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Associate Professor
Firpi-Morell, Roberto
Positions
- Advanced Fellowship in Liver Transplantation and Hepatology , Cedars Sinai Medical Center University of California, Los Angeles
- Fellowship in Gastroenterology, Gastroenterology, Hepatology, and Nutrition , Medicine
- Program Director, Fellowship, Gastroenterology, Hepatology, and Nutrition , Medicine
- Associate Professor, Gastroenterology, Hepatology, and Nutrition , Medicine 2002 -
- Programs Director and Associate Professor, Gastroenterology, Hepatology, and Nutrition , Medicine 2005 -
- Medical Director, Liver Transplant, Gastroenterology, Hepatology, and Nutrition , Medicine 2010 - 2015
- Director, Clinical Hepatology, Gastroenterology, Hepatology, and Nutrition , Medicine 2010 - 2015
research areas
Overview
Affiliation
home department
Publications
selected publications
presentations
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invited talk
- Boston Scientific GI Fellows Course. Hands-On session on rescue net, rescue rat-tooth, and snares, Opal Sands Resort 2018
- Liver Diseases in the GI Practice: Opal Sands Resort 2018
- Management of Upper and Lower GI Bleeding, Opal Sands Resort 2018
- Show and Tell in Liver, UF GI Fellows Lecture Series 2018
- Asymptomatic Liver Masses: New Approaches for Diagnosis, Florida Gastroenterologic Society 2017 Annual Meeting 2017
- Myths or Facts, Evidence Based Medicine in Hepatology, UF GI State of the Art Lecture 2017
- Prioritization for Liver Transplant: Role of HCV Therapy, 11th Annual Update in Liver & Gastrointestinal Diseases: Hot Topics for Clinical Practice 2017
- Self-Assessment Program for Maintenance of Certification (MOC) ABIM, Florida Gastroenterologic Society 2017 Annual Meeting 2017
- The Best of DDW in Hepatology, AGA Institute, International Committee, Digestive Disease Week 2017 2017
- New Updates in Hepatitis C, AGA Institute, International Committee, PanAmerican Digestive Disease Week 2016 2016
- Non-Alcoholic Fatty Liver Diasease, 47th Annual Topics in Internal Medicine 2016
- PBC: What does the future hold? , 10th Annual Liver & Gastrointestinal Diseases Update: Hot Topics for the Clinical Practice 2016
- Primary Biliary Cholangitis, AGA Institute, International Committee, PanAmerican Digestive Disease Week 2016 2016
- The Best of DDW in Spanish, Hepatology, AGA Institute, International Committee, PanAmerican Digestive Disease Week 2016 2016
- Fulminant Hepatic Failure Part II, UF GI Fellows Lecture Series 2015
- Hepatitis C Treatment: Part II, Digestive Disease Week 2015 2015
- Hepatitis C Update, Florida Gastroenterologic Society Annual Meeting 2015
- Non-Alcoholic Fatty Liver Disease: Not as benign as it sounds, 56th Annual Convention UPR Sociedad de Médicos Graduados 2015
- The Best of DDW in Spanish, Hepatology, AGA Institute, International Committee, Digestive Disease Week 2015 2015
- The best of AASLD & EASL, 9th Annual Liver & Gastrointestinal Diseases Update: Hot Topics for the Clinical Practice 2015
- Coagulopathy in Liver Disease: Risk of bleeding during GI procedures, 8th Annual Liver & Gastrointestinal Diseases Update: Hot Topics for the Clinical Practice 2014
- Fulminant Hepatic Failure Part I, UF GI Fellows Lecture Series 2014
- Hepatitis C Treatment: On the Horizon, Digestive Diseases Week 2014 2014
- NASH: A New Look at an Old Beast, 45th Annual Topics in Internal Medicine 2014
- New Therapies in Hepatitis C, Florida Gastroenterologic Society Annual Meeting 2014
- New Treatment Paradigms for Chronic Hepatitis C Infection, 18th Annual Infectious Disease & HIV/AIDS 2014
- Abnormal LFTs, 44th Annual Topics in Internal Medicine 2013
- Fulminant Hepatic Failure, UF GI Fellows Lecture Series 2013
- Fulminant Hepatic Failure and Liver Transplantation, UF IM Residents Lecture Series 2013
- The best of AASLD & EASL, 7th Annual Liver & Gastrointestinal Diseases Update: Hot Topics for the Clinical Practice 2013
- Toxic and Drug induced live injury, UF IM Residents Lecture Series 2013
- Viral Hepatitis: Bench to Bedside, Digestive Disease Week 2013 2013
