SAN FRANCISCO — When administered at 600 mg twice daily, NVR 3-778 successfully reduced HBV DNA serum levels in patients with chronic hepatitis B virus infection, according to a Late Breaker at The Liver Meeting 2015.
In a phase 1b clinical trial, researchers, including Man-Fung Yuen, MBBS, MD, PhD, chair and professor of gastroenterology and hepatology, The University of Hong Kong, and colleagues assessed the safety and efficacy of NVR 3-778 (Novira Therapeutics) in four dosing cohorts: 10 patients in two cohorts, eight patients in two other cohorts and two patients received placebo for 28 days. The first three cohorts of patients received 100, 200 or 400 mg of NVR 3-778 four times daily and the last cohort received 600 mg twice daily. By the end of the study, 36 patients had received active NVR 3-778 therapy.
Patients who received 200 mg and 400 mg of NVR 3-778 four times daily showed small decreases in HBV DNA after treatment. After tripling therapy to 1,200 mg, or 600 mg twice daily, the mean 28-day reduction in HBV DNA increased to 1.72 log10 IU/mL.
“The study is advancing to evaluation of a combination of NVR 3-778 and peg-interferon,” the researchers wrote. “A higher dose will be tested to define a maximal-effect dose for NVR 3-778, and a nucleotide combination regimen will be tested later.”
Overall, no patients discontinued treatment and all adverse events were mild and deemed unrelated to NVR 3-778. One patient who received 100 mg of NVB 3-778 four times daily developed a serious rash on hands and feet.
The researchers concluded: “When used alone or in combination with current HBV antivirals, NVR 3-778 may contribute substantial efficacy by unique Core-related mechanisms, toward a goal of increased durable response rates in HBV patients.”
Man-Fung Y, et al. Abstract LB-10. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.
Disclosures: Yuen reports no relevant financial disclosures. Please see the abstract for a full list of all other authors’ relevant financial disclosures.