The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial)

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.

Keywords: boceprevir; genotype 1; hepatitis C virus; naïve; partial responder; relapser.

Conflict of interest statement

Conflict of interest statement: FP discloses grants/research support from AbbVie, Achillion, Bristol-Myers Squibb, CLDF, Gilead, Idera, Intercept, Janssen, and Merck; consultant/speaker bureau for AbbVie, Gilead, Kadmon, Janssen, and Salix; and advisory board membership for AbbVie, Achillion, Bristol-Myers Squibb, Gilead, Merck, Novartis, and Tibotec/Janssen. VR discloses grants/research support from CLDF and Gilead; consultant/speaker bureau for AbbVie; and advisory board membership for AbbVie, Gilead, and Merck. VP discloses consultant/speaker bureau for Abbvie, Gilead, Salix and Bayer, and advisory board membership for Gilead. RB discloses grants/research support from AbbVie, Gilead, Janssen, and Merck; and consultant/speaker bureau for AbbVie, Gilead, Janssen, and Merck. MK discloses grants/research support, consultant/speaker bureau, and advisory board membership from/for AbbVie, Bristol-Myers Squibb, CLDF, Gilead, Janssen, Merck, Roche, and Salix. FR discloses grants/research support from Bristol-Myers Squibb, CLDF, and Merck; consultant/speaker bureau for Gilead; and advisory board membership for Gilead and Janssen. LB discloses grants/research support from AbbVie, Bayer, CLDF, GI Dynamics, Gilead, Merck, Ocera, Salix, and Takeda; consultant/speaker bureau for AbbVie, Gilead, and Janssen; and advisory board membership for AbbVie and Merck. DL discloses grants/research support from CLDF; consultant/speaker bureau for AbbVie, CLDF, and Simply Speaking; and advisory board membership for Bristol-Myers Squibb. KB discloses grants/research support from AbbVie, Bristol-Myers Squibb, CDC Foundation, CLDF, Duke, Gilead, Hyperion, Janssen, Merck, and Vertex; consultant/speaker bureau for AbbVie, CLDF, Gilead, HCV Viewpoint, Peer to Peer, and Simply Speaking; advisory board membership for AbbVie, Bristol-Myers Squibb, CLDF, Gilead, Janssen, Merck, and Vertex; editorial board involvement for the American Journal of Transplantation, CLD Journal, Images in Transplantation; and other financial material support/boards from/for ABIM, A2All, CLDF, and DSMB. SF discloses consultant/speaker bureau for Merck and Vertex. HM discloses consultant/speaker bureau and advisory board membership for Gilead, BMS, Merck, Vertex, Abbvie and Salix. SH discloses grants/research support from CLDF; consultant/speaker bureau for AbbVie, FibroGen, GI Consultants SA, Nimbus Discovery, NGM Biopharmaceuticals, CLDF, Gilead, Janssen, and Vidico; advisory board membership for CLDF; and editorial board involvement with the Hepatology Journal. MA, MB, GF, RS, MB, HA, JC, and WK disclose grants/research support from CLDF.

Figures

Figure 1.

Reasons for patient discontinuation. Other reasons for discontinuation included severe depression, a positive test for nonprescription opiates, methamphetamines or cocaine, and the occurrence of pregnancy during the study. SAE, serious adverse event.

Figure 2.

Sustained virological response rate by group. TW, treatment week.