Researchers developed a predictive risk score for the development hepatocellular carcinoma during oral antiviral therapy in patients with chronic hepatitis B, according to recently published data.
“The score requires simple information that is readily available in all treated patients,” Yao-Chun Hsu, MD, from the Fu-Jen Catholic University, Taiwan, and colleagues wrote. “By stratifying patients at different risks of HCC, the easily applicable score may inform the clinical practice and healthcare policy in the era of antiviral treatment for [chronic HBV].”
To develop the predictive tool, Hsu and colleagues analyzed data on patients from the National Health Insurance Research Database (NHIRD) in Taiwan and the Hospital Authority (HA) database in Hong Kong who received entecavir or tenofovir for chronic HBV.
The researchers selected the patients from Taiwan to develop the score and patients from Hong Kong to validate its efficacy. Patients from Taiwan and those from Hong Kong differed significantly by age, sex distribution, presence of cirrhosis, medication exposure and presence of diabetes (P < .001).
The final adjusted model from the development cohort showed that presence of cirrhosis, age, male sex and the presence of diabetes independently correlated with an increased risk for HCC. Cirrhosis and age also significantly interacted with each other in association with HCC.
The researchers refer to the combined factors as the CAMD score, which ranges from 0 to 19 points, and determined that a score of less than 8 points demonstrated a low risk for HCC, between 8 points and 13 points demonstrated an intermediate risk, and a score higher than 13 points was considered high-risk.
In the validation cohort, the 3-year cumulative incidences of HCC were 0.72% (95% CI, 0.49-0.94) for patients with a score of less than 8 points, 3.35% (95% CI, 2.93-3.76) for those with a score between 8 points and 13 points, and 9.17% (95% CI, 7.29-11.05) for those with more than 13 points. Similarly, the 5-year cumulative incidences of HCC were 0.91% (95% CI, 0.64-1.19%) for patients with 8 points, 4.95% (95% CI, 4.37-5.52%) for those between 8 points and 13 points, and 13.62% (95% CI, 11.21-16.04%) among the high-risk patients with more than 13 points.
“The risk of HCC in patients with [chronic HBV] is not static during the antiviral therapy,” the researchers wrote. “We and others have shown that the HCC incidence significantly decreased over the years on treatment. However, it remains elusive whether a prolonged therapy can eventually eliminate the risk and if so, how long the regimen should be.” – by Talitha Bennett
Disclosure: Hsu reports he served as an advisory committee member for Gilead Sciences and received lecture fees from AbbVie, Bristol-Myers Squibb and Gilead Sciences.