This study was designed to determine the percentage of treatment-naïve patients infected with chronic hepatitis C virus who make an informed choice to forego (defer) treatment with pegylated interferon regimens in the absence of any medical, psychosocial, or other contraindications, and to reassess their decision by using a questionnaire at least 1 year later. Patient charts dating from 2001 were retrieved and retrospectively analyzed for the following data: patient age, gender, race, hepatitis C viral load, genotype, liver biopsy results, hepatic imaging results, peak alanine aminotransferase (ALT) levels, comorbid conditions, source of infection, estimated duration of infection, and reasons given by the patient for declining pegylated interferon-based treatment at the time of their consultation. A questionnaire survey sought to determine their satisfaction with their initial decision. Of 446 patient charts reviewed, 280 patients were treatment-naïve and were judged to have no contraindications to receiving interferon-based therapy. Of these, 115 (41%) opted to defer treatment and are the subject of this analysis. Women declining therapy outnumbered men by approximately 3 to 2. Middle-aged patients (45-55 years) were most likely to choose expectant therapy compared with older or younger individuals. The proportion of African American patients who deferred therapy (48%) was higher than non-African American patients (36.6%). More than 90% of the patients choosing to be followed were genotype 1. Peak ALT values were normal in 37% and<2X upper limits of normal (ULN) in another 40%. The estimated duration of chronic hepatitis C infection was >16 years in approximately three-quarters of individuals. The most common source of their infection was intravenous drug use followed by transfusion-related. The most common reason for opting not to receive treatment, given by nearly two-thirds of patients, was the asymptomatic nature of their infection coupled with their concern about side effects of the medications. Approximately 10% had unfavorable social situations, including a lack of support or health insurance, that precluded receiving therapy (despite the availability of indigent care programs offered by the pharmaceutical manufacturers). Only five patients (4.3%) cited doubts about efficacy as the main reason that they did not want to be treated. The questionnaire survey at 1 year found that 79% of the patients confirmed their ongoing satisfaction with their initial decision to decline treatment, and another 10.6% indicated that they were still "moderately satisfied" with their decision and unlikely to change it in the near-future. Only six patients (7%) voiced their current dissatisfaction with expectant management and expressed the desire to have a follow-up discussion about treatment options. Of the remaining three patients (3.5%), two had already started treatment and one was deceased (of non-liver-related causes). A significant proportion of patients infected with hepatitis C virus who are otherwise eligible for the...

Objective. To assess the degree of awareness of the American College of Rheumatology (ACR) guidelines and package insert information on the screening for and management of hepatitis B virus (HBV) infection by rheumatologists in patients receiving immunomodulation drug therapies. Method. A questionnaire survey was administered to a nationwide sample of 1,000 members of the ACR. Each participating physician answered questions regarding their awareness of the risk of HBV reactivation, familiarity with published guidelines regarding HBV reactivation, their decision process in screening patients for HBV, knowledge of antiviral treatments for HBV, personal experience with HBV reactivation, and preferred approach to prophylaxis and subsequent monitoring of those patients. Results. Responses were highly variable with regard to awareness, screening, and treatment options. The overall response rate was 15.3%. Of those surveyed, 7.4% had seen HBV reactivation. Depending on the agent, 19 -53% were aware of manufacturers' warnings for HBV reactivation within drug package inserts. Nearly three-quarters (72%) would screen for HBV reactivation regardless of the presence/absence of manufacturers' warnings. Only 69% reported performing universal screening prior to initiating therapy with biologic disease-modifying antirheumatic drugs. The majority (81%) would defer to a gastroenterologist/hepatologist to determine prophylactic therapy for HBV. Only 22% had managed patients who were given prophylaxis against HBV reactivation while receiving immunosuppressants. Conclusion. Based on this survey, improving education among rheumatologists regarding the risks of HBV reactivation and its prevention for patients receiving immunosuppressants seems warranted. More specific consensus guidelines are recommended to achieve universal screening as the standard of care in these patients, especially with the increasing prevalence of HBV infection estimated in the US.

Patients with inflammatory bowel disease (IBD) are at risk for hepatobiliary disease and toxicity, and the diagnosis of drug-induced liver disease in patients being treated for IBD can represent a clinical challenge. There are a number of disease states associated with IBD, which are primary sclerosing cholangitis, cholangiocarcinoma and autoimmune hepatitis. There is a wide spectrum of hepatic injury that can occur from the agents used to treat IBD, such as acute or chronic hepatic injury directly attributable to the drugs used to treat IBD (e.g. sulfasalazine, mesalamine, thiopurines, methotrexate, TNF antagonists, quinolone antibiotics); liver toxicity from drugs used to treat complications of immunomodulators and TNF antagonists (e.g. isoniazid for treatment of reactivation tuberculosis), and exacerbation of underlying chronic viral hepatitis with infliximab and other TNF antagonists. Thiopurines are also associated with the development of hepatic vascular lesions, such as nodular regenerative hyperplasia and peliosis hepatic. In addition, biologics can be associated with the reactivation of underlying chronic viral hepatitis, mandating universal screening prior to initiation of TNF-alpha antagonist therapy.

Background/Aims: The risk of chronic hepatitis B virus reactivation under the influence of chemotherapy or immunosuppression is being increasingly recognized. However, many oncologists either have not observed this complication or are not aware of current recommendations for hepatitis B prophylaxis. Our aims were to determine the awareness of the reactivation risk and to understand the screening and prevention practices among oncologists. Methods: A questionnaire survey was administered to oncologists in the Washington, D.C., area. Results: Responses from 131 practitioners to the 10 questions were received. Nearly 80% of respondents were aware of reactivation, but only 30% had seen a case and only 56% were aware of prophylactic therapy. Fourteen percent of oncologists screened all patients, whereas 86% screened selectively based on risk factors. Most (76%) would use prophylaxis in a patient with active hepatitis B virus, but only about half would treat chronic carriers or those with resolved infection. Regarding choice of prophylaxis, nearly half (48%) were unsure of which agent to use. Conclusions: Improving awareness of hepatitis B virus reactivation and antiviral prophylaxis in the oncology community seems warranted.

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