Treating chronic HBV with tenofovir disoproxil reduces HCC risk
Individuals who are treated with tenofovir disoproxil for chronic hepatitis B virus (HBV) infection have a decreased risk of developing hepatocellular carcinoma (HCC), according to a recent study.
“Tenofovir disoproxil was associated with an approximately 70 percent reduction in the development of HCC, compared with patients who were not treated,” said the researchers.
“[O]ur findings confirm that tenofovir disoproxil for Asian patients with chronic hepatitis B is an appropriate and beneficial treatment for cirrhotic and noncirrhotic patients with chronic hepatitis B and active disease,” they said.
This multicentre (six centres in the US and the Taiwan community-based REVEAL-HBV cohort), retrospective cohort study included 6,914 patients aged ≥18 years who were diagnosed with chronic HBV mono-infection between 2000 and 2016, of whom 774 had been treated with tenofovir disoproxil (approved in 2008), while 6,140 were untreated. Propensity score matching was used to balance the groups, leaving the treated and untreated groups with 591 patients each (mean age 44.84 years, 59.31 percent male, 95.43 percent Asian). Patients were followed up for an average 42 months.
In the treated group, 34.85 percent of patients with cirrhosis had received prior treatment compared with 19.64 percent of patients without cirrhosis.
At 8 years, the overall cumulative incidence of HCC was significantly higher among patients who had not been treated compared with those who were treated with tenofovir disoproxil (20.13 percent vs 4.69 percent; p<0.0001), be it among patients with cirrhosis (69.67 percent vs 12.71 percent; p<0.0001) or without (5.81 percent vs 1.36 percent; p=0.029). [J Infect Dis 2018;doi:10.1093/infdis/jiy391]
After adjusting for age, sex, HBV DNA level, ALT level, and study centre, patients who had received treatment with tenofovir disoproxil had a reduced risk of developing HCC than those who were untreated (adjusted hazard ratio [adjHR], 0.34, 95 percent confidence interval [CI], 0.16–0.71; p=0.005), a finding demonstrated in cirrhotic (adjHR, 0.23, 95 percent CI, 0.56–0.92; p=0.038) and noncirrhotic patients (fibrosis stage ≤3; adjHR, 0.27, 95 percent CI, 0.07–0.98; p=0.047).
According to the researchers, viral loads were suppressed in all patients who were receiving tenofovir disoproxil at time of HCC diagnosis.
Overall, presence of cirrhosis (adjHR, 5.36, 95 percent CI, 2.73–10.51; p<0.001), male sex (adjHR, 2.28, 95 percent CI, 1.04–4.96; p=0.038), and age (adjHR, 1.37, 95 percent CI, 1.20–1.58; p<0.001) were factors associated with an increased risk of developing HCC.
Of the 28 deaths – 17 and 11 in the untreated and treated groups, respectively – five and three in each group were attributed to HCC.
“[W]e demonstrated that Asian patients with chronic hepatitis B, a patient population most affected with chronic hepatitis B-associated HCC, benefitted significantly with tenofovir disoproxil therapy whether cirrhosis was present or not,” said the researchers, who highlighted the importance of early diagnosis and appropriate treatment in reducing HCC risk. “[A]s HBV is more prevalent in the Asian population … our findings [are] especially relevant and encouraging for the treatment of HBV in this population.”
With Asians forming the bulk of the study population, the results may not extend to other ethnicities, and as such, further research is needed in other populations, in particular African Americans who are also at high-risk for chronic hepatitis B, they said.