HealthDay News — For adolescents with chronic hepatitis C virus (HCV) genotype 1 infection, ledipasvir-sofosbuvir is highly effective, according to a study published in Hepatology.
William F. Balistreri, MD, 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%, 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%.
“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.
Balistreri WF, Murray KF, Rosenthal P, et al. The safety and effectiveness of ledipasvir−sofosbuvir in adolescents 12 to 17 years old with hepatitis C virus genotype 1 infection [published online December 20, 2016]. Hepatology. doi: 10.1002/hep.28995