7 recent reports on HBV treatment approvals, efficacy

Direct-acting antivirals have provided a highly viable cure for hepatitis C, but hepatitis B remains a complicated infectious disease and requires lengthy treatment and management in chronic cases. While HBV is vaccine-preventable, individuals who do contract HBV must be aware of its progression as it can lead to severe liver-related complications such as acute liver failure and may require liver transplantation.

The following reports provide recent findings on tenofovir treatment advocacy, premarket approval of an HBV assay, and the recent availability of the Heplisav-B vaccine in the U.S.

Combined tenofovir therapy reduces HBV antigens better than monotherapy

Combined pegylated-interferon alpha 2b with tenofovir therapy for hepatitis B was safe in patients positive for HBV e-antigen and resulted in a greater reduction of HBeAg and HBV surface antigen compared with tenofovir monotherapy, according to recently published data.

“Monotherapy with [pegylated-interferon alpha 2b] or tenofovir has limited efficacy in HBeAg positive chronic hepatitis B. Combination therapy with [pegylated-interferon alpha 2b] and tenofovir may improve serological response rates,” Ankur Jindal, MD, MBBS, from the Institute of Liver and Biliary Sciences, India, and colleagues wrote. “Viral load reduction followed by immune modulation is a potentially useful approach. This approach may reduce the relapse, increase off-treatment response and may therefore facilitate the discontinuation of [nucleos(t)ide analogues].” Read more

Model predicts progression to acute liver failure in chronic HBV

A new prediction model revealed that hepatitis B DNA, international normalized ratio and older age correlated with an increased risk for the development of acute-on-chronic liver failure in patients with acute exacerbation of chronic HBV.

“During the natural course of chronic HBV infection, most patients will experience hepatitis flares with various degrees of liver injury,” researchers from the department of infectious disease, Affiliated Hospital of Zunyi Medical Center, Guizhou, China, wrote. “Patients with [acute exacerbation] of chronic HBV infection are at risk of further deterioration and progression to hepatic decompensation and acute-on-chronic liver failure (ACLF).” Read more

Heplisav-B HBV vaccine for adults available in US

Dynavax announced in a recent press release its hepatitis B vaccine, Heplisav-B, is now available in the U.S.

“Dynavax is prepared and proud to launch our first product, Heplisav-B, in the United States,” Eddie Gray, CEO of Dynavax, said in the press release. “We believe the increase in the rate of infections and poor compliance with current three-shot regimens has the medical community eager for access to Heplisav-B for adults.” Read more

FDA grants premarket approval to HBV assay

Hologic Inc. announced today that the FDA has granted premarket approval to the company’s Aptima HBV Quant Assay.

The assay is designed to measure hepatitis B virus DNA across all major genotypes, according to a press release. It uses a dual-target approach for accurate quantification over a broad linear range (from 10 IC/mL to 1 billion IU/mL) and can tolerate various mutations in the HBV genome. Read more

Patients with HBV who discontinue tenofovir relapse sooner

Patients with chronic hepatitis B virus infection who discontinued the antiviral tenofovir faced a significantly earlier relapse compared with those who discontinued entecavir, researchers in Taiwan reported.

Jia-Horng Kao, MD, PhD, FAASLD, distinguished professor at National Taiwan University College of Medicine, and colleagues wrote that HBV often requires lifelong treatment, but nucleotide analogue therapies have raised growing renal and bone safety concerns, as well as concerns about lactic acidosis. Read more

Biologic non-TNF inhibitors increase HBV reactivation risk in rheumatic diseases

Patients with rheumatic diseases who have a history of hepatitis B virus and who are receiving treatment with non-TNF inhibitor biologic therapies are at risk for hepatitis B virus reactivation, and may need to be monitored, according to findings published in Clinical and Experimental Rheumatology.

“This was the first study to directly compare non-anti-TNF biologic agents, as a group, with anti-TNFs in terms of risk for HBV reactivation in patients with past HBV infection,” Antonis Fanouriakis, MD, of the University Hospital of Heraklion, in Greece, told Healio.com/Hepatology. “In patients with the latter, optional means of protection from HBV reactivation is not clear.” Read more

Tenofovir alafenamide effectively treats HBV, no virologic resistance

Treatment with tenofovir alafenamide was as effective in suppressing hepatitis B replication as tenofovir disoproxil fumarate with no virologic resistance, according to recently published data on two 96-week trials.

“Tenofovir alafenamide (TAF) is an orally bioavailable prodrug of tenofovir (TFV), a nucleotide analog that inhibits reverse transcription of HIV and HBV,” Kosh Agarwal, MD, from Kings College Hospital, United Kingdom, and colleagues wrote. “TAF was designed to have greater plasma stability than tenofovir disoproxil fumarate (TDF) allowing delivery of the active metabolite, tenofovir diphosphate, to hepatocytes more efficiently than TDF, which must be dosed at relatively high levels to achieve a therapeutic concentration in hepatic cells.” Read more

Direct-acting antivirals have provided a highly viable cure for hepatitis C, but hepatitis B remains a complicated infectious disease and requires lengthy treatment and management in chronic cases. While HBV is vaccine-preventable, individuals who do contract HBV must be aware of its progression as it can lead to severe liver-related complications such as acute liver failure and may require liver transplantation.

