Roberto J Firpi-Morell

Roberto J Firpi-Morell, M.D., M.S.

Professor

Department: MD-GASTROENTERLOGY-LIVER
Business Phone: (352) 273-9477

About Roberto J Firpi-Morell

I am a professor of medicine in the University of Florida Division of Gastroenterology, Hepatology & Nutrition, where I also oversee a multidisciplinary team as the director of hepatology and medical director of Liver Transplant and Program, and director of the Transplant Hepatology Fellowship for the section of hepatobiliary diseases and liver transplantation.

I received my medical degree in 1994 from the University of Puerto Rico School of Medicine, where I subsequently completed my internal medicine internship and residency. During my residency, I served as chief resident. Thereafter, I relocated to the U.S. and completed my gastroenterology fellowship here at UF under an NIH T32 training grant. I completed an additional fellowship in hepatology and liver transplant at Cedars-Sinai Medical Center/David Geffen School of Medicine at the University of California, Los Angeles (UCLA), where I received the AASLD Advanced Hepatology Fellowship Award in 2001. My area of clinical expertise is hepatology with an emphasis on the management of liver transplantation, viral hepatitis and immunosuppression after liver transplantation.

I have strong clinical and translational research interests, with more than five active clinical trials and multiple translational research initiatives underway. I have extensive interest in chronic hepatitis C infection and liver transplantation, publishing multiple papers related to hepatitis C and liver transplant and becoming a leader in the area. I serve as a reviewer for several journals, including the Journal of Liver Transplantation, American Journal of Gastroenterology, American Journal of Transplantation, Journal of Hepatology and Journal of Transplantation. I present my research annually at national meetings such as DDW, AASLD and the European International Meetings (EASL).

I also enjoy traveling to national and international universities as a visiting professor, including University of North Carolina, University of Puerto Rico, Oregon Health & Science University, Saint Luc Hospital in Montreal, Canada, Toronto General Hospital, University of Alberta Hospital and others.

Teaching Profile

Courses Taught
2018
MDC7200 Medicine Clerkship
2018
MDC7203 Senior Medicine Clerk

Board Certifications

  • Gastroenterology
    American Board of Internal Medicine
  • Internal Medicine
    American Board of Internal Medicine
  • Transplant Hepatology
    American Board of Internal Medicine

Clinical Profile

Specialties
  • Gastroenterology
  • Transplant Hepatology
Areas of Interest
  • Autoimmune hepatitis
  • Cirrhosis
  • Hepatitis B
  • Hepatitis C
  • Liver Transplant
  • Liver biopsy
  • Liver cancer – hepatocellular carcinoma
  • Liver disease
  • Liver disease – resources
  • Primary biliary cirrhosis

