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Disclosures: Graham reports no relevant financial disclosures. Hwang reports receiving research funding from Merck and Gilead. Kuwahara reports being a member of the American Association for the Study of Liver Diseases’ (AASLD) National Public Policy Committee and former federal policy fellow at the Association of Asian Pacific Community Health Organizations (AAPCHO), where she represented community health centers nationwide and worked on federal hepatitis B policy. She is also the 2020 National Copello Health Advocacy Fellow at Doctors for America (DFA) working on prescription drug pricing policy. Her views expressed in this article are her own and do not represent official views of AASLD, AAPCHO or DFA. Lok reports serving on the advisory board for Gilead, receiving research funding from Bristol Myers Squibb, Gilead and TARGET, and receiving consulting fees from Gilead, TARGET and GlaxoSmithKline.
December 15, 2020
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USPSTF publishes HBV recommendation amid declines in screening, vaccination

Disclosures: Graham reports no relevant financial disclosures. Hwang reports receiving research funding from Merck and Gilead. Kuwahara reports being a member of the American Association for the Study of Liver Diseases’ (AASLD) National Public Policy Committee and former federal policy fellow at the Association of Asian Pacific Community Health Organizations (AAPCHO), where she represented community health centers nationwide and worked on federal hepatitis B policy. She is also the 2020 National Copello Health Advocacy Fellow at Doctors for America (DFA) working on prescription drug pricing policy. Her views expressed in this article are her own and do not represent official views of AASLD, AAPCHO or DFA. Lok reports serving on the advisory board for Gilead, receiving research funding from Bristol Myers Squibb, Gilead and TARGET, and receiving consulting fees from Gilead, TARGET and GlaxoSmithKline.
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The United States Preventive Services Task Force recently published a new statement strengthening its 2014 recommendation to screen for hepatitis B virus in adolescents and adults who are at an increased risk for infection.

However, experts said the recommendation is inadequate as it excludes patients who would benefit from HBV screening, which has declined amid the COVID-19 pandemic.

Camilla S. Graham, MD

“This recommendation is disappointing and a disservice to public health and patient needs in hepatitis B. It advocates a failed strategy of risk-based testing.” Camilla S. Graham, MD, assistant professor of medicine at Harvard Medical School, told Healio Primary Care.

Experts endorse universal HBV screening

The USPSTF based its recommendation on a review of randomized clinical trials and cohort studies that were published from January 2014 to August 2019. The studies evaluated the benefits and harms of HBV screening and treatment in nonpregnant adolescents and adults.

The USPSTF concluded “with moderate certainty” (B recommendation) that HBV screening “has moderate net benefit” in adolescents and adults who have an increased risk for infection.

In an editorial accompanying the USPSTF’s recommendation, Jessica P. Hwang, MD, MPH, a professor in the department of general internal medicine at the University of Texas MD Anderson Cancer Center, and Anna S. Lok, MD, a professor in the division of gastroenterology and hepatology at the University of Michigan Medical School, said the recommendation helps ensure that HBV screening is covered by insurance companies for certain patients who are at risk for infection, including those who were born in a country with a 2% or higher prevalence of HBV; unvaccinated patients who were born in the U.S. and whose parents are from a country with a prevalence of 8% or higher; household contacts and sex partners of people with chronic HBV infection; people who have injected drugs and their needle-sharing contacts; men who have sex with men; and people with HIV.

While this is a “comprehensive list” of at-risk patients, Hwang and Lok said it should also include patients with chronic liver disease and those with cancer or other diseases that require immunosuppressive therapy.

“HBV screening in the latter group is important to identify those who might benefit from prophylactic antiviral therapy to prevent HBV reactivation, which can be fatal in some cases,” they wrote.

Hwang and Lok also said it “may soon be time” for the United States to transition to universal HBV screening, especially if more effective therapies become available.

Graham said there was a similar shift from risk-based to age-based screening in HIV and hepatitis C virus after risk-based screening was shown to miss “too many people living with these infections.”

“This HBV recommendation also misses a critical opportunity to identify people without exposure to HBV who would benefit from vaccination against HBV,” she said. “We need a universal, age-based HBV screening program that simultaneously identifies people with chronic HBV infection who require additional evaluation and management as well as HBV vaccination for their close contacts and universal vaccination of all unexposed adults, since a high number of us either currently have, or will develop, factors associated with a benefit of HBV vaccination.”

