Program Director/Principal Investigator (Last, First, Middle):
Afdhal, Nezam
BIOGRAPHICAL SKETCH
NAME
POSITION TITLE
NEZAM HASSAN AFDHAL
Associate Professor of Medicine, Harvard
Medical School
eRA COMMONS USER NAME
nafdhal
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION
ROYAL COLLEGE OF SURGEONS IN
IRELAND
St. Laurences Hospital, Dublin, Ireland
St. Vincents Hospital, Dublin, Ireland
Boston University
DEGREE
(if applicable)
YEAR(s)
M.D.
1981
Resident
Fellow
Clin. Fellow
1981-84
1984-87
1987-88
FIELD OF STUDY
Medicine
Internal Medicine
Gastroenterology
Hepatology
A. Personal Statement
I’m director of the BIDMC Liver Center. Dr Alatrakchi et al. propose to study the impact of HCV-specific T cell
subsets on the HCV-related liver pathogenesis. This might provide us with new therapeutic tools for preventing
liver fibrosis progression. In that effort, we provided her group with more than 100 liver biopsies and matched
peripheral blood samples. Later within the project, once the immunology data available, we will provide deidentified complete pathology reports, clinical and demographic data. Liver biopsies are performed for
diagnostic purposes. For subjects who will need a follow up biopsy, we can provide Dr Alatrakchi’s group with
surplus material if available.
B. Positions and Honors
Positions and Employment
1984 - 87
1987 - 88
1988 - 89
1989 - 1994
1994 - 2000
2000 - current
Resident in Internal Medicine, St. Laurences Hospital, Dublin, Ireland
Fellow in Gastroenterology and Hepatology, St. Vincents Hospital, Dublin, Ireland
Fellow in Gastroenterology and Hepatology, Boston University, Boston, MA
Assistant Professor of Medicine, Boston University School of Medicine, Boston
Associate Professor of Medicine, Boston University School of Medicine, Boston
Associate Professor of Medicine, Beth Israel Deaconess Medical Center and Harvard
Medical School, MA
Other Experience and Professional Memberships
1999
2001
2002
2003
Advisor, Advisor, Fibrosis Markers Panel, NIH HALT-C Trial
Member, NIH Study Section, NIAAA Special Emphasis Panel RFA AA01-004-HIV
Ad-Hoc Member, NIH Study Section, Adult to adult living donor liver transplantation
Member, NIH Study Section, Pathogenesis of HCV (RFA DK-03-011)
Honors
1995
1989
2001
2003
Award of Excellence for Clinical Care, American Liver Foundation
Charles Trey Research Award, American Liver Foundation
Fellow, American College of Gastroenterology
Fullbright Scholarship, Director, US-Egypt Fullbright Program in HCV
PHS 398/2590 (Rev. 06/09)
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Program Director/Principal Investigator (Last, First, Middle):
Afdhal, Nezam
C. Selected peer-reviewed publications last 3 years (in chronological order).
1.
Zinkin NT, Grall F, Bhaskar K, Otu HH, Spentzos D, Kalmowitz B, Wells M, Guerrero M, Asara JM,
Libermann TA, Afdhal NH. Serum Proteomics and Biomarkers in Hepatocellular Carcinoma and Chronic
Liver Disease. Clin Cancer Res. 2008;14(2):470-477.
2.
Patel K, Nelson DR, Rockey DC, Afdhal NH, Smith KM, Oh E, Hettinger K, Vall_e M, Dev A, SmithRiggs M, McHutchison JG. Correlation of FIBROSpect II with histologic and morphometric evaluation of liver
fibrosis in chronic hepatitis C. Clin Gastroenterol Hepatol. 2008;6(2):242-7.
3.
Cardenas A, Lowe R, Oh S, Bodkin S, Kenney T, Lamorte WW, Afdhal NH. Hemodynamic effects of
substance P and its receptor antagonist RP67580 in anesthetized rats with carbon tetrachloride-induced
cirrhosis. Scand J Gastroenterol. 2008;43(3):328-33.