Publications

2023
Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 21(11):2889-2900.e10 [DOI] 10.1016/j.cgh.2023.02.024. [PMID] 36871772.
2022
Prevalence and Factors Associated With Statin Use Among Patients With Nonalcoholic Fatty Liver Disease in the TARGET-NASH Study.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 20(2):458-460.e4 [DOI] 10.1016/j.cgh.2021.03.031. [PMID] 33775894.
2021
Opioid Use Is More Common in Nonalcoholic Fatty Liver Disease Patients with Cirrhosis, Higher BMI, and Psychiatric Disease.
Digestive diseases (Basel, Switzerland). 39(3):247-257 [DOI] 10.1159/000511074. [PMID] 32836224.
2020
Performance of Plasma Biomarkers and Diagnostic Panels for Nonalcoholic Steatohepatitis and Advanced Fibrosis in Patients With Type 2 Diabetes.
Diabetes care. 43(2):290-297 [DOI] 10.2337/dc19-1071. [PMID] 31604692.
2019
Elbasvir/Grazoprevir in People With Hepatitis C Genotype 1 Infection and Child-Pugh Class B Cirrhosis: The C-SALT Study.
Clinical and translational gastroenterology. 10(4) [DOI] 10.14309/ctg.0000000000000007. [PMID] 30939489.
2019
Performance of the SteatoTest, ActiTest, NashTest and FibroTest in a multiethnic cohort of patients with type 2 diabetes mellitus.
Journal of investigative medicine : the official publication of the American Federation for Clinical Research. 67(2):303-311 [DOI] 10.1136/jim-2018-000864. [PMID] 30309884.
2018
An Unusual Case of Gastritis in One Patient Receiving PD-1 Blocking Therapy: Coexisting Immune-Related Gastritis and Cytomegaloviral Infection.
Gastroenterology research. 11(5):383-387 [DOI] 10.14740/gr1068w. [PMID] 30344812.
2018
Malignant Peritoneal Mesothelioma Presenting as Mucinous Ascites
. 14(5):1-3
2017
Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study.
Transplant international : official journal of the European Society for Organ Transplantation. 30(2):196-208 [DOI] 10.1111/tri.12896. [PMID] 27896858.
2017
Liver Transplantation in the Twenty-First Century
. 21(2):xv-xvi
2015
Biliary duct hamartomas in polycystic liver disease
.
2015
Hepatitis C Cirrhosis: New Perpectives for diagnosis and treatment
World Journal of Hepatology. 7(14):1842-1855
2015
Hepatitis C: Treatment of difficult to treat patient
World Journal of Hepatology. 7(15):1953-1963
2015
Open Label Study to Evaluate the Safety and Tolerability if Telaprevir in Combination with Sofosbuvir in Treatment Naïve Subjects Chronically Infected with Hepatitis C Virus Genotype 1
. 4(5):1599-1604
2015
Sustained Virological Response to antiviral therapy in a randomized trial of Cyclosporine vs Tacrolimus in Liver Transplant Patients with Recurrent Hepatitis C Infection
Annals of Transplantation. 20:25-35
2014
Hepatitis C Management in Post Transplant Patients
Minerva Gastroenterologica E Dietologica.
2013
CC genotype donors for the interleukin-28B single nucleotide polymorphism are associated with better outcomes in hepatitis C after liver transplant.
Liver international : official journal of the International Association for the Study of the Liver. 33(1):72-8 [DOI] 10.1111/liv.12013. [PMID] 23107586.
2013
CC Genotype Donors for the Interleukin-28B Single-Nucleotide Polymorphism are Associated with Better Outcomes in Hepatitis C after Liver Transplant
Liver International. 33(1):72-78
2013
Factors Associated With Intolerance To Peginterferon Alfa/Ribavirin in Treatment-Naive, Cirrhotic/Non-Cirrhotic Hcv Genotype 1-Infected Patients: Analysis of Data From the Multinational Prophesys Cohorts
. 58
2013
Hepatic preservation injury: severity of hepatitis C recurrence and survival after liver transplantation.
Digestive diseases and sciences. 58(5):1403-9 [DOI] 10.1007/s10620-012-2521-9. [PMID] 23306846.
