Antivirals Benefit Hep B Patients With Normal or Elevated ALT

SAN FRANCISCO, CA—Antiviral therapy in patients with non-cirrhotic chronic hepatitis B (CHB) and normal to minimally-elevated alanine aminotransferase (ALT) levels significantly reduced the risk of hepatocellular carcinoma (HCC), reported Joseph K. Hoang from Stanford University Medical Center, Palo Alto, CA, at The Liver Meeting® 2015.

"In patients with ALT less than 2 times ULN [upper limit of normal], we also observed significantly higher HCC incidence in untreated patients compared to treated patients," the research team reported. Non-cirrhotic patients with ALT less than 2 times ULN who are older than 40 may benefit from antiviral therapy, they concluded.

The AASLD guideline for CHB identify ALT ≥2 times ULN as a major criteria to initiate antiviral therapy. 

"However, patients with ALT less than 2 times the ULN may still be at risk for future complications such as HCC," the researchers explained. They therefore sought to evaluate whether ALT levels below the AASLD guidelines threshold also affect HCC risk in patients with noncirrhotic CHB.

Their team performed a retrospective cohort study of 3,649 treatment-naïve, non-cirrhotic CHB patients age ≥40 years who had been evaluated at 4 U.S. clinics between 1991 and 2014, and in Taiwan during 1991–1992 as part of the REVEAL HBV Cohort. Patients were categorized as either ALT ≥2 x ULN (30 IU/L for men; ≥19 IU/L for women) or <2 x ULN.

In both categories, treated patients had significantly lower HCC incidence rates than untreated patients.

"At 10-year follow-up, the cumulative probability of developing HCC [in the ALT <2x ULN category] was 0.9% in the untreated group and 0% in the treated group," (P=0.0042) the researchers reported. For the ALT ≥2 x ULN category, the cumulative probability of HCC at 10-year follow-up was 12.7% vs. 5.2% in untreated and treated patients, respectively (P<0.0218), the researchers reported.

REACH-B score was a "significant, independent predictor of HCC, with each point increase in REACH-B score associated with a 36% increase in the development of HCC," they reported (hazard ratio [HR] 1.59; 95% CI: 1.49, 1.70; P<0.0001).

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