- Category: Approved HBV Drugs
- Published on Wednesday, 26 September 2012 00:00
- Written by Liz Highleyman
Teenagers with chronic hepatitis B virus (HBV) infection responded well to 2 years of treatment with tenofovir (Viread) in the first study of the drug in this population, researchers reported in the August 27, 2012, advance online edition of Hepatology.
Tenofovir disoproxil fumarate has been shown to be highly effective for suppression of HBV in chronically infected adults, but adolescents have been an understudied population.
Karen Murray from Seattle Children's and University of Washington School of Medicine and colleagues conducted a double-blind, placebo-controlled trial that included 106 adolescents, age 12 to 18 years, with chronic hepatitis B. Most (91%) were hepatitis B "e" antigen (HBeAg) positive and 85% had previously been treated for hepatitis B.
Participants were randomly assigned (1:1) to receive 300 mg tenofovir DF or placebo once-daily for 72 weeks. The primary endpoint was virological response at the end of treatment, defined as HBV DNA < 400 copies/mL
- 101 of the 106 enrolled participants completed all 72 weeks of treatment.
- 89% of tenofovir recipients experienced virological response, compared with none of the patients who received placebo.
- 85% of patients in the tenofovir arm achieved an even lower viral load < 169 copies/mL.
- Treatment response rates were similar in treatment-experienced participants and those being treated for the first time.
- Among people who started with alanine aminotransferase (ALT) levels above the upper limit of normal at baseline, 74% of tenofovir recipients experienced ALT normalization, compared with 31% of placebo recipients.
- Participants receiving tenofovir were significantly less likely than placebo recipients to experience serious grade 3 or 4 side effects (10% vs 24%, respectively).
- No participants experienced a 6% or greater decrease in spine bone mineral density at week 72.
- No HBV resistance to tenofovir was observed through week 72.
Based on these findings, the study authors concluded, "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 adolescents and those with prior exposure to HBV therapy."
The finding that tenofovir use was not associated with bone loss is reassuring, as this known potential adverse effect of the drug may be particularly detrimental in growing adolescents.
KF Murray, L Szenborn, J Wysocki, et al. Randomized, placebo-controlled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B. Hepatology. August 27, 2012 (Epub ahead of print).