People with hepatitis C virus (HCV)
who are candidates for therapy with new all-oral regimens want information on
the potential harms and benefits, details of treatment regimens and also basic
information on HCV-related liver disease, US investigators report in the
journal Patient. Information priorities
included viral cure, long-term prognosis, side-effects and lifestyle changes
needed during therapy.
“The findings from this study demonstrate that
patients with HCV wish to consider a plethora of information to assist them to
make informed decisions about their HCV treatment options,” comment the
investigators. “The data derived from this study provide an in-depth
understanding of the most important informational needs of patients
contemplating HCV treatment…the findings have implications for clinical
practice, including patient-provider communication and patient information.”
effective, all oral HCV treatment combinations are now available. There are
limited data regarding the topics which people consider most important when
making decisions on the use of HCV treatment.
the University of North Carolina, Chapel Hill, therefore designed a study with
- the information categories that
people need to make informed decisions about treatment
- the importance of each
- which information categories had
the highest priority to reach a decision about therapy.
The study involved
two groups of people. The first listed all information topics they thought
would be important to reach a decision about therapy. The investigators grouped
their response into broad topics and subcategories. This group was recruited
between November 2013 and January 2014, coinciding with approval of two new
all-oral regimens, simprenavir/sofosbuvir and sofosbuvir/ribavirin. The second
group ranked the importance of the individual subcategories identified by the
first group. Recruitment of this group took place between February and March
2015, shortly after the approval of sofosbuvir/ledipsavir. None of the people
in either group were currently taking therapy.
A total of 45 people
were recruited to the first group. Their mean age was 45 years, 58% were male
and 60% had previous experience of HCV therapy. There were 57 people in group
two. Their mean age was 67 years, two-thirds were male and 79% had been
previously been treated for HCV.
needs identified by the first group fell into five broad categories:
- Harms of treatment, identified
by all 45 participants. Information needs in this category fell into five
subcategories: side-effects, impact on quality of life, cost of therapy,
worsening of HCV, and impact on wider health and other illnesses.
- Details of treatment regimen.
This was identified by 86% of individuals. There were three subcategories:
treatment protocol, such as length of therapy; information on specific medicines,
including how are they taken and potential interactions; lifestyle changes
after changing treatment, for instance changes in diet and use of alcohol.
- Benefits of treatment. This was
identified by approximately two-thirds of individuals. Subcategories included
viral cure, impact on long-term survival, potential improvements in other
health conditions and HCV symptoms and functioning.
- Basic information about HCV and
liver disease. Approximately half of individuals stated they required this
information in order to reach an informed decision about therapy.
Individuals in group
two considered the importance of 17 individual subcategories. They rated
16 of these categories as “extremely important” or “pretty important” to reach
a decision about treatment. Information on viral cure was rated as the most
important information need; information on support groups had the lowest
where more research was needed in order to provide information to people were
viral cure, followed by long-term survival, and side-effects of treatment. The
most important subcategories for which there was already a sufficient research
basis were liver disease, lifestyle change needed for treatment and information
about treatment protocols and individual medications.
“Knowing what treatment
issues matter most to patients is important for both patient education as well
as designing patient-centered studies,” conclude the authors. “Patient provider
communication should focus on what is currently known in the literature and
help to distill the advantages and disadvantages of each treatment option
relative to what is important to the individual patient. The findings from this
study also provide the foundation on which to develop future…studies to
evaluate treatment issues that have not been studied but which are salient to
patients contemplating their treatment options.”