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The Impact of Intervening Substance Abuse on Hepatitis C Treatment Outcomes in Recovering Injection Drug Users: An Interim Analysis
Diana L. Sylvestre, Barry J. Clements, Oakland, CA

There are 1,000,000 heroin users in the United States mostly who use needles. Among IDU’s there is a 65-95% seroprevalence rate for hepatitis C. 60% of all the new cases of hepatitis C are among IDU’s. To date IDU’s have been excluded from the majority of trials for hepatitis C. In addition it has been reported that the recidivism rate among IDU’s that are not maintained on agonist methadone maintenance therapy is 80% in the first year and 90% by the end of the second year. Treating hepatitis C in active injection drug users (IDUs) is a controversial topic. Despite their high prevalence of HCV, there are little data on the impact of alcohol ingestion, length of sobriety, and intervening drug use on treatment outcomes with interferon/ribavirin combination therapy in this population.

To date over 1000 patients have been screened and 120 have initiated therapy. The results are available for fifty-seven recovering injection drug users enrolled in a methadone maintenance program treated with interferon/ribavirin combination therapy at standard dosing regimens. African Americans account for 27%, Latino 15% and Caucasians 57% of the total patients. The average age is 47 years and the patient population is comprised of 51% male who have been infected with HCV for approximately 29 years as determined by when injecting was initiated. Substance abuse behaviors were assessed by patient self-report as well as urine toxicology testing.

The overall end-of-treatment response rate (ETR) in this population was 54%, with a treatment discontinuation rate of 22%. Those who drank alcohol during treatment (n=12) exhibited a trend toward reduced treatment efficacy when compared with those who didn't (n=45), with ETRs of 67% and 42%, respectively (p=0.13). Although those with brief drug sobriety (<6 mo., n=9) appeared to have similar ETRs to those with more extended sobriety (n=37), 56% vs 62%, respectively, subjects without pretreatment drug sobriety (n=11) showed a trend toward a reduced ETR of 36% (p=0.15). Subjects who used injection drugs during treatment (n=17) showed a trend toward reduced ETRs when compared to nonusers (n=40), 62% vs 45% (p=0.11). However, when drug use was quantified, regular injection drug use (n=7) impacted dramatically upon treatment outcomes, with none of the daily injection drug users exhibiting a positive ETR (p=0.02). The impact of marijuana use was not associated with other drug use and did not impact adherence significantly. If during treatment patients felt like they were in withdrawal it was recommended that their methadone dose be increased. In fact, 42% of the patients had an increase of 10mg in their methadone therapy during treatment for hepatitis C. Of the patients that have completed 72 weeks of evaluation the overall SVR in this difficult to treat population is 28% compared to 41% as seen in the general HCV population. Keep in mind though that these results include all patients even those that were using drugs on a daily basis, none of which achieved an SVR so if patients are selected appropriately, better results can be anticipated.

Intervening alcohol use and lack of pretreatment drug sobriety appear to lead to modest reductions in hepatitis C treatment efficacy. However, regular injection drug use during treatment has a substantial negative impact upon HCV treatment outcomes. Further study is needed to more fully understand the impact of these behaviors on HCV treatment.


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