MITCHELL N. DAVIS, DO, FACOI, FACG
Dr. Mitchell Davis has been providing medical care in Palm Beach County Florida since 1991. He was a partner in the largest Gastroenterology Group in Florida from 2006-2018, and has been the Medical Director of the Hepatitis Treatment Institute of Florida since 1997. In this capacity, Dr. Davis worked with National and International colleagues to develop the only successful treatments for Hepatitis C. Dr. Davis’ many published papers can be read in medical journals worldwide.
Dr. Davis is Board Certified in Internal Medicine and Gastroenterology, and has achieved Fellowship status in the American College of Osteopathic Internists, as well as the American College of Gastroenterology. Dr. Davis has been named a “Top Doctor” in Florida.
Dr. Davis has expert knowledge in the use of both low THC CBD therapy, as well as the many uses of medicinal to treat approved conditions in Florida. He is acknowledged to be an exceptional patient educator, and desires all of his patients to become educated regarding their qualifying medical conditions. Dr. Davis and staff will advise all patients on alternative options that do not have significant side effects, and are non-addicting.
Dr. Davis’ Curriculum Vitae
PERSONAL:
Date of Birth: November 6, 1957
Birthplace: Philadelphia, PA
RESEARCH FACILITY PRINCIPAL INVESTIGATOR:
South Florida Center of Gastroenterology, P.A. d/b/a Hepatitis Treatment Institute of Florida 1447 Medical Park Boulevard, Suite #205
Wellington, Florida 334141996-2018
EMPLOYMENT
Dec 2006 – Feb 2017: South Florida Center of Gastroenterology, LLC, a subsidiary gastrulae, LLP d/b/a Digestive Care
Oct 1991 – Dec 2006: South Florida Center of Gastroenterology, PA
EDUCATION
Aug 1975 – Jun 1979: Pennsylvania State University, University Park, PA. Bachelor of Science
Aug 1980 – Jun 1984: Philadelphia College of Osteopathic Medicine, Philadelphia, PA. Doctor of Osteopathy
July 1984 – Jun 1985: Metropolitan Hospital – Parkview Division, Philadelphia, PA. Rotating Internship
July 1985 – Jun 1988: UMDNJ-SOM/Kennedy Memorial Hospitals, Stanford, NJ Residency in Internal Medicine
July 1988 – Jun 1990: University of Medicine and Dentistry of New Jersey, School of Osteopathic Medicine, Stanford, NJ. Fellowship in Gastroenterology
BOARD CERTIFICATIONS
1985: Diplomat, National Board of Examiners of Osteopathic Physicians and Surgeons
1991: Diplomat, American Osteopathic Board of Internal Medicine, Subsection of Gastroenterology
1998: Diplomat, American Osteopathic Board of Internal Medicine
2002: Fellow, American College of Osteopathic Internist
2012: Fellow, American College of Gastroenterology
PROFESSIONAL ORGANIZATIONS
American Medical Marijuana Physicians Association
Society of Cannabis Clinicians American
Society of Cannabis Medicine American
College of Gastroenterology American
Society for Gastroenterology Endoscopy
American College of Osteopathic Internists
American Osteopathic Association
Florida Osteopathic Medical Association
Member, American Association for the Study of Liver Diseases (AASLD)
Member, European Association for the Study of Liver Diseases (EASL)
SPECIAL TRAINING
Good Clinical Practice, Level 2,
GenED, Inc. 2007
National Institutes of Health (NIH)
Protecting Human Research Participants
Certification Number: 721061. 25 July, 2011
GCP/ICH TRAINING
Abbvie, Inc. June 2014
Overcoming the Challenges to HCV Elimination Among Individuals Who Are Incarcerated.
October 2019
TEACHING APPOINTMENTS
Clinical Adjunct Professor of Gastroenterology
Lake Erie College of Osteopathic Medicine
10/96 to 6/17
Clinical Instructor in Gastroenterology
NOVA-Southeastern University
Department of Internal Medicine
10/91 – 10/96
Clinical Instructor in Gastroenterology
Philadelphia College of Osteopathic Medicine
7/90 – 10/91
RESEARCH PROJECTS and PUBLICATIONS as PRIMARY INVESTIGATOR
Rebetron/Intron A – Protocol R 97-023, Phase In.
