Patients on Methadone Maintenance Can Be Successfully Treated for Hepatitis C

By Liz Highleyman

Since many patients with hepatitis C virus infection have a history of injection drug use, effective therapies for this population are urgently needed.

At last month's Digestive Disease Week 2007 meeting, researchers presented data from a prospective, open-label study to determine whether directly-observed therapy (DOT) would enhance adherence compared with self-administration in patients on methadone maintenance therapy for opiate addiction.

In this multicenter pilot study, 48 patients in methadone maintenance programs who had not previously been treated for hepatitis C were randomly assigned to receive 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus ribavirin, either as DOT or as self-administered therapy. Patients with genotype 1 were treated for 48 weeks and received 1000-1200 mg/day weight-based doses of ribavirin, while those with genotypes 2 or 3 were treated for 24 weeks and received a fixed-dose of 800 mg/day ribavirin.

Participants in the DOT group were seen every week at methadone clinics, while the others were seen less often at the investigative sites. Subjects in the 2 groups were well matched for baseline characteristics including sex, age, race/ethnicity, HCV genotype, baseline serum HCV RNA, and body mass index (BMI).

Results

• The overall sustained virological response (SVR) rates were 54% in the DOT group and 29% in the self-administration group.

• Outcomes did not differ significantly by treatment group among genotype 1 patients.

• Among genotype 1 patients, SVR rates were 29% with DOT and 31% with self-administration.

• Among genotype 2 or 3 patients, however, the SVR rate was 90% in the DOT group, compared with just 25% in the self-administration group.

• In a stepwise logistic regression analysis accounting for various factors including sex, age (greater or less than 40 years), race/ethnicity (Caucasian vs other), BMI (greater or less than 27 kg/m2), genotype, baseline HCV RNA (greater or less than 800,000 IU/mL), and ALT (greater or less than 90 U/L), the only significant predictor of SVR was treatment type (DOT vs self-administration).

• Based on defined treatment stopping rules, 75% of all patients completed the prescribed length of therapy.

• 2 DOT and 3 self-administration patients withdrew early due to adverse events.

• 6 and 8 patients, respectively, withdrew for reasons not related to drug safety.

• The most common adverse events in both treatment groups were fatigue, nausea, depression, and headache.

Conclusion

"These findings suggest that peginterferon alfa-2a/ribavirin can be used safely and successfully to treat chronic hepatitis C patients on methadone maintenance," the investigators concluded. "Moreover, there may be a benefit of DOT in this challenging population."

University of Connecticut Health Center, Farmington, CT; University of Hawaii, Honolulu, HI; Good Samaritan Hospital, Downers Grove, IL; Beth Israel Medical Center, New York, NY; Veterans Affairs Medical Center, San Francisco, CA; Johns Hopkins University, Baltimore, MD; Roche Laboratories, Nutley, NJ.

06/12/07

Reference
HL Bonkovsky, A Tice, RG Yapp, and others. Efficacy and Safety of Peginterferon Alfa-2a/Ribavirin in Methadone Maintenance Patients: Randomized Comparison of Direct Observed Therapy and Self Administration. Digestive Disease Week 2007. Washington, DC. May 19-24, 2007. Abstract M1861.

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