Abstract
A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA, alanine aminotransferase (ALT), and hepatitis B e antigen (HBeAg). The data reveal that 33 of 66 NASVAC-recipient CHB patients became negative for HBV DNA in the blood two years after EOT. The ALT levels were within the upper limit of normal (ULN) in 37 patients, although all 66 CHB patients had elevated ALT (above ULN) before the start of therapy. Out of the total twelve HBeAg-positive patients, eight patients became negative for HBeAg. None of the patients developed cirrhosis of the liver within this period. NASVAC is a finite treatment regimen with sustained antiviral and liver-protecting properties. This study is the first to report follow-up data of immune therapy for CHB. NASVAC, an immune therapy of finite duration, is endowed with sustained antiviral and liver protection properties in CHB patients.
Highlights
Hepatitis B virus (HBV) infection is preventable by vaccination and other public health measures
The World Health Organization (WHO) estimates that as of 2019, approximately 296 million people worldwide are currently chronically infected with HBV, expressing HBV DNA and hepatitis B surface antigen (HBsAg) in the blood
After analyzing the design of different immune therapy regimens, we developed a new immune-modulatory drug by mixing HBsAg and hepatitis B core antigen (HBcAg) (NASVAC, Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba), and we systematically developed an immune therapy for chronic hepatitis B (CHB) patients
Summary
Hepatitis B virus (HBV) infection is preventable by vaccination and other public health measures. The World Health Organization (WHO) estimates that as of 2019, approximately 296 million people worldwide are currently chronically infected with HBV, expressing HBV DNA and hepatitis B surface antigen (HBsAg) in the blood. Among 296 million chronic HBV-infected subjects, approximately 12–25% exhibit considerable levels of liver damage (elevated alanine aminotransferase (ALT) levels) in addition to harboring HBV DNA and HBsAg, and these patients suffer from chronic hepatitis B (CHB) [2]. The estimated number of deaths due to HBV-related liver diseases increased from 786,000 in 2010 to 820,000 in 2019, even after developing a series of drugs with antiviral potentialities for treating CHB patients [2,4]. Most of the professional liver organizations of the world, such the American Association for the Study of Liver Diseases (AASLD) [5], the European Association for the Study of the Liver (EASL) [6], the Asia-Pacific Association for the Study of the Liver (APSL) [7], and other regional and national liver organizations, have recommended two types of drug therapy for treating CHB patients: interferon (standard and pegylated (Peg-IFN)) and nucleos(t)ide analogs (NUCs)
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