17 May 2011

German hep C study reports excellent results.

High rates of sustained virological response in hepatitis C virus-infected injection drug users receiving directly observed therapy with peginterferon alpha-2a (40KD) (PEGASYS) and once-daily ribavirin. Waizmann M, Ackermann G. Journal of Substance Abuse Treatment 2010 38:338-345

Dear Colleagues,

This report is more good news for those considering anti-viral treatment for hepatitis C from an opioid pharmacotherapy setting. The authors did a retrospective analysis of 49 opioid maintenance patients having anti-viral treatment for HCV infection over 3 year period. There were regular reviews of liver function tests, full blood counts and viral loads.

Out of 49 patients 48 obtained a sustained viral response (SVR). Side effects were modest and none required cessation or alteration of treatment schedules. Uniquely they gave treatment under supervision in the clinic on a daily basis with ribavirin given as single daily dose of 800mg (1200mg for genotypes 1/4) rather than the more usual twice daily regimen, given for 26 weeks (48 weeks for genotype 1/4). Furthermore, all patients were given antidepressant citalopram (Cipramil) 20mg daily starting 2 weeks before commencement of anti-viral drugs as a prophylactic regardless of whether they had clinical depression or not at the outset.

Study patients’ mean age was 30 years, 50% male; genotypes 1 (41%), 2 (4%), 3 (53%), 4 (2%). Subjects had to have been ‘stable’ for at least 3 of 6 months in opiate treatment. They were taking buprenorphine 0.6mg - 7.4mg or levo-methadone 10 - 50mg (equivalent to 20 - 100mg of the regular racemic methadone). They had been taking opiates for an average of 6 years and had HCV for an estimated 3.5 years. This makes it an earlier intervention than for most other series where opiate use/HCV were of substantially longer duration.

Their clinic in Leipzig typically treated a population of 125 patients on a daily basis including weekends. Doctors and counsellors were available on-site every day and a hotline was available to patients.

While the results seem extremely favourable, the authors cite another study with compliance rate of 100% and SVR rate of 94% from 17 HCV genotype 3-infected MMT patients treated with IF plus RBV, the former under observation and using psychosocial supports (Krook et al. Norway 2007).

These enviable results are also consistent with numerous studies showing improved results from directly observed treatment (DOT) in HIV anti-viral infection (see Sharkey 2011). There are also favourable reports in the treatment of tuberculosis, urinary tract infections, malaria and other conditions where adherence is crucial to success. Antabuse and naltrexone have also shown to be more effective with supervised dosing schedules, along with traditional methadone treatment.

We should all be encouraging our patients with HCV to consider assessment and treatment where appropriate. If these outcomes can be corroborated we should also probably consider the benefits of additional supervision of medication for better adherence as well as possibly once daily antivirals and antidepressants.

Comments by Andrew Byrne ..

Krook AL, Stokka D, Heger B, Nygaard E. Hepatitis C treatment of opioid dependants receiving maintenance treatment: Results of a Norwegian pilot study. 2007 European Addiction Research 13:216-221

Sharkey KM, Kurth ME, Anderson BJ, Corso RP, Millman RP, Stein MD. Directly observed antiretroviral therapy improves adherence and viral load in drug users attending methadone maintenance clinics: A randomized controlled trial. Drug Alc Depend 2011 114;2-3:245-248