There
are few data available on the number of people with choose to defer treatment
for chronic HCV infection, and even less on
their reasons for doing so. Researchers at Georgetown University Medical Center
in Washington, DC conducted a retrospective study to assess the size, characteristics
and the motivations of patients who decline treatment.
The
study was designed to determine the percentage of treatment-naive patients infected
with chronic hepatitis C virus who make an informed choice to defer treatment
with pegylated interferon regimens in
the absence of any medical, psychosocial, or other contraindications. In addition,
at least 1 year later a questionnaire was used to reassess the patients' decision
not to seek treatment.
The
investigators analyzed patient charts dating from 2001 for the following characteristics:
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, and estimated duration
of infection.
In
addition, the researchers assessed the reasons given by each patient for declining
pegylated interferon-based treatment at the time of their consultation.
Results
•
Of the 446 patient charts reviewed, 280 patients were treatment-naive and were
judged to have no contraindications to receiving interferon-based therapy.
•
115 (41%) opted to defer treatment and became the subject of this study.
•
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 number of African Americans
who declined therapy was higher than non-African Americans (48% vs 36%, respectively).
•
> 90%
of genotype 1 patients chose to be followed up.
•
37% of patients had normal peak ALT values and 40% had <2X upper limits of
normal (ULN).
•
Approximately 75% had >16 years estimated duration of chronic hepatitis C infection.
•
Intravenous
drug use was the most common source of infection, followed by transfusion-related
infection.
•
The two most frequently-expressed reasons for declining therapy in almost 66%
of patients were asymptomatic disease and concern about medication
(interferon and ribavirin) side effects; approximately 10% cited lack of health
insurance or support.
•
Only 4.3% of patients
gave doubts about efficacy as the primary reason for foregoing treatment.
•
The questionnaire survey
administered 12 months after the initial analysis showed that 79% of the patients
were satisfied with their decision to decline treatment, while 10.6% indicated
that they were "moderately satisfied" with their decision and unlikely
to change it in the near-term.
•
Only six patients (7%)
voiced current dissatisfaction with their original decision and requested a follow-up
discussion concerning treatment options.
•
Of
the remaining three patients (3.5%), two had already initiated therapy and one
died of non-liver-related causes.
Based
on these findings, the study authors concluded, "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)." They noted a higher
proportion of deferrals among African Americans than non-African Americans.
Further,
the authors emphasized that almost all the study participants had genotype 1 HCV
"with clinically and histologically mild hepatitis of reasonably long duration."
Finally,
the authors stated their questionnaire showed that most of these patients were
satisfied with the decision to defer therapy (at least one year after their initial
decision).
Of
note, the authors wrote in their conclusion, "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."
Division
of Gastroenterology, Hepatology Section, Georgetown University Medical Center,
Washington, DC, USA.
04-10-07
Reference
O S Khokhar and J H Lewis. Reasons Why Patients Infected with Chronic
Hepatitis C Virus Choose to Defer Treatment: Do They Alter Their Decision with
Time? Digestive Diseases
and Sciences .
[Epub ahead of print] March 15, 2007.
