“A corporate press release that contains no data has set the hepatitis B research field abuzz. On Wednesday, GSK announced its candidate drug bepirovirsen—bepi for short—has shown positive results against the disease in two pivotal phase 3 efficacy trials, and the company will soon ask drug regulators to greenlight it…

An estimated 300 million people in the world live with chronic hepatitis B virus (HBV) infections, which can eventually lead to cirrhosis, liver cancer, and other maladies that together kill more than 1 million people annually. Removing the virus from the body—known as a ‘sterilizing cure’—presents a staggering challenge because, like HIV, HBV integrates its DNA into our genomes. It also has an unusual genetic form called cccDNA that forms miniature chromosomes inside the nucleus of cells that no current drugs directly attack…

GSK’s two placebo-controlled, phase 3 trials together enrolled 1800 people in 29 countries who were taking existing HBV drugs. The treatment groups received bepi and the other drugs for either 24 or 48 weeks, whereas control groups took only the approved drugs. Then all participants stopped taking HBV medicines. Although the GSK press release provided no data, it said the trials ‘demonstrated a statistically significant and clinically meaningful functional cure rate’ and that ‘global regulatory filings’ are planned before April.”

From Science.