Researchers Set to Study Hepatitis C Therapy in Children
Eileen Oldfield, Associate Editor
Eileen Oldfield, Associate Editor
Published Online: Saturday, October 4, 2014
The all-oral regimen will be tested in children aged 3 to 17 with a goal of curing hepatitis C without the flu-like side effects seen with traditional therapies. “Many times patients would be on the traditional medication but quit within a year,” said principal investigator Jeffrey Teckman, MD, in a press release. “It’s a cure rate of 50%.
The new study will consist of all-oral medication. That would mean no shots or flu-like side effects, and also much shorter course of treatment.” The FDA approved the all-oral medication regimen in 2013. More than 95% of patients achieved cure rates in clinical trials for the drug, and very few patients discontinued the therapy.
Furthermore, a study published in the April 2014 edition of Journal of Hepatology suggests that sofosbuvir therapy impacts patients’ health-related quality of life less than traditional interferon regimens. Researchers hope to see similar results in children, although their main aim is to determine whether side effects are as low in children as in adults.
The researchers will also investigate whether children will need extra time for the therapy to work. “I think this treatment is a real game changer,” Dr. Teckman said. “The previous treatments were arduous. People would often start the treatment, but eventually drop out. This new therapy is a revolution that affects people around the world.” Despite the adherence success seen in clinical trials, a recent study by the CVS Health Research Institute suggests that higher rates of patients are dropping off of sofosbuvir therapy, particularly if the patients were new to any hepatitis C treatment.
The analysis found discontinuation rates of 8.1% overall, with discontinuation rates of 8.7% in patients who were not previously treated for hepatitis C. The high price tag for sofosbuvir therapy tag has come under fire as well. Teckman believes the study will close the gap between pediatric and adult medical research. “A lot of times, studies for children don’t get approved,” Dr. Teckman said. “The exciting part with our study is that the medication has already been tested in adults, and we are moving rapidly to test it in children.”
Related
Sofosbuvir/Ribavirin - Adolescents and Children
Conditions: Hepatitis C Virus Infection
Drug: SOF
Drug: RBV
Phase 2
ClinicalTrials.gov Identifier: NCT02175758
Drug: SOF
Drug: RBV
Phase 2
ClinicalTrials.gov Identifier: NCT02175758
Ledipasvir/Sofosbuvir - Adolescents and Children
This study is not yet open for participant recruitment
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children With Chronic HCV-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children With Chronic HCV-Infection
Condition: Hepatitis C Virus Infection
Drug: LDV/SOF
Phase 2
ClinicalTrials.gov Identifier: NCT02249182
Drug: LDV/SOF
Phase 2
ClinicalTrials.gov Identifier: NCT02249182
View Additional Trials
Upcoming/Recruiting HCV Clinical Trials - Sofosbuvir Based Including Ledipasvir/Sofosbuvir
No comments:
Post a Comment