98 of 100 patients reached sustained virologic response at 12 weeks; no virologic failure observed
FRIDAY, Dec. 30, 2016 (HealthDay News) — For adolescents with chronic hepatitis C virus (HCV) genotype 1 infection, ledipasvir-sofosbuvir is highly effective, according to a study published online Dec. 20 in Hepatology.
William F. Balistreri, M.D., from the Cincinnati Children’s Hospital Medical Center, and colleagues conducted a phase 2 multi-center study to examine the efficacy and safety of ledipasvir-sofosbuvir in 100 adolescents (aged 12 to 17 years) with chronic HCV genotype 1 infection. Intensive pharmacokinetic evaluation of sofosbuvir, ledipasvir, and the sofosbuvir metabolite GS-331007 were conducted in 10 patients on the 10th day following initiation of dosing.
The researchers found that 98 patients reached a sustained virological response at 12 weeks after treatment (SVR12); the two patients who did not achieve SVR12 were lost to follow-up during or after treatment. Virological failure did not occur among the patients. The most commonly reported adverse events were headache, diarrhea, and fatigue (27, 14, and 13 percent, respectively). There were no reports of serious adverse events. When compared with adults from phase 2 and 3 trials of ledipasvir and sofosbuvir, the AUCtau and Cmax values for sofosbuvir, ledipasvir, and GS-331007 were within the predefined pharmacokinetic equivalence boundaries of 50 to 200 percent.
“Ledipasvir-sofosbuvir was highly effective in treating adolescents with chronic HCV genotype 1 infection,” the authors write. “The dose of ledipasvir-sofosbuvir currently used in adults was well tolerated in adolescents and had an appropriate pharmacokinetic profile.”
Several authors disclosed financial ties to pharmaceutical companies, including Gilead Sciences, which manufactures ledipasvir-sofosbuvir and funded the study.
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