, Volume 52, Issue 5, pp 1168-1176
Date: 15 Mar 2007

Reasons Why Patients Infected with Chronic Hepatitis C Virus Choose to Defer Treatment: Do They Alter Their Decision with Time?

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Abstract

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 therapy opt to defer treatment (41% overall in our series, with African American patients deferring in a higher proportion than non-African American patients). Nearly all of our patients were genotype 1 with clinically and histologically mild hepatitis of reasonably long duration. Our questionnaire survey found that most remained satisfied with their decision to defer treatment at the present time. Few patients cited a perceived low rate of efficacy of pegylated interferon and ribavirin therapy as the principal reason that they chose not to initiate treatment.

Presented in part at the meeting of the American College of Gastroenterology, Honolulu, Hawaii, November 2005.