2013
Incidentally discovered HCC (iHCC) in explant liver-Histopathologic features and Outcome
. 4(2a):394-398
2013
Neutrophil-lymphocyte ratio predicts overall and recurrence-free survival after liver transplantation for hepatocellular carcinoma.
Hepatology research : the official journal of the Japan Society of Hepatology. 43(7):757-64 [DOI] 10.1111/hepr.12019. [PMID] 23193965.
2013
Recurrent hepatitis C virus infection post liver transplantation: impact of choice of calcineurin inhibitor.
Transplant international : official journal of the European Society for Organ Transplantation. 26(4):358-72 [DOI] 10.1111/tri.12065. [PMID] 23413991.
2013
The Anti-Viral Effect of Sorafenib in Hepatitis C-Related Hepatocellular Carcinoma
Alimentary Pharmacology & Therapeutics. 37(1):91-97 [DOI] 10.1111/apt.12098. [PMID] 23094860.
2013
Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma.
Oncology reports. 29(4):1259-67 [DOI] 10.3892/or.2013.2290. [PMID] 23426976.
2012
Impact of transarterial therapy in hepatitis C-related hepatocellular carcinoma on long-term outcomes after liver transplantation.
American journal of clinical oncology. 35(4):345-50 [DOI] 10.1097/COC.0b013e31821631f6. [PMID] 21552101.
2012
Incidentally Discovered Hcc (Ihcc) in Explant Liver- Clinical and Histopathologic Features and Outcome
Higher Education Policy. 56:476A-477A
2012
Sirolimus Conversion Regimen Versus Continued Calcineurin Inhibitors in Liver Allograft Recipients: a Randomized Trial
American Journal of Transplantation. 12(3):694-705 [DOI] 10.1111/j.1600-6143.2011.03919.x. [PMID] 22233522.
2011
A Sustained Viral Response Dramatically Improves Survival in Patients With Hepatitis C Infection After Liver Transplant
. 54
2011
Antiviral Effect of Sorafenib in Hcv Related Hepatocellular Carcinoma
Higher Education Policy. 54
2011
Klatskin Tumor- Clinical Outcome and Prognostic Factors
Higher Education Policy. 54
2011
Management of recurrent hepatitis C infection after liver transplantation.
Clinics in liver disease. 15(4):845-58 [DOI] 10.1016/j.cld.2011.08.003. [PMID] 22032532.
2011
Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid.
Alimentary pharmacology & therapeutics. 33(2):235-42 [DOI] 10.1111/j.1365-2036.2010.04512.x. [PMID] 21083674.
2011
Racial Disparities in hepatitis C treatment eligibility
Hepatology. 54(1):70-78
2011
The combination of sorafenib with transarterial chemoembolisation for hepatocellular carcinoma.
Alimentary pharmacology & therapeutics. 34(2):205-13 [DOI] 10.1111/j.1365-2036.2011.04697.x. [PMID] 21605146.
2010
Characterization of Anti-HCV Antibodies in IL-10-Treated Patients.
Viral immunology. 23(4):359-68 [DOI] 10.1089/vim.2009.0095. [PMID] 20712480.
2010
Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate.
Gastroenterology. 139(5):1602-11, 1611.e1 [DOI] 10.1053/j.gastro.2010.07.059. [PMID] 20723545.
2010
Interleukin-28B Polymosphism Improves Viral Kinetics and Is the Strongest Pretreatment Predictor of Sustained Virologic Response in Genotype 1 Hepatitis C Virus
Gastroenterology. 139:120-129
2010
The Impact of Preservation Injury On Accelerated Hepatitis C Recurrence After Liver Transplantation
Higher Education Policy. 52
2010
The Impact of Transarterial Therapy in Recurrent Hepatocellular Carcinoma After Liver Transplant
Higher Education Policy. 52
2010
The Prevention of Cytomegalovirus after Liver Transplantation
Annals of Gastroenterology. 1(2):20-30
2010
The use of cyclosporine for recurrent hepatitis C after liver transplant: a randomized pilot study.
Digestive diseases and sciences. 55(1):196-203 [DOI] 10.1007/s10620-009-0981-3. [PMID] 19798576.
2010
Transfusion has no effect on recurrence in hepatitis C after liver transplantation.