HBV increases in US

Photo of Rita Kuwahara
Rita K. Kuwahara

The USPSTF is publishing its recommendation amid an increase in HBV infections caused by the opioid epidemic and a decrease in vaccination and testing due to the COVID-19 pandemic, according to Healio Primary Care Peer Perspective Board Member Rita K. Kuwahara, MD, MIH, a primary care internal medicine resident physician and member of the American Association for the Study of Liver Diseases’ National Public Policy Committee.

“While the COVID-19 pandemic has significantly complicated our ability to stem the rise in infectious disease consequences of the opioid epidemic, we cannot afford to lose ground on the work we have been doing to eliminate viral hepatitis,” Kuwahara, who is also the former national policy fellow working on federal hepatitis B policy at the Association of Asian Pacific Community Health Organizations, said during a presentation at the U.S. Conference on HIV/AIDS.

She cited data from the CDC and state health departments that demonstrate substantial increases in acute HBV infections among states most affected by the opioid epidemic, including a 729% increase in Maine from 2015 to 2017, a 114% increase in Tennessee, Kentucky and West Virginia from 2009 to 2013, a 78% increase in Southeastern Massachusetts in 2017, and a 62% increase in North Carolina from 2012 to 2016.

Anecdotal evidence suggests that the opioid epidemic may be worsening during the COVID-19 pandemic. In an interview, Kuwahara referenced a report from the AMA that claims more than 40 states have reported an increase in opioid-related mortality. The AMA also said in the report that it “is greatly concerned by an increasing number of reports from national, state and local media suggesting increases in opioid-and other drug-related mortality — particularly from illicitly manufactured fentanyl and fentanyl analogs.”

In light of this, as well as already low HBV vaccination rates and limited access to testing during the pandemic, Kuwahara indicated there could be additional rises in HBV.

Screening services decline

A public survey conducted by the National Viral Hepatitis Roundtable and other national viral hepatitis advocacy organizations from June to September demonstrated the impact of the COVID-19 pandemic on viral hepatitis services in the United States.

The survey included responses from community-based organizations that provide services for viral hepatitis. Among them, nearly two-thirds received inadequate (26%) or no (34%) funding to adapt their services during the pandemic, and more than half were forced to furlough or lay off staff or reduce operations. Only 42% of the organizations were able to continue providing HBV and HCV testing during the pandemic, and 58% were able to continue providing hepatitis A and hepatitis B vaccinations, according to Kuwahara. In addition, only half of the organizations were able to continue engaging in viral hepatitis-related community outreach efforts.

Clinical providers who participated in the survey also reported a 15% decline in services for viral hepatitis vaccinations and treatment — from 95% to 80% — during the pandemic. They said the most common barriers to providing viral hepatitis care were interruptions in bloodwork, limited access to telehealth and staffing shortages.

Another survey conducted by the World Hepatitis Alliance from March 30 to May 4 revealed the global impact of COVID-19 on viral hepatitis. The survey, published in The Lancet Gastroenterology and Hepatology, included responses from civil society organizations and viral hepatitis service providers in 32 countries. Only 36% of respondents reported that people were able to access testing. In addition, 8% of respondents in the U.S. and 34% of those outside the country said that people on treatment for viral hepatitis were unable to access their medications.

“Based on the findings — a lot of which are anecdotally reported — at the start of the COVID-19 pandemic, there was initially a steep decline in in-person events, including community-based education and screening programs, and closures of viral hepatitis testing and vaccination facilities,” Kuwahara said. “A lot of those services have since restarted, but even with the recent approval of a COVID-19 vaccine, with the current surge in COVID-19 throughout the nation, we will likely be grappling with the effects of the pandemic for quite some time.”

Kuwahara also noted there has been limited access to syringe service programs and other support systems for people with substance use disorder.

“If they don’t have access to viral hepatitis testing or some of the community-based programs like clean syringes and supplies, they could be at increased risk for acquiring hepatitis B,” Kuwahara said. “With decreased testing or testing availability, there are going to be more people who are not aware that they have acute hepatitis B, which can be a significant problem.”

Preventing outbreaks through vaccination

The implications of limited testing extend beyond case identification, according to Kuwahara. Testing can also be used to determine whether a patient needs hepatitis B vaccination.

