Fred Poordad1, Vinod Rustgi2, Robert S Brown3, Vishal Patel4, Marcelo Kugelmas5, Fredric Regenstein6, Luis Balart7, Douglas LaBrecque8, Kimberly Brown9, Mark Avila10, Michael Biederman11, Glenn Freed12, Richard Smith13, Marc Bernstein14, Hays Arnold15, Joel Cahan16, Scott Fink17, William Katkov18, Hatef Massoumi19, Stephen Harrison20. 1. The Texas Liver Institute, University of Texas Health Science Center, 607 Camden St, Suite 101, San Antonio, TX 78215, USA. 2. Metropolitan Research, Fairfax, VA, USA. 3. Weill Cornell Medical College, New York, NY, USA. 4. Temple University School of Medicine, Philadelphia, PA, USA. 5. South Denver Gastroenterology, Englewood, CO, USA. 6. Saint Luke's Hospital, Kansas City, MO, USA. 7. Tulane University School of Medicine, New Orleans, LA, USA. 8. University of Iowa School of Medicine, Iowa City, IA, USA. 9. Henry Ford Hospital, Detroit, MI, USA. 10. Digestive Medicine Associates, Hialeah, FL, USA. 11. South Oakland Gastroenterology Associates, Farmington Hills, MI, USA. 12. Private Practice, Pottsville, PA, USA. 13. Flint Gastroenterology Associates, Grand Blanc, MI, USA. 14. Mercy Clinic Hepatology, Saint Louis, MO, USA. 15. Gastroenterology Consultants of San Antonio, San Antonio, TX, USA. 16. Consultants in Gastroenterology, Munster, IN, USA. 17. Main Line Gastroenterology Associates, Wynnewood, PA, USA. 18. St John's Health Center, Santa Monica, CA, USA. 19. New York Associates in Gastroenterology, Bronx, NY, USA. 20. Brooke Army Medical Center, Fort Sam Houston, TX, USA.
Abstract
OBJECTIVES: Although effective, direct acting antiviral (DAA) therapies for genotype 1 (GT 1) hepatitis C virus (HCV) have been associated with compliance challenges. Additionally, treatment at predominantly community-based centers has been associated with low retention of patients on treatment and higher dropout rates. The OPTIMAL Phase IV interventional trial (ClinicalTrials.gov Identifier: NCT01405027) was designed to evaluate the impact of an education program for community investigator (CI) sites participating in a Chronic Liver Disease Foundation study treating chronic GT 1 HCV patients. METHODS: This physician educational program was administered by 22 Hepatology Centers of Educational Expertise (HCEE) academic sites to 33 CI sites asked to participate from December 2011 to July 2012. The HCEE mentors from DAA-experienced academic sites educated those at CI sites on therapeutic management, practice, and patient outcomes through a series of four standardized educational sequence visits regarding the use of first generation HCV protease inhibitors and the overall treatment of HCV. RESULTS: Treatment duration compliance rates for patients treated at CI sites versus those treated at HCEE academic sites were evaluable in 77 of 84 HCEE academic site patients, 102 of 113 patients treated at CI sites, and 179 of 197 overall patients. The treatment duration compliance rates for patients treated at HCEE academic sites, CI sites and overall were 85.4 ± 25.39%, 83.8 ± 27.37%, and 84.5 ± 26.48%, respectively, and did not differ statistically between the groups (p = 0.49). Almost half (47%) of the patients in the study achieved a sustained virological response for 24 weeks (SVR24) regardless of the type of site (p = 0.64). Safety profiles were similar at both HCEE and CI sites. CONCLUSIONS: These results demonstrated that education of CI sites unfamiliar with DAAs resulted in patient outcomes consistent with those observed at DAA-experienced academic sites.
