6 recent HBV reports: new vaccines on the horizon

As the global effort toward hepatitis infection elimination continues, companies and researchers have recently focused on hepatitis B vaccines and related risks.

Healio.com/Hepatology presents recent reports on HBV research and product development, including an FDA recommendation for a new HBV vaccine that can be administered over the span of a month, Janssen’s collaboration with Bavarian Nordic to develop HIV and HBV vaccines, and a report on the risk for vaccination failure in children born to mothers with HBV during gestation.

FDA recommends approval of new HBV vaccine for adults

FDA Vaccines and Related Biological Products Advisory Committee voted 12 to 1 to recommend approval of the new Heplisav-B vaccine for hepatitis B today.

“The safety and the data is reassuring; the company has addressed the issues,” Jay M. Portnoy, MD, from Children’s Mercy Hospital, Kansas City, Missouri, said during the meeting. “In my opinion, part of the safety includes the fact that it is extremely effective. It is safer to get the ... vaccine than it is to get hepatitis B.” Read more

Janssen joins Bavarian Nordic to develop HIV, HBV vaccines

Janssen Pharmaceuticals has announced that it is collaborating with Bavarian Nordic to develop vaccines for HIV and hepatitis B virus.

The worldwide exclusive license agreement aims to use Bavarian Nordic’s MVA-BN technology and Janssen’s AdVac and DNA-based vaccine technologies to develop the vaccines, according to a Janssen news release. Read more

Gilead announces continued focus on HBV, HCV, NASH

During an earnings conference call today, executives from Gilead Sciences disclosed second quarter earnings and projected pipeline goals with a focus on the company’s hepatitis B, hepatitis C and nonalcoholic steatohepatitis treatments.

Product sales for HIV and HBV as a combined market were $3.6 billion in the second quarter of 2017, compared with $3.1 in the same quarter of 2016. According to Robin Washington, company executive vice president and chief financial officer, the increase was primarily due to continued uptake of the company’s Vemlidy (tenofovir alafenamide)-based products. Overall sales increased 11% from the previous quarter. Read more

HBV while pregnant increases risk for HBV vaccination failure in newborns

Researchers observed a significant association between the presence of higher hepatitis B DNA at 28 to 30 weeks of gestation in pregnant women and immunoprophylaxis failure in newborns.

“The risk of vertical transmission leading to chronic infection is dramatically reduced by administering hepatitis B immunoglobulin (HBIG) to newborns at birth together with a complete course of HBV vaccination,” the researchers wrote. “A high maternal HBV DNA level during pregnancy is the strongest risk factor leading to immunoprophylaxis failure.” Read more

HCC risk increases in men with HBV, multiple metabolic risk factors

Men aged 40 to 65 years with chronic hepatitis B and a high burden of metabolic risk factors had increased risk for hepatocellular carcinoma, especially is they were smokers, according to a recently published study.

“If our findings are confirmed, then the results of this study suggest that a substantial fraction of HBV-related HCC cases, especially those with low viral loads, might be prevented by management of metabolic risk factors and cessation of smoking,” Ming-Whei Yu, PhD, from the National Taiwan University, and colleagues wrote. Read more

Sex dictates liver disease risk in hepatitis B

Men with hepatitis B are at increased risk for severe liver disease compared with women; however, lifestyle and environmental related exposures cannot explain the sex differences, suggesting biological causes, according to data published in PLoS One.

“Previous studies have observed that, among hepatitis B chronic infection patients, males are more likely than females to develop and die from [hepatocellular carcinoma],” Jing Sun, PhD, a post-doctoral fellow at Johns Hopkins University, and colleagues wrote. “Some have speculated that the gender discrepancy may be due to lifestyle-related differences, since previous epidemiologic studies have shown that lifestyle-related exposures (eg, alcohol consumption and smoking habits) increased the risk of hepatocellular carcinoma in hepatitis B infected patients.” Read more

As the global effort toward hepatitis infection elimination continues, companies and researchers have recently focused on hepatitis B vaccines and related risks.

Healio.com/Hepatology presents recent reports on HBV research and product development, including an FDA recommendation for a new HBV vaccine that can be administered over the span of a month, Janssen’s collaboration with Bavarian Nordic to develop HIV and HBV vaccines, and a report on the risk for vaccination failure in children born to mothers with HBV during gestation.

FDA recommends approval of new HBV vaccine for adults

FDA Vaccines and Related Biological Products Advisory Committee voted 12 to 1 to recommend approval of the new Heplisav-B vaccine for hepatitis B today.

“The safety and the data is reassuring; the company has addressed the issues,” Jay M. Portnoy, MD, from Children’s Mercy Hospital, Kansas City, Missouri, said during the meeting. “In my opinion, part of the safety includes the fact that it is extremely effective. It is safer to get the ... vaccine than it is to get hepatitis B.” Read more

Janssen joins Bavarian Nordic to develop HIV, HBV vaccines

Janssen Pharmaceuticals has announced that it is collaborating with Bavarian Nordic to develop vaccines for HIV and hepatitis B virus.

The worldwide exclusive license agreement aims to use Bavarian Nordic’s MVA-BN technology and Janssen’s AdVac and DNA-based vaccine technologies to develop the vaccines, according to a Janssen news release. Read more

Gilead announces continued focus on HBV, HCV, NASH

During an earnings conference call today, executives from Gilead Sciences disclosed second quarter earnings and projected pipeline goals with a focus on the company’s hepatitis B, hepatitis C and nonalcoholic steatohepatitis treatments.

Product sales for HIV and HBV as a combined market were $3.6 billion in the second quarter of 2017, compared with $3.1 in the same quarter of 2016. According to Robin Washington, company executive vice president and chief financial officer, the increase was primarily due to continued uptake of the company’s Vemlidy (tenofovir alafenamide)-based products. Overall sales increased 11% from the previous quarter. Read more

HBV while pregnant increases risk for HBV vaccination failure in newborns

Researchers observed a significant association between the presence of higher hepatitis B DNA at 28 to 30 weeks of gestation in pregnant women and immunoprophylaxis failure in newborns.

“The risk of vertical transmission leading to chronic infection is dramatically reduced by administering hepatitis B immunoglobulin (HBIG) to newborns at birth together with a complete course of HBV vaccination,” the researchers wrote. “A high maternal HBV DNA level during pregnancy is the strongest risk factor leading to immunoprophylaxis failure.” Read more

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HCC risk increases in men with HBV, multiple metabolic risk factors

Men aged 40 to 65 years with chronic hepatitis B and a high burden of metabolic risk factors had increased risk for hepatocellular carcinoma, especially is they were smokers, according to a recently published study.

“If our findings are confirmed, then the results of this study suggest that a substantial fraction of HBV-related HCC cases, especially those with low viral loads, might be prevented by management of metabolic risk factors and cessation of smoking,” Ming-Whei Yu, PhD, from the National Taiwan University, and colleagues wrote. Read more

Sex dictates liver disease risk in hepatitis B

Men with hepatitis B are at increased risk for severe liver disease compared with women; however, lifestyle and environmental related exposures cannot explain the sex differences, suggesting biological causes, according to data published in PLoS One.

“Previous studies have observed that, among hepatitis B chronic infection patients, males are more likely than females to develop and die from [hepatocellular carcinoma],” Jing Sun, PhD, a post-doctoral fellow at Johns Hopkins University, and colleagues wrote. “Some have speculated that the gender discrepancy may be due to lifestyle-related differences, since previous epidemiologic studies have shown that lifestyle-related exposures (eg, alcohol consumption and smoking habits) increased the risk of hepatocellular carcinoma in hepatitis B infected patients.” Read more

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