September 1999 – June 2002
Infergen Protocol #980102, Phase IV
November 1999 – January 2001
Infergen Protocol #980170, Phase IV
November 1999 – January 2001
Rebetron Protocol #156-03-99, Phase III
December 1999 – December 2002
Rebetron Protocol #157-03-99, Phase III
June 2001 – June 2003
Peg-Intron/ribavirin Protocol #215-04-00, Phase III
June 2001 – June 2003
Peg-Intron/Rebetol Protocol #244-11-00, Phase III
July 2003 – October 2005
Peg-Intron/Rebetol Co-Infected Protocol #266-07-01, Phase III
April 2001 – May 2003
Hoffman La-Roche Protocol #NV17317, Phase IV
November 2003 – October 2005
Hoffman La-Roche Protocol #ML17756B, Phase IV
January 2004 – May 2006
Hoffman La-Roche Protocol #NV17318, Phase IV
April 2004 – February 2006
Hoffman La-Roche Protocol #NV17590, Phase IV
April 2005 – January 2007
Schering-Plough Ideal Protocol #P03471, Phase IV
April 2004 – February 2008
Schering-Plough Protocol #P03523, Phase II
November 2006 – December 2007
Schering-Plough Protocol #P05063, Phase III
August 2007 – October 2014
Schering-Plough Protocol #P05101, Phase III
July 2008 – July 2010
Schering-Plough Protocol #P05216, Phase III
July 2008 – August 2010
Vertex Protocol #VX08-950-111, Phase III
September 2008 – August 2010
Schering-Plough Protocol #P05685, Phase III
November 2008 – January 2011
Schering-Plough Protocol #P05514, Phase III
December 2008 – October 2014
Schering-Plough Protocol #P06086, Phase III
December 2009 – January 2012
Merck & Co. Protocol MK7009-009-04, Phase II
March 2010 – May 2013
Gilead, Inc. Protocol GS-US-196-0140, Phase II
February 2011 – Aug 2013
Pharmasset, Inc. Protocol P7977-0724,ATOMIC Phase II
March 2011 – Dec 2012
Gilead Inc. Protocol GS-US-256-0124, Phase IIb
August, 2011 – Dec 2012
Pharmasset, Inc. Protocol P7977-1231, FISSION Phase II
December 2011 – May 2013
Pharmasset, Inc. Protocol P2938-0721,QUANTUM Phase II
October 2011 – July 2013
Bristol-Myers Squibb, Inc. Protocol AI444-038 Phase III
December 2011- June 2014
Abbott Laboratories, Inc., Protocol M11-652, Phase III
December 2011 – November 2013
Bristol-Myers Squibb, Inc. Protocol AI444-052, Phase III
February 2012- July 2012
Gilead Inc. Protocol GS-US-248-0122, A Long Term Follow-up Registry – SVR
August, 2012 – Present
Gilead Inc. Protocol GS-US-248-0123, A Long Term Follow-up Registry – No SVR
August, 2012 – Present
Gilead Inc. Protocol GS-US-334-0107, Phase III
April, 2012 – July 2013
Gilead Inc. Protocol GS-US-334-0108, Phase III
April, 2012 – July 2013
Gilead Inc. Protocol GS-US-334-0109, Phase III
May, 2012 – July 2009
Gilead Inc. Protocol GS-US-334-0110, Phase III
May, 2012 – July 2013
Janssen Research & Development, Inc. TMC435HPC2002, Phase IIa
July 2012 – March 2014
Gilead Sciences, Inc. GS-US-337-0102, Phase III
Sept 2012- June 2014
Abbott Laboratories, Inc., M11-646, Phase III
Oct 2012- July 2014
Abbott Laboratories, Inc., M13-099, Phase III
January 2013 – August 2014
Abbott Laboratories, Inc., M14-002, Phase III
April, 2013 – July 2014
Gilead Inc. Protocol GS-US-337-0108, Phase III
April, 2013 – June 2014
Gilead Inc. Protocol GS-US-342-0102, Phase II
May, 2013 – July 2014
Gilead Inc. Protocol GS-US-342-0109, Phase II
May, 2013 – July 2014
Gilead Inc. Protocol GS-US-334-0153, Phase IIIb
December, 2013 – June 2015
Gilead Inc. Protocol GS-US-337-1118
November, 2013 – September 2014
Abbott Laboratories, Inc., M13-102, A Long Term Follow-up Registry – SVR
April 2014 – December 2014
Janssen Research & Development, Inc. TMC435HPC3017, Phase III
May 2014 – Present
Janssen Research & Development, Inc. TMC435HPC3018, Phase III
