HCV Therapy in Methadone Maintenance
Reported by Jules Levin
"The Impact of Intervening Substance Abuse on Hepatitis C Treatment Outcomes
in Recovering Injection Drug Users: an interim analysis"
brief summary: ...a 28% viral response rate was seen in this study and
regular drug use during HCV therapy had a severe negative impact..32%
response rate was seen in patients who abstained from illicit drug use.
Diana Sylvestre from Oakland, CA presented an oral talk at the DDW conference
that was considered interesting and peaked the interest of the audience,
which included doctors from the NIH. She offered some background. There are 1
million heroin users in the US. 65-96% of them have HCV. 60% of the new and
existing cases of HCV are IVDUs, although I think this figure has increased
in recent years. 60-90% of IVDUs experience recidivism (go back to drug use)
without intervention such as with methadone maintenance. For IV drug users,
there are many barriers to treatment: distrust, psychiatric conditions,
psychosocial instability, reinfection.
The subject of reinfection was brought up at this talk as a key issue and
concern. Although this study has not reported on HCV reinfection following
HCV therapy, interest was expressed in studying the potential for reinfection.
Sylvestre briefly described OASIS, an HCV Program for IVDUs, which provides
"one-stop shopping": education, peer support, and medical monitoring. At
previous conferences she has described the OASIS Program and how it helps
support treatment for HCV-infected IVDUs.
She raised these questions that her study addresses:
--Can IVDUs be safely treated for HCV
--Does methadone affect HCV treatment
--How does length of drug sobriety impact upon HCV treatment outcomes in
methadone maintenance treatment (MMT)
--Does intervening alcohol use by MMT affect treatment outcomes
--Does illicit drug use by MMT during HCV treatment affect virologic outcomes
OASIS HCV patients:
--The majority are IVDUs in all stages of recovery, more than 50% are on MMT
--About 75% have active substance abuse issues
--OASIS has screened about 1000 patients to date: all with LFTs, most with
PCR and/or genotype
--Over 120 have been treated
--51% are male
--average 47 years of age
--57% caucasian, 27% African-American, 15% Latino
--average duration of infection approximated at 29 years using the first year
of needle use as a proxy (she said 65% of IVDUS get HCV-infection in the
first year of drug use
--61% have a psychiatric diagnosis, the vast majority with depression
The ongoing study of HCV treatment in MMT is being conducted at OASIS,
Gourevitch/Litwin, Bronx, NY; A Williams, Philadelphia, PA. Patients receive
IFN 3 MU 3x/week plus ribavirin 1000/1200 mg per day. Patients receive
standard monitoring and group participation is encouraged.
22% treatment dropout rate, which is similar to 20% rate seen in studies. The
end-of-treatment response rate was 54%, which is also similar to the 51%
response rate seen in studies. However, the sustained virologic response rate
was only 28% which is less than the 40% seen in studies. Sylvestre said about
64% of her patients have completed past the 6 month treatment period.
IMPACT OF ALCOHOL USE
She said most of her patients did not have alcohol use problem. Alcohol use
did not affect the SVR outcome very much as 25% was the SVR for alcohol users
compared to 29% (n=14) who did not use alcohol.
LENGTH OF PRETREATMENT DRUG SOBRIETY
Sylvestre found that any length of drug sobriety was protective of virologic
outcome. In other words, whether patients had 0-6 months sobriety or >1 year
the response to HCV therapy was similar. The only exception in this study was
that patients with no sobriety before HCV therapy had a lower response rate
IMPACT IF DRUG USE DURING HCV TREATMENT
These were patients on methadone maintenance, so the extreme use of heroin
was not such a problem. And the use of drugs, which was mostly heroin, did
not appear to affect the overall outcome very much as the response rate was
25% (n=20) compared to 29% for patients who did not use drugs during HCV
IMPACT OF THE QUANTITY OF DRUG USE
They divided drug use by category: rare (1-3 times drug use during HCV
treatment period); intermittent use (which was 1 time per week or less);
regular use which was every day or every other day).
28% was the overall SVR in this study (n=61)
32% (n=42) of patients with no drug use had an SVR
29% (n=7) with rare drug use had an SVR
20% (n=6) with intermittent use had an SVR
0% with regular use (n=7) had a SVR
IMPACT OF MARIJUANA USE ON HCV TREATMENT
15 patients smoked marijuana in any quantity during treatment, and they had a
71% end-of-treatment response rate and a 60% SVR. This compared to a 47% ETR
and 14% SVR (n=43) who did not smoke marijuana.
Sylvestre concluded that HCV treatment in MMT is safe, tolerable, and
reasonably effective. Drug sobriety of any length appears to be protective.
Alcohol and illicit drug use may have a modest negative impact on treatment
outcomes in MMT. Regular drug use has a substantial and negative effect on
HCV treatment outcomes. Although Sylvestre commented that she feels the use
of pegylated interferon may improve outcomes. Marijuana use appears to have a
significant positive impact on treatment outcome. Since the impact of alcohol
and non-regular drug use in these patients is modest, early and aggressive
intervention if drug relapse occurs may help preserve virologic outcomes and
may eliminate the need to discontinue HCV therapy.