AbbVie’s “3D” hepatitis C virus (HCV) regimen is safe for use with opioid replacement therapy to treat drug addiction, MedPage Today reports. Researchers presented their findings of a small study of 38 people with genotype 1 of the virus at the 20th International AIDS Conference (AIDS 2014) in Melbourne, Australia.
The 3D regimen consists of a daily dose of the fixed-dose combination of the protease inhibitor ABT-450 and ritonavir coformulated with the NS5A inhibitor ombitasvir (ABT-267), as well as a twice-daily dose of the non-nucleoside polymerase inhibitor dasabuvir (ABT-333). In this study, the regimen was given with ribavirin. AbbVie applied for U.S. Food and Drug Administration approval of the 3D regimen in April. A decision is expected by the end of the year.
The study participants were taking either methadone or buprenorphine, with or without naloxone, to treat drug addiction.
After 12 weeks of therapy, all but one participant achieved a sustained virologic response 12 weeks after completing treatment (SVR12, considered a cure), for a response rate of 97.4 percent. The one uncured participant stopped treatment early after suffering a stroke, which was thought to be unrelated to the study drugs.
Most of the participants reported at least one adverse side effect from the 3D regimen, including nausea, fatigue and headache.
The hep C drugs did not appear to interfere with the opioid replacement therapies.
To read the MedPage Today story, click here.
To read the study report, click here.
AbbVie’s Hep C Regimen Is Safe With Opioid Replacement Therapy
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