SAN FRANCISCO, Nov. 15, 2015 /PRNewswire/ -- Injection drug use is a major risk factor for transmission of hepatitis C virus (HCV). In May 2015, the Centers for Disease Control reported that acute HCV infection in three Appalachian states rose by 364 percent among people under 30 years old, and 73 percent of those asked had used intravenous drugs.
According to a presentation by Gregory Dore, MD, at the annual meeting of the American Association for the Study of Liver Diseases, very little data are available on interferon-free treatment of patients who have HCV and who use drugs. When asked why, Dr. Dore replied, "There has been concern that people who use illicit drugs will not be adherent with new HCV therapies or outcomes would be poorer in more marginalized populations."
For this placebo-controlled, randomized study, antiviral therapy using Grazoprevir and Elbasvir in an all-oral, once-daily, one-pill regimen was highly effective and well-tolerated. All patients had chronic HCV and were on opiate agonist therapy of either methadone or buprenorphine. Patients with cirrhosis and/or HIV were eligible, with 301 subjects randomized to immediately receive therapy (n=201) or placebo followed by active study therapy (n=100).
Researchers found that although 79 percent of those in the immediate therapy group used drugs during the 12 weeks of therapy, 99 percent of them completed the therapy and 95 percent achieved sustained virologic response (SVR). There were five subjects who developed HCV reinfection following treatment, and if considered as failures the SVR is 92%. There was also no significant difference in adverse events between the active and placebo groups.
While acknowledging that these data are preliminary, researchers concluded this therapy regimen is safe and highly effective and supports efforts to address to barriers to treatment for patients with HCV who use drugs. According to Dr. Dore, "The CO-STAR study is the first phase III evaluation of interferon-free and ribavirin-free therapy in a population on drug dependency treatment, most of whom had ongoing illicit drug use. The safety and high efficacy convincingly demonstrate the benefits of treating HCV within this population. Such evidence should enhance access to new HCV therapies, including removal of restrictions to access in many settings based on illicit drug use."
When asked about the significance of these results, Dr. Dore responded, "CO-STAR demonstrates that Elbasvir/Grazoprevir can successfully treat patients with chronic HCV infection on opiate agonist therapy who may also be using illicit drugs. There is high efficacy which shows that this patient population took their medication as prescribed. This study offers reassurance to providers who are concerned that patients who actively use illicit drugs will not be adherent to their chronic HCV treatment. This comprehensive study indicates that these patients could adhere to this once-daily, single-tablet regimen as much as patients who are not actively using illicit drugs."
"The CO-STAR study provides even more support for treating patients with chronic HCV infection on opiate agonist therapy, thus reducing individual-level disease burden in this population and providing potential reduction in HCV transmission," concluded Dr. Dore.
Abstract title: C-EDGE CO-STAR: efficacy of grazoprevir/elbasvir fixed dose combination for 12 weeks in HCV-infected persons who inject drugs on opioid agonist therapy
AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in San Francisco, CA, November 14-17, will bring together more than 9,000 researchers from 55 countries.
A pressroom will be available from November 13 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.
Press releases and all abstracts are available online at www.aasld.org.
Media Contact: Gregory Bologna
Press Room: November 13 – 17, 2015
Moscone West Convention Center, San Francisco, CA
Researcher: Gregory Dore, PhD, MPH
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SOURCE American Association for the Study of Liver Diseases (AASLD)