Opiate users on methadone maintenance therapy can be
successfully treated for chronic hepatitis C and can achieve outcomes similar
to those of people not on methadone, according to data presented at the 13th
European AIDS Conference last week in Belgrade.
Shared use of injection drug equipment is a major risk
factor for both HIV and hepatitis C virus (HCV) infection; an estimated 30% of
people with HIV also have hepatitis C. But some clinicians have been reluctant to
treat active or former drug users for hepatitis C, largely due to concern about
suboptimal adherence and poor outcomes.
Karin Neukam
from Hospital Universitario de Valme in Seville, Spain,
and colleagues compared treatment response amongst 214 hepatitis C patients - a majority of them injection drug
users - who started treatment with pegylated
interferon plus ribavirin between January 2003 and May 2010. Just over
one-third of participants (38%) were on methadone
maintenance whilst 62% were not.
Glossary
- IL28B
An inherited gene which all individuals have. There are three genotypes of IL28B; these influence response to hepatitis C and its treatment. People with CC genotype are more likely to spontaneously clear acute infection or (during chronic infection) respond well to interferon-based treatment. The other two genotypes are known as CT and TT.
- sustained virological response (SVR)
Undetectable hepatitis C RNA after treatment has come to an end. Usually SVR refers to RNA remaining undetectable for 24 weeks (six months) after ending treatment and is considered to be a cure. SVR4 and SVR12 refer to RNA remaining undetectable for 4 and 12 weeks respectively.
Most
participants were men (88% in the methadone group, 77% in the non-methadone
group) and the average age was about 42 years. About 25% in both arms were
HIV-positive. Methadone recipients were slightly less likely to have the
favourable IL28B "CC" gene pattern and more likely to have liver
cirrhosis, but were significantly less likely to have hard-to-treat hepatitis C
genotypes 1 or 4.
Almost all
participants in both study groups reported 80% or better adherence to hepatitis
C therapy. Rates of sustained virological response (SVR) - or continued undetectable HCV
viral load 24 weeks after completion of treatment - were similar in the methadone and non-methadone
groups.
In an
intention-to-treat analysis, the overall SVR rate was 48% in both groups. Amongst people with the more difficult-to-treat HCV
genotypes 1 or 4, 35% of methadone recipients and 42% of non-methadone patients
achieved SVR. Amongst people with easier-to-treat genotypes 2 or 3, the
corresponding rates were 69% and 65%. Neither difference was statistically
significant. The same pattern was seen in an on-treatment analysis, with
overall SVR rates of 57% and 59%, respectively.
Participants with HIV/HCV coinfection,
high baseline HCV viral load, unfavourable IL28B gene pattern and cirrhosis at
study entry were less likely to achieve sustained response. Other
factors including gender, history of injection drug use, depression and
ribavirin dose were not significantly associated with treatment response.
Other outcomes in addition to sustained
response were also similar in the methadone and non-methadone groups:
post-treatment relapse (11% vs 12%, respectively), virological breakthrough (1%
in both groups), null response (22% vs 21%, respectively) and treatment
discontinuation due to adverse events (5% vs 7%, respectively).
"The efficacy of HCV therapy in methadone maintenance therapy patients is
similar to that found in subjects not taking methadone," the researchers
concluded. "Methadone maintenance therapy patients should be equally
considered for treatment with pegylated interferon plus ribavirin."
These
findings indicate that methadone maintenance should not be considered a
contraindication to hepatitis C treatment. Session
moderator Stefan Mauss from Heinrich-Heine University said data like
these are especially needed in Eastern Europe
to convince clinicians and others that hepatitis C in patients on
methadone can be successfully treated.