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    Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.

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    Date
    2016-02
    Authors
    Afdhal, N
    Gitlin, N
    Howell, C
    Jeffers, LJ
    Kowdley, K
    McHutchison, JG
    Muir, Andrew
    Pang, PS
    Poulos, J
    Ravendhran, N
    Reddy, KR
    Shiffman, ML
    Sulkowski, MS
    Wilder, Julius Middleton
    Workowski, K
    Yang, JC
    Zhu, Y
    Show More
    (17 total)
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    Abstract
    UNLABELLED: Black patients chronically infected with genotype 1 hepatitis C virus (HCV) have historically had lower rates of response to interferon-based treatment than patients of other races. In the phase 3 ION program, the single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population. The aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from the three open-label ION clinical trials, which evaluated the safety and efficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the treatment of treatment-naïve and treatment-experienced patients with genotype 1 HCV, including those with compensated cirrhosis. The primary endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). For our analysis, rates of SVR12, treatment-emergent adverse events, and graded laboratory abnormalities were analyzed in black versus non-black patients. Of the 1949 patients evaluated, 308 (16%) were black. On average, black patients were older, had higher body mass index, were more likely to be IL28B non-CC, and had a lower serum alanine aminotransferase at baseline than non-black patients. Overall, 95% of black and 97% of non-black patients achieved SVR12. The rate of relapse was 3% in black patients as compared with 2% in non-black patients. The most common adverse events included fatigue, headache, nausea, and insomnia. The majority of adverse events occurred more frequently in the ribavirin-containing arms of the studies. No differences were observed in overall safety by race. CONCLUSION: A once-daily dosage of ledipasvir/sofosbuvir was similarly effective in black and non-black patients with genotype 1 HCV infection. The addition of ribavirin did not appear to increase SVR12 but was associated with higher rates of adverse events.
    Type
    Journal article
    Subject
    Adolescent
    Adult
    African Americans
    Aged
    Aged, 80 and over
    Antiviral Agents
    Benzimidazoles
    Female
    Fluorenes
    Hepatitis C, Chronic
    Humans
    Male
    Middle Aged
    Retrospective Studies
    Treatment Outcome
    Uridine Monophosphate
    Young Adult
    Permalink
    https://hdl.handle.net/10161/12751
    Published Version (Please cite this version)
    10.1002/hep.28334
    Publication Info
    Afdhal, N; Gitlin, N; Howell, C; Jeffers, LJ; Kowdley, K; McHutchison, JG; ... Zhu, Y (2016). Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology, 63(2). pp. 437-444. 10.1002/hep.28334. Retrieved from https://hdl.handle.net/10161/12751.
    This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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    Scholars@Duke

    Muir

    Andrew Joseph Muir

    Professor of Medicine
    Hepatitis C  Primary sclerosing cholangitis Cirrhosis Liver Transplantation Clinical Trials Healthcare disparities in liver disease  Outcomes Research
    Wilder

    Julius Middleton Wilder

    Assistant Professor of Medicine
    Alphabetical list of authors with Scholars@Duke profiles.
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    Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

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