The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial).
OBJECTIVE
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.
The Texas Liver Institute, University of Texas Health Science Center, 607 Camden St, Suite 101, San Antonio, TX 78215, USA.
Fred
F
Poordad
Metropolitan Research, Fairfax, VA, USA.
Vinod
V
Rustgi
Weill Cornell Medical College, New York, NY, USA.
Robert S
RS
Brown
Temple University School of Medicine, Philadelphia, PA, USA.
Vishal
V
Patel
South Denver Gastroenterology, Englewood, CO, USA.
Marcelo
M
Kugelmas
Saint Luke's Hospital, Kansas City, MO, USA.
Fredric
F
Regenstein
Tulane University School of Medicine, New Orleans, LA, USA.
Luis
L
Balart
University of Iowa School of Medicine, Iowa City, IA, USA.
Douglas
D
LaBrecque
Henry Ford Hospital, Detroit, MI, USA.
Kimberly
K
Brown
Digestive Medicine Associates, Hialeah, FL, USA.
Mark
M
Avila
South Oakland Gastroenterology Associates, Farmington Hills, MI, USA.
Michael
M
Biederman
Private Practice, Pottsville, PA, USA.
Glenn
G
Freed
Flint Gastroenterology Associates, Grand Blanc, MI, USA.
Richard
R
Smith
Mercy Clinic Hepatology, Saint Louis, MO, USA.
Marc
M
Bernstein
Gastroenterology Consultants of San Antonio, San Antonio, TX, USA.
Hays
H
Arnold
Consultants in Gastroenterology, Munster, IN, USA.
Joel
J
Cahan
Main Line Gastroenterology Associates, Wynnewood, PA, USA.
Scott
S
Fink
St John's Health Center, Santa Monica, CA, USA.
William
W
Katkov
New York Associates in Gastroenterology, Bronx, NY, USA.
Hatef
H
Massoumi
Brooke Army Medical Center, Fort Sam Houston, TX, USA.
Stephen
S
Harrison
boceprevir; genotype 1; hepatitis C virus; naïve; partial responder; relapser