- AASLD Position on Acute Liver Failure, UF GI Fellows Lecture Series 2012
- Parallel Session: HCV, The Liver Meeting (AASLD) 2012
- The best of AASLD & EASL, 6th Annual Liver & Gastrointestinal Diseases Update: Hot Topics for the Clinical Practice 2012
- . AASLD Practice Guidelines and Practical Application for the New HCV Therapies, UF GI Fellows Lecture Series 2011
- Acute Liver Failure in 2011, Critical Care Medicine Grand Rounds 2011
- Long Term Management of the Liver Transplant Patient, Florida Gastroenterologic Society Annual Meeting 2011
- Making Sense of hepatitis B Guidelines and Treatment, Florida Gastroenterologic Society Annual Meeting 2011
- Practical Application for the New Therapies: Case Based HCV Treatment, 5th Annual Liver & Gastrointestinal Diseases Update: Hot Topics for the Clinical Practice 2011
- The Basics in Hepatology, Shands Hospital-In-service for Nursing Staff 2011
- The Best of DDW in Spanish, Hepatitis, AGA Institute, International Committee, Digestive Disease Week 2011 2011
- Acute Liver Failure, UF GI Fellows Lecture Series 2010
- GERD 2010: What’s new? , 2010 Scientific Meeting: American College of Physicians 2010
- NASH 2010: Diagnosis and Management, 2010 Scientific Meeting: American College of Physicians 2010
- e Best of DDW in Spanish, Hepatitis and Cirrhosis, AGA Institute, International Committee. Digestive Disease Week 2010 2010
- Complications of Cirrhosis, UF IM Residents Lecture Series 2009
- Complications of Cirrhosis, Internal Medicine Residency Noon Conference- DOM 2009
- Non-Alcoholic Fatty Liver Disease & NASH, 50th Annual Meeting Alumni Society – UPR School of Medicine 2009
- Optimization of Current Therapy for HCV, 3rd Annual Viral Hepatitis & Liver Diseases & Gastroenterology Update: Topics for the Clinical Practice 2009
- Approach to Patients with Fatty Liver Disease, Internal Medicine Grand Round; Medical Sciences Campus, University of Puerto Rico 2008
- Calcineurin Inhibitors and Hepatitis C Replication after Liver Transplantation, Cyclophilin Inhibitors Seminar 2008
- Cyclosporine Helps to Achieve a Higher SVR in Patients Receiving PEG-Interferon/ Ribavirin for Recurrence Hepatitis C After Liver Transplantation: Final Analysis of a Randomized-Controlled Study, University of Florida Department of Medicine Research Day 2008
- Emerging Advances in HCV Management. Gastroenterology Private Group 2008
- GI Show and Tell, UF GI Fellows Lecture Series 2008
- Hepatitis C: Evaluation, Monitoring and Treatment, GI Specialty Group 2008
- New Insights into the Management of HCV, UF GI Fellows Lecture Series 2008
- New Insights into the Management of HCV, UF GI Fellows Lecture Series 2008
- Optimizing Treatment Success in your Hepatitis C Patients, St Vincent’s & Beth Israel Hospitals 2008
- Response-Guided Algorithm for HCV, 2nd Annual Viral Hepatitis & Liver Diseases Update: Liver Cancer, Fatty Liver and Viral Hepatitis 2008
- Response-Guided Algorithm for Hepatitis C: Rubio Memorial Lecture, Puerto Rico Gastroenterological Society 2008
- Treatment of the difficult patients with HCV, University of Florida, Gainesville, FL 2008
- Hepatitis C and Liver Transplant, Multi-organ Transplant Research Forum 2007
- Hepatitis C and Liver Transplant, Liver Transplant Research Conference, University of Alberta Hospital 2007
- Hepatitis C and Liver Transplant , Liver Transplant Conference. Toronto General Hospital 2007
- Hepatitis C in Liver Transplantation, Hepatology & Liver Transplant Conference, St. Luc Hospital 2007
- Optimizing Outcomes in HCV Liver Transplant Recipients, Liver Transplant Grand Rounds, Oregon Health & Science University 2007
- Optimizing Outcomes in HCV Liver Transplant Recipients, Thomas Jefferson College of Medicine - Transplant Rounds 2007
- Optimizing Outcomes in HCV Liver Transplant Recipients, Life Link Transplant Team - Tampa General Hospital 2007
- Optimizing treatment in Hepatitis C Patients, Medicine Grand Rounds, Queen Elizabeth II Hospital 2007
- Factors Impacting Survival in HCV Liver Transplant Recipients, Novartis 2006
