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  DDW Liver Conference
San Francisco, May 19-22, 2002
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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.
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.
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 (18%; n=11).
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 therapy.
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
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.