4.
Mehta SH, Lau B, Afdhal NH, Thomas DL. Exceeding the limits of liver histology markers. J Hepatol.
2009;50(1):36-41.
5.
Becker L, Salameh W, Sferruzza A, Zhang K, Chen R, Malik R, Reitz R, Nasser I, Afdhal NH.
Validation of Hepascore, compared to simple indices of fibrosis, in US patients with chronic hepatitis C virus
infection. Clin Gastroenterol Hepatol. 2009;7:696-701
6.
Kirk GD, Astemborski J, Mehta SH, Spoler C, Fisher C, Allen D, Higgins Y, Moore RD, Afdhal NH,
Torbenson M, Sulkowski M, Thomas DL. Assessment of liver fibrosis by transient elastography in persons with
hepatitis C virus infection or HIV-hepatitis C virus coinfection. Clin Infect Dis. 2009;48(7):963-72.
7.
Malik R, Chang M, Bhaskar K, Nasser I, Curry M, Schuppan D, Byrnes V, Afdhal NH. The clinical
utility of biomarkers and the nonalcoholic steatohepatitis CRN liver biopsy scoring system in patients with
nonalcoholic fatty liver disease. J Gastroenterol Hepatol. 2009;24(4):564-8.
8.
Rustgi VK, Lee WM, Lawitz E, Gordon SC, Afdhal NH, Poordad F, Bonkovsky HL, Bengtsson L,
Chandorkar G, Harding M, McNair L, Aalyson M, Alam J, Kauffman R, Gharakhanian S, McHutchison JG,
Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and
ribavirin nonresponders. Hepatology. 2009:50;1719 - 1726
9.
Celli JP, Turner BS, Afdhal NH, Keates S, Ghiran I, Kelly CP, Ewoldt RH, McKinley GH, So P,
Erramilli S, Bansil R. Helicobacter pylori moves through mucus by reducing mucin viscoelasticity. Proc Natl
Acad Sci U S A. 2009;106(34):14321-6.
10.
Benhamou Y, Afdhal NH, Nelson DR, Shiffman ML, Halliman DG, Heise J, Chun E, Pockros PJ. A
phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naive patients with chronic
hepatitis C: ViSER1 results. Hepatology. 2009;50(3):717-26.
11.
Hawke RL, Schrieber SJ, Soule TA, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH,
Navarro VJ, Berman J, Liu QY, Doo E, Fried MW. Silymarin Ascending Multiple Oral Dosing Phase I Study in
Noncirrhotic Patients With Chronic Hepatitis C. J Clin Pharmacol. 2009.
12.
McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem
S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM, Telaprevir for
previously treated chronic HCV infection. N Engl J Med. 2010;362(14):1292-303.
13.
Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, Urban T, Afdhal NH, Jacobson
IM, Esteban R, Poordad F, Lawitz EJ, McCone J, Shiffman ML, Galler GW, Lee WM, Reindollar R, King JW,
Kwo PY, Ghalib RH, Freilich B, Nyberg LM, Zeuzem S, Poynard T, Vock DM, Pieper KS, Patel K, Tillmann
HL, Noviello S, Koury K, Pedicone LD, Brass CA, Albrecht JK, Goldstein DB, McHutchison JG. IL28B
Polymorphism Improves Viral Kinetics and Is the Strongest Pre-treatment Predictor of SVR in HCV-1 Patients.
Gastroenterology. 2010.
14.
Thompson AJ, Fellay J, Patel K, Tillmann HL, Naggie S, Ge D, Urban TJ, Shianna KV, Muir AJ, Fried
MW, Afdhal NH, Goldstein DB, McHutchison JG. Variants in the ITPA Gene Protect Against RibavirinInduced Hemolytic Anemia and Decrease the Need for Ribavirin Dose Reduction. Gastroenterology.
