The HCVguidelines.org
website does not yet include recommendations about one of the most
vexing questions facing people with hepatitis C and their providers: who
should start treatment and when? Given the difficulty and suboptimal
cure rates of interferon-based therapy, traditionally treatment has only
been recommended for people with hepatitis C who have progressive liver
disease, as determined by liver biopsy or non-invasive methods such as FibroScan.
With the advent of more effective and better-tolerated direct-acting
antivirals, many experts believe that more people are now eligible for
treatment. But given the rapid advances in the field, it is often
unclear whether to treat someone now with available drugs or to wait for
something better.
Many patients have been "warehoused" for the past
few years awaiting interferon-free therapy. The first such regimens are
now available for people who are unable or unwilling to use interferon,
but new and potentially better options are in the pipeline, including
Gilead Science's sofosbuvir/ledipasvir coformulation, Bristol-Myers Squibb's daclatasvir (a candidate for combination with sofosbuvir), and AbbVie's '3D' combination. The
panel is currently working on recommendations about which patients to
treat and when, as well as guidelines for managing acute hepatitis C
infection and monitoring during and after treatment.
One issue the panel
did not address is the cost of treatment. "The guidelines are not
designed to address cost, and we haven’t really taken that into full
consideration," said Jensen. "Our recommendations are based on what we
think is best for a patient who needs treatment at this time." In
countries with single-payer health systems like the United Kingdom,
however, cost is one of the factors taken into account.
European
advocates have expressed concern that patients may be required to start
with less effective and poorly tolerated interferon-based regimens due
to their lower cost.
"We're all really excited that for the first time
we have curative therapies for hepatitis C which are much more effective
than what we had before and much easier to tolerate," said Henry Masur
of the US National Institutes of Health. "This is really a revolution,
and it's very important that clinicians have access to guidance on how
to use these drugs as new trials are quickly done and as new information
becomes available."