- Implications of Hepatitis C after Liver Transplantation: Treatment, Fibrosis progression and Immunosuppression, GI Grand Rounds, University of North Carolina, UNC Medical Center 2006
- Management of the Cirrhotic Patient: Complications of Cirrhosis, UF GI Fellows Lecture Series 2006
- Non-Alcoholic Fatty Liver Disease in 2006, GI/Liver State of the Art Lecture 2006
- Update in Non-Alcoholic Fatty Liver Disease, Lee Memorial Hospital-Clinical Advance In Gastroenterology 2006
- Update on Hepatitis C, Alachua County Medical Society 2006
- Hepatitis C: Treatment of Non-Responders & Relapsers, Florida Hospital 2005
- Management of HCV Patients, South Georgia Medical Center 2005
- Chylous Ascites, University of Florida Department of Medicine Grand Rounds 2003
- GI Board Review for GI Fellows, Shands Hospital 2003
- Hepatitis C and HIV Co-infection, University of South Florida 2003
- New treatments on Chronic Hepatitis B, Cedars-Sinai Medical Center (UCLA), Liver Transplant Conference 2002
- Update on Hepatitis B, Cedars-Sinai Medical Center (UCLA), Gastroenterology Clinical Conference 2002
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presentation
- Real World Evidence Showing High Rates of Cardiovascular Events in NALFD Patient Regardless of Liver Disease, 53th Annual Meeting for the European Association for the Study of the Liver (EASL) 2018
- Clinical Insights into the Management of Primary Biliary Cholangitis (PBC), Chronic Liver Disease Foundation 2017
- Efficacy and Safety of Grazoprevir and Elbasvir in Hepatitis C Genotype 1 infected patients with Child-Pugh class B cirrhosis (C-SALT Part A), European Association of the Liver Annual Meeting 2015
- Management of PBC, PBC Preceptor Program 2015
- Update in Hepatology, UF GI State of the Art Lecture 2015
- Sustained Virological Response with Cyclosporine and Tacrolimus in Maintenance Liver Transplant Recipients with Recurrent HCV: Results from the SUSTAIN Study, 2014 World Transplant Congress 2014
- Anticoagulation in liver patients, UF GI State of the Art Lecture 2013
- Factors associated with intolerance to peginterferon alfa/ribavirin in treatment-naive, cirrhotic/noncirrhotic hepatitis C virus (HCV) genotype 1−infected patients: analysis of data from the multinational PROPHESYS cohorts, 48th Annual Meeting for the European Association for the Study of the Liver (EASL) 2013
- Treatment of HCV: from pre to post liver transplant care, UF Advance Liver Disease Preceptor Program 2013
- Optimizing Outcomes in Hepatitis C and Liver Transplant Patients, Internal Medicine Grand Round, Veterans Medical Center 2011
- Sunrise Symposium: Hepatitis C Infection after Liver Transplantation, American Transplant Congress 2011 2011
- Sustained Viral Response Dramatically Improves Survival In Patients with Hepatitis C Infection After Liver Transplant, 46th Annual Meeting for the European Association for the Study of the Liver (EASL) 2011
- Cyclosporine Helps to Achieve a Higher SVR in Patients Receiving PEG-Interferon/ Ribavirin for Recurrence Hepatitis C After Liver Transplantation: Final Analysis of a Randomized-Controlled Study, 43rd Annual Meeting for the European Association for the Study of the Liver (EASL) 2008
- New Findings in NAFLD, Viral Hepatitis & Liver Diseases: Update on management and treatment strategies, University of Puerto Rico 2007
- Optimizing Outcomes in HCV Liver Transplant Recipients, Shands Hospital Liver Transplant Team 2007
- A Randomized Controlled Trial of Cyclosporine vs. Tacrolimus Immunosuppression in Patients Receiving Pegylated Interferon and Ribavirin for Recurrence Hepatitis C Virus Infection After Liver Transplantation: Interim Results, 57th Annual Meeting of the AASLD 2006
- Anti-HCV Activity of Cyclosporine: In Vitro Data, Novartis 2006
- Target HCV-HBV, Chronic Liver Disease Foundation 2006
- New Insights Into the Management of HCV , Chronic Liver Disease Foundation 2005
- Failure of Sirolimus to impact major variables in Tacrolimus-based immunosuppression regimens in Liver Transplant Recipients, 53rd Annual Meeting of the AASLD 2002