Acta anaesthesiologica Scandinavica. 54(10):1224-32 [PMID] 21069900.
2009
Autoantibodies in Hepatitis C Infection: What Do They Mean
. 8:153-157
2009
Fenofibrate Improves Liver Biochemistries in Primary Biliary Cirrhosis
Higher Education Policy. 50
2009
Intraoperative Red Cell and Platelet Transfusion Have No Effect On Survival Or Histologic Disease Recurrence in Hepatitis C Patients After Liver Transplantation
Liver Transplantation. 15
2009
Peg interferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection
New England Journal of Medicine. 361(6):580-593
2009
The Management of Hepatitis C
Minerva Gastroenterologica E Dietologica. 55(1):23-35
2009
The Management of Hepatitis C
Minerva Gastroenterologica E Dietologica. 55(1):23-35
2009
The natural history of hepatitis C cirrhosis after liver transplantation.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 15(9):1063-71 [DOI] 10.1002/lt.21784. [PMID] 19718647.
2009
Using an immune functional assay to differentiate acute cellular rejection from recurrent hepatitis C in liver transplant patients.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 15(2):216-22 [DOI] 10.1002/lt.21666. [PMID] 19177434.
2008
Cyclosporine Helps To Achieve a Higher Svr in Patients Receiving Peg-Interferon/Ribavirin for Recurrent Hepatitis C After Liver Transplantation: Final Analysis of a Randomized-Controlled Study
Journal of Hepatology. 48 [DOI] 10.1016/S0168-8278(08)60197-X.
2008
Factors predicting survival after transjugular intrahepatic portosystemic shunt creation: 15 years’ experience from a single tertiary medical center.
Journal of vascular and interventional radiology : JVIR. 19(11):1576-81 [DOI] 10.1016/j.jvir.2008.07.021. [PMID] 18789725.
2008
Hepatocellular Carcinoma Is Associated With An Impaired Cd4 T Cell Immune Response
Journal of Hepatology. 48 [DOI] 10.1016/S0168-8278(08)60360-8.
2008
Is sonographic surveillance of polytetrafluoroethylene-covered transjugular intrahepatic portosystemic shunts (TIPS) necessary? A single centre experience comparing both types of stents.
Clinical radiology. 63(10):1142-8 [DOI] 10.1016/j.crad.2008.04.016. [PMID] 18774362.
2008
Management of Viral Hepatitis in Hematologic Malignancies
Blood Reviews. 22(3):117-126
2008
Management of viral hepatitis in hematologic malignancies.
Blood Reviews. 22(3):117-126 [DOI] 10.1016/j.blre.2008.02.001. [PMID] 18343002.
2008
Recurrent Hepatocellular Carcinoma in Liver Transplant Recipients With Hepatitis C
American Journal of Transplantation. 8
2008
The Natural History of Hcv-Related Cirrhosis After Liver Transplantation
Journal of Hepatology. 48 [DOI] 10.1016/S0168-8278(08)60003-3.
2008
Using Immune Functional Assay To Differentiate Acute Cellular Rejection From Recurrent Hepatitis C in Liver Transplant Patients
Higher Education Policy. 48
2007
Listeria monocytogenes following orthotopic liver transplantation: Central nervous system involvement and review of the literature
World Journal of Gastroenterology. 13(32):4391-4393
2007
Current and future hepatitis C therapies.
Archives of Medical Research. 38(6):678-690 [DOI] 10.1016/j.arcmed.2006.09.002. [PMID] 17613359.
2007
Hepatocellular carcinoma cell supernatants increase expansion and function of CD4(+)CD25(+) regulatory T cells.
Laboratory investigation; a journal of technical methods and pathology. 87(6):582-90 [PMID] 17372588.
2007
Is early recurrence of hepatitis C associated with biliary anastomotic stricture after liver transplantation?
Transplantation. 84(12):1631-1635 [DOI] 10.1097/01.tp.0000295983.55088.96. [PMID] 18165775.
2007
Prevalence and predictors of esophageal varices in patients with primary biliary cirrhosis.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 5(7):803-8 [PMID] 17544879.
