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Exviera, Viekirax regimen yields high SVR in former injection drug users with HCV

In a phase 2 clinical trial, a regimen of Viekirax and Exviera plus ribavirin for 12 weeks was safe and effective for the treatment of hepatitis C virus infection in former injection drug users who were undergoing stable opioid replacement therapy, according to study data.

“This all-oral regimen may provide an effective alternative to interferon-based therapies for HCV-infected patients with a history of injection drug use,” the researchers wrote.

Researchers, including Jacob P. Lalezari, MD, of Quest Clinical Research in San Francisco, California, dosed 38 patients with Viekirax (ombitasvir/paritaprevir/ritonavir; 25 mg/150 mg/100 mg; AbbVie) once daily and Exviera (dasabuvir; 250 mg; AbbVie) twice daily plus weight-based ribavirin for 12 weeks. None of the patients had cirrhosis and were undergoing opioid replacement therapy with methadone (n = 19) or buprenorphine (n = 19) with or without naloxone.

Jacob P. Lalezari

The primary endpoint was sustained virologic response (SVR) 12 weeks post-treatment.

Overall, 97.4% of patients experienced SVR at 12 weeks after treatment ended (n = 37). In addition, all 37 patients achieved end of treatment response and SVR at 4 and 24 weeks post-treatment. None of the patients experienced viral breakthrough or relapse during or upon completion of therapy. Approximately 92% of patients experienced at least one adverse event, with the most common and frequent being nausea, fatigue and headache. One patient discontinued treatment due to serious adverse events unrelated to the study drug.

Pharmacokinetic analyses showed that neither methadone nor buprenorphine had a clinical, meaningful impact on any of the study drugs. “No dose adjustments of methadone or buprenorphine were required” during the course of the study, the researchers wrote.

“Given the burden of disease and pending availability of better tolerated and more efficacious regimens, greater efforts should be undertaken to screen, evaluate, and treat HCV-infected patients with a history of drug use,” the researchers concluded. – by Melinda Stevens

Disclosures: Lalezari reports receiving research support from AbbVie for the study. Please see the full study for a list of all other authors’ relevant financial disclosures.