- Sirolimus induced Hypertriglyceridemia in Liver Transplant Recipients is not Dose-dependent, 53rd Annual Meeting of the AASLD 2002
Research
principal investigator on
- A Phase 3B, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic .... awarded by Intercept Pharmaceuticals 2014 - 2017
- An Open-Label Re-Treatment Study With Peg-Interferon Alfa-2Aribavirin and Bms-790052 With or Without Bms650032...... awarded by Bristol Myers Squibb Company Pharmacy Research Institute 2012 - 2017
- An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Abt-450/Ritonavir and Dasabuvir In... awarded by Abbvie 2014 - 2017
- An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With Abt-450/Ritonavir/Abt-267 (Abt-450/R/Abt-267) awarded by Abbvie 2014 - 2017
- A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Mk-5172/Mk-8742... awarded by Merck Sharp and Dohme 2014 - 2017
- A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Gs-5816 Fixed-Dose . . . awarded by Gilead Sciences 2014 - 2017
- A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Mk-5172/Mk-8742... awarded by Merck Sharp and Dohme 2014 - 2017
- A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Mk-5172 and Mk-8742 awarded by Merck Sharp and Dohme 2014 - 2017
- A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial 2015 - 2016
- A Multicenter, Double-Blind, Sponsor-Open Trial of IDN-6556 in Sbj Who had HCV Reinfection & Liver Fibrosis following Orthotopic Liver Transplantation for HCV Infection & Who subsequently Achieved a SVR Following anti-HCV Therapy 2015 - 2016
- 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 2015 - 2016
- A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant... awarded by Janssen Research and Development 2014 - 2016
- ...Asunaprevir and Daclatasvir (Dual) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R),... awarded by Bristol Myers Squibb Company Pharmacy Research Institute 2012 - 2015
- 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 2014 - 2015
- 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 2014 - 2015
- 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 2014 - 2015
- A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK- 5172 and MK-8742 ± Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency 2014 - 2015
- A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, GT5, and GT6 Infection 2014 - 2015
- 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) 2014 - 2015
- An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1 Infection 2014 - 2015
- 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 Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III) 2014 - 2015
- A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peg interferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naïve Subjects with Chronic Hepatitis C Genotype 1b Infection 2012 - 2014
- An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects with Chronic Hepatitis C 2012 - 2014
- Sustain: a Multi-Center Randomized Open Label Controlled Study to Compare the Sustained Virological Response During.. awarded by Novartis Pharmaceuticals Corporation 2009 - 2014
- Cyclosporine in Hepatitis C Viral Clearance Following Liver Transplant awarded by Novartis Pharmaceuticals Corporation 2004 - 2008
- Comparison of Peg-Intron 1.5Ug/Kg/Wk Plus Rebetol Vs Peg-Intron 1Ug/Kg/Wk Plus Rebetol Vs Pegasys 180Ug/Wk ..... awarded by Schering Plough Research Institute 2005 - 2008
- Rndmz Opn-Lbl Compare Evaluation of Conversion From Calcineurin Inhibitor Trtmnt to Sirolimus Trtmnt Vs Continued Calcineuri awarded by American Home Prods Wyeth Ayerst Labs Inc
co-principal investigator on
- A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naïve and Treatment Experienced Subjects with Genotype 3 Chronic Hepatitis C Infection 2014 - 2015
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV Infection 2014 - 2015
- A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 12 Weeks in Subjects with Chronic Genotype 2 HCV Infection’ 2014 - 2015
- A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection 2014 - 2015
- A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection and Chronic Kidney Disease 2014 - 2015
