2225. Real World Effectiveness of Ledipasvir/Sofosbuvir (LDV/SOF) for 8 weeks in Patients Coinfected with HCV and HIV-1
Session: Poster Abstract Session: HIV and HCV
Saturday, October 7, 2017
Room: Poster Hall CD
Posters
  • Ruane_P2225.pdf (407.5 kB)
  • Background: Real world cohorts (RWC) have demonstrated excellent efficacy of LDV/SOF for 8 weeks in HCV monoinfected patients. Real world effectiveness data of LDV/SOF for 8 weeks in HIV/HCV coinfection is emerging from several multiple single-center and multicenter prospective and retrospective cohorts.  The aim of this study was to describe the effectiveness of the single tablet regimen of LDV/SOF for 8 weeks in HCV genotype (GT) 1 patients with HIV/HCV coinfection in RWC.

    Methods: In this descriptive analysis, data from two prospective studies, one investigator sponsored and 1 registrational trial, one prospective RWC, three retrospective RWC of LDV/SOF for 8 weeks in HIV/HCV co-infected patients were compared.  RWC were selected based on willingness to participate and had at least 15 HIV/HCV co-infected patients.  The prospective trials include data from Ain et al (investigator sponsored) and Isakov et al (registrational trial). The RWC include the Deutsches Hepatitis C-Register, Madrid Coinfection Registry (Madrid-CoRe),Veterans Affairs HCV Registry, and Slim et al,  representing diverse patient populations from Europe and US.  Baseline characteristics and efficacy were analyzed.

    Results:  The majority of the 294 patients included in this descriptive analysis were GT 1, treatment naïve (TN), noncirrhotic (NC), and had a HCV viral load < 6 million.  The prospective cohorts  enrolled 79 patients with the following baseline characteristics: mean age (43 years), male (66%), white (89%), and GT 1a (41%).  The RWC studies assessed enrolled 215 patients with the following overall baseline characteristics:  mean age (54 years) male (84%), white (82%), and GT 1a (75%) in those that reported demographics. The overall SVR12 from six diverse real world and post-marketing cohorts was 94% (277/294).  The individual study results are presented in Table 1.

    Conclusion: This analysis of diverse cohorts from the EU and US yielded high SVR rates similar to SVR rates seen in multiple RW monoinfected cohorts and supports the use of 8 weeks of LDV/SOF in TN, NC GT 1 HIV/HCV coinfected patients with a baseline HCV viral load < 6 million.

    Peter Ruane, MD1, Peter Buggisch, MD2, ANA Moreno, MD, PhD3, Vasily Isakov, MD4, Lisa Backus, MD, PhD5, Dani Ain, BS6, Juan Gonzalez-Garcia, MD7, Sarjita Naik, PharmD, MPH8, Swarup Mehta, PharmD, MBA8, Jina Lee, PharmD8, Joe Llewellyn, PharmD8, Michael Mertens, PhD8, Macky Natha, MD, FRCP8, Anu Osinusi, MD, MPH8, Jihad Slim, MD9, Konstantin Zhdanov, MD10, Juan Berenguer, MD PhD11 and Stefan Zeuzem, MD12, (1)Ruane Clinical Research Group, Inc., Los Angeles, CA, (2)Ifi-Institute for Interdisciplinary Medicine, Hamburg, Germany, (3)HOSPITAL RAMON Y CAJAL.INFECTIOUS DISEASES, MADRID, Spain, (4)Institute of Nutrition of Russian Academy of Medical Sciences, Moskow, Russian Federation, (5)Department of Medicine, Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, (6)Ruane Medical and Liver Health Institute, Los Angeles, CA, (7)Hospital Universitario La Paz/IdiPaz Internal Medicine, Madrid, Spain, (8)Gilead Sciences, Foster City, CA, (9)Infectious Disease, St. Michael's Medical Center, Newark, NJ, (10)Military Medical Academy, St Petersburg, Russian Federation, (11)Hospital Gregorio Marañon, Madrid, Spain, (12)Gastroeneterology, Klinikum der Johann-Wolfgang-Goethe-Universität–Med. Klinik I, Frankfurt, Germany

    Disclosures:

    P. Ruane, Gilead: Investigator , Scientific Advisor and Shareholder , Consulting fee and Research support
    Merck: Speaker's Bureau , Speaker honorarium
    Boehringer: Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Janssen: Investigator , Scientific Advisor and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Abbott: Investigator , Scientific Advisor and Speaker's Bureau , Research support and Speaker honorarium
    Idenix: Investigator , Research support
    ViiV: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
    BMS: Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium

    P. Buggisch, Janssen: Scientific Advisor , Consulting fee
    Abbvie: Scientific Advisor , Consulting fee
    BMS: Scientific Advisor , Consulting fee
    Falk: Speaker's Bureau , Speaker honorarium
    MSD: Speaker's Bureau , Speaker honorarium
    Gilead: Speaker's Bureau , Speaker honorarium
    Merz: Speaker's Bureau , Speaker honorarium

    A. Moreno, None

    V. Isakov, BMS: Speaker's Bureau , Speaker honorarium
    Abbvie: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
    Gilead: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
    Merck: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
    Janssen: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
    R-Pharm: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium

    L. Backus, None

    D. Ain, None

    J. Gonzalez-Garcia, Gilead: Board Member and Speaker's Bureau , Speaker honorarium
    MSD: Speaker's Bureau , Speaker honorarium
    Abbvie: Board Member and Speaker's Bureau , Speaker honorarium
    Janssen: Board Member and Speaker's Bureau , Speaker honorarium
    Ciliag: Speaker's Bureau , Speaker honorarium
    BMS: Board Member and Speaker's Bureau , Speaker honorarium

    S. Naik, Gilead Sciences: Employee , Salary

    S. Mehta, Gilead Sciences: Employee , Salary

    J. Lee, Gilead Sciences: Employee , Salary

    J. Llewellyn, Gilead Sciences: Employee , Salary

    M. Mertens, Gilead Sciences: Employee , Salary

    M. Natha, Gilead Sciences: Employee , Salary

    A. Osinusi, Gilead Sciences: Employee , Salary

    J. Slim, Gilead: CME/CE , Consultant , Investigator and Speaker's Bureau , Consulting fee , Research support and Speaker honorarium
    Abbvie: CME/CE , Consultant and Investigator , Consulting fee , Research support and Speaker honorarium
    Merck: CME/CE , Consultant and Investigator , Consulting fee , Research support and Speaker honorarium
    ViiV: CME/CE , Consultant and Investigator , Consulting fee , Research support and Speaker honorarium
    Janssen: CME/CE and Consultant , Consulting fee and Speaker honorarium
    BMS: CME/CE , Speaker honorarium

    K. Zhdanov, MSD: Speaker's Bureau , Speaker honorarium
    Novartis: Speaker's Bureau , Speaker honorarium
    Roche: Speaker's Bureau , Speaker honorarium
    Biocad: Speaker's Bureau , Speaker honorarium
    BMS: Consultant , Consulting fee
    Abbvie: Investigator , Research support
    Gilead: Investigator , Research support
    R-Pharm: Investigator , Research support
    Janssen: Scientific Advisor , Consulting fee

    J. Berenguer, None

    S. Zeuzem, Abbvie: Consultant , Consulting fee
    Gilead: Consultant , Consulting fee
    Merck: Consultant , Consulting fee
    BMS: Consultant , Consulting fee
    Janssen: Consultant , Consulting fee

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    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.