OBJECTIVES: Although effective, direct acting antiviral (DAA) therapies for genotype 1 (GT 1) hepatitis C virus (HCV) have been associated with compliance challenges. Additionally, treatment at predominantly community-based centers has been associated with low retention of patients on treatment and higher dropout rates. The OPTIMAL Phase IV interventional trial (ClinicalTrials.gov Identifier: NCT01405027) was designed to evaluate the impact of an education program for community investigator (CI) sites participating in a Chronic Liver Disease Foundation study treating chronic GT 1 HCVpatients. METHODS: This physician educational program was administered by 22 Hepatology Centers of Educational Expertise (HCEE) academic sites to 33 CI sites asked to participate from December 2011 to July 2012. The HCEE mentors from DAA-experienced academic sites educated those at CI sites on therapeutic management, practice, and patient outcomes through a series of four standardized educational sequence visits regarding the use of first generation HCV protease inhibitors and the overall treatment of HCV. RESULTS: Treatment duration compliance rates for patients treated at CI sites versus those treated at HCEE academic sites were evaluable in 77 of 84 HCEE academic site patients, 102 of 113 patients treated at CI sites, and 179 of 197 overall patients. The treatment duration compliance rates for patients treated at HCEE academic sites, CI sites and overall were 85.4 ± 25.39%, 83.8 ± 27.37%, and 84.5 ± 26.48%, respectively, and did not differ statistically between the groups (p = 0.49). Almost half (47%) of the patients in the study achieved a sustained virological response for 24 weeks (SVR24) regardless of the type of site (p = 0.64). Safety profiles were similar at both HCEE and CI sites. CONCLUSIONS: These results demonstrated that education of CI sites unfamiliar with DAAs resulted in patient outcomes consistent with those observed at DAA-experienced academic sites.
Authors: Fred Poordad; Jonathan McCone; Bruce R Bacon; Savino Bruno; Michael P Manns; Mark S Sulkowski; Ira M Jacobson; K Rajender Reddy; Zachary D Goodman; Navdeep Boparai; Mark J DiNubile; Vilma Sniukiene; Clifford A Brass; Janice K Albrecht; Jean-Pierre Bronowicki Journal: N Engl J Med Date: 2011-03-31 Impact factor: 91.245
Authors: Bruce R Bacon; Stuart C Gordon; Eric Lawitz; Patrick Marcellin; John M Vierling; Stefan Zeuzem; Fred Poordad; Zachary D Goodman; Heather L Sings; Navdeep Boparai; Margaret Burroughs; Clifford A Brass; Janice K Albrecht; Rafael Esteban Journal: N Engl J Med Date: 2011-03-31 Impact factor: 91.245
Authors: Kenneth E Sherman; Steven L Flamm; Nezam H Afdhal; David R Nelson; Mark S Sulkowski; Gregory T Everson; Michael W Fried; Michael Adler; Hendrik W Reesink; Marie Martin; Abdul J Sankoh; Nathalie Adda; Robert S Kauffman; Shelley George; Christopher I Wright; Fred Poordad Journal: N Engl J Med Date: 2011-09-15 Impact factor: 91.245
Authors: Stefan Zeuzem; Pietro Andreone; Stanislas Pol; Eric Lawitz; Moises Diago; Stuart Roberts; Roberto Focaccia; Zobair Younossi; Graham R Foster; Andrzej Horban; Peter Ferenci; Frederik Nevens; Beat Müllhaupt; Paul Pockros; Ruben Terg; Daniel Shouval; Bart van Hoek; Ola Weiland; Rolf Van Heeswijk; Sandra De Meyer; Don Luo; Griet Boogaerts; Ramon Polo; Gaston Picchio; Maria Beumont Journal: N Engl J Med Date: 2011-06-23 Impact factor: 91.245
Authors: Ira M Jacobson; John G McHutchison; Geoffrey Dusheiko; Adrian M Di Bisceglie; K Rajender Reddy; Natalie H Bzowej; Patrick Marcellin; Andrew J Muir; Peter Ferenci; Robert Flisiak; Jacob George; Mario Rizzetto; Daniel Shouval; Ricard Sola; Ruben A Terg; Eric M Yoshida; Nathalie Adda; Leif Bengtsson; Abdul J Sankoh; Tara L Kieffer; Shelley George; Robert S Kauffman; Stefan Zeuzem Journal: N Engl J Med Date: 2011-06-23 Impact factor: 91.245