- An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir with or without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, with Severe Renal Impairment or End-Stage Renal Disease 2014 - 2015
- An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin For 12 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study 2014 - 2015
- A Follow-up Study to Assess Resistance and Durability of Response to Abbott Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection 2013 - 2015
- A Multicenter, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Efficacy of IDN-6556 in Subjects with Liver Cirrhosis 2013 - 2015
- A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF TIVANTINIB (ARQ 197) IN SUBJECTS WITH MET DIAGNOSTIC-HIGH INOPERABLE HEPATOCELLULAR CARCINOMA (HCC) TREATED WITH ONE PRIOR SYSTEMIC THERAPY 2013 - 2015
- A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Experienced Subjects with Chronic HCV Infection 2013 - 2015
- A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naïve Subjects with Chronic HCV Infection 2013 - 2015
- A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection 2013 - 2015
- A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib 2013 - 2015
- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE PREVENTION OF COMPLICATIONS IN SUBJECTS WITH EARLY DECOMPENSATED LIVER CIRRHOSIS 2013 - 2015
- A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations with Simeprevir and/or TMC647055/Ritonavir with or without Ribavirin for 12 Weeks in Subjects with Chronic Hepatitis C Infection 2013 - 2015
- A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib 2013 - 2015
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I) 2012 - 2015
- A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II) 2012 - 2015
- A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon 2012 - 2015
- A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection 2011 - 2015
- A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection 2011 - 2015
- A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH) 2013 - 2014
- A Phase 3, Multicenter, Open-label Study to Investigate the Efficacy and Safety of GS-7977 with Peg interferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1, 4, 5, or 6 HCV Infection awarded by Gilead Sciences 2012 - 2014
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects with Chronic Genotype 2 or 3 HCV Infection who are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon awarded by Gilead Sciences 2012 - 2014
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection awarded by Gilead Sciences 2012 - 2014
- A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects with Chronic Genotype 1 HCV Infection 2012 - 2014
- An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon α-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous Abbott DAA Combination Study 2012 - 2014
- Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients with Cirrhotic Ascites awarded by Otsuka America Pharmaceutical 2012 - 2014
- A MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF RIFAXIMIN 550 MG WITH AND WITHOUT LACTULOSE IN SUBJECTS WITH A HISTORY OF RECURRENT OVERT HEPATIC ENCEPHALOPATHY 2012 - 2013
- A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 2b Study to Compare the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, Ribavirin) to Triple Therapy (with VX-222-Placebo) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis 2012 - 2013
- An Open-Label Study to Evaluate the Safety and Efficacy of IDX184 in Combination with Telaprevir and Ribavirin for 12 Weeks in Subjects with Genotype 1 Chronic Hepatitis C Infection 2012 - 2013
- An Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects 2012 - 2013
- An Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ABT-450 with Ritonavir (ABT-450/r) in Combination with ABT-267 With and Without ABT-333 and/or Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C (CHC) 2012 - 2013
- A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naïve and Prior Relapser Subjects with Genotype 1 Chronic Hepatitis awarded by Vertex Pharmaceuticals 2011 - 2013
