April 15, 2016, Barcelona, Spain: A new study presented today demonstrates a potential link between treatment of long-term oral nucleos(t)ide analogues and an increased risk of colorectal (p=0.029) and cervical (p=0.049) cancer in patients with chronic Hepatitis B virus (HBV). The study results were presented at The International Liver CongressTM 2016 in Barcelona, Spain.
Chronic HBV infection remains a global public health issue and continued prevention and control strategies are needed.1 Prolonged treatment with nucleos(t)ide analogues, which are used to prevent the virus from reproducing, are recommended for selected chronic HBV patients.2,3 However, questions have been raised regarding the long-term safety of such treatments.4
"Although our analysis showed that nucleos(t)ide analogue treatment does not increase overall incidence of liver, lung, breast and urinary/renal malignancies, it did reveal that patients with Hepatitis B virus on this treatment had a higher risk of developing colorectal and cervical cancers," said Professor Grace Wong, Department of Medicine & Therapeutics Academic at the Chinese University of Hong Kong and lead study author. "In light of these findings we strongly urge regular screening of these cancers to help prevent them from developing in patients taking nucleos(t)ide analogue treatment."
For their research, the authors of the Chinese study selected 45,299 patients who had been diagnosed with chronic HBV. Of these, 7,323 (16.16%) had undergone nucleos(t)ide analogue treatment. The primary outcome of the study was incident malignancies excluding hepatocellular carcinoma (HCC), the most common type of primary liver cancer.5 Follow-up duration was up to seven years, during this period the relative risk of primary outcome in patients with or without nucleos(t)ide analogue treatment was measured.
At the median follow-up of 4.4 years, malignancies occurred in 538 (2.1%) of untreated patients and 274 (5.7%) of those who had received nucleos(t)ide analogue therapy. Nucleos(t)ide analogue-treated patients had higher risks of developing colorectal cancer (adjusted Hazard Ratio (aHR) 2.17, 95% Confidence Interval (Cl) 1.08-4.36, p=0.029) and cervical cancer (aHR 4.41, 95% Cl 1.01-19.34, p=0.049). However, across treated and non-treated groups nucleos(t)ide analogue-treated patients had similar risks of developing other malignancies, including lung and pleural cancers, breast cancer and renal conditions.
"This large-scale study determines an important link between nucleos(t)ide analogue treatment and cervical and colorectal cancer," said Professor Tom Hemming Karlsen, EASL Vice-Secretary. "The results are important and could change cancer surveillance and management of patients treated for Hepatitis B."
About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.
Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
For more information, please contact the ILC Press Office at:
Telephone: +44 (0)7841 009 252
Onsite location reference
Viral Hepatitis B and D, Hall 6.0
Friday 15 April, 16:00 - 18:00
Presenter: Grace Wong, Hong Kong
Abstract: PS052, Incidences of all malignancies in patients with chronic hepatitis B receiving long-term oral nucelos(t)ide analogue treatment - a study of 45,299 subjects
Author disclosures of interest
Advisory committee member for Otsuka and Gilead. Speaker for Abbott, Abbvie, Bristol-Myers Squibb, Echosens, Furui, Gilead, Janssen, Otsuka and Roche.
1 Schweitzer A, et al. Estimations of worldwide prevalence of chronic hepatitis virus infection: a systematic review of data published between 1965 and 2013. The Lancet. October 2015;386(100030:1546-1555.
2 Fontana RJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Hepatology. 2009 May;49(5 Suppl):S185-95.
3 Emedicine Health. Hepatitis B Treatment. Available from: http://www.
4 Zoutendijk R, et al. Serum HBsAg Decline During Long-term Potent Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B and Prediction of HBsAg Loss. J Infect Dis. 2011 Aug 1;204(3):415-8.
5 Cancer Research UK. Types of primary liver cancer. Available from: http://www.