Search

Objectives This study compares the characteristics of treated and non-treated patients with Hepatitis C (HCV) infection. Methods Information on patient demographics, clinical data, and treatment regimens were collected from a retrospective medical record review of 998 patients diagnosed with HCV, representing a diverse geographic sample of 200 U.S. physicians including 130 gastroenterologists, 50 infectious disease physicians, and 20 hepatologists. A total of 551 patients were randomly selected and 447 were provided as an augmented sample in an intent-to-treat analysis based on treatment decisions. Pretreatment factors examined included age, gender, race, weight, HCV genotype, HCV viral load, serum ALT levels, liver biopsy results, cirrhosis, HIV co-infection, HBV co-infection, IV drug use, and insurance status. Univariate analyses were performed using Chi-squared or ANOVA tests. Factors that were significant in univariate analyses were entered into a multivariate logistic regression model with HCV treatment as the outcome variable. Results Of the 998 patients reviewed, 778 were treated for HCV and 220 were not treated. In univariate analyses, non-treated patients were more likely to be African American, HBV co-infected, HIV co-infected, IDUs, alcoholics, Medicaid insured, and were less likely to have had biopsies. The multivariate regression analysis demonstrated that performance of a liver biopsy, treatment with psychiatric medications (antidepressants and anxiolytics), and patient weight were independently associated with treatment, while Medicaid insurance and HIV co-infection were independently associated with a decreased likelihood of receiving HCV therapy. Conclusion This study suggests that it is not the clinical stage of HCV infection but the patient's demographic characteristics and co-morbid conditions that impact the decision to initiate HCV therapy. Copyright © 2005 John Wiley & Sons, Ltd.

To evaluate the association between a regimen of cyclosporine microemulsion (CsA) + sirolimus (Rapa) treatment versus CsA and mycophenolate mofetil (MMF) and renal allograft survival, we analyzed 23 016 primary recipients reported to the Scientific Registry of Transplant Recipients between January 1, 1998 and July 26, 2003. Univariate Kaplan-Meier analysis and multivariate Cox proportional hazard models correcting for demographic and clinical covariates were used to estimate the relative risks for CsA+Rapa versus CsA+MMF-treated patients reaching study endpoints. Subgroup analyses were conducted for recipient ethnicity and donor type. CsA+Rapa was associated with significantly lower graft survival (74.6% vs. 79.3% at 4 years, p = 0.002) and death-censored graft survival (83.7% vs. 87.2%, p = 0.003) compared to CsA+MMF. In multivariate analyses, CsA+Rapa was associated with a significantly increased risk for graft loss, death-censored graft loss and decline in renal function (HR = 1.22, p = 0.002; HR = 1.22, p = 0.018 and HR = 1.25, p < 0.001, respectively). Similar results were obtained in recipient ethnicity and donor type subgroups. In summary, CsA+Rapa was associated with significantly worse graft survival and death-censored graft survival compared to CsA+MMF, and likely reflects full-dose CsA +Rapa. Outcomes regarding alternative strategies of Rapa utilization with reduced CsA, with alternative agents or with no calcineurin inhibitor cannot be extrapolated from these data.

Background:Hepatitis C virus (HCV) infection is the most common blood-borne virus in the United States. Several mono- and combination therapies have been approved by the US Food and Drug Administration for the treatment of HCV, but their routes of administration, dosing approaches, eras of introduction, and actual use in clinical practice and resulting effectiveness have not yet been reported.Objectives:The aim of this article was to characterize clinical use and virologic response (VR) of the HCV treatments interferon alfa-2b plus ribavirin (IFN + RBV) and peginterferon alfa-2b plus ribavirin (peg-IFN + RBV).Methods:This retrospective chart review of office-based practices in theUnited States was conducted at 200 physicians' offices across the United States. We collected data concerning dosing patterns, VR (HCV RNA load, ≤1000 IU/mL or “negative” on polymerase chain reaction qualitative analysis), and adverse events (AEs) from the medical records of a geographically diverse sample of patients receiving treatment for chronic HCV infection in the United States from July 2001 to June 2002. For efficacy assessment, factors that were statistically different at baseline were adjusted using logistic regression. Providers also reviewed the medical records for symptoms or signs consistent with HCV treatment-related AEs.Results:Data from the records of 675 patients (423 men, 252 women; mean [SD] age of 45.5 [8.2] years; mean [SD] body weight, 80.8 [19.4] kg) were analyzed. At baseline, the IFN + RBV treatment group (330 patients) had significantly higher percentages of black patients (22.1% vs 15.7%; P = 0.032) and patients with hepatic disease based on clinician-reported cirrhosis and liver dysfunction (18.8% vs 9.9%; P < 0.001), and a significantly lower percentage of white patients (60.3% vs 69.6%; P = 0.012) compared with the peg-IFN + RBV treatment group (345 patients). The difference in log-transformed baseline HCV RNA loads between the 2 treatment groups in this study was