The following reports provide recent findings on tenofovir treatment advocacy, premarket approval of an HBV assay, and the recent availability of the Heplisav-B vaccine in the U.S.

Combined tenofovir therapy reduces HBV antigens better than monotherapy

Combined pegylated-interferon alpha 2b with tenofovir therapy for hepatitis B was safe in patients positive for HBV e-antigen and resulted in a greater reduction of HBeAg and HBV surface antigen compared with tenofovir monotherapy, according to recently published data.

“Monotherapy with [pegylated-interferon alpha 2b] or tenofovir has limited efficacy in HBeAg positive chronic hepatitis B. Combination therapy with [pegylated-interferon alpha 2b] and tenofovir may improve serological response rates,” Ankur Jindal, MD, MBBS, from the Institute of Liver and Biliary Sciences, India, and colleagues wrote. “Viral load reduction followed by immune modulation is a potentially useful approach. This approach may reduce the relapse, increase off-treatment response and may therefore facilitate the discontinuation of [nucleos(t)ide analogues].” Read more

Model predicts progression to acute liver failure in chronic HBV

A new prediction model revealed that hepatitis B DNA, international normalized ratio and older age correlated with an increased risk for the development of acute-on-chronic liver failure in patients with acute exacerbation of chronic HBV.

“During the natural course of chronic HBV infection, most patients will experience hepatitis flares with various degrees of liver injury,” researchers from the department of infectious disease, Affiliated Hospital of Zunyi Medical Center, Guizhou, China, wrote. “Patients with [acute exacerbation] of chronic HBV infection are at risk of further deterioration and progression to hepatic decompensation and acute-on-chronic liver failure (ACLF).” Read more

Heplisav-B HBV vaccine for adults available in US

Dynavax announced in a recent press release its hepatitis B vaccine, Heplisav-B, is now available in the U.S.

“Dynavax is prepared and proud to launch our first product, Heplisav-B, in the United States,” Eddie Gray, CEO of Dynavax, said in the press release. “We believe the increase in the rate of infections and poor compliance with current three-shot regimens has the medical community eager for access to Heplisav-B for adults.” Read more

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FDA grants premarket approval to HBV assay

Hologic Inc. announced today that the FDA has granted premarket approval to the company’s Aptima HBV Quant Assay.

The assay is designed to measure hepatitis B virus DNA across all major genotypes, according to a press release. It uses a dual-target approach for accurate quantification over a broad linear range (from 10 IC/mL to 1 billion IU/mL) and can tolerate various mutations in the HBV genome. Read more

Patients with HBV who discontinue tenofovir relapse sooner

Patients with chronic hepatitis B virus infection who discontinued the antiviral tenofovir faced a significantly earlier relapse compared with those who discontinued entecavir, researchers in Taiwan reported.

Jia-Horng Kao, MD, PhD, FAASLD, distinguished professor at National Taiwan University College of Medicine, and colleagues wrote that HBV often requires lifelong treatment, but nucleotide analogue therapies have raised growing renal and bone safety concerns, as well as concerns about lactic acidosis. Read more

Biologic non-TNF inhibitors increase HBV reactivation risk in rheumatic diseases

Patients with rheumatic diseases who have a history of hepatitis B virus and who are receiving treatment with non-TNF inhibitor biologic therapies are at risk for hepatitis B virus reactivation, and may need to be monitored, according to findings published in Clinical and Experimental Rheumatology.

“This was the first study to directly compare non-anti-TNF biologic agents, as a group, with anti-TNFs in terms of risk for HBV reactivation in patients with past HBV infection,” Antonis Fanouriakis, MD, of the University Hospital of Heraklion, in Greece, told Healio.com/Hepatology. “In patients with the latter, optional means of protection from HBV reactivation is not clear.” Read more

Tenofovir alafenamide effectively treats HBV, no virologic resistance

Treatment with tenofovir alafenamide was as effective in suppressing hepatitis B replication as tenofovir disoproxil fumarate with no virologic resistance, according to recently published data on two 96-week trials.

“Tenofovir alafenamide (TAF) is an orally bioavailable prodrug of tenofovir (TFV), a nucleotide analog that inhibits reverse transcription of HIV and HBV,” Kosh Agarwal, MD, from Kings College Hospital, United Kingdom, and colleagues wrote. “TAF was designed to have greater plasma stability than tenofovir disoproxil fumarate (TDF) allowing delivery of the active metabolite, tenofovir diphosphate, to hepatocytes more efficiently than TDF, which must be dosed at relatively high levels to achieve a therapeutic concentration in hepatic cells.” Read more

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