History of Whooping Cough: Outbreaks and Vaccine Timeline

Barinthus Bio Shares Ongoing Phase IIb Chronic Hepatitis B Trial Results

Barinthus Biotherapeutics has shared its most significant recent data from the ongoing Phase IIb HBV003 clinical trial for chronic hepatitis B.

The newest data was cut off on 30 September (for lab data) and 8 October (for clinical data). Eight participants were reported to have complete hepatitis B surface antigen (HBsAg) loss – defined as HBsAg levels below the lower limit of quantitation (<LLOQ, 0.05IU/mL).

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Two participants also met the criteria for functional cure, meaning that results demonstrated sustained HBsAg loss and hepatitis B virus DNA <LLOQ for six months off-treatment.

Two of the eight participants with HBsAg loss became positive for anti-hepatitis B antibodies (HBsAb) that they did not have before. This included one of the individuals who met functional cure criteria.

The HBV003 study contains 121 participants, 69 of whom entered the trial with HBsAg levels below 200IU/mL. The trial is ongoing, but current data indicates that stronger responses may occur in chronic hepatitis B patients treated with the combination of VTP-300 and a low dose of the anti-PD1 antibody nivolumab (groups 1 and 2).

Preliminary safety data also indicated that VTP-300 in combination with low-dose nivolumab was generally well tolerated. No treatment-related serious adverse events had been observed or reported as of the data cut-off.

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The data will be presented at the American Association for the Study of Liver Diseases (AASLD)'s 2024 liver meeting later today by Dr Chun-Jen Li, investigator on the Phase IIb HBV003 and director of the Hepatitis Research Center and Clinical Trial Center at the National Taiwan University Hospital.

NUC discontinuation in the trial

A total of 40 participants were assessed for nucleos(t)ide analogue (NUC) discontinuation. These were chronic hepatitis B patients with HBsAg below 200IU/mL at screening, who had reached day 169 of the trial. Of the 40 assessed participants, 24 were eligible for NUC discontinuation. Eight of these were the aforementioned participants who achieved HBsAg loss at any time. Two of these participants achieved it after day 169.

Of the 24 eligible, nine participants chose to discontinue NUCs. Of these nine, six remained off NUC therapy, and five remained off NUC therapy for over six months. Two of the six have met the criteria for functional cure, while two of the six seroconverted to HBsAb positivity.

The most recent results also demonstrated durable HBsAg declines across all treatment groups, consistent with data previously presented at the European Association for the Study of the Liver (EASL) Congress, in June 2024.

"Sustained HBsAg loss has proven to be the largest hurdle in getting chronic hepatitis B patients to functional cure," said Dr Liu. "The data we are seeing with VTP-300 is unique because they indicate a durable loss of HBsAg in participants, including two who met the criteria for functional cure. Although the study is still ongoing, these early data may bring us a step closer to potentially allowing some patients with chronic hepatitis B to come off antiviral treatment without their chronic hepatitis B progressing."

Chronic hepatitis B worldwide

Over 250 million people have chronic hepatitis B worldwide, according to World Health Organisation (WHO) guidelines issued earlier this year.

In a briefing issued at the time, GlobalData's senior epidemiologist Molly Moran explained that the high infection and death rates were "driven by mother-to-child transmission or infection shortly after birth through infected body fluids".

She commented: "There has been progress to reduce this mode of transmission, including timely universal infant HBV vaccination, which is nearly 100% effective against this virus. Immunisation coverage, however, is only 45% globally, with notably poor coverage in the WHO Africa Region, where only 20% of infants receive immunisation.

"Treatment for chronic hepatitis B infection by antivirals is very effective and improves survival and reduces progression of liver disease and subsequent development of liver cancer."

According to data provided by GlobalData epidemiologists in April 2024, diagnosed prevalent cases of hepatitis B in the 16 major markets are expected to rise from 21,499,000 in 2024 to 22,430,000 cases in 2029. These include France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain and the UK.

However, new WHO guidelines aim to curb that trajectory by reducing new infections by 90% and deaths by 65% by 2030.

GlobalData is the parent company of Clinical Trials Arena.

