Signe Bollerup[1], Sofie Hallager[2], Jan Gerstoft[3], Nina Weis[4]

Affiliates

Department of infectious diseases, Copenhagen University Hospital, Hvidovre, Denmark [1][2][4] Department of infectious diseases, Rigshospitalet, Copenhagen, Denmark [3]

Abstract

Background: Chronic Hepatitis B virus infection is a major global health burden and can lead to liver cirrhosis and hepatocellular carcinoma. However, chronic infection does not necessarily cause chronic hepatitis characterized by inflammation and eventually fibrosis of the liver. There is currently no available cure for chronic hepatitis B (CHB), and treatment is long-term and often lifelong. Long-term treatment is associated with the risk of adverse reactions, nonadherence and costs. Therefore, clinicians strive to treat only those who show signs of disease progression and clinical guidelines have been developed to support this endeavor. The first Danish national clinical guidelines on management of CHB were published in 2009. Current treatment criteria are liver fibrosis and HBV DNA >2000 IU/ml or elevated alanine aminotransferase (ALT). Moreover, treatment is recommended in the following situations: liver cirrhosis, family history of hepatocellular carcinoma, immunosuppressant treatment and pregnancy with high viral load. In this study we aim to evaluate clinicians’ adherence to national guidelines on treatment initiation in CHB patients in a department of infectious diseases in Denmark.
Methods: Using DANHEP, a national cohort of all chronic hepatitis B or C patients, at least 16 years of age who had at least one visit to a hospital unit specialized in infectious diseases or gastroenterology in Denmark since January 2002, we performed a descriptive observational cohort study based on prospectively collected data assembled between January 2002 and December 2017. We identified all patients with chronic hepatitis B, who had at least one visit at the unit for infectious diseases at Copenhagen University Hospital, Hvidovre in Denmark. We included data on treatment status, laboratory testing and liver fibrosis.. Missing data were recovered from patient files.
Results: We found that 623 CHB patients had at least one visit. Of these, 158 were terminated due to failure to show up, death, occult HBV infection or emigration, 53 had missing information on treatment status, 284 are still in follow-up and have not received treatment and 128 initiated treatment at least once with either nucleos(t)ide analogues or pegylated interferon. At their latest follow-up visit, 264/284 (93%) still in follow-up did not meet current criteria for treatment initiation, whereas 3/284 (1%) did meet criteria. We were unable to determine if the remaining 17 still in follow-up met the treatment criteria due to missing data. Of the 128 who received treatment 43 initiated treatment before publication of the national treatment guidelines in 2009. Of the 85 remaining patients who received treatment, 44 (52%) met the criteria for treatment initiation at the time of first treatment, whereas 32 (38%) did not. For 8 patients insufficient data were available to determine whether they met the treatment criteria at the time of first treatment initiation. Overall, 44 of the 47 patients who meet treatment criteria initiated treatment.
Conclusion: In this descriptive observational study of treatment initiation in CHB patients at a single center in Denmark, we found that almost all patients who met treatment criteria according to national guidelines received treatment. However, only about half of the patients who received treatment met criteria as stated by the national guidelines at time of initiation. These findings imply that some patients may receive long-term often lifelong treatment unnecessarily.