Bilive is the first, and currently the only combined inactivated hepatitis A and B vaccine developed by Chinese scientists. The R&D and clinical trial period for Bilive was completed in only four years (1999 to 2003). The China State Food and Drug Administration (China SFDA) issued a production license in January 2005.
Similar to hepatitis A, hepatitis B is endemic in China, a major disease worldwide and a serious global public health issue. A substantial percentage of people infected with the hepatitis B virus carry chronic or lifelong infections. The chronically infected are at high risk of death from cirrhosis of the liver or liver cancer. Sinovac is one of the only two manufacturers in China that produce a combined inactivated hepatitis A and B vaccine. Sinovac’s market share in China, according to National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) lot release records, increased to 94.4% in 2009 from 43.9% in 2007.
Bilive vaccine has only one directly competing product in the world, GlaxoSmithKline’s Twinrix®. Only the adult dosage of Twinrx is registered with the China SFDA. Furthermore, it is very expensive with only a few thousand doses have been sold in China followings its launch into the market.
Bilive is a combination vaccine formulated with purified inactivated hepatitis A virus antigen, which Sinovac manufactures, and recombinant (yeast) hepatitis B surface antigen, which is sourced from a third-party supplier. Bilive induces the body's immune system to generate antibodies as a reaction against hepatitis A and hepatitis B viruses.
Bilive® junior is suitable for use in non-immune infants, children and adolescents from one year up to and including 15 years old who are at risk of Hepatitis A and Hepatitis B infection.
Bilive® adult is suitable for use in non-immune adults and adolescents 16 years of age and older, who are at risk of Hepatitis A and Hepatitis B infection.
Bilive can be recommended for persons who remain in the vicinity of HAV and/or HBV, users of illicit intravenous drugs, homosexuals and bisexuals, hemophiliacs who receive therapeutic blood products, persons with nephropathy who receive dialysis treatment, and those persons who receive long term blood dialysis.
The standard, primary Bilive vaccination schedule consists of three doses. The second dose is administered one month after the first, and the third dose six months after the first. After three shots, there is no need to receive a booster.
Side Effect Profile
Side effects associated with Bilive are rare and of low intensity. The most common reactions are those at the site of injection, which included transient pain, redness and swelling. Systemic adverse events seen were fever, headache, fatigue, nausea and vomiting. These events were transient, only rarely reported and were considered by the subjects as mild.