Infectious Disease

With rising HBV burden, experts say it is critical to implement new vaccine guideline

December 21, 2021

7 min read

Source/Disclosures

Disclosures:
Cohen is senior vice president of the Hepatitis B Foundation, which she said receives unrestricted educational grants from companies that manufacture vaccines. Kuwahara reports serving on the National Public Policy Committee at the American Association for the Study of Liver Diseases and on Hepatitis B United’s National Advisory Committee, and previously served as the policy fellow at the Association of Asian Pacific Community Health Organizations working on hepatitis B policy.

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The CDC’s Advisory Committee on Immunization Practices recently issued a universal recommendation that all adults aged 19 to 59 years receive the hepatitis B vaccine.

“This new recommendation by the ACIP will be instrumental in raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” Rita Kuwahara, MD, MIH, a primary care internal medicine physician and health policy fellow at Georgetown University and a Healio Primary Care Peer Perspective Board member, said during the 2021 U.S. Conference on HIV/AIDS. “But the next essential step is to figure out how to effectively implement these new guidelines nationwide, so that everyone eligible for the hepatitis B vaccine is immunized.”

Kuwahara RK, et al. Preventing Acute Rises in Hepatitis B Within the Opioid Epidemic: Policy and Primary Care Practice-Based Opportunities to Increase Adult Hepatitis B Vaccination in the United States. Presented at: NFID Annual Conference on Vaccinology Research; June 18-19, 2020 (virtual meeting).

The ACIP previously recommended that all newborns receive their first hepatitis B virus (HBV) vaccine dose before hospital discharge. This led to large decreases in new cases among children and adolescents, Healio previously reported. However, adult vaccination rates have plateaued in the last decade. Currently, only about 25% of adults in the U.S. are vaccinated against HBV, according to Chari Cohen, DrPH, MPH, the senior vice president of the Hepatitis B Foundation. She estimated that around 16 million people in the U.S. would benefit from the new vaccine recommendation.

Chari Cohen

“[The recommendation] is a very important step as we work towards eliminating hepatitis B by 2030,” Cohen told Healio Primary Care. “We can’t eliminate hepatitis B in the U.S. without the vaccine playing an important role.”

Healio Primary Care spoke with Cohen and Kuwahara to learn more about the HBV burden and how primary care physicians will implement the new recommendation.

HBV burden in the US

CDC medical officer Mark K. Weng, MD, MSc, FAAP, who leads the ACIP’s Hepatitis Vaccines Work Group, estimated that about 20,700 acute HBV infections occur annually in the U.S. Also, he projected that almost 2 million people are living with chronic HBV infection. These individuals carry a 15% to 25% risk for premature death from cirrhosis or liver cancer, Weng said during the ACIP meeting. Moreover, the financial burden of HBV-related hospitalizations amounts to more than $1 billion annually.

Cohen noted that HBV is the leading cause of liver cancer worldwide, and that the HBV vaccine was the first anti-cancer vaccine created.

“About 840,000 people die from hepatitis B-related liver cancer each year,” Cohen said. “Can you imagine if everybody was able to get vaccinated, all those future deaths we would be able to prevent?”

The burden of opioid-related infectious diseases such as HBV could be even higher now due to the worsening opioid epidemic amid the COVID-19 pandemic, according to Kuwahara.

Rita Kuwahara

“Recent data from the CDC has shown that 36% of new hepatitis B infections in the U.S. are attributed to the opioid epidemic,” she said.

Kuwahara added that “a record-high number of overdose-related deaths, along with very low adult HBV vaccination rates, would suggest that many more people would subsequently be at risk of acquiring acute HBV during this time.”

Implementing the recommendation into practice

Despite HBV infection being one of the most common infections worldwide, “we don’t talk about it a lot,” Cohen said. “It is a stigmatized disease.”
According to results from a small survey conducted by Kuwahara, 0% of PCPs knew that the adult HBV vaccination coverage rate is as low as 25%. Moreover, 86% of respondents incorrectly believed that the vaccination rate was significantly higher at 75%, and 29% had not considered vaccinating their patients, despite caring for patients with at least one risk factor for HBV.

Based on the survey results, Kuwahara said that it will be important to raise awareness of the low HBV vaccination rates among PCPs in addition to providing information on the ACIP’s new recommendation.

“Federal efforts must be made to develop educational materials to raise physician awareness of the new recommendations, so that they routinely order hepatitis B vaccines for their patients in conjunction with hepatitis B testing,” she said during a listening session for the HHS Viral Hepatitis Federal Implementation Plan.

While physician awareness of the new recommendation is difficult to gauge, Cohen said it could increase once the new guidance is published in the CDC’s Morbidity and Mortality Weekly Report.

“I’m hoping that within the next year, we’ll see awareness of the importance of vaccination go way up among primary care providers,” Cohen said.

However, it will likely take years before the recommendation is fully implemented, she added.

As physicians start rolling out universal HBV vaccination, Cohen noted that the pandemic could help vaccination efforts since the COVID-19 vaccine can be bundled with the HBV vaccine. In addition, access to HBV vaccination should improve since insurance coverage often relies on ACIP recommendations, she said. Still, Kuwahara stressed that the new recommendation’s success will depend on the availability of resources to enable physicians to stock HBV vaccines in their clinics and develop automatic electronic health record alerts to remind members of clinical care teams when patients are due for their initial and follow-up doses.

“In addition, we must strengthen pharmacy-clinic communication so that patients receiving vaccines in a pharmacy have their vaccine records sent back to their PCP’s office. Further, for patients without insurance, it will be important for states to receive adequate Section 317 funding to stock and administer hepatitis B vaccines for adults requiring vaccination,” she said.

