New data has confirmed that a novel first-in-class treatment for hepatitis B, called NVR 3-778, is well-tolerated and can reduce levels of the virus’ genetic material in the body when combined with Pegylated Interferon after four weeks of treatment.
NVR 3-778 is a first-in-class HBV capsid assembly inhibitor which modulates the function of the core protein. This protein plays an essential role in viral replication and persistence of the virus.
Approximately 14 million people within the World Health Organization European region are chronically infected with hepatitis B. There are several medicines that are effective at suppressing the virus over many years, slowing down damage to the liver, and allowing the body to repair itself. However, it is unusual for these treatments to clear the virus permanently.
The international phase 1b study was conducted in 64 patients who had not previously received any treatment for hepatitis B. There were six dosing cohorts in the study: 100mg daily, 200mg daily, 400mg daily, 600mg twice a day, or 600mg twice a day combined with Pegylated Interferon, and finally Pegylated Interferon combined with placebo. Treatment was given for a total of 28 days.
The results have demonstrated that NVR 3-778 was well tolerated in all cohorts with no discontinuations. Most adverse events were mild and not attributed to the study drug. Dose-related reductions in HBV DNA were observed, the largest of which was in the NVR 3-778 and Pegylated Interferon combination ( 1.97 log IU/mL ).
Using NVR 3-778 alone, the HBV DNA reduction was 1.72 log10 in the 600 mg BID ( bis in die ) group, and in the Pegylated Interferon alone group the HBV DNA reduction was 1.06 log10.
Study results have also indicated early reductions in levels of HBeAg ( a sign that the virus is actively replicating in the body and that the infection is worse ) across all groups, which were greatest in the NVR 3-778 group. ( Xagena )
Source: The International Liver Congress, 2016