Care Quality and Outcomes Among US Veterans With Chronic Hepatitis B in the Hepatitis C Direct-acting Antiviral Era

David E. Kaplan; Elina Medvedeva; Marina Serper

Disclosures

J Viral Hepat. 2020;27(10):1082-1092. 

In This Article

Abstract and Introduction

Abstract

Adherence to guideline-recommended hepatitis B virus (HBV) care is suboptimal. We hypothesized that national hepatitis C eradication efforts during the era from 2015 to 2017 would improve the quality of care for cHBV given increased recognition and specialty referrals for liver disease. The study described herein is a retrospective cohort study of veterans with at least one positive HBsAg (HBsAg+) result from 1 January 2003 to 31 December 2017 using the VA Corporate Data Warehouse (CDW) analysed by era (2003–2004, 2005–2009, 2010–2014, 2015–2017). Relevant covariates such as HCV co-infection, demographics, cirrhosis and baseline laboratory testing were obtained through previously validated approaches. We evaluated completion of process measures within 2 years of the index HBsAg + result: specialty care referral; testing of ALT, HBV-DNA, HBeAg and anti-HBe; testing for co-infection and/or vaccination for HAV, HCV, HDV and HIV; and hepatocellular carcinoma (HCC) surveillance among those meeting criteria. We also measured use of antiviral therapy in appropriate candidates (ALT ≥ 2 × ULN, HBV-DNA ≥ 2000 IU/mL). Of the 16 673 individuals with HBsAg + test results, 9,521 were confirmed as chronic HBV. Era-related (Era 3:2010–2014 vs Era 4:2015–2017) increases in guideline-recommended process measures included the following: outpatient visits with GI/ID specialists (78%-89%), HBV-DNA testing (73%-79%), HDV testing (27%-35%), appropriate HBV antiviral utilization (55%-70%) and HCC surveillance (40%-43%); all P < .0001. In the subset of HBV/HCV-co-infected patients, HCV DAA therapy was associated with a trend towards improved overall survival. In conclusion, the overall quality of care for HBV has significantly improved in the era of widespread HCV DAA therapy in an integrated health system possibly due to increased recognition and referral for liver disease.

Introduction

Approximately 250 million people worldwide are chronically infected with hepatitis B virus (HBV).[1] Chronic HBV infection remains a significant cause of morbidity and mortality, leading to liver failure, cirrhosis and hepatocellular carcinoma (HCC) in 15%–40% of chronically infected persons.[2] In the United States, HBV affects 1.4–1.8 million people and contributes to approximately 7000 cirrhosis-related and 3200 liver cancer-related deaths annually.[3,4]

Despite the existence of multiple comprehensive management guidelines for the evaluation and treatment of chronic HBV,[5–7] adherence to recommended HBV guidelines has repeatedly been shown to be suboptimal, including low rates of HBV-DNA level monitoring and infrequent HCC surveillance.[8–10] These gaps in care quality exist in both academic settings and integrated health systems.[10–17] We previously demonstrated overall low adherence to HBV care quality measures in the Veterans Affairs (VA) healthcare system and showed that patients receiving specialty care had a higher frequency of recommended laboratory testing, higher receipt of appropriate antiviral therapy and greater adherence with liver cancer surveillance.[10] In follow-up work, we found that patient engagement with primary care services was associated with improved rates of attending visits with HBV specialists, while severe psychiatric disease was a significant barrier.[18]

All-oral direct-acting antivirals for chronic hepatitis C infection (HCV DAAs) became available in the VA in 2014. Given the high prevalence of HCV infection among veterans, to accommodate increased demand and achieve HCV elimination, in 2015 the US Congress allocated $2B for medication acquisition and personnel to treat chronic viral hepatitis in the VA resulting in two potential changes in HBV care. First, there was increased referral from primary to specialty care for viral hepatitis. Second in October 2016, the Food and Drug Administration (FDA) issued a black box warning related to the risk of hepatitis B reactivation among recipients with hepatitis C undergoing DAA therapy,[19] recommending testing for current or prior hepatitis B infection among all candidates for HCV DAAs bringing further attention to the need for HBV testing. Given these changes in healthcare delivery for viral hepatitis, we sought to determine whether widespread HCV DAA treatment was associated with improved adherence to guideline-recommended care for HBV. We hypothesized that as a consequence of widespread HCV DAA treatment and requirements for HBV testing, there would be an improvement in adherence to guideline-recommended care for HBV compared to the pre-all-oral HCV DAA era.

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