Patients who were treated for hepatitis C virus infection through an opiate addiction program overwhelmingly achieved SVR even though many of them injected drugs, according to researchers.
The results counter widely entrenched policies in the United States denying HCV treatment coverage to those who inject drugs on the presumption that they will not adhere to therapy. Studies have shown that injection drug use has driven the current HCV epidemic.
Alain H. Litwin, MD, hepatitis C treatment network lead and attending physician at Montefiore Health System, and professor of medicine in psychiatry at the Albert Einstein College of Medicine, presented the findings at the sixth International Symposium on Hepatitis Care in Substance Abusers in New York City.
“We actually found in rigorous fashion that drug use — whether it was prior to treatment, at baseline, right before treatment or during treatment — was not associated with adherence or cure,” Litwin told Infectious Disease News. “So, [drug use] is not a good reason to deny treatment.”
The study, dubbed PREVAIL, compared the effectiveness of three HCV care models among 158 patients enrolled in opiate agonist therapy (OAT) in the Bronx, New York City. Of those, 150 patients initiated treatment. Patients were randomly assigned to any one of the three models.
Fifty-one patients were assigned to directly observed treatment (DOT), whereby they took HCV medications in the presence of providers. Another 48 were assigned to group visits, in which they gathered with fellow patients as a means of support while also having access to providers for advice or to receive medication. The remaining 51 patients were assigned to treatment as usual (TAU), in which they would pick up medications on site and take them home to administer on their own.
The mean patient age was 51.2 years, according to the researchers, and 14% were coinfected with HIV, 65% had used illicit drugs within 6 months of treatment and 51% had positive urine screens for drugs at baseline.
In the DOT arm, 98% of patients achieved SVR12. Meanwhile, 94% of those who attended group visits and 90% of those in the TAU arm achieved SVR12.
According to the researchers, 96% of patients included in PREVAIL achieved end-of-treatment response, with no detectable HCV at the end of their treatment course, and 94% achieved SVR12.
The differences between arms were not significant, but the results could be significant in a larger study involving perhaps thousands of patients, Litwin said. The results also debunk an the unfounded assertion about treatment adherence among people who inject drugs, he said, adding that an HCV cure on the individual level can lead to wider benefits.
“What we’re showing is that on an individual basis, you can be cured,” Litwin explained. “But equally important, on a public health basis — and what others have shown in modeling studies — is that by treating these patients, not only are you helping the individual, but you’re decreasing the community viral loads and you’re decreasing ongoing transmission.” – by Joe Green
Disclosure: Litwin reports that he has served on advisory boards for Gilead Sciences and Merck, and has received research grants from both companies.