This is a proposal for a K24 Midcareer Investigator Award in Patient-oriented research (POR) for Mark S. Sulkowski, MD of the Johns Hopkins University School of Medicine. Dr. Sulkowski is an Associate Professor of Medicine in the Division of Infectious Diseases (ID) and Medical Director of the ID Viral Hepatitis Center. He leads two complementary POR programs for hepatitis C virus (HCV): HCV/HIV Liver Outcomes Research.
The aims of this research are to evaluate long-term outcomes of HCV disease in an NIH-supported longitudinal cohort of adults coinfected with HIV and HCV. Current efforts emphasize the use of tools to determine the impact of antiretroviral therapy and HCV treatment on liver disease including histology and noninvasive transient elastography as well as interventions to improve HCV outcomes such as behavioral reinforcement for HCV treatment. HCV Therapeutics.
The aim of this research is to conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV with the broad goals of validating new therapeutic targets, increasing eradication rates, improving safety and tolerability and translating these findings to the community. The principal aims of this K24 Award proposal are: 1) To create a comprehensive training program that brings together expertise in outcomes research and clinical trials to prepare early clinical investigator for academic careers in POR related to HCV;2) To dedicate research effort to the advancement of the HCV research agenda in the AIDS Clinical Trials Group (ACTG). This network has led research in HIV/HCV coinfection and has expertise in virology, immunology, pharmacology, metabolic, biostatics, bioethics, and research implementation that are critical to the HCV field;3) To expand the scope HCV disease management in coinfected adults through the development of a research program focused on harmful alcohol intake which is prevalent in this population, accelerates HCV disease and is a contraindication to HCV treatment.
These aims will be addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students. The K24 will allow Dr. Sulkowski to more effectively pursue his long-term career goals of improving HCV treatment and translating these treatments to populations of individuals with the highest HCV disease burden. Public Health Relevance: This is a proposal for a Midcareer Investigator Award in Patient-Oriented Research (K24) for Mark S. Sulkowski, M.D. This award will support Dr. Sulkowski's clinical research programs in Hepatitis C;the overarching aim of this research is to improve clinical outcomes in persons with HCV through the conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV and the translation of improved therapies to populations with the greatest disease burden.
These aims are addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students.

Public Health Relevance

This is a proposal for a Midcareer Investigator Award in Patient-Oriented Research (K24) for Mark S. Sulkowski, M.D. This award will support Dr. Sulkowski's clinical research programs in Hepatitis C;the overarching aim of this research is to improve clinical outcomes in persons with HCV through the conduct clinical trials of novel direct acting antivirals (DAAs) for the treatment of HCV and the translation of improved therapies to populations with the greatest disease burden. These aims are addressed in the context of providing mentorship to new and existing junior faculty, infectious diseases fellows and graduate students.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
1K24DA034621-01
Application #
8224954
Study Section
Microbiology and Infectious Diseases B Subcommittee (MID)
Program Officer
Khalsa, Jagjitsingh H
Project Start
2012-04-15
Project End
2017-03-31
Budget Start
2012-04-15
Budget End
2013-03-31
Support Year
1
Fiscal Year
2012
Total Cost
$118,638
Indirect Cost
$8,788
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Kowdley, Kris V; Lawitz, Eric; Poordad, Fred et al. (2014) Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 370:222-32
Hagan, Liesl M; Sulkowski, Mark S; Schinazi, Raymond F (2014) Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals. Hepatology 60:37-45
Konerman, Monica A; Mehta, Shruti H; Sutcliffe, Catherine G et al. (2014) Fibrosis progression in human immunodeficiency virus/hepatitis C virus coinfected adults: prospective analysis of 435 liver biopsy pairs. Hepatology 59:767-75
Martel-Laferriere, V; Brinkley, S; Bichoupan, K et al. (2014) Virological response rates for telaprevir-based hepatitis C triple therapy in patients with and without HIV coinfection. HIV Med 15:108-15
Sulkowski, Mark S; Gardiner, David F; Rodriguez-Torres, Maribel et al. (2014) Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 370:211-21
Melia, Michael T; Bräu, Norbert; Poordad, Fred et al. (2014) Infections during peginterferon/ribavirin therapy are associated with the magnitude of decline in absolute lymphocyte count: results of the IDEAL study. Clin Infect Dis 58:960-9
Sulkowski, Mark S; Kang, Minhee; Matining, Roy et al. (2014) 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 209:658-67
Wyles, David L; Rodriguez-Torres, Maribel; Lawitz, Eric et al. (2014) All-oral combination of ledipasvir, vedroprevir, tegobuvir, and ribavirin in treatment-naïve patients with genotype 1 HCV infection. Hepatology 60:56-64
Sulkowski, Mark S (2014) Interferon-containing and interferon-free HCV therapy for HIV-infected patients. Semin Liver Dis 34:72-8
Sulkowski, Mark S; Poordad, Fred; Manns, Michael P et al. (2013) Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial. Hepatology 57:974-84

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