Harvoni safe, effective in adolescents with HCV
BARCELONA — Adolescents treated with Harvoni achieved 97% rates of sustained virologic response, similar to that of adult counterparts, a presenter said here at the International Liver Congress.
“Direct acting antivirals have transformed the treatment of adults with chronic hepatitis C, but the standard of care for children and adolescents is still limited to the formulation of pegylated interferon plus ribavirin treatment for a time period of 24 to 48 weeks,” Sanjay Bansal, MD, from Kings College Hospital, London, said during his presentation. “This fixed-dose combination of ledipasvir and sofosbuvir represents an important treatment option for adolescent patients with chronic hep C infection.”
In this first interferon-free trial in adolescents, Bansal and colleagues conducted an open-label study using Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) to treat 100 adolescents aged 12 to 17 years, both treatment-naive and treatment-experienced, with and without cirrhosis.
They performed a pharmacokinetic lead-in with the first 10 patients to confirm the dose used in the approved-for-adults version of the combination was suitable for adolescents. The mean age of the participants was 15 years, 81% had genotype 1, 20% were treatment-experienced and only one participant had cirrhosis.
The pharmacokinetic study showed that the fixed-dose combination already in use for adults produced plasma exposures comparable to those seen in adults.
Overall, 97 of the 100 patients achieved SVR12, Bansal said, with three lost to follow-up after achieving SVR4. All 20 of the treatment-experienced patients achieved SVR12 while the only patient with cirrhosis, who happened to be treatment-naive, also achieved the clinical endpoint.
When considering safety, Bansal showed that while 72% of participants had an adverse event, they were all mild to moderate.
This study has been extended with the same fixed-dose combination in children aged 3 to 12 years, Bansal said. – by Katrina Altersitz
Bansal, S. GS17. Presented at International Liver Congress. April 13-17, 2016; Barcelona.
Disclosure: This study was funded by Gilead Sciences.