Jamie Forlenza

Assessing adherence-based quality measures in epilepsy

OBJECTIVEnTo examine the relationship of three alternative measures of adherence with seven negative outcomes associated with epilepsy for development of a quality measure in epilepsy.nnnDESIGNnRetrospective cohort analysis.nnnSETTINGnPharMetrics national claims database.nnnPARTICIPANTSnPatients in the PharMetrics database for the years 2004-08 taking antiepileptic drugs.nnnINTERVENTIONnNone.nnnMAIN OUTCOME MEASURESnFor each definition of adherence, the odds ratios (ORs) comparing non-adherent with adherent groups were assessed for consistency and direction for the number of hospital admissions, emergency room (ER) visits, head injuries including traumatic brain injuries, falls, motor vehicle accidents (MVAs), fractures and a seizure outcome defined as hospital admissions or ER visits with a primary diagnosis of epilepsy or convulsions.nnnRESULTSnThe inclusion criteria were met by 31 635 individuals. In the multivariate analysis, the adherent group had lower odds of hospital admissions with ORs for the eight specifications ranging from 0.729 to 0.872 and ER visits where ORs for the eight specifications ranged from 0.750 to 0.893. The eight ORs for head injuries ranged from 0.647 to 0.888. For fractures, the ORs ranged from 0.407 to 0.841. Our proxy for seizure was inconsistently associated with adherence status.nnnCONCLUSIONSnAll the adherence measures defined non-adherent groups that were associated with negative outcomes in epilepsy.

Real-World Effectiveness of Simeprevir-containing Regimens Among Patients With Chronic Hepatitis C Virus: The SONET Study

Abstract Background The Simeprevir ObservatioNal Effectiveness across practice seTtings (SONET) study evaluated the real-world effectiveness of simeprevir-based treatment for hepatitis C virus (HCV) infection. Methods The SONET study was a phase 4, prospective, observational, United States–based study enrolling patients ≥18 years of age with chronic genotype 1 HCV infection. The primary endpoint was the proportion of patients who achieved sustained virologic response 12 weeks after the end of treatment (SVR12), defined as HCV ribonucleic acid undetectable ≥12 weeks after the end of all HCV treatments. Results Of 315 patients (intent-to-treat [ITT] population), 275 (87.3%) completed the study. Overall, 291 were treated with simeprevir + sofosbuvir, 17 with simeprevir + sofosbuvir + ribavirin, and 7 with simeprevir + peginterferon + ribavirin. The majority of patients were male (63.2%) and white (60.6%); median age was 58 years, 71.7% had genotype/subtype 1a, and 39.4% had cirrhosis. The SVR12 was achieved by 81.2% (255 of 314) of ITT patients (analysis excluded 1 patient who completed the study but was missing SVR12 data); 2 had viral breakthrough and 18 had viral relapse. The SVR12 was achieved by 92.4% (255 of 276) of patients in the modified ITT (mITT) population, which excluded patients who discontinued treatment for nonvirologic reasons before the SVR12 time point or were missing SVR12 assessment data. Among mITT patients, higher SVR12 rates were associated with factors including age ≥65 years, non-Hispanic/Latino ethnicity, and employment status, but not genotype/subtype nor presence of cirrhosis. Simeprevir-based treatment was well tolerated; no serious adverse events were considered related to simeprevir. Conclusions In the real-world setting, simeprevir + sofosbuvir treatment was common and 92% of mITT patients achieved SVR12. Simeprevir-based treatment was effective and well tolerated in this cohort, including patients with cirrhosis.

Effectiveness of Simeprevir-Containing Regimens among Patients with Chronic Hepatitis C Virus in Various Us Practice Settings: The Sonet Study

EFFECTIVENESS OF SIMEPREVIR-CONTAINING REGIMENS AMONG PATIENTS WITH CHRONIC HEPATITIS C VIRUS IN VARIOUS US PRACTICE SETTINGS: THE SONET STUDY I. Alam, K. Brown, C. Donovan, J. Forlenza, K. Lauwers, M.A. Mah’moud, R. Manch, S.R. Mohanty, A. Prabhakar, R. Reindollar, G. Sawyerr, J. Slim, N. Tandon, S. Villadiego, S. Naggie. Austin Hepatitis Center, Austin, TX; Janssen Scientific Affairs, Titusville, NJ, United States; Janssen Research & Development, Beerse, Belgium; Duke University School of Medicine/Boice-Willis Clinic, Rocky Mount, NC; St. Joseph’s Hospital & Medical Center, Phoenix, AZ; New York Methodist Hospital, Brooklyn, NY; Piedmont Healthcare, Gastroenterology and Hepatology, Statesville, NC; Saint Michael’s Medical Center, Newark, NJ; DurhamVAMedical Center/Duke University School of Medicine, Durham, NC, United States E-mail: dralam@austin.rr.com