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Tenofovir disoproxil fumarate effective in patients with high hepatitis B viral loads
Patients with chronic hepatitis B and a high viral load benefited from tenofovir disoproxil fumarate therapy, but may require a longer dosing schedule, according to recent results.
Researchers administered 48 weeks of 300 mg tenofovir disoproxil fumarate (TDF) or 10 mg adefovir dipivoxil (ADV), followed by 192 weeks of open-label TDF, to 641 patients with chronic hepatitis B. The cohort included 129 patients with a high viral load (HVL, defined as HBV DNA of at least 9 log10 copies/mL), of whom 82 initially received TDF and 47 received ADV.
Median HBV DNA levels at baseline were 7.34 log10 copies/mL for those without HVL and 9.52 log10 copies/mL for patients with HVL (P<.001). Among 489 evaluable patients at 240 weeks of treatment, HBV DNA below 400 copies/mL was observed in 98.3% of patients with initial HVL and 99.2% of those without. The groups displayed similar histologic regression rates, although investigators said the HVL group took longer to achieve the goal viral load, and patients who received TDF initially reached the goal faster than ADV patients.
Among patients who were hepatitis B e antigen-positive at baseline, hepatitis B surface antigen (HBsAg) loss was more common for those with HVL (19.3% of cases vs. 4.3%; P<.001). Anti-HBsAg seroconversion also was more common in patients with HVL at baseline (13.6% vs. 4.3%; P=.011).
Stuart C. Gordon
“There is a perception among clinicians that hepatitis B patients with extremely high viral levels may respond less well to therapy, may not become virus undetectable, and therefore might develop resistance mutations,” researcher Stuart C. Gordon, MD, director of hepatology at Henry Ford Health System and professor of medicine at Wayne State University School of Medicine, told Healio.com. “In our group of patients who were followed for up to 240 weeks, all patients became viral negative, and no patient developed resistant variants. … Patients with chronic hepatitis B who have extremely high viral levels ultimately respond just as well to tenofovir dipivoxil therapy as do those patients with lesser levels of virus.”
Disclosure: See the study for a full list of relevant disclosures.