- A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 with Ritonavir (ABT-450/r) in Combination with ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12, or 24 Weeks in Treatment-Naïve and Null Responder Subjects with Genotype 1 Chronic Hepatitis C Virus infection awarded by Abbott Laboratories 2011 - 2013
- A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly with GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naïve Subjects with Chronic Genotype1 HCV Infection awarded by Gilead Sciences 2011 - 2013
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peg interferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 2011 - 2013
- An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients with Chronic HCV Infection 2011 - 2013
- An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination with ABT-333 and Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection 2011 - 2013
- Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination with BMS-790052 with or without Ribavirin in Treatment Naïve Subjects Chronically Infected with Hepatitis C Virus Genotypes 1, 2, or 3 2011 - 2013
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peg interferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection awarded by Gilead Sciences 2010 - 2013
- Multicenter, Randomized Pilot Study of the Effect of Sorafenib Dosing Schedule on Tolerability and Drug Delivery awarded by Bayer Healthcare Pharmaceuticals 2010 - 2013
- A Phase 2b Study of BMS-790052 in Combination with Peg- Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects with Chronic Hepatitis C 2010 - 2013
- A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Oral Administration of PSI-7977 in Combination with Pegylated Interferon and Ribavirin in Treatment-Naïve Patients with Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients with HCV Genotypes 2 or 3 2010 - 2012
- A Phase 2B Study of BMS-790052 in Combination with Peg interferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment with Peg interferon Alfa plus Ribavirin Therapy 2010 - 2012
- Opn-Lbl Randomized 5-Arm Prl-Grp Study of Eff on Viral Kinetics, SAF and Pharmocokinetics of Diff Dosing Reg of Debio 025... awarded by Debiopharm SA 2007 - 2011
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 or 24 Weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peg interferon Alfa 2a (PEG, Pegasys®), and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection awarded by Gilead Sciences 2011
- A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Oral Administration of PSI-7977 in Combination with Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients with Chronic HCV Infection Genotype 1 awarded by Pharmasset 2010
- Boceprevir/Peg interferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naïve Subjects: A Comparison of Erythropoietin Versus Ribavirin Dose Reduction for the Management of Anemia 2010
- A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy 2009 - 2010
- A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis awarded by Intercept Pharmaceuticals 2008 - 2010
- A two-stage, multicenter, open-label study of Mapatumumab ([HGS1012], A fully-human monoclonal antibody to trail-R1) in combination with Sorafenib as a first line therapy in subjects with advanced hepatocellular CA awarded by Human Genome Sciences 2008 - 2010
- Phase II Comparison of Fibroscan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B & C....... awarded by Echosens 2007 - 2009
- A Trial of Cts-1027 in Interferon -Naive Hepatitis C Patients awarded by South Carolina Liver Research Consortium 2009
- A Phase III randomized, double-blind, placebo-controlled study of sorafenib or placebo in combination with transarterial chemoembolization (TACE) performed with drug-eluting beads and doxorubicin for intermediate stage hepatocellular carcinoma (HCC) awarded by Bayer Healthcare Pharmaceuticals 2009
- A Phase III randomized, placebo controlled, double blind trial of Sorafenib plus Erlotinib vs. Sorafenib plus placebo as First Line systemic treatment for Hepatocellular Carcinoma (HCC) awarded by Bayer Healthcare Pharmaceuticals 2009
