Program Schedule

820
Triple Combination Treatment With Peginterferon Lambda-1a, Daclatasvir and Ribavirin for 12 Weeks in Patients Infected With HCV Genotype 1b

Session: Poster Abstract Session: Clinical - Clinical Trials
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • 1014036 4612555_IDW_Triple_Brunetto_Poster_PRINT.pdf (277.5 kB)
  • Background: Peginterferon lambda-1a (Lambda, Type III IFN) is currently under Phase 3 evaluation as part of combination treatment for HCV infection. The triple regimen of Lambda, daclatasvir (DCV; NS5A inhibitor) and ribavirin (RBV) achieved sustained virologic response (SVR) rates of >90% in a pilot study of patients chronically infected with genotype 1b HCV when treated for 24 weeks. This triple combination regimen was evaluated for 12 weeks of treatment in a cohort of patients with genotype 1b infection (Study AI452-008c).

    Methods: 24 treatment-naive, non-cirrhotic HCV genotype 1b infected patients were treated with open-label Lambda 180 mcg/week + DCV 60mg daily + RBV 1000-1200mg daily for 12 weeks. The primary endpoint is HCV RNA <LLOQ (25 IU/mL) at 12 weeks post-treatment (SVR12). SVR4 results are reported here with SVR12 available at presentation.

    Results: Baseline characteristics were male 46%, Caucasian 96%, and IL28B non-CC genotype 67%. Mean baseline HCV RNA was 6.3 (range 5.1–7.4) log10 IU/mL. SVR4 was achieved in 21/23 (91%) patients with available data. Both patients who did not achieve SVR4 experienced relapse posttreatment. No patients discontinued treatment due to AEs or treatment futility; there were no deaths and no serious AEs. The most frequent AEs were asthenia, pruritus, dry skin and diarrhea. One patient each (n=3/24) had a Grade 3/4 lab abnormality of elevated ALT/AST, reduced hemoglobin, or increased bilirubin.

    Conclusion: 12 weeks of treatment with Lambda + DCV + RBV achieved a high SVR4 rate in treatment-naïve, non-cirrhotic HCV genotype 1b-infected patients. The regimen was generally well tolerated.

     

    Observed

    mITT

    HCV RNA <LLOQ at end of treatment, n/N (%)

    24/24 (100)

    24/24 (100)

    SVR4, n/N (%)

    21/23 (91)*

    21/24 (88)

    Post-treatment relapse (n)

    2

    *1 patient was lost to follow-up (Week 8 undetectable), counted as failure for mITT analysis

    Maurizia Brunetto, MD1, Khurram Rana2, Gloria Taliani3, Eric Lawitz4, Christophe Hézode5, Patrick Marcellin6, Lawrence Serfaty7, David Cohen2 and Subasree Srinivasan2, (1)Liver Unit, University Hospital of Pisa, Pisa, Italy, (2)Bristol-Myers Squibb, Wallingford, CT, (3)Azienda Ospedaliera Universitaria, Policlinico Umberto I, Roma, Italy, (4)Texas Liver Insititute, University of Texas Health Science Center, San Antonio, TX, (5)CHU Henri Mondor, Service d’Hépato-Gastroentérologie, Créteil, France, (6)Hôpital Beaujon, Clichy, France, (7)St Antoine Hospital, Pierre and Marie Curie University, Paris, France

    Disclosures:

    M. Brunetto, AbbVie, BMS, Gilead, Janssen, MSD, Roche, Novartis: Speaker's Bureau, Speaker honorarium

    K. Rana, Bristol-Myers Squibb: Employee, Salary

    G. Taliani, None

    E. Lawitz, AbbVie, Achillion Pharmaceuticals, BioCryst, Biotica, Enanta, Idenix Pharmaceuticals, Janssen, Merck: Scientific Advisor, Consulting fee
    AbbVie, Achillion Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Idenix Pharmaceuticals,: Grant Investigator, Grant recipient and Research support
    Gilead, Kadmon, Merck, Vertex: Speaking and Teaching, Speaker honorarium

    C. Hézode, Abbvie, BMS, Gilead, Janssen, MSD, Roche: Consultant, Personal fee

    P. Marcellin, Roche: Consultant, Grant Investigator and Speaker, Consulting fee, Grant recipient and Speaker honorarium
    Gilead: Consultant, Grant Investigator and Speaker, Consulting fee, Grant recipient and Speaker honorarium
    Bristol-Myers Squibb: Consultant, Grant Investigator and Speaker, Consulting fee, Grant recipient and Speaker honorarium
    Vertex: Consultant and Investigator, Consulting fee
    Novartis: Consultant, Grant Investigator and Speaker, Consulting fee, Grant recipient and Speaker honorarium
    Janssen-Tibotec: Consultant, Grant Investigator and Speaker, Consulting fee, Grant recipient and Speaker honorarium
    MSD: Consultant, Grant Investigator and Speaker, Consulting fee, Grant recipient and Speaker honorarium
    Boehringer: Investigator, Consulting fee
    Abbott: Consultant and Investigator, Consulting fee
    Pfizer: Investigator, Consulting fee
    Alios BioPharma: Grant Investigator, Grant recipient

    L. Serfaty, None

    D. Cohen, Bristol-Myers Squibb: Employee, Salary

    S. Srinivasan, Bristol-Myers Squibb: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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