, 22 treatment-experienced cirrhotic) received LDV/SOF 90/400 mg daily for 12 weeks.  This pooled analysis will assess safety and sustained virologic response at week 12 (SVR12).

    Results: Overall, 865 patients were treated with 12 weeks of LDV/SOF in the Phase III ION program. In ION 1-3, the majority of patients were male (329, 61%), nonblack (449, 83%), and treatment-naïve (430, 80%).  56 (10%) patients had cirrhosis.  In ION-4, the majority of patients were male (276, 82%), nonblack (220, 66%), and treatment-experienced (185, 55%).  67 (20%) patients had cirrhosis.  SVR12 and relapse data are reported in the table.  Treatment was well tolerated in both mono-infected and co-infected patients.   Most common adverse events (>10% reported in any arm) were fatigue, headache, diarrhea, and nausea.  Only two patients discontinued treatment due to an adverse event.

    Conclusion: In this pooled analysis, the once daily, single tablet regimen of LDV/SOF for 12 weeks provided high rates of SVR regardless of presence of HIV infection and is a safe, well-tolerated option for patients with both HCV mono-infection and HIV/HCV co-infection.

    Study

    ION 1

    ION 2

    ION 3

    ION 1-3 Combined

    ION 4

    N (GT 1)

    213

    109

    216

    538

    327

    SVR12 (%)

    99

    94

    96

    97

    96

    Relapse rates (%)

    <1

    6

    1

    2

    3

    Discontinuation rates (%)

    0

    0

    1

    <1

    0

    Susanna Naggie, MD, MHS1, Curtis Cooper, MD, FRCPC2, Mark Sulkowski, MD3, Paul Kwo, MD4, Kris Kowdley, MD5, Sarjita Naik, PharmD6, Macky Natha, MD, FRCP6, Luisa Stamm, MD, PhD6 and Phillip S. Pang, MD, PhD6, (1)Infectious Diseases Research, Duke Clinical Research Institute, Durham, NC, (2)The Ottawa Hospital and Regional Hepatitis Program, The Ottawa Hospital-Division of Infectious Diseases, Ottawa, ON, Canada, (3)Johns Hopkins University School of Medicine, Baltimore, MD, (4)Gastroenterology/Hepatology Division, Indiana University School of Medicine, Indianapolis, IN, (5)Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, WA, (6)Gilead Sciences, Inc., Foster City, CA

    Disclosures:

    S. Naggie, AbbVie: Consultant and Investigator , Consulting fee and Research grant
    Achillion: Consultant and Investigator , Consulting fee and Research grant
    BMS: Investigator , Research grant
    Gilead Sciences: Consultant and Investigator , Consulting fee and Research grant
    Vertex: Investigator , Research grant
    Janssen: Investigator , Research grant
    Merck: Consultant and Investigator , Consulting fee and Research grant
    IAS-USA: Educational Activities for this company generates revenue for DUKE , Revenue generated for Duke
    IDSA: Consultant , Consulting fee

    C. Cooper, Gilead Sciences: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    AbbVie: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Merck: Consultant and Investigator , Consulting fee and Research support
    BMS: Consultant , Consulting fee
    Roche: Investigator , Research support

    M. Sulkowski, None

    P. Kwo, AbbVie: Investigator and Scientific Advisor , Consulting fee and Research grant
    BMS: Investigator and Scientific Advisor , Consulting fee and Research grant
    Gilead Sciences: Investigator and Scientific Advisor , Consulting fee and Research grant
    Janssen: Investigator and Scientific Advisor , Consulting fee and Research grant
    Merck: Investigator and Scientific Advisor , Consulting fee and Research grant

    K. Kowdley, Evidera: Consultant , Investigator and Scientific Advisor , Consulting fee and Research grant
    Gilead Sciences: Consultant , Investigator and Scientific Advisor , Consulting fee and Research grant
    Immuron: Investigator , Research support
    Intercept: Investigator , Research support
    Tobira: Investigator , Research grant
    AbbVie: Consultant and Scientific Advisor , Consulting fee
    Achillion: Consultant and Scientific Advisor , Consulting fee
    BMS: Consultant and Scientific Advisor , Consulting fee
    Merck: Consultant and Scientific Advisor , Consulting fee
    Novartis: Consultant and Scientific Advisor , Consulting fee
    Trio Health: Consultant and Scientific Advisor , Consulting fee
    Up-To-Date: Collaborator , Licensing agreement or royalty
    Annals of Hepatology: Editorial Board , None

    S. Naik, Gilead Sciences: Employee , Salary

    M. Natha, Gilead Sciences: Employee , Salary

    L. Stamm, Gilead Sciences: Employee , Salary

    P. S. Pang, Gilead Sciences, Inc.: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.