During a recent major global trial, individuals receiving opioid-agonist therapy (OAT, such as methadone treatment) did well on hepatitis C virus (HCV) treatment, regardless of whether they were still injecting drugs. This finding, say the study’s authors, supports removing drug use as a restriction to receiving hep C treatment.
Publishing their findings in the Annals of Internal Medicine, researchers conducted a randomized, placebo-controlled, double-blind trial in Australia, Canada, France, Germany, Israel, the Netherlands, New Zealand, Norway, Spain, Taiwan, the United Kingdom and the United States. The study included 301 individuals with hep C genotypes 1, 4 or 6 who had not been treated for the virus before. The participants were in OAT programs and were at least 80 percent adherent to that treatment.
The immediate treatment group received Zepatier (elbasvir/grazoprevir) for 12 weeks. The deferred treatment group received a placebo for 12 weeks, no treatment for 4 weeks and then Zepatier on an open-label basis (meaning they knew they were receiving the active drug and not a placebo) for 12 weeks.
A total of 91.5 percent of the immediate treatment group achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 89.5 percent of the deferred group. Reported recreational drug use at the study’s outset did not affect individuals’ chance of achieving a hep C cure or their adherence to the HCV drug regimen.
Of the 18 people whose virus returned during the 24-week follow-up, six were probably reinfected. If the study had counted those reinfections as treatment successes, the cure rate in the immediate treatment group would have been 94 percent.
The study is limited by the fact that its findings may not be generalizable to injection drug users who are not receiving OAT. They also do not apply to those with genotype 3 of hep C.
The researchers concluded: “These results support the removal of drug use as a barrier to interferon-free HCV treatment for patients receiving OAT.”
To read a press release about the study, click here.
To read the study abstract, click here.