“Hepatitis B testing should always be done with the hepatitis B surface antigen, the hepatitis B core antibody IgG and the hepatitis B surface antibody IgG,” she said. “That will indicate whether a person is currently infected with hepatitis B or at risk for hepatitis B reactivation from prior infection, and if they are not, whether or not they are susceptible to hepatitis B. If they are susceptible, they would require immunization and should complete the full course of hepatitis B vaccination.”

Currently, only 25% of adults in the U.S. have been vaccinated against HBV, Kuwahara said. She previously conducted a survey of primary care physicians at a community health center and found that 0% knew the vaccination coverage rate was this low, with the majority of surveyed physicians assuming adult vaccination rates were at least 75%.

“It is important for primary care providers to be aware of the low rates of adult hepatitis B vaccination, so they will think about ordering hepatitis B testing and vaccination for their patients when they are thinking about ordering other vaccines such as those protecting against influenza, shingles, and pneumonia,” she said.

The HBV vaccination rate is even lower in certain subpopulations. For example, it is just 12% among patients with diabetes who are aged 60 years and older, according to Kuwahara. To address this issue, she said PCPs can add HBV testing and vaccination to routine diabetes protocols that are already in place in primary care clinics.

Another way to improve vaccination rates among all patients is for PCPs to implement standing orders, Kuwahara said. There should also be a system in place to remind patients when they need their follow-up vaccine dose or doses, she added.

“With the approval of HEPLISAV-B [(Dynavax)], which is the two-dose adult hepatitis B vaccine, things have become much easier because you can achieve immunity by administering two doses over a 1-month period vs. three doses over 6 months, as is required for the other adult hepatitis B vaccine formulations,” Kuwahara said. “Increasing provider awareness of the two-dose hepatitis B vaccine option is important to improve successful completion of the vaccine series.”

Graham stressed that more efforts are needed from state and local public health departments.

“We need to make adult vaccination easier by making vaccination routine in places adults frequent such as pharmacies, community centers, and other nonclinical settings,” she said. “Even in the setting of the COVID-19 pandemic, adults continued to go to these places even if they did not see their primary care clinicians face to face.”

Kuwahara said that many patients are now being vaccinated at their local pharmacies during the COVID-19 pandemic. She encouraged pharmacies that administer vaccinations to send the records back to the patient’s primary care clinic so their provider will know when the vaccine was administered, which brand was administered and when the repeat doses are due. She also advocated for nationwide integrated health information exchanges and modernized immunization information systems that communicate across state and regional lines, so that vaccine administration records can be accessed and updated in real time by pharmacies, clinics, hospitals and other nonclinical settings where vaccines are administered in order for patients’ immunization records to be centrally accessible.

These vaccination strategies and other efforts will be crucial to preventing outbreaks during the pandemic, Kuwahara said.

“We must increase provider awareness, commit to widespread testing, and reconsider the public health benefits of recommending universal adult hepatitis B vaccination over risk-based vaccination in the same way that we already recommend universal childhood hepatitis B vaccination so that we can definitively end transmission of hepatitis B in the United States,” she said during her presentation.

References:

AMA. Issue brief: Reports of increases in opioid-and other drug-related overdose and other concerns during COVID pandemic. https://www.ama-assn.org/system/files/2020-12/issue-brief-increases-in-opioid-related-overdose.pdf. Accessed Dec. 13, 2020.

Hwang JP, Lok AS. JAMA. 2020;doi:10.1001/jama.2020.18831.

Krist AH, et al. JAMA. 2020;doi:10.1001/jama.2020.22980.

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).

Kuwahara RK. Supporting adult hepatitis B vaccination during the dual opioid epidemic and COVID-19 pandemic: Policy and practice-based strategies to eliminate hepatitis B. Presented at: U.S. Conference on HIV/AIDS; Oct. 19-21, 2020 (virtual meeting).

National Association of County and City Health Officials. Infographic: COVID-19 impact on viral hepatitis care. https://www.naccho.org/blog/articles/infographic-covid-19-impact-on-viral-hepatitis-care. Accessed Dec. 13, 2020.

Wingrove C, et al. Lancet Gastroenterol Hepatol. 2020;doi:10.1016/S2468-1253(20)30238-7.