May 2014 – Present
Abbvie Inc., M14-222, Phase IIIb
June 2014 – Present
Gilead Inc. Protocol GS-US-342-1140, Phase III
July 2014 – Present
Gilead Inc. Protocol GS-US-342-1138, Phase III
August 2014 – Present
Gilead Inc. Protocol GS-US-342-1139, Phase III
October 2014 – Present
Gilead Inc. Protocol GS-US-342-1553
December 2014 – 2016
Gilead Inc. Protocol GS-US-367-1168, Phase II
January 2015- Present
Gilead Inc. Protocol GS-US-367-1169, Phase II
January 2015- Present
Gilead Inc. Protocol GS-US-342-1446
February 2015- 2016
Gilead Inc. Protocol GS-US-337-1431, A Long Term Follow-up Cirrhotic Registry – SVR
June 2015- Present
Gilead Inc. Protocol GS-US-367-1170, Phase III
January 2016 – Present
Gilead Inc. Protocol GS-US-367-1171, Phase III
January 2016 – Present
Gilead Inc. Protocol GS-US- 367-1172, Phase III
January 2016 – Present
Gilead Inc. Protocol GS-US-367-1173, Phase III
January 2016 – Present
Intercept Pharmaceuticals, Inc. Protocol 747-303 REGENERATE, Phase III
January 2016 – Present
Intercept Pharmaceuticals, Inc. Protocol 747-209 CONTROL, Phase II
January 2016- Present
Shire Human Genetic Therapies, Inc. Protocol SHP 626-201, Phase II
June 2016 – Present
Octeta Therapeutics LLC, Protocol MSDC-0602K-C009NASH, Phase II, EMMINENCE
August 2016 – March 2018
PUBLICATIONS
“Chronic Lymphocyte Leukemia Presenting with Massive Chylous Ascites”
Davis, MN, Chiesa, JC, Alloy, AM, et al.
The American Journal of Gastroenterology, 1990; 8:593-596
“Low Dose Pegylated Interferon Alpha-2b is as Effective as the High Dose in HIV/HCV Coinfected Patients”
Hammon G, Li J, Vega K.
Hepatology, 2004; 40:4 Suppl. 1,520A
“Pharmacolkinetics and Pharmacodynamics of Pegylated Interferon Alpha-2a or Alpha-2b with Ribavirin in Treatment Naïve Patients with Genotype I Chronic Hepatitis C”
DiBisceglie AM, Rustgi VK, Thuluwath P, et al.
Hepatology, 2004; 40:4, Suppl. 1, LB18
“Weight-based Ribavirin Dosing (WBD) Increases Sustained Viral Response (SVR) in Patients with Chronic Hepatitis C )CHC): Final Results of the WIN-R Study, A US Community based Trial”
Jacobson IM, Brown RS, Freilich B, et al.
Hepatlogy, 2005; 42 (4 Suppl 1):LB03, P749A
“Prior HCV Treatment Expreience and Its Relationship to Sustained Virologic Response (SVR): An Analysis of the WIN-R Study Database, a US Academic Community Based Trial”
Kwo P, Jacobson IM, Brown RS, et al.
Gastroenterology, 2006; 130 (4), T1802, PA-836
“Peginterferon Alfa-2b or Alfa-2a with Ribavirin for treatment of Hepatitis C Infection”
McHutchinson JG, Lawitz EJ, Shiffman ML, et al.
N Engl J Med.2009 Aug 6;361(6):580-93. Epub 2009 Jul 22. N Engl J Med. 2009 Sep 3;361(10):1027
“Induction Pegylated Interferon Alfa-2b in Combination with Ribavirin in Patients with Genotype 1 and 4 Chronic Hepatitis C: A Prospective, Randomized, Multi-Center, Open-Label Study”
Brady DE, Torres DM, An JW, et al.
Clin Gastroenterol Hepatol. 2009 Sep 9 [Epub ahead of print]
“High Sustained Virologic Response (SVR) in Genotype 1 (G 1) Null Responders to Peg-Interferon Alfa-2B (P) Plus Ribavirin (R) when treated with Boceprevir (BOC) Combination Therapy.”
Kwo, P.Y., E. Lowitz, J. McCone, et al.
Hepatology, 50(4 Suppl):72A, 2009.
“Efficacy of Boceprevir, an NS3 Protease Inhibitor in combination with PegInterferon alfa-2b and Ribavirin in Treatment-Naïve Patients with Genotype 1 Hepatitis C Infection (SPRINT-1): An Open Label, Randomized, Multicentre Phase 2 Trial.”
Kwo PY, Lawitz EJ, McCone J, et al.
Lancet, 2010 Aug 28;376(9742):662-3.
“Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate.”
