FDA Issues Chronic Hepatitis B Virus Draft Guidance

Clinical trials of drugs for treatment of chronic hepatitis B viral infections may use multiple efficacy endpoints, the FDA said in new draft guidance released Nov. 1.

The endpoints can include the suppression of hepatitis B virus (HBV) DNA on-treatment, the agency said. Other endpoints could include suppression of HBV DNA for more than six months off-treatment after an initial therapy period and sustained suppression off-treatment with loss of HBV surface antigens.

Liver disease progression is an important endpoint, but assessing it can be challenging as the endpoints can occur infrequently until late in the course of chronic HBV progression. However, treatment effects on such endpoints often result in useful clinical data that could support expanding the indication or patient population, the agency said.