714. Sofosbuvir and Peginterferon alfa-2a/RibavirinTreatment of na´ve Genotype 1-4 HCV infected patients that are co-infected with HIV
Session: Poster Abstract Session: Antimicrobials: Novel Agents
Friday, October 4, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • Rodriguez IDWeek 88x44@275%-Final.pdf (66.1 kB)
  • Background: HIV/HCV co-infected patients are in need of safe and effective HCV treatments without risk for resistance and that can be given with antiretroviral treatment (ART). The efficacy and safety of the once daily, oral HCV NS5B inhibitor sofosbuvir in combination with peginterferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, was examined in a pilot study of HCV treatment-naive HCV/HIV-coinfected patients.

    Methods: Twenty-three naïve, non-cirrhotic genotype 1-4 HCV/HIV co-infected patients received sofosbuvir 400mg QD, RBV 1000-1200 mg/day,and peg-IFN 180 μg/week for 12 weeks. Patients were required to be on stable ART with HIV RNA suppression.  The primary efficacy endpoint was SVR12 and safety assessments included HIV RNA and CD4 T-cell counts/percentages.

    Results: Baseline characteristics of the study population and stable ART regimens are shown in the table.  Most patients had rapid on-treatment HCV RNA suppression; 22/23 (96%) had Week 2 HCV RNA below the limit of quantification, and there was no virologic breakthrough during therapy. Of the 12 patients to complete therapy to date, 10 (83%) achieved SVR4.   The most frequently reported AEs (>10%) were fatigue (30%), anemia (30%), and thrombocytopenia (17%).   No HIV viral breakthrough or reductions in CD4 T-cell percent occurred.  Complete HCV SVR12 results for all patients will be presented.

    Conclusion: Treatment with sofosbuvir, peg-IFN and RBV for 12 weeks achieves high SVR-4 in this pilot trial in genotype 1-4, HCV treatment-naïve HCV/HIV co-infected patients. Therapy was well tolerated, without evidence of HIV viral breakthrough or changes in CD4 T-cell percent.

     

    Sofosbuvir + peg-IFN + RBV

    Baseline Characteristics (N=23)

     

    Male, n (%)

    18 (78)

    Black, n (%)

    8 (35)

    IL28b CC genotype, n (%)

    5 (22)

    HCV Genotype, n (%)

    19 (83)

    1a

    15 (65)

    1b

    4 (17)

    2b

    1 (4)

    3a

    2 (9)

    4a/4b/4c

    1 (4)

    Log10 HCV RNA (IU/mL), mean (SD)

    6.59 (0.87)

    CD4 T-cell count (cells/μl), mean (SD)

    562 (302)

    CD4 T-cell percent, mean (SD)

    28.8 (9.7)

    ARV Regimen (N=23): Tenofovir/Emtricitabine PLUS

     

    Efavirenz, n (%)

    10 (43)

    Ritonovir/Atazanavir, n (%)

    8 (35)

    Ritonovir/Raltegravir, n (%)

    7 (30)

    Ritonovir/Darunavir, n (%)

    6 (26)

    Rilpilvirine, n (%)

    1 (4)

    SVR4, n/N (%)

    10/12 (83)

    Maribel Rodriguez-Torres, MD1, Jose Rodriguez-Orengo, PhD2, Anuj Gaggar, MD, PhD3, William Symonds, PharmD3, John Mchutchison, MD3 and Milagros Gonzalez, MD4, (1)Gastroenterology, Fundacion de Investigacion, Rio Piedras, PR, (2)Biochemistry, University of Puerto Rico, San Juan, PR, (3)Gilead Sciences, Foster City, CA, (4)Fundacion de Investigacion, Rio Piedras, PR

    Disclosures:

    M. Rodriguez-Torres, None

    J. Rodriguez-Orengo, None

    A. Gaggar, Gilead Sciences: Employee, Salary

    W. Symonds, Gilead Sciences: Employee, Salary

    J. Mchutchison, Gilead Sciences: Employee, Salary

    M. Gonzalez, None

    Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 2nd with the exception of research findings presented at the IDWeek press conferences.