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Liz Highleyman
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In This Issue: Hepatitis C
Quality of Life
Patient-Physician Communication
New Hepatitis C Guidelines
Quality
of Life
Quality of life is a crucial issue for people with chronic
hepatitis C. While combination therapy can slow HCV replication
and improve liver health, individuals are understandably concerned
about how treatment and its side effects will affect their
everyday life. In addition, decreased quality of life can
contribute to poor adherence and early discontinuation of
treatment.
In the April 2004 issue of the Journal
of Hepatology, Tarek Hassanein and colleagues report
on the impact of different types of HCV therapy on health-related
quality of life. In this study 1,121 patients with chronic
hepatitis C were randomly assigned to receive pegylated interferon
(Pegasys) monotherapy, Pegasys plus ribavirin or placebo,
or conventional interferon plus ribavirin. To assess health-related
quality of life, the researchers used two surveys, the SF-36
Health Survey and the Fatigue Severity Scale, which measure
factors such as physical functioning, bodily pain, social
functioning, mental health, vitality, and fatigue. Patients
receiving Pegasys plus ribavirin had better quality of life
score—including less fatigue, more energy, and less
pain—than those taking conventional interferon plus
ribavirin, especially during the first two weeks. These results
are consistent with past research suggesting that Pegasys
is associated with fewer flu-like symptoms and less depression
than conventional interferon.
In a related report in the March 2004 issue
of the Journal of Viral Hepatitis, R. Perrillo and
colleagues looked at quality of life, work productivity, and
use of medical resources in patients receiving HCV therapy.
In this study 412 patients were randomly assigned to receive
Pegasys monotherapy or conventional interferon plus ribavirin.
These researchers also used the SF36 scale, along with the
Hepatitis Quality of Life Questionnaire. They found that patients
receiving Pegasys had less impaired quality of life than those
taking conventional interferon, especially during the first
24 weeks. The Pegasys group had better work functioning and
productivity, improved ability to perform other activities,
better adherence, and less need for adjunct medications to
manage adverse side effects. Unlike Hassanein’s study,
this one did not include a Pegasys plus ribavirin arm, and
thus did not test whether adding ribavirin led to more impairment
than Pegasys alone.
Patient-Physician
Communication
Unfortunately, according to a study by Susan Zickmund and
colleagues in the April 2004 issue of Hepatology,
many hepatitis C patients report conflicts or problems communicating
with their physicians. This study included 322 participants
with chronic HCV seen at a hospital hepatology clinic in Iowa.
Subjects completed a 24-question interview, the Sickness Impact
Profile, and the Hospital Anxiety Depression scale. Forty-one
percent reported some type of negative interaction with their
doctor(s). The main problems were perceived poor communication
skills on the part of physicians (reported by 28% of patients),
a belief that physicians were incompetent in diagnosing or
treating hepatitis C (23%), feelings of being “misdiagnosed,
misled, or abandoned” (16%), and perceived stigmatization
by physicians (e.g., being considered sexually promiscuous
or a drug abuser) (9%). Many patients reported feeling rushed,
being treated unkindly, not being listened to, or feeling
misunderstood. Some felt physicians dismissed their physical
complaints as psychological. Interestingly, patients were
twice as likely to report difficulties with specialists (such
as gastroenterologists and infectious disease specialists)
compared with general practitioners, even though specialists
would be expected to have more competence in diagnosing and
treating hepatitis C.
In a multivariate analysis, “psycho-social
problems” were the best predictors of communication
difficulties. These included depression, anxiety, poor coping
skills, pessimistic outlook, lack of social support, feelings
of isolation, interpersonal problems with family or coworkers,
perceived lack of control, and lower quality of life. However,
diagnosed psychiatric illness and past or present substance
use were not associated with a higher likelihood of patient-physician
conflict. In this study conflict was associated with lack
of response to therapy, although the direction of cause and
effect was not clear.
In an accompanying editorial, Robert Fontana
and Ziad Kronfol noted that patients and physicians alike
may experience “frustration with the lack of safe and
effective treatment options,” and be unaware of recent
improvements in HCV therapy. But, the authors emphasize, “Patients
who feel their needs and concerns are being addressed are
more likely to comply with prescribed treatments and experience
improved health outcomes.” They suggested that physicians
should provide additional time for questions, engage patients
in decision making, provide up-to-date educational materials,
and encourage patients to participate in support groups.
New Hepatitis
C Guidelines
Finally, new practice guidelines from the American Association
for the Study of Liver Diseases (AASLD) for the diagnosis,
management, and treatment of hepatitis C were published in
the April 2004 issue of Hepatology. The recommendations
are based on a review of worldwide medical literature, existing
guidelines from other groups and agencies (such as the Centers
for Disease Control and Prevention), and the experience of
recognized experts. The guidelines cover issues such as who
should be tested for hepatitis C (people with risk factors,
including anyone who has ever injected drugs) and the utility
of liver biopsy (laboratory markers of fibrosis are “currently
insufficiently accurate” and biopsy “remains the
only means of defining the severity of damage from HCV infection
in many patients”). Pegylated interferon is recommended
as the “treatment of choice,” with no distinction
made between Pegasys and Peg-Intron.
The guidelines also include discussion
about managing hepatitis C in several special populations,
including previous non-responders and relapsers (retreatment
is recommended for those previously treated with conventional
interferon); patients with persistently normal ALT (treatment
decisions should not be based solely on ALT level); children
(those over age 3 may be treated with conventional interferon
plus ribavirin, but pegylated interferon is not yet approved);
individuals coinfected with HIV (should be carefully monitored
for side effects and drug interactions); people with kidney
disease (should not receive ribavirin); patients with decompensated
cirrhosis and transplant recipients (both should be managed
by experienced practitioners); individuals with acute HCV
(no definitive recommendations can be made, but it seems reasonable
to delay treatment for 2-4 months to allow for spontaneous
HCV clearance); and active drug users or those on methadone
maintenance (treatment should not be withheld).
In summary, these guidelines do not include
any drastic departures in standards of care, but they reflect
the latest refinements in testing, diagnosis, and therapy
suggested by the most recent clinical studies.
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