FDA Approves First Two-Dose Vaccine for Hepatitis B
Early this month, the U.S. Food and Drug Administration (FDA) approved Heplisav-B – a vaccine for preventing infections for all known subtypes of hepatitis B virus (HBV) in adults ages 18 and older. Heplisav-B, which was developed by Dynavax Technologies Corporation, is the first new HBV vaccine approved in the U.S. in more than 25 years. It is also the only two-dose HBV vaccine available for adults. The approval of Heplisav-B “provides an important new tool for reversing the unfortunate trend of increased acute hepatitis B infections in the U.S.,” noted Ryan Clary, the executive director of the National Viral Hepatitis Roundtable (NVHR).
Previously approved HBV vaccines have required three doses given over a six-month period for full protection against infection. However, nearly half of adults fail to complete the full three-dose series within one year. Heplisav-B’s compressed dosing schedule – two doses given over a one-month period – increase the likelihood that people will successfully complete the full vaccination series, according to NVHR.
Nine Countries Are on Course to Eliminate Hepatitis C by 2030
Nine countries – Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar – are now on track to eliminate hepatitis C (HCV) by 2030, according to a report from the Polaris Observatory presented at the 2017 World Hepatitis Summit in Sao Paolo, Brazil. Viral hepatitis kills more than one million people worldwide each year, and over 300 million people are chronically infected with hepatitis B (HBV) or HCV. However, thanks to the development of highly effective direct acting antivirals (DAAs) for treating HCV and the increasing rates of HBV treatment and vaccination coverage globally, elimination of viral hepatitis has become a real possibility, according to the World Hepatitis Alliance.
“What we are seeing is that some countries, especially those with a high burden, are making the elimination of viral hepatitis a priority and are looking at innovative ways to do it,” noted Home Razavi, director of the Center for Disease Analysis in Lafayette, Colorado. “However, it will be nearly impossible for most other countries to meet the World Health Organization targets [for HBV and HCV elimination] without a huge scale-up in political will and access to diagnostics and treatment.”
In other news from the Summit, researchers reported that approximately 52 million children (those under 19 years old) are currently living with viral hepatitis worldwide. Of this total, 4 million are living with HCV and 48 million are living with HBV. Just 21 countries account for about 80% of the total cases of pediatric HCV infections, with the highest prevalence rates generally in developing nations. “We must act and treat as many children as possible,” urged professor Manal El-Sayed of Ain Shams University in Cairo, Egypt.
“The economic and social benefit of early HCV treatment in children is substantial. This includes avoiding disease progression, removing social stigma and improving activity and school performance, and reducing fatigue. However, the fundamental principle is to avoid transmission by adopting ‘cure as prevention’ at an early age and before high risk behaviors emerge that enable transmission.”