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New study results show that people with chronic HCV who inject drugs and are on opioid agonist therapy respond well to an investigational therapy.
Despite the fact that injection drug use is the most common risk factor for hepatitis C infection, limited research has been done in this population.
However, new research recently presented during the American Association for the Study of Liver Disease’s President’s Press Conference at The Liver Meeting, shows that treating hepatitis C in this complex demographic can be effective, and patients in this trial showed high adherence to their HCV treatment.
C-EDGE CO-STAR, a phase 3 randomized, double-blind, placebo-controlled study, evaluated treatment with elbasvir/grazoprevir in patients with chronic HCV GT 1, 4 or 6 infection who were on opioid agonist therapy, such as methadone or buprenorphine.
The study showed that these patients not only respond well to treatment with investigational elbasvir/grazoprevir, but also have a high adherence rate (97%)-even though some continued to use illicit drugs during the trial.
“Injection drug use is the most common risk factor for hepatitis C and new research. This is an important finding that can help reveal ways to treat this often overlooked patient population that can be a major driver of the hepatitis C crisis,” says Eliav Barr, MD, vice president of infectious diseases at Merck.
The study randomly assigned 301 patients to one of two study arms. The first was an immediate treatment group (ITG) that received elbasvir/grazoprevir (blinded) for 12 weeks (n=201). The second was a deferred treatment group that received 12 weeks of placebo (control arm) followed by a four-week follow-up period and then elbasvir/grazoprevir (open-label) for 12 weeks (n=100).
There were no restrictions on concomitant use of drugs with abuse potential (e.g., heroin, cocaine, marijuana).
“The C-EDGE CO-STAR efficacy and patient adherence data suggests that patients on opioid agonist therapy-even if they continue to use illicit drugs-can complete therapy and achieve high rates of efficacy with an acceptable safety profile,” Barr says.