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EACS 2011: People on Methadone Maintenance Can Be Successfully Treated for Hepatitis C

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Opiate users on methadone maintenance therapy can be successfully treated for chronic hepatitis C virus (HCV) infection and can achieve outcomes similar to those of patients not on methadone, according to data presented at the 13th European AIDS Conference (EACS 2011) this week in Belgrade.

Shared use of injection drug equipment is a major risk factor for both HIV and HCV infection; an estimated 30% of people with HIV also have HCV. Coinfection is associated with more rapid disease progression and poorer response to interferon-based therapy, but outcomes among drug users on opioid substitution therapy, including methadone maintenance, has not been well studied.

Some clinicians have been reluctant to treat active or former drug users -- largely due to concerns about poor adherence -- but current treatment guidelines state that drug use is not a contraindication and patients should be evaluated on an individual basis regardless of drug use history.

Karin Neukam from Hospital Universitario de Valme in Seville, Spain, and colleagues compared treatment response among hepatitis C patients -- largely injection drug users -- receiving or not receiving methadone maintenancetherapy.

This prospective cohort study included 214 chronic hepatitis C patients at a university hospital outpatient clinic in Seville who started treatment with pegylated interferon plus ribavirin between January 2003 and May 2010.

Just over one-third of participants (38%) were on methadone maintenance while 62% were not. A majority of people in both groups had a history of injection drug use, but not surprisingly, this was more likely among methadone recipients (84% vs 63%).

Most participants were men (88% in the methadone group, 77% in the non-methadone group) and the average age was about 42 years. Just over 25% in both arms were HIV positive. Methadone recipients were slightly less likely to have the favorable IL28B "CC" gene pattern and more likely to have cirrhosis, but were significantly less likely to have hard-to-treat HCV genotypes 1 or 4.

Results

  • Almost all participants in both study groups reported 80% or better adherence to hepatitis C therapy.
  • In an intention-to-treat analysis, rates of sustained virological response (SVR), or continued undetectable HCV RNA 24 weeks after completion of treatment, were similar in the methadone and non-methadone groups:

o      Overall: 48% in both groups;

o      Genotypes 1 or 4: 35% vs 42%, respectively;

o      Genotypes 2 or 3: 69% vs 65%, respectively.

  • The same pattern was seen in an on-treatment analysis:

o      Overall: 57% vs 59%, respectively;

o      Genotypes 1 or 4: 39% vs 48%, respectively;

o      Genotypes 2 or 3: 76% vs 71%, respectively.

  • People with HIV/HCV coinfection, high baseline HCV RNA, unfavorable IL28B gene pattern, and baseline cirrhosis were less likely to achieve sustained response.
  • Other factors including gender, history of injection drug use, depression, and ribavirin dose were not significantly associated with treatment response.
  • Other outcomes were also similar in the methadone and non-methadone groups:

o      Post-treatment relapse: 11% vs 12%, respectively;

o      Virological breakthrough: 1% in both groups;

o      Null response: 22% vs 21%, respectively;

o      Voluntary discontinuation: 12% vs 11%, respectively;

o      Adverse events: 5% vs 7%, respectively.

"The efficacy of HCV therapy in methadone maintenance therapy patients is similar to that found in subjects not taking methadone," the researchers concluded. "Methadone maintenance therapy patients should be equally considered for treatment with pegylated interferon plus ribavirin."

These findings indicate that methadone maintenance should not be considered a contraindication to hepatitis C treatment.

Session co-chair Stefan Mauss from Heinrich-Heine University in Duesseldorf said that this was a very important study, and Eastern Europe especially needs data like these to convince clinicians and others that hepatitis C patients on methadone can be successfully treated.

Investigator affiliations: Hospital Universitario de Valme, Unit of Infectious Diseases and Microbiology, Seville, Spain; Ambulatory Care Centre for Drug Addiction ANTARIS, Dos Hermanas, Spain; Centro Penitenciario Sevilla, Medical Services, Alcalá de Guadaira, Spain; Hospital Universitario de Valme, Unit of Investigation, Seville, Spain.

10/14/11

Reference

K Neukam, JA Mira, I Gilabert, et al. Methadone Maintenance Therapy Does Not Influence on the Outcome of Chronic Hepatitis C Treatment with Pegylated Interferon and Ribavirin. 13th European AIDS Conference (EACS 2011). Belgrade, October 12-15, 2011. Abstract PS7/5.