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Day 3, NIDA HCV & Substance Abuse Conference
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Reported by Jules Levin
November 14, 2003 Washington, DC
This 3 day conference has been an important meeting as it addresses a most pressing need in hepatitis C, a need receiving little attention. Clearly, we know that injection drug use and sharing paraphernalia is the leading cause of transmission for hepatitis C. This means that IDUs and their behaviors need attention if we are to address this problem of HCV in the US & worldwide. Unfortunately, HCV and in particular the problems related to substance users (past and current) and HCV are not addressed. About 80 people attended this meeting convened by NIDA (Natl Institute of Drug Abuse) and apparently cosponsored by several other Federal agencies: NIDDK, HRSA, NIAID.
I filed 2 reports following each of the first two days and they are attached below. Here is the report from the final day of the conference, Thursday. We heard several key presentations of model programs that have provided care and treatment to substance abusers. There are very few of these types of programs that directly provide HCV care and treatment to substance abusers, ie individuals who currently use injection drugs and people on Methadone Maintenance Programs. These programs exist on a hope and a prayer and little government funding. There are few of these programs when many are needed to adequately address the need. As well, these programs have limited funding and resources so are limited in the services they can offer. But these programs are pioneering this important work.
Diana Sylvestre, MD, is an important pioneer at the OASIS Clinic in Oakland, CA. She has been presenting data at liver conferences for 2 years on the results of her studies at this clinic that provides treatment for HCV to individuals on Methadone Maintenance. This is the latest update from her study which provides interesting insights. 76 patients on Methadone Maintenance received IFN/RBV. Patients at the OASIS Clinic receive intense support services including group support; intense support services is the key to success in treating HCV for substance abusers and for others. This is reported by other studies at this conference and from other anecdotal and published reports. The patients in this study at OASIS were an ill group. 59% had psychiatric illness. The methadone dose at start of study was 71 mg/day. 60% were genotype 1. Fibrosis stage was 2.5 (0-4). 26% were stage 4 or had platelet count <75,000. Patients had a long history of heroin use, I think she said 20 years on average. 42% used cocaine for median of 3 years.
RESULTS OF STUDY
20% drank alcohol during HCV treatment. 36% used hard drugs. 45% increased their methadone dose by an everage of 15 mg/day (0-180). Overall, 24% of patients dropped out of study. 15% of individuals with no negative predictive factors (outlined below) discontinued. The End-Of-Treatment Response was 49% had viral clearance. 55% of individuals with no negative predictive factors had an ETR. 28% of patients (n=76, ITT) had a sustained viral response (SVR). 40% of individuals with no negative predictive factors had an SVR.
Compared to the overall 28% SVR, 30% of patients with >6 months sobriety had SVR vs 22% with <6 months sobriety. (p=0.18). Sylvestre said this did not impact SVR in major way. .
HARD DRUG USE
Patients who did not use hard drugs, 34% had SVR vs 15% who used hard drugs (p=0.14). Again Sylvestre said hard drug use did not impact SVR in major way.
Sylvestre said drug quantity did impact outcome. Individuals who did not use drugs had 35% SVR vs 21% for occasional users vs 0% for regular users (p=0.09).
Marijuana appeared to affect outcome. Patients who smoked marijuana had 52% SVR vs 16% who did not. Adherence was significantly better for individuals who used marijuana. I think Sylvestre reported 87% adherence rate for individuals who used marijuana. The implication is that using marijuana may have been a substitute for using hard drugs, this is speculation.
Individuals with history of psychiatric illness had lower response rates: 22% for individuals with history of psych illness vs 35% for patients without such history, compared to 28% overall SVR.
ADHERENCE
Patients with >6 mos sobriety were more adherent (73%) vs 56% for individuals who were <6 mos sober, compared to overall 60% adherence for individuals with overall 28% SVR (adherence: 80/80/80-taking 80% of medications, 80% of the time), (p=0.19).
Individuals with regular drug use had 25% adherence rate (n=8) vs 73% for individuals who did not use drugs vs 73% for individuals who rarely used drugs vs 75% for individuals who used drugs intermittently.
Patients who received anti-depressants had better adherence, 77% vs 54% for those who did not receive antidepressants.
FACTORS CONTRIBUTING TO ADHERENCE
In order of significance
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| Anti-depressants |
0.01 |
| Length of sobriety |
0.04 |
| Marijuana use |
0.06 |
| Psychiatric illness |
0.08 |
| Drug use |
0.26 |
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DRUG USE RELAPSE
16% (9/57) had cravings to use drugs related to HCV treatment. 5% said it contributed to relapse. 26% used drugs due to HCV therapy. 7% used hard drugs due to HCV therapy.
This is a relatively small study but the findings taken together with reports at this conference and not at this conference from other clinics show rather convincingly that current drug users can and should receive HCV therapy, and be treated successfully. What is lacking is the funding to support programs like this which can provide an integrated network of the key services required to guide patients through the difficulty of HCV therapy. Sylvestre reported preliminary findings from an ongoing study she’s conducting using PegIFN/RBV. Patients on methadone maintenance had 35% SVR (9/26) compared to 54% (13/24) not on methadone maintenance. 15-17% discontinued. There was 1 death. There were regular drug users: 1 SVR (genotype 3), 2 relapsers (genotype 3 & 1). She is also conducting a Buprenorphine study where individuals who are street heroin users will receive 12-24 weeks of BUP buildup and will be treated for HCV.
I have to rush off to meeting now so I’ll finish my report later on the other studies reported at thisconference, which report on clinics treating substance abusers successfully at Miriam Hospital in Rhode Island (Brown University), Highland Park, Oakland, CA, Germany, Norway, Boston, Australia, and at a large Methadone Maintenance Program at Montefiore Hospital in the Bronx, NY. Clearly, these researchers are pioneering a pressing new and important area in hepatitis C care and treatment. |
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