Sulkowski MS, Shiffman ML, Afdhal NH, et al.
Gastroenterology. 2010 Nov;139(5):1602-11, 1611.e1. doi:10.1053/j.gastro.2010.07.059.
“Racial differences in hepatitis C treatment eligibility.”
Melia MT, Muir AJ, McCone J, et al.
Hepatology. 2011 Jul;54(1):70-8.
“Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.”
Lawitz E, Mangia A, Wyles D, et al.
N Engl J Med. 2013 May 16;368(20)
“Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.”
Kowdley KV, Lawitz E, Crespo I, et al.
Lancet. 2013 Jun 15;381(9883):2100-7.
“Resistance-associated amino acid variants associated with boceprevir plus pegylated interferon-?2b and ribavirin in patients with chronic hepatitis C in the SPRINT-1 trial.”
Ogert RA, Howe JA, Vierling JM, et al.
Antivir Ther. 2013;18(3):387-97
“Sofosbuvir for previously untreated chronic hepatitis C infection.”
Lawitz E, Mangia A, Wyles D, et al.
N Engl J Med. 2013 May 16;368(20):1878-87
“Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.”
Jacobson IM, Gordon SC, Kowdley KV, et al.
N Engl J Med. 2013 May 16;368(20):1867-77.
“Overall safety profile of boceprevir plus peginterferon alfa-2b and ribavirin in patients with chronic hepatitis C genotype 1: a combined analysis of 3 phase 2/3 clinical trials.”
Manns MP, McCone J Jr, Davis MN, et al.
Liver Int. 2013 Aug 2.
“Boceprevir for Chronic HCV Genotype 1 Infection in Patients with Prior Treatment Failure to Peginterferon/Ribavirin, including Prior Null Response.”
Vierling JM, Davis M, Flamm S, et al.
J Hepatol. 2013 Dec 19. pii: S0168-8278(13)00881-7.
“Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.”
Kowdley KV, Gordon SC, Reddy KR, et al.
N Engl J Med. 2014 May 15;370(20):1879-88. Epub 2014 Apr 10
“Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.”
Afdhal N, Zeuzem S, Kwo P, Chojkier M, et al.
N Engl J Med. 2014 May 15;370(20):1889-98. Epub 2014 Apr 11.
“Sofosbuvir With Velpatasvir in Treatment-Naïve Noncirrhotic Patients with Genotype 1 to 6 Hepatitis C Virus infection: A Randomized Trial.”
Everson GT, Towner WJ, Davis MN, et al.
Ann intern Med. 2015 Dec 1;163(11):818-26.
Epub 2015 Nov 10.
“Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 3, 4, 5, and 6 Infection.”
Feld JJ, Jacobson IM, Hezode C, Asselah T, et al.
N Engl J Med. 2015 Dec 31;373(27):2599-607.
Epub 2015 Nov 16.
“Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.”
Foster GR, Afdhal N, Roberts SK, Brau N, et al.
N Engl J Med. 2015 Dec 31;373(27):2608-17
Epub 2015 Nov 17.
“Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study.”
Kwo P, Gitlin N, Nahass R, Bernstein D, et al.
Hepatology. 2016 Aug;64(2):370-80.
Epub 2016 Mar 22.
“Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 infections in an Open-Label, Phase 2 Trial.”
Gane EJ, Kowdley KV, Pound D, et al.
Gastroenterology. 2016 Nov;151(5):902-909.
Epub 2016 Jul 30.
“Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients with Chronic HCV Infection: 2 Phase 3 Randomized Trials.”
Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgja SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR.
Gastroenterology. 2017 Jul;153(1):113-122. doi: 10. 1053/j.gastro.2017.03 .047.
Epub 2017 Apr 5.
“Sofosbuvir-velpatasvir with ribavirin for 24 weeks in hepatitis C virus patients previously treated with a direct-acting antiviral regimen.”
Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman CAM, Davis MN, Hinestrosa F, Dvory Sobol H, Huang KC, Osinusi A, McNally J, Brainard DM, McHutchison JG, Thompson AJ, Sulkowski MS; GS-US-342-1553 Investigators.
Hepatology. 2017 Oct;66(4):1083-1089. doi: 10 .100 2/hep.292 56.
Epub 2017 Aug 26.
“Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated BCV Infection.”
Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SJ, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-I and POLARIS-4 Investigators.
N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi:10.1056/NEJMoa1613512.
“Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 12 22 4 and 6 infection.”
Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. J Viral Hepat. 2019, Jun 19, doi: 10.1111 / jv h 13159 (Epub ahead of print)