title: A comparison of modified directly observed therapy to standard care for chronic hepatitis C.
abstract: Hepatitis C virus (HCV) is the most common chronic blood-borne infection in the United States. Effective treatments are available, however adherence to treatment is challenging. Modified directly observed therapy (mDOT) with weekly administration of pegylated interferon might improve adherence and outcomes for patients infected with chronic HCV. The purpose of this study was to compare two treatment protocols and examine predictors of sustained virologic response (SVR). This retrospective review compares HCV treatment outcomes in two outpatient clinics at an urban academic medical center. Gastroenterology fellows provided standard treatment (SC) in one clinic; a nurse practitioner administered weekly pegylated interferon injections weekly in a primary care clinic. All patients received oral ribavirin. Data was extracted from the medical records of all treated patients over a 5-year period. 155 treatment-naïve, chronically infected HCV patients were treated. Ninety-seven patients received mDOT treatment and 58 received standard care. Mean age was 46 years. Genotype 1 represented 59 % of the sample. The mDOT patients were significantly more likely to be younger (44 vs. 50 years), have a history of injection drug use (93.1 vs. 50.0 %), and be HIV-infected (13.5 vs. 2 %) compared to SC patients. The overall SVR rate was 45.2 % and did not differ between the groups in unadjusted analyses (p = 0.95). Genotype was the only predictor of SVR. Patients treated by nurse practitioners trained in HCV care and seen weekly for interferon injections have comparable treatment outcomes to patients treated by specialists.
authors.affiliation: Center for Alcohol and Addiction Studies, Brown University, Providence, RI 02903, USA. Patricia_Cioe@brown.edu
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Cioe
authors.forename: Michael D
authors.initials: MD
authors.lastname: Stein
authors.forename: Kittichai
authors.initials: K
authors.lastname: Promrat
authors.forename: Peter D
authors.initials: PD
authors.lastname: Friedmann
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use; D023801:Directly Observed Therapy / Q000379:methods; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a