2010;139:120-129
15.
Sulkowski MS, Shiffman ML, Afdhal NH, Reddy KR, McCone J, Lee WM, Herrine SK, Harrison SA,
PHS 398/2590 (Rev. 06/09)
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Program Director/Principal Investigator (Last, First, Middle):
Afdhal, Nezam
Poordad FF, Koury K, Deng W, Noviello S, Pedicone LD, Brass CA, Albrecht JK, McHutchison JG; IDEAL
Study Team. HCV treatment related anemia is associated with higher sustained virological response.
Gastroenterology 2010; Aug Epub
D. Research Support.
Ongoing Research Support
2007 - 2010
2008 -
2008 -
2008 -
2008 -
2008 -
2008 -
2008 -
2008 -
A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy Safety and
Tolerability of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared
with Peginterferon and ribavirin in genotype 2/3 patients
Human Genome sciences
PI ($43,372)
Randomized, placebo-controlled, multi-centre study to assess the efficacy and safety of
eltrombopag in thrombocytopenic subjects with hepatitis C virus infection who are
otherwise eligible to initiate Peginterferon and ribavirin therapy
GSK
PI ($80,467)
Randomized, Double-Blind, Placebo-Controlled, Multi-Centre, Study to Evaluate the Safety
and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in
Thrombocytopenic Subjects with Chronic liver disease undergoing invasive procedures
GSK
National PI ($33,321)
Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in
Combination with Peginterferon a-2a and Ribavirin in Treatment-Naive Patients with
Hepatitis C
Romark Laboratories
PI ($21,104)
A Phase 3 study of 2 Dose Regimens of Telaprevir in Combination with Peginterferon Alfa2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects with Genotype 1 Chronic
Hepatitis C
Vertex
PI ($97,360)
A randomized study of stopping treatment at 24 weeks or continuing treatment to 48 weeks
in treatment-naive subjects with genotype 1 chronic hepatitis who achieve an extended
rapid viral response with Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) and
telaprevir
Vertex
PI ($74,423)
A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C
Genotype 1 Who Failed Prior Treatment with Peginterferon/Ribavirin
Schering Plough
PI ($59,252)
A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With
Chronic Hepatitis C Genotype 1
Schering Plough
PI ($41,297)
A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of teleprevir
(with and without delayed start) combined with pegylated interferon alfa-2a and ribavirin in
subjects with chronic HCV genotype 1
Tibotec
PI ($23,074)
PHS 398/2590 (Rev. 06/09)
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Program Director/Principal Investigator (Last, First, Middle):
2008 – 2012
2009
2010 -2011
2010 - 2012
Afdhal, Nezam
Harvard Hepatitis B Consortium
NIDDK UO1 DK082919-02 PI: Daryl Lau M.D.
Co-PI: Investigator in clinical core and in substudies of liver fibrosis biomarkers
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of
the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered with Pegylated
Interferon and Ribavirin in Treatment naïve genotype 1 HCV
Anadys
PI
Single and Multiple dose open label study of the pharmacokinetics and safety of an oral
food supplement Hepaleve in patients with non-alcoholic fatty liver disease (NAFLD) and
Hepatitis C (HCV)
Marcus Foundation
PI ($1,131,140)
NIH / NIAAA SBIR 2-R33-AA015223-04
A Phase 1 Safety and Pharmacokinetic Study of Single and Repeat Infusions of BB3
Intravenously in Subjects with Hepatic Fibrosis
PI ($1,050,000)
Completed Research Support
UO1 DK 60340 Nezam H. Afdhal
8/21/2001 - 6/30/2006
N.I.H. Virahep C: A multicenter trial on viral resistance
Role: P.I.
DA16708 D. Thomas
N.I.H. HIV-HCV antiviral therapy and fibrosis
Role: PI: Fibrosis Core
PHS 398/2590 (Rev. 06/09)
7/1/2002 - 7/1/2007
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