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Research Shows Low Vaccination Rates For Hepatitis A And B In Men Who Have Sex With Men

Research analyzing European survey data from 113,884 men who have sex with men (MSM) and published in Eurosurveillance indicates that while most MSM have a basic understanding of viral hepatitis, only 44% report having been vaccinated against both hepatitis A and B. The data highlight notable immunisation gaps despite available vaccination and recommendations. Strong public health support and creating an open environment that enables MSM to follow recommendations will be crucial to reduce outbreaks among MSM and eliminate hepatitis B.

Men who have sex with men are more likely to get infected with viral hepatitis, with risks being exacerbated by stigma and discrimination, which can affect access to healthcare services. While sex between men is the second most commonly reported route of acute hepatitis B virus infection in Europe, only three quarters of European countries (32/42) recommend vaccination against hepatitis B specifically for MSM. Outbreaks of hepatitis A have been reported among MSM worldwide, including a large multi-country outbreak in Europe in 2016–2018. However, just under half of European countries (19/43) recommend hepatitis A vaccination for MSM.

The two studies looked at data from 113,884 participants in the WHO European Region from the European MSM Internet Survey 2017 (EMIS-2017) with Brandl et al. Analysing vaccination uptake data, and Burdi et al. Reviewing basic knowledge about hepatitis A and B. EMIS-2017 was an anonymous, open access internet survey carried out between late 2017 and early 2018 on the sexual health of MSM. Both studies looked at data from respondents that were above the age of consent in their country, identified as cis or trans men, and indicated that they were attracted to men and/or had sex with men.

Vaccination uptake data

Brandl et al. Reviewed data on self-reported hepatitis A and B vaccination status by age, education, financial coping, settlement size, openness about sexual orientation, migration history and diagnosis with hepatitis C or HIV. The study also compared these data against information on national hepatitis A and B vaccination recommendations.

Only 48% of respondents reported being vaccinated against hepatitis A, and 53% against hepatitis B, with significant differences in uptake between countries. Reported vaccination rates for either disease were higher among respondents that were more open about their sexual orientation ('outness'), and in countries where vaccination for that disease was specifically recommended for MSM. Participants were more likely to report being vaccinated if they were older, living in bigger cities, more financially comfortable, or had been diagnosed with hepatitis C and/or HIV.

Basic knowledge on viral hepatitis

Burdi et al. Looked at the basic knowledge on viral hepatitis and hepatitis vaccination, which may correlate with higher vaccination uptake. Basic knowledge was defined as correctly identifying at least 4 out of 5 statements related to hepatitis in EMIS-2017. Researchers also collected data on sociodemographic characteristics, history of hepatitis C and/or HIV diagnosis, sexual orientation disclosure at the last sexually transmitted infection (STI) test, and outness.

While two thirds of respondents (68%) demonstrated basic knowledge, there was significant disparity among MSM in Europe. Respondents who were older, had a history of hepatitis C and/or HIV diagnosis, were out or had disclosed their sexual orientation at their last STI test were more likely to have basic knowledge. Knowledge was also higher among those who had been vaccinated against viral hepatitis or were immune due to a previous infection. Of the vulnerable, not vaccinated or immune respondents, 58% and 62%, respectively, reported not having been offered a vaccine for hepatitis A or B.

While there were national differences, individual factors played a larger role in reported knowledge levels about viral hepatitis.

Targeted public health action and supportive environment highly beneficial

Both studies highlight the importance of actively recommending vaccination against both hepatitis A and B to MSM, with Brandl et al. Also pointing to the benefits of national recommendations for MSM and offering the vaccines for free or with a co-payment. Burdi et al. Also suggest improving access to information among younger MSM in smaller settlements with a low level of education, and poorer financial resources.

Researchers for both studies emphasized the crucial role of a supportive, accepting climate to encourage openness, facilitate targeted public health action, and improve health outcomes for MSM.

Source:

Journal reference:

Burdi, S., et al. (2024). Viral hepatitis knowledge and vaccination awareness among men who have sex with men (MSM) in 43 countries of the WHO European Region: results from the European MSM Internet Survey, EMIS-2017. Eurosurveillance. doi.Org/10.2807/1560-7917.ES.2024.29.45.2400099.

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