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Clinical Studies of Viral Hepatitis

Marks, Burke, Glesby

Hepatitis C infection is the leading cause of end stage liver disease and need for liver transplantation in this country. Studies have shown that patients with HIV/HCV coinfection have an accelerated course of progression to cirrhosis and end stage liver disease compared to patients with HCV infection alone. Strategies for improving treatment outcomes are needed for this population. Current studies being conducted at Cornell focus on initial treatment of HCV infection as well as treatment of refractory disease. CCTU investigators are conducting ACTG studies of direct-acting antivirals for acute and chronic HCV infection. Completed studies include an epidemiologic investigation of risk factors for hepatic steatosis in HIV/HCV coinfection, a pilot study examining the safety and efficacy of treatment of acute HCV infection in HIV-infected patients, as well as additional clinical trials of DAAs conducted with the ACTG. The Center for the Study of Hepatitis C, a multidisciplinary center involving Rockefeller University, Weill Cornell Medical College, and NewYork-Presbyterian Hospital, provides additional opportunities for translational research, access to a serum and tissue bank, and collaboration with experts in the field of virology and hepatitis treatment (e.g. Dr. Charlie Rice).

  • Branch AD, Kang M, Hollabaugh K, Wyatt CM, Chung RT, Glesby MJ. In HIV/hepatitis C virus co-infected patients, higher 25-hydroxyvitamin D concentrations were not related to hepatitis C virus treatment responses but were associated with ritonavir use. Am J Clin Nutr. 2013; 98(2):423-29.
  • Marks KM, Kitch D, Chung RT, Hadigan C, Andersen J, Tien P, Luetkemeyer A, Alston-Smith B, Glesby MJ. A5239 Team. Pilot study of pioglitazone before HCV retreatment in HIV/HCV genotype 1-infected subjects with insulin resistance and previous nonresponse to peginterferon and ribavirin therapy. J Acquir Immune Defic Syndr. 2014; 65(3):345-9.
  • Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E, Santana-Bagur J, Stamm LM, Yang JC, German P, Dvory-Sobol H, Ni L, Pang PS, McHutchison JG, Stedman CA, Morales-Ramirez JO, Bräu N, Jayaweera D, Colson AE, Tebas P, Wong DK, Dieterich D, Sulkowski M; ION-4 Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med 2015 (epub).
  • Sulkowski MS, Kang M, Matining R, Wyles D, Johnson VA, Morse GD, Amorosa V, Bhattacharya D, Coughlin K, Wong-Staal F, Glesby MJ; AIDS Clinical Trials Group A5277 Protocol Team. Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis. 2014; 209:658-67.
  • Tavakkoli M, Ferrando SJ, Rabkin J, Marks K, Talal AH. Depression and fatigue in chronic hepatitis C patients with and without HIV co-infection. Psychosomatics. 2013; 54:466-71.

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Roy M. Gulick, M.D., Chief

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