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Tenofovir effectively treated adolescents with chronic HBV
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Tenofovir disoproxil fumarate, used to treat adults with chronic hepatitis B, was effective and well tolerated in a cohort of adolescents with the illness in a recent study.
In a double blind, multicenter, phase 3 trial, researchers randomly assigned 106 adolescents (aged 12 to 17 years) with chronic hepatitis B (CHB) to receive either 300 mg tenofovir disoproxil fumarate (DF) (n=52) or placebo (n=54) once daily for 72 weeks. Evaluated factors included treatment response at 72 weeks (defined as HBV DNA levels below 400 copies/mL) and changes to HBV and alanine aminotransferase (ALT) levels over time.
Eighty-nine percent of patients who received tenofovir DF achieved virologic response at 72 weeks, compared with none of those receiving placebo (P<.001). Treated patients had DNA levels below 169 copies/mL at week 72 in 85% of cases. Virologic breakthrough occurred in four treated patients who had undetectable plasma levels of tenofovir DF, indicating nonadherence to treatment.
Most patients (73%) had elevated ALT levels at baseline (mean 101 U/L). Upon trial completion, 77% of treated patients had normal ALT levels, compared with 39% of placebo recipients (P<.001). Mean ALT among tenofovir DF recipients decreased to approximately 44 U/L by week 16 and remained at or below this level for the trial’s duration.
Adverse events occurred in 85% of tenofovir DF recipients and 89% of placebo recipients, with grade 3/4 events more common in the placebo group (24% vs. 10%). Commonly reported events included pharyngitis, acne, increased ALT and upper respiratory tract infection. Increased ALT (P=.024), acne (P=.029) and lymphadenopathy (P=.027) occurred more frequently among placebo patients. No deaths occurred during the trial, and no participants experienced a decrease of 6% or more in lumbar spine bone mineral density.
“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 researchers concluded. “No resistance to tenofovir DF was observed through week 72. Tenofovir DF is, therefore, a valuable treatment option for the management of CHB in adolescents.”
References:
Murray KF. Hepatology. 2012;56:2018-2026.
Disclosure: The researchers report numerous financial disclosures.