2007
Viral Hepatitis: Current and Future Hepatitis C Therapies
Archives of Medical Research. 28(6):578-690
2006
Cyclosporine suppresses hepatitis C virus in vitro and increases the chance of a sustained virological response after liver transplantation.
Liver Transplantation. 12(1):51-57 [DOI] 10.1002/lt.20532. [PMID] 16382464.
2006
Impact of implementation of the MELD Scoring system on the prevalence and incidence of chronic liver disease following liver transplantation
Liver Transplantation. 12(5):754-761 [DOI] 10.1002/lt.20686. [PMID] 16528716.
2006
Late presentation of a biliary tract complication after right hepatic donation resulting in secondary biliary cirrhosis.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 12(2):306-9 [PMID] 16447188.
2006
Viral hepatitis: manifestations and management strategy.
Hematology. American Society of Hematology. Education Program. 375-80 [PMID] 17124086.
2005
Early hepatic stellate cell activation is associated with advanced fibrosis after liver transplantation in recipients with hepatitis C.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 11(10):1235-41 [PMID] 16184580.
2005
Liver retransplantation: a single-center outcome and financial analysis.
Transplantation proceedings. 37(2):1161-3 [DOI] 10.1016/j.transproceed.2004.11.046. [PMID] 15848656.
2005
Pathogenesis of Recurrent Hepatitis C after Liver Transplantation
. 4(4):138-144
2005
Pathogenesis of recurrent hepatitis C after liver transplantation
. 4(4):138-144
2005
Pathogenesis of recurrent hepatitis C after liver transplantation
. 4(4):138-144
2005
Short recovery time after percutaneous liver biopsy: should we change our current practices?
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 3(9):926-9 [PMID] 16234032.
2004
Virologic Response Following Interferon-Based Therapy is durable and associated with Long-Term Histologic Improvement in the Post-Transplant Setting
Liver Transplantation. 10(2):199-207
2004
An immunomodulatory role for CD4(+)CD25(+) regulatory T lymphocytes in hepatitis C virus infection.
Hepatology (Baltimore, Md.). 40(5):1062-71 [PMID] 15486925.
2004
Nephrogenic Fibrosing Dermopathy: A Rare Entity in Patients Awaiting Liver Transplantation
Liver Transplantation. 10(3):465-466
2004
One-year protocol liver biopsy can stratify fibrosis progression in liver transplant recipients with recurrent hepatitis C infection.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 10(10):1240-7 [PMID] 15376304.
2004
Sirolimus-induced hypertriglyceridemia in Liver Transplant Recipients Is Not Dose Dependent
. 19(9):1033-1039
2004
Sustained viral response to interferon and ribavirin in liver transplant recipients with recurrent hepatitis C.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 10(2):199-207 [PMID] 14762857.
2003
Immunopathogenesis of Hepatitis C
. 1(2):3-4
2003
Immunopathogenesis of Viral Hepatitis
. 1(2):3-4
2003
Immunopathogenesis of Viral Hepatitis
. 1(2):3-4
2003
Lack of antiviral effect of a short course of mycophenolate mofetil in patients with chronic hepatitis C virus infection.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 9(1):57-61 [PMID] 12514774.
2002
Combination of interferon alfa-2b and ribavirin in liver transplant recipients with histological recurrent hepatitis C.
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 8(11):1000-6 [PMID] 12424712.
2002
Hepatology Focus: Update on Hepatitis B Treatment
. 4(9)
2002
Update on Hepatitis B Treatment
MedGenMed. 4(3)
2002
Update on Hepatitis B Treatment
MedGenMed. 4(3)
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
New England Journal of Medicine. 373(27):2618-2628

