EASL: Sustained Virologic Response Equals Cure for HCV Infection
by Swain, M.
BARCELONA, Spain, April 12 -- Patients with hepatitis C virus infection who
achieve a sustained virologic response to therapy should be considered
cured, said investigators here today.
Only eight of 997 HCV patients who achieved the response later developed
reinfection with the disease, reported Mark Swain, M.D., of the University
of Calgary (Alberta), His research was selected as the opening paper of the
opening session of the European Association for the Study of the Liver
meeting. Action Points
Use the positive message of the study to reinforce adherence to hepatitis C
virus treatment regimens.
Note that prior studies show that two-thirds of patients on combination
therapy achieve sustained virologic responses.
These data were presented orally at a conference
and should be considered to be preliminary as they have not yet been
reviewed and published in a peer-reviewed publication.
In reviewing long-term outcomes from nine studies, Dr. Swain identified
patients who achieved a sustained virologic response after treatment with
pegylated interferon alpha-2a (40 kD) (Pegasys) as monotherapy or in
combination with ribavirin (Copegus).
"I tell my patients who have had a sustained virologic remission that they
can go home and get on with their lives and not to worry about hepatitis,"
Dr. Swain said. "I tell them that there is less than a 0.5 percent chance
that the disease will ever return."
The study included three trials in which patients were treated with
monotherapy and six trials in which the combination treatment was employed.
Dr. Swain said the combination therapy is now considered standard of care
and as many as 66% of patients infected with HCV who faithfully take their
antiviral medication -- usually for 48 weeks -- are able to achieve the
sustained virologic response.
Sustained virologic response was defined as an undetectable viral load in
the blood six months following cessation of treatment.
"Although the benefits of viral eradication have been well established, the
overall durability of a sustained virologic response is less well known,"
Dr. Swain said.
Of the patients who achieved a sustained virologic response, 163 who only
had HCV infections were treated with peginterferon alfa-2a monotherapy; 741
with peginterferon alfa-2a plus ribavirin combination therapy. Ninety-three
patients co-infected with HIV and HCV were treated with either monotherapy
or combination therapy.
"We found that a sustained virologic response is a sustained virologic
response whether it occurs in an immunosuppressed patient due to disease
such as HIV or who has undergone transplantation and requires
immunosuppressive drugs," Dr. Swain said.
There was no falloff in response. Of the eight patients who relapsed or were
re infected, just one patient in the combined hepatitis C-HIV group was
listed as a relapse. He also noted that only one of the eight cases involved
a patient who had taken a full course of treatment.
Dr. Swain said that because of the way the studies were conducted it will be
impossible to determine whether the patients relapsed or were re-infected.
In only one case did a patient's records contain viable virus for a DNA
comparison to be made. In that case, the patient appeared to become
re-infected with a different strain of HCV. "We are never going to know the
answer to whether these are relapses or re-infections," he said.
"This is a very important message," commented Xavier Forns, M.D., of the
Hospital Clinic, Barcelona, and a member of the program committee for the
conference. "This is a cure. We can cure people with this disease."
"We made this paper Abstract 1 because we thought this was a significant
finding that is important to our patients and to the clinicians."
Dr. Forns said, however, that a cure does not mean that re-infection can't
occur if they continue to have risky activities.
Primary source: Journal of Hepatology
Swain M, et al "Durable Sustained Virological Response After Treatment with
Peginterferon a-2a (PEGYSUS) or in Combination with ribavarin (COPEGUS):
5-Year Follow-UP and the Criteria of a Cure" Journal of Hepatology,
Supplement No 1, Volume 46, April 2006, page S3.