Sustained long-term antiviral maintenance therapy in HCV/HIV-coinfected patients (SLAM-C)

Kenneth E. Sherman, Janet W. Andersen, Adeel A. Butt, Triin Umbleja, Beverly Alston, Margaret J. Koziel, Marion G. Peters, Mark Sulkowski, Zachary D. Goodman, Raymond T. Chung

Research output: Contribution to journalArticle

Abstract

Background: Hepatitis C virus (HCV)/HIV coinfection treatment is suboptimal with low sustained viral response rates to standard therapies. A multicenter randomized clinical trial designed to assess the efficacy/safety of pegylated interferon maintenance therapy was performed by the National Institutes of Health-funded AIDS Clinical Trials Group network. Methods: HCV treatment-naive and nonresponding interferon-experienced subjects with confirmed HCV and HIV, CD4 >200 cells per cubic millimeter, and at least stage 1 fibrosis were enrolled and treated for 12 weeks with pegylated interferon alfa 2a 180 mcg per week (PEG) + weight-based ribavirin to determine response status. Nonresponder subjects (failure to clear HCV RNA or achieve 2-log drop) underwent liver biopsy and were randomized to receive full dose PEG or observation only for 72 weeks. Paired biopsies were evaluated by a central pathologist. Results: Three hundred thirty subjects were enrolled; median age was 48 years; 43% white, 37% black, non-Hispanic; 83% male; CD4+ 498 cells per cubic millimeter; 32% were interferon experienced; 74% had entry HIV RNA <50 copies per milliliter. early virologic responder was observed in 55.9% and 42.5% achieved complete Early Viral Response (cEVR). A planned interim analysis of occurred when 84 subjects were randomized. With data on 40 paired biopsies available, a safety monitoring board stopped the trial due to lack of fibrosis progression (median = 0 Metavir units/year) in the observation arm. Conclusions: Lack of fibrotic progression in the control arm was unexpected and may represent a short-term PEG/ribavirin therapy effect, high levels of HIV viral suppression, and use of antiretroviral regimens that may be less toxic than prior generations of therapy.

Original languageEnglish (US)
Pages (from-to)597-605
Number of pages9
JournalJournal of acquired immune deficiency syndromes
Volume55
Issue number5
DOIs
StatePublished - Dec 15 2010

Keywords

  • HCV
  • HIV
  • fibrosis
  • maintenance
  • racial disparity

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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  • Cite this

    Sherman, K. E., Andersen, J. W., Butt, A. A., Umbleja, T., Alston, B., Koziel, M. J., Peters, M. G., Sulkowski, M., Goodman, Z. D., & Chung, R. T. (2010). Sustained long-term antiviral maintenance therapy in HCV/HIV-coinfected patients (SLAM-C). Journal of acquired immune deficiency syndromes, 55(5), 597-605. https://doi.org/10.1097/QAI.0b013e3181f6d916