(HealthDay News) – In adolescents infected with hepatitis B virus (HBV), once-daily tenofovir treatment for 72 weeks effectively suppresses HBV DNA and normalizes alanine aminotransferase (ALT) values, regardless of prior HBV treatment exposure, according to research published in the December issue of Hepatology.
Karen F. Murray, MD, of the University of Washington School of Medicine in Seattle, and colleagues conducted a randomized, placebo-controlled trial involving 106 adolescents aged 12 to <18 years with chronic hepatitis B (CHB) infection who received either tenofovir disoproxil fumarate (DF; 52 adolescents) or placebo (54 adolescents) once daily for 72 weeks.
The researchers found that 89% of tenofovir-treated patients achieved a virologic response, defined as HBV DNA <400 copies/mL, compared with none of the placebo-treated patients. Response to treatment was not affected by prior HBV treatment. Over the 72-week study trial period, no tenofovir resistance was observed. For patients with ALT levels above the upper limit of normal at baseline, levels normalized in 74% of tenofovir-treated patients and 31% of placebo-treated patients. However, Grade 3 and 4 adverse events were more common in tenofovir- compared with placebo-treated patients (24% vs. 10%). At Week 72, no patients met the safety end point (6% decrease in spine bone mineral density).
“In conclusion, tenofovir DF therapy in HBV-infected adolescents was well tolerated and highly effective at suppressing HBV DNA and normalizing ALT values in both treatment-naive patients and those with prior exposure to oral HBV therapy,” the authors write. “Tenofovir DF is, therefore, a valuable treatment option for the management of CHB in adolescents.”
Several authors disclosed financial ties to pharmaceutical companies, including Gilead Sciences, which sponsored the study and markets tenofovir.