The labeling for Viread (tenofovir disoproxil fumarate; Gilead Sciences) has been updated to include use in chronic hepatitis B patients aged 2 to <12 years old based on safety, efficacy, and pharmacokinetic data from the GS-US-174-0144 trial.
The Indication section has been revised to state that Viread is intended for use in the treatment of chronic hepatitis B in adults and pediatric patients 2 years of age and older weighing at least 10kg. The Dosage and Administration section was also updated to distinguish Viread tablets from Viread oral powder for ease of use by the provider; the revision also highlights that the dosing is the same for both HIV and HBV indications.
In Trial 144 (N=89), HBeAg positive patients aged 2 to <12 years were assigned to Viread 8mg/kg (max 300mg dose) or placebo once daily for 48 weeks. At week 48, 77% of Viread-treated patients had HBV DNA <400 copies/mL vs 7% of placebo-treated patients. The safety and efficacy of Viread in patients <2 years and weighing <10kg have not been established. ALT normalization was seen in 66% vs 15% of patients in the Viread and placebo groups, respectively. HBeAg seroconversion was seen in 25% and 24% of patients treated with Viread and placebo, respectively.
Safety data from Trial 144 showed the mean percentage bone mineral density (BMD) gains from baseline to week 48 in lumbar spine and total body BMD in Viread-treated patients were less than the mean percentage BMD gains seen in placebo-treated patients. Also at week 48, the cumulative percentage of patients with ≥4% decreases in spine or whole body BMD was numerically higher in the Viread group vs the placebo group. Height was not affected for the duration of the clinical trial.
Viread, a nucleotide analogue (HIV-1 and HBV reverse transcriptase inhibitor), is also approved to treat HIV-1 infection in combination with other antiretrovirals in children and adults.
Viread is available as 150mg, 200mg, 250mg, and 300mg strength tablets in 30-count bottles. It is also supplied as a 40mg/g oral powder in 60g bottles.
For more information call (800) 445-3235 or visit FDA.gov.