At-risk populations

The ACIP recommendation specifically targets adults aged 59 years or younger. The age cap is disappointing, according to Cohen, who said that many people older than 59 years would benefit from HBV vaccination.

The argument for an age cap is supported by evidence that suggests older adults who become infected with HBV are less likely to develop liver cancer. However, older adults who develop acute infections, and who probably have comorbidities, are at risk for liver failure, Cohen said.

“Hopefully, the age cap won’t deter people from asking their doctor about whether they should get vaccinated for hepatitis B, and it won’t deter health care providers from asking their older patients about the hepatitis B vaccination,” Cohen said.

Kuwahara emphasized that the ACIP recommended that anyone over 60 may get vaccinated, even if they don’t have any risk factors.

“It’s not necessarily a limiting recommendation, but it’s just a difference of who should get vaccinated, according to ACIP, and who may get vaccinated,” she said.

Many people at high risk for HBV are from more vulnerable populations, including those from Asian American/Pacific Islander or African immigrant communities or persons who inject drugs.

“There need to be concerted efforts to make sure that we are going out of our way to reach those who are at greatest risk for acquiring hepatitis B as we roll out universal guidelines,” Kuwahara said.

Vaccine series options

There are three single-antigen and two combination HBV vaccines available in the U.S., according to the Association of American Medical Colleges. Moreover, the FDA recently approved the first recombinant trivalent HBV vaccine, PreHevbrio (VBI Vaccines), for adults. It is expected to be available in the U.S. in the first quarter of 2022, the manufacturer said.

While most HBV vaccines are given in three doses over a 6-month period, a newer two-dose vaccine, HEPLISAV-B (Dynavax), can be given over a 1-month period, Kuwahara said. For dual protection against hepatitis A and B, physicians can administer three doses of Twinrix (GlaxoSmithKline) over a 6-month period.

Compared with older vaccines, HEPLISAV-B appears to have greater efficacy among immunocompromised patients, Cohen said. Also, phase 3 data showed that the newest vaccine, PreHevbrio, produced significantly higher seroprotection rates in adults with diabetes compared with a monovalent vaccine. However, all HBV vaccines are currently recommended equally by the ACIP, according to Kuwahara

“In some cases, larger vaccine doses or additional doses might be required,” Cohen said.

Cohen recommended that physicians take a blood sample from immunocompromised patients after they complete the vaccine series to ensure that antibodies are present.

Following up with patients to guarantee they complete their vaccination series will be important for achieving full immunity, Kuwahara said.

“If it’s a two-dose vaccine, they have to get both doses. If it’s three doses, they have to get all three doses,” Kuwahara told Healio Primary Care. “Creating reminders to get patients to come back and get the subsequent vaccines will be really critical, and it will also be important not to mix and match vaccines.”

Screening

Now that ACIP has recommended universal HBV vaccination for adults up to aged 59 years, Kuwahara said “it would make the most sense to recommend universal hepatitis B screening.” That way, patients who are susceptible to HBV can get vaccinated, and anyone with chronic HBV can be diagnosed and appropriately linked to care, she said.

In 2020, the U.S. Preventive Services Task Force published a statement strengthening its 2014 recommendation to screen for HBV in adolescents and adults who are at increased risk for infection, but both Kuwahara and Cohen said the CDC is expected to recommend universal adult screening in the spring.

“Providers are going to have to navigate screening and vaccinating,” Cohen said. “What you don’t want is for people to be vaccinated if they’re already infected, and the only way to know if someone has hepatitis B is to screen for it with a simple blood test.”

She expects physicians, in many cases, will have to conduct a two-part evaluation for screening and vaccination to identify people who have HBV and link them to care and vaccinate those who are susceptible to HBV.

Looking ahead

Overall, this is “a very big win,” Cohen said.

“The ACIP recommendation is just the beginning. What we have to do now is implement it,” she added.

She expects that news surrounding the new recommendation will bring about webinars, education efforts, conferences and articles about HBV.

Kuwahara noted that increasing HBV vaccination “is an issue of health equity, and we really need to address it from that perspective.”

“In order to prevent further outbreaks of infectious diseases within the opioid epidemic and current COVID-19 pandemic, we really must step up adult HBV vaccinations,” she said. “Where a vaccine is available, we really should be able to make sure that everyone in the community is protected through vaccination.”

References:

AAMC standardized immunization form 2020 hepatitis B vaccine – frequently asked questions. https://www.aamc.org/system/files/2020-12/AAMC%20FAQs-HepB-2020.pdf. Accessed Dec. 6, 2021.

CDC. Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/acip/index.html. Accessed Nov. 23, 2021.

Diaz-Mitoma F, et al. Higher seroprotection rates (SPR) and anti-HBs titers achieved in adults with a 3-antigen hepatitis B vaccine (3A-HBV) compared to a 1-antigen hepatitis B vaccine (1A-HBV): Results of the PROTECT study. Presented at: NFID Annual Conference on Vaccinology Research; April 26-28, 2021 (virtual meeting).

Kuwahara RK, et al. Preventing Acute Rises in Hepatitis B Within the Opioid Epidemic: Policy and Primary Care Practice-Based Opportunities to Increase Adult Hepatitis B Vaccination in the United States. Presented at: NFID Annual Conference on Vaccinology Research; June 18-19, 2020 (virtual meeting).

Universal adult hepatitis B vaccination: work group considerations. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/02-HepWG-weng-508.pdf. Published Nov. 3, 2021. Accessed Dec. 6, 2021.

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