- A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C who Achieve an Extended Rapid Viral Response (eRVR) While Receiving Telaprevir, Peg interferon Alfa2a (Pegasys®) and Ribavirin (Copegus®) awarded by Vertex Pharmaceuticals 2009
- A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment awarded by Vertex Pharmaceuticals 2009
- Satavaptan in the Prevention of Ascites Recurrence: a double-blind, randomized, parallel-group comparison of satavaptan at 5 to 10 mg daily versus placebo with concomitant diuretics in patients with recurrent ascites due to cirrhosis of the liver awarded by Sanofi-Synthelabo Research US 2007
- A Multiple-Center, Observer-Blinded, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Food Effect of RO5024048 in Healthy Volunteers and in Patients with Chronic HCV Infection of Genotype 1 awarded by Pharmasset 2007
- A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNa2a) in Combination with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 1 awarded by Human Genome Sciences 2007
- A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNa2a) in Combination with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3 awarded by Human Genome Sciences 2007
- A Phase II, Randomized, Double-Blinded, Multi-Center, Dose Finding Study Evaluating the Efficacy and Safety of the HCV Polymerase Inhibitor Prodrug (RO4588161) When Given in Combination with Pegasys and Copegus versus the Currently Approved Combination of Pegasys and Copegus in Treatment-Naïve Patients with Chronic Hepatitis C Genotype a Virus Infection awarded by Hoffmann La Roche Inc 2007
- An open-label, randomized, 5-arm, parallel-group study of the effects on viral kinetics safety and pharmacokinetic of different dosing regimens of Debio 025 in combination with peginterferon alpha-2a and ribavirin in chronic HCV genotype 1 2007
- Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Combination with Peginterferon α-2a and Ribavirin in Patients with Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin awarded by Romark Laboratories 2007
- A Phase II, Randomized, Multicenter, Double-Blinded Study Evaluating the Safety and Tolerability of the HCV Polymerase Inhibitor Prodrug (RO4588161) When Given in Combination with Pegasys With or Without Copegus Versus the Currently Approved Combination of Pegasys and Copegus in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection awarded by Hoffmann La Roche Inc 2006
- A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys) With Ribavirin (Copegus) in Subjects with Genotype 1 Hepatitis C Who Have Not Received Prior Treatment awarded by Vertex Pharmaceuticals 2006
- A Phase 2, Randomized, Open-Label Study of the Safety, Antiviral Activity, and Pharmacokinetics of HCV-796 administered in combination with Peginterferon alfa-2b (PEG-Intron), with or without concomitant ribavirin (REBETOL), versus PEG-Intron plus REBETOL in subjects with hepatitis C virus genotype 1 infection 2006
- A Phase III, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Albumin Interferon Alfa-2a (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNa2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1 2006
- Satavaptan Cirrhotic Ascites Treatment Study: a double-blind, randomized, parallel-group comparison of treatment with satavaptan at 5 to 10mg daily versus placebo on top of conventional treatment in patients with ascites due to cirrhosis of the liver 2006
- Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS® doses of 180 µg or 270 µg in Combination with Copegus® doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater than 85 kg awarded by Hoffmann La Roche Inc 2004 - 2006
- A Randomized, Placebo-Controlled Trail of Betaine in Patients with Nonalcoholic Steatohepatitis 2003 - 2006
- Metformin for Patients with Non-Alcoholic Fatty Liver Disease 2003 - 2006
- A Multicenter Double-Blinded Study in Non Cirrhotic Patients with Chronic Hepatitis C Who Are Non-Responders To Prior Interferon Alfa or Interferon Alfa + Ribavirin Therapy, Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alfa-2a With Peginterferon Alfa-2a + Placebo 2002 - 2006
