Hepatitis B virus (HBV) infection is estimated to affect 292 million people worldwide, 90% of them are unaware of their HBV status. The Determine HBsAg 2 (Alere Medical Co, Ltd Chiba Japan [Now Abbott]) is a rapid test that meets European Union (EU) regulatory requirements for Hepatitis B surface antigen 2 (HBsAg) analytical sensitivity, detecting the 0.1 IU/mL World Health Organization (WHO) International HBsAg Standard. This prospective, multicentre study was conducted to establish its clinical performance. 351 evaluable subjects were enrolled, 145 HBsAg‐positive. The fingerstick whole blood sensitivity and specificity were 97.2% and 98.5% (15′ reading, reference assay cut‐off 0.05 IU/mL), sensitivity increasing to 97.9% with the prespecified cut‐off 0.13 IU/mL (EU regulations). The venous whole blood, serum and plasma sensitivity was 97.2%, 97.9%, and 98.6%, respectively (15′ reading); reaching 99%, 99.5% and 100% specificity. A testing algorithm following up an initial positive fingerstick test result with plasma/serum test demonstrates 100% specificity. The Determine HBsAg 2 test gives 15‐minute results with high sensitivity and specificity, making it an ideal tool for point‐of‐care testing, with the potential to enable large‐scale population‐wide screening to reach the WHO HBV diagnostic targets. The evaluated test improves the existing methods as most of the reviewed rapid tests do not meet the EU regulatory requirements of sensitivity.

BackgroundThe new direct acting antiviral agents (DAAs) for the treatment of hepatitis C have resulted in more effective and safer combinations. While interferon has been almost banished from actual treatment, improving tolerance, this is not the case for ribavirin, which is still part of many of the  combinations, contributing to some of the adverse effects of the therapy. Pancreatitis and hyperbilirubinaemia are two of them, usually associated with combinations with peginterferon or with coadministration with other drugs. However, there are no data of such adverse effects when administered with  DAAs.PurposeDescription of one case of hyperbilirubinaemia and pancreatitis possibly associated (according to Naranjo´s algorithm) with ribavirin administration in combination with ombitasvir, paritaprevir, ritonavir and dasabuvir (OTV/PTV/RTV/DSV).Material and methodsA 75-year-old man was admitted to the gastroenterology unit with abdominal pain and vomiting, 3 weeks after starting treatment with OTV/PTV/RTV/DSV and ribavirin 1200 mg daily. He was taking no other concomitant medication. Blood analysis showed the following values: total and conjugated bilirubin 7.1 and 1.3 mg/dL, respectively; alpha amylase 1166 U/L; lipase 5537 U/L and haemoglobin 10.5 g/dL. He was diagnosed with acute pancreatitis. On admission HCV viral load was undetectable.ResultsDuring hospitalisation total bilirubin values rose to 9 mg/dL while haemoglobin decreased to 10.3 g/dL. The pharmacy was consulted in order to request a change in treatment to ledipasvir/sofosbuvir. The pharmacy recommended ribavirin withdrawal. 2 days after withdrawal, total bilirubin dropped to 5.9. Similarly, alpha amylase and lipase decreased to normal values. The patient was discharged with a total bilirubin value of 1.6 mg/dL; 2 weeks later, haemoglobin increased to  13.9 g/dL.Although pancreatitis mechanism is not yet well known, hyperbilirubinaemia is thought to be caused by erythrocyte destruction. Applying Naranjo´s algorithm, these two adverse effects were considered probable. The quick resolution of symptoms after withdrawal of ribavirin was thought to be secondary to this drug.ConclusionPancreatitis and hyperbilirubinaemia are adverse events previously related to ribavirina in combination with peginterferon. Further studies are needed to determine its specific role in combination with DDAs.No conflict of interest.

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