Grants

Feb 2024 ACTIVE
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Nonalcoholic Fatty Liver Disease (NAFLD)
Role: Principal Investigator
Funding: SC LIVER RESEARCH CONSORTIUM via AKERO THERAPEUTICS
Dec 2023 ACTIVE
Akero AK-US-001-0105 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis
Role: Principal Investigator
Funding: SC LIVER RESEARCH CONSORTIUM via AKERO THERAPEUTICS
Aug 2023 ACTIVE
The potential of kava in enabling tobacco cessation – its holistic effects in managing stress and insomnia associated with abstinence
Role: Co-Investigator
Funding: NATL CTR FOR COMPLEM AND INTEGRATIVE HLT
Jan 2023 ACTIVE
A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 with Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA
Role: Principal Investigator
Funding: COUR PHARMACEUTICALS DEVELOPMENT
Oct 2022 ACTIVE
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Role: Principal Investigator
Funding: SYNEOS HEALTH via MIRUM PHARMACEUTICALS
Feb 2022 ACTIVE
A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)
Role: Principal Investigator
Funding: PHARMACEUTICAL RES ASSO via GILEAD SCIENCES
Jun 2021 ACTIVE
Reducing tobacco-associated lung cancer risk: A randomized clinical trial of AB-free kava
Role: Co-Investigator
Funding: FL DEPT OF HLTH BIOMED RES PGM/J&E KING
Sep 2019 – Aug 2023
A phased clinical trial of a dietary supplement kava: biomarker changes and anxiolytic effects
Role: Co-Investigator
Funding: NATL CTR FOR COMPLEM AND INTEGRATIVE HLT
Jul 2019 ACTIVE
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
Role: Principal Investigator
Funding: PRA HEALTH SCIENCES via MADRIGAL PHARMACEUTICALS
Jul 2019 – Jun 2020
AASLD 2019 NP/PA CLINICAL HEP0ATOLOGY FELLOWSHIP PROGRAM
Role: Principal Investigator
Funding: AMER ASSO FOR STUDY OF LIVER DISEASE
Jun 2019 – Dec 2023
A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) In Adults with Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Role: Principal Investigator
Funding: PRA HEALTH SCIENCES via BRISTOL MYERS SQUIBB CO
Mar 2018 – Apr 2024
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)
Role: Principal Investigator
Funding: PRA HEALTH SCIENCES via GILEAD SCIENCES
Mar 2017 – Jan 2023
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Role: Principal Investigator
Funding: GILEAD SCIENCES
Mar 2017 – Aug 2022
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
Role: Principal Investigator
Funding: GILEAD SCIENCES
Dec 2016 ACTIVE
A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
Role: Principal Investigator
Funding: TARGET PHARMASOLUTIONS dba TARGET RWE
Oct 2015 – Oct 2018
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT3 Infection.
Role: Principal Investigator
Funding: MERCK SHARP & DOHME
Sep 2015 ACTIVE
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
Role: Principal Investigator
Funding: SYNEOS HEALTH via INTERCEPT PHARMACEUTICALS
May 2015 – Mar 2019
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT1, GT2, and GT4 Infection
Role: Principal Investigator
Funding: Merck Sharp & Dohme
Apr 2015 – May 2022
Merck MK5172-017 "A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/orViral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have BeenPreviously Treated with MK-5172 in a Prior Clinical Trial"
Role: Principal Investigator
Funding: Merck Sharp & Dohme
Mar 2015 – Apr 2019
Conatus IDN-6556-07 A Multicenter, Double-Blind, Sponsor-Open Trial of IDN-6556 in Subjects Who had HCV Reinfection & Liver Fibrosis following Orthotopic Liver Transplantation for HCV Infection & Who Subsequently Achieved a SVR Following anti-HCV Therapy
Role: Principal Investigator
Funding: SC LIVER RESEARCH CONSORTIUM
Dec 2014 – Dec 2022
A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis"
Role: Principal Investigator
Funding: SYNEOS HEALTH
Dec 2014 ACTIVE
DR. FIRPI-MORELL PAYROLL OPERATING ACCOUNT
Role: Principal Investigator
Funding: UNIV OF FLORIDA
Sep 2014 – Sep 2017
"AbbVie M14-490" An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic HCV Infection and Cirrhosis (TURQUOISE-III)
Role: Principal Investigator
Funding: ABBVIE
Aug 2014 – Jul 2021
An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
Role: Principal Investigator
Funding: ABBVIE
Jun 2014 – Jan 2016
A Phase 2 open-label study in patients with recurrent Genotype 1 hepAtitis C post-orthotopic Liver transplAnt to eXplore the safety and efficacY of simeprevir and sofosbuvir with and without ribavirin
Role: Principal Investigator
Funding: JANSSEN RESEARCH AND DEVELOPMENT
Jun 2014 – Jun 2017
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Role: Principal Investigator
Funding: GILEAD SCIENCES
Apr 2014 – Apr 2017
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who Failed Prior Tx with Peg/RBV with HCV GT1, GT4, GT5, and GT6
Role: Principal Investigator
Funding: Merck Sharp & Dohme
Apr 2014 – Jun 2017
'MK5172-060: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Na?ve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection.
Role: Principal Investigator
Funding: Merck Sharp & Dohme
Apr 2014 – Apr 2017
'MK5172-059 A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic HCV Infection with Advanced Cirrhosisand Child-Pugh (CP)-B Hepatic Insufficiency'
Role: Principal Investigator
Funding: Merck Sharp & Dohme
Sep 2012 – Sep 2017
BMSAI444-026 "An Open-Label Re-treatment Study with Peg-Interferon alfa-2a, Ribavirin and BMS-790052 With or Without BMS650032 for Subjects with Chronic Hepatitis C"
Role: Principal Investigator
Funding: BRISTOL MYERS SQUIBB CO

Education

Fellowship – Hepatology & Liver Transplant
2002 · Cedars-Sinai Medical Center UCLA
Fellowship – Gastroenterology
2001 · University of Florida
Residency – Internal Medicine
1998 · University of Puerto Rico
Internship – Internal Medicine
1995 · University of Puerto Rico
Medical Degree
1994 · University of Puerto Rico

Contact Details

Phones:
Business:
(352) 273-9477
Emails:
Addresses:
Business Mailing:
PO Box 100214
GAINESVILLE FL 32610
Business Street:
LIVER UNIT
1329 SW 16th St., Suite 5251
ROBERTO J. FIRPI , MD
GAINESVILLE FL 32608