OBJECTIVES:Mental health and substance abuse (MH/SA) comorbidities are the most oft-cited reasons for deferral from peginterferon (PegIFN) therapy for chronic hepatitis C virus (HCV). We sought to determine whether an integrated care intervention (INT) for patients deferred from PegIFN owing to MH/SA could improve subsequent treatment eligibility rates. METHODS: In this randomized controlled trial, 101 HCV patients who were evaluated at two hepatology centers and deferred from antiviral therapy owing to MH/SA were enrolled. Participants were randomized to an INT (N=50) or standard of care (SC; N=51). The INT group received counseling and case management for up to 9 months. All participants underwent 3-, 6-, and 9-month clinical follow-up visits, where hepatologists, masked to group, re-evaluated patients for treatment eligibility. Standardized mood and alcohol use instruments were administered to all participants to aid clinicians in treatment decisions. RESULTS:Of 101 participants, the mean age was 48 years and 50% were men, 61% Caucasian, and 77% genotype 1. Patients were initially deferred owing to psychiatric issues (35%), alcohol abuse (31%), drug abuse (9%), or more than one of these reasons (26%). In an intent-to-treat analysis, 42% (21/50) of INT participants became eligible for therapy compared to 18% (9/51) of SC participants (P=0.009, relative risk (RR)=2.38, 95% confidence interval (CI) (1.21, 4.68)). When baseline predictors significant at P<0.10 in univariate models were entered into multivariate models adjusted for treatment group, only baseline depression remained significant (P=0.05, RR=0.98, 95% CI (0.96, 1.00)). With the exception of a model adjusted for genotype, treatment group remained significant in all models. CONCLUSIONS: This trial suggests that INTs can increase eligibility for HCV treatment and expand treatment to the underserved population with MH/SA comorbidities.
RCT Entities:
OBJECTIVES: Mental health and substance abuse (MH/SA) comorbidities are the most oft-cited reasons for deferral from peginterferon (PegIFN) therapy for chronic hepatitis C virus (HCV). We sought to determine whether an integrated care intervention (INT) for patients deferred from PegIFN owing to MH/SA could improve subsequent treatment eligibility rates. METHODS: In this randomized controlled trial, 101 HCVpatients who were evaluated at two hepatology centers and deferred from antiviral therapy owing to MH/SA were enrolled. Participants were randomized to an INT (N=50) or standard of care (SC; N=51). The INT group received counseling and case management for up to 9 months. All participants underwent 3-, 6-, and 9-month clinical follow-up visits, where hepatologists, masked to group, re-evaluated patients for treatment eligibility. Standardized mood and alcohol use instruments were administered to all participants to aid clinicians in treatment decisions. RESULTS: Of 101 participants, the mean age was 48 years and 50% were men, 61% Caucasian, and 77% genotype 1. Patients were initially deferred owing to psychiatric issues (35%), alcohol abuse (31%), drug abuse (9%), or more than one of these reasons (26%). In an intent-to-treat analysis, 42% (21/50) of INT participants became eligible for therapy compared to 18% (9/51) of SC participants (P=0.009, relative risk (RR)=2.38, 95% confidence interval (CI) (1.21, 4.68)). When baseline predictors significant at P<0.10 in univariate models were entered into multivariate models adjusted for treatment group, only baseline depression remained significant (P=0.05, RR=0.98, 95% CI (0.96, 1.00)). With the exception of a model adjusted for genotype, treatment group remained significant in all models. CONCLUSIONS: This trial suggests that INTs can increase eligibility for HCV treatment and expand treatment to the underserved population with MH/SA comorbidities.
Authors: Jason Grebely; Elizabeth Knight; Krista A Genoway; Mark Viljoen; Milan Khara; Doug Elliott; Lesley Gallagher; Michelle Storms; Jesse D Raffa; Stanley DeVlaming; Fiona Duncan; Brian Conway Journal: Eur J Gastroenterol Hepatol Date: 2010-03 Impact factor: 2.566
Authors: Astrid Knott; Eric Dieperink; Mark L Willenbring; Sara Heit; Janet M Durfee; Mary Wingert; James R Johnson; Paul Thuras; Samuel B Ho Journal: Am J Gastroenterol Date: 2006-10 Impact factor: 10.864
Authors: Jason A Craw; Lytt I Gardner; Gary Marks; Richard C Rapp; Jeff Bosshart; Wayne A Duffus; Amber Rossman; Susan L Coughlin; DeAnn Gruber; Lauretta A Safford; Jon Overton; Karla Schmitt Journal: J Acquir Immune Defic Syndr Date: 2008-04-15 Impact factor: 3.731
Authors: Jason Grebely; Krista Genoway; Milan Khara; Fiona Duncan; Mark Viljoen; Doug Elliott; Jesse D Raffa; Stanley DeVlaming; Brian Conway Journal: Int J Drug Policy Date: 2007-04-27
Authors: Jeffrey J Weiss; Sarah Prieto; Norbert Bräu; Douglas T Dieterich; Sue M Marcus; Alicia Stivala; Jack M Gorman Journal: Int J Psychiatry Med Date: 2018-01-03 Impact factor: 1.210
Authors: Jason Grebely; Geert Robaeys; Philip Bruggmann; Alessio Aghemo; Markus Backmund; Julie Bruneau; Jude Byrne; Olav Dalgard; Jordan J Feld; Margaret Hellard; Matthew Hickman; Achim Kautz; Alain Litwin; Andrew R Lloyd; Stefan Mauss; Maria Prins; Tracy Swan; Martin Schaefer; Lynn E Taylor; Gregory J Dore Journal: Int J Drug Policy Date: 2015-07-17
Authors: Christopher E McGowan; Ali Monis; Bruce R Bacon; Josep Mallolas; Fernando L Goncales; Ioannis Goulis; Fred Poordad; Nezam Afdhal; Stefan Zeuzem; Teerha Piratvisuth; Patrick Marcellin; Michael W Fried Journal: Hepatology Date: 2013-04 Impact factor: 17.425