People who inject drugs adhere better to their hepatitis C virus (HCV) medication regimen if they receive directly observed treatment compared with being given therapy to take on their own, MedPage Today reports. That said, in a recent small trial, there was no difference in the hep C cure rate based on whether participants received either of these forms of hep C treatment.
Publishing their findings in the Annals of Internal medicine, researchers conducted a randomized controlled trial called PREVAIL between October 2014 and April 2017 at three medication-assisted treatment (MAT) programs in the Bronx in New York City.
The study’s eligibility requirements included being 18 years old or older, having genotype 1 of HCV, speaking English or Spanish and being willing to receive hep C treatment on-site at one of the MAT programs.
The researchers assessed adherence to the daily hep C regimens through the use of electronic blister packs.
A total of 158 people were enrolled in the study and randomized to one of three treatment groups. One hundred fifty of them were ultimately assigned into these study arms, including 51 into the directly observed treatment group, 48 into an arm in which they received treatment as a group and 51 into an arm in which they were provided with hep C treatment to take on their own.
The participants had an average age of 51 years old. More than half were male; more than half were Latino; more than half were unemployed; and more than half had genotype 1A. About two out of three of the participants reported using drugs during the previous six months and almost half used opioids or cocaine. Three quarters of the study members reported a history of injection drug use.
Overall, the participants took 78% of their assigned doses of hep C treatment on average. Those in the directly observed therapy group took an average of 86% of their doses, compared with 75% of those in the self-administered individual treatment group. This difference was statistically significant, meaning it is unlikely to have been driven by chance. However, those in the group-treatment arm had an average adherence rate of 80%, a rate that was not statistically significantly different from that of the self-administered treatment group.
Of those who started treatment for the virus, 97% finished therapy. There was no significant difference between the three study arms in the rate of treatment completion.
As a whole, 94% of the study members achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). There was no difference in the cure rate based on the study group or on other participant characteristics.
Noting that research has not clarified the optimal level of adherence to hep C treatment that best predicts whether someone will be cured, the study authors called for a larger study that might definitively conclude whether these three ways of delivering therapy for the virus truly differ in terms of cure outcomes.
To read the MedPage Today article, click here.
To read the study abstract, click here.