- A Multicenter Double-Blinded Study in Patients with Compensated Cirrhosis due to Chronic Hepatitis C Who Are Non-Responders To Prior Interferon Alfa or Interferon Alfa + Ribavirin Therapy, Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alfa-2a With Peginterferon Alfa-2a + Placebo 2002 - 2006
- Dose-ranging study of viramidine in combination with Pegasys in treatment naïve subjects with chronic hepatitis C virus infection 2002 - 2006
- A Phase IIb Clinical Trial to Evaluate the Combination of Pegylated Interferon Alfa plus Valopicitabine (NM283) in Treatment-Naïve Patients with Chronic Hepatitis C awarded by Idenix Pharmaceuticals Inc 2005
- A Twelve-Week, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Dose Response Study of the Anti-viral Effect of Oral UT-231B in Non-Cirrhotic Patients with Chronic Hepatitis C Infection who have Failed Interferon-Based Therapy 2004 - 2005
- Randomized, Multicenter, Open-Label, Phase IV Study Evaluating the Efficacy and Safety of 16-Week Versus 24-Week Treatment with PEGASYS® in Combination With Copegus® in Interferon-naïve Patients with Chronic Hepatitis C Genotype 2 or 3 Virus Infection awarded by Hoffmann La Roche Inc 2004 - 2005
- Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naïve Patients with Chronic Hepatitis C 2003 - 2005
- A phase ½ study to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of albuferon recombinant human albumin-interferon alpha fusion protein in subjects with chronic hepatitis C virus infection awarded by Human Genome Sciences 2002 - 2005
- Phase II, Double Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Antifibrotic Efficacy of Interferon- gamma 1b in Patients with Severe Liver Fibrosis or Compensated Cirrhosis Due to Hepatitis C 2002 - 2005
- A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) plus Ribavirin Administered Daily for 48 Weeks Versus No-treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa plus Ribavirin Therapy 2004
- A Prospective, Randomized, Multicenter, Open-Label, Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon alfa-2a (Pegasys®) Plus Ribavirin vs. No Prophylaxis Following Liver Transplantation for Hepatitis C 2004
- A Double-Blind, Placebo-Controlled Rising Multiple-Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Hepavir B in Adult Subjects with Compensated Hepatitis B Virus (HBV) Infection 2003 - 2004
- A Multiple Rising-Dose Study of Fk788 in Subjects with Chronic Hepatitis C Virus Infection awarded by Fujisawa Healthcare Inc 2002 - 2004
- Comparison of Liver Fibrosis Serodiagnostic Panel Results With Histologic Evaluations of Liver Fibrosis in Patients Presenting for Liver Biopsy 2002 - 2004
- A Trial of Zadaxin (Thymalfasin) With Trans Arterial Chemoembolization (TACE) in the Treatment of Adult Patients with Unresectable Hepatocellular 2003
Teaching
teaching activities
- BCC7110 Fall 2008 7236 BCC7110 Fall 2008 7236
- BCC7110 Fall 2009 7236 BCC7110 Fall 2009 7236
- BCC7110 Fall 2010 7236 BCC7110 Fall 2010 7236
- BCC7110 Spring 2009 8569 BCC7110 Spring 2009 8569
- BCC7110 Spring 2010 8569 BCC7110 Spring 2010 8569
- BCC7110 Summer 2009 8017 BCC7110 Summer 2009 8017
- BCC7110 Summer 2010 8017 BCC7110 Summer 2010 8017
- BCC7111 Fall 2009 8637 BCC7111 Fall 2009 8637
- BMS6602C Spring 2009 8506 BMS6602C Spring 2009 8506
- BMS6834 Spring 2011 6935 BMS6834 Spring 2011 6935
- BMS6834 Summer 2010 8865 BMS6834 Summer 2010 8865
- MEL7948 Fall 2008 2356 MEL7948 Fall 2008 2356
- MEL7948 Fall 2009 2356 MEL7948 Fall 2009 2356
- MEL7948 Fall 2010 2356 MEL7948 Fall 2010 2356
Background
education and training
- M.D., University of Puerto Rico
- M.S. in Clinical and Translational Science, University of Florida 2008 - 2009
- UCLA School of Medicine , Hepatology and Liver Transplatation 2001 - 2002
- B.S. in Biology, University of Puerto Rico 1986 - 1990
- University of Florida College of Medicine , Gastroenterology, Hepatology and Nutrition 1998 - 2001
- University of Puerto Rico School of Medicine , Internal Medicine 1995 - 1997