ABSTRACT FINAL ID: 706
Article: Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Adolescents with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection.
Author/Source: Dr. Kathleen Schwarz / ABSTRACT # 706
There are on-going clinical trials with direct-acting antiviral medications to treat children infected with chronic hepatitis C. But to-date there has been very little data available to guide clinicians and pediatric care-givers on treatment decisions. The current study evaluated the safety and effectiveness (sustained virological rates(SVR)/cure) of Sovaldi (sofosbuvir) plus ribavirin to treat adolescents (12 to 17 year old) infected with HCV genotypes genotype 2 and 3.
Fifty adolescents were enrolled in the current clinical trial. Thirteen HCV genotype 2 adolescents were treated for 12 weeks and 37 HCV genotype 3 adolescents were treated for 24 weeks. All the adolescents were treated with Sovaldi plus ribavirin—the ribavirin dose was based on the adolescent’s weight (15mg/kg/day to a maximum of 1400 mg/day—divided into two doses a day. There was intensive blood sampling on day 7 in the first 10 patients to make sure that the ribavirin dose was safe and effective for the adolescents.
The cure rate was 100% for the genotype 2 adolescents and 97% for the genotype 3 adolescents. The side effects reported in more than or equal to 10% of the adolescents included headache, nausea, upper stomach pain, diarrhea and dizziness. No one stopped treatment due to side effects.
Editorial Comment: These are very good cure rates and this study supports treating adolescents with Sovaldi plus ribavirin especially for those who are in high need of treatment.
There are on-going studies of this therapy and others listed on our Clinical trials Reference Guide: http://hcvclinical.hcvadvocate.org/category/hcv-populations/children/
Sustained virologic response 12 weeks after elbasvir/grazoprevir (EBR/GZR, Zepatier) therapy ended (SVR12) reached 93% among HCV genotype 1 and 4 patients in the double-blind, placebo-controlled C-CORAL trial. SVR12 rates did not differ by sex, age or fibrosis stage.
HCV prevalence in the Asia/Pacific region and Russia ranges from 1% to 5%, with genotype 1b accounting for about half of infections. Fixed-dose one-tablet once-daily EBR/GZR is licensed for treatment of genotype 1 and 4 HCV in the United States, the European Union and elsewhere. C-CORAL collaborators conducted this trial to assess EBR/GZR efficacy and safety in Korea, Taiwan, Vietnam, Thailand, Australia and Russia. EBV is an NS5A inhibitor, and GZR is an NS3/4A protease inhibitor.
The phase 3 trial randomized 250 participants to immediate EBR/GZR and 86 to placebo for 12 weeks, followed by unblinding and EBR/GZR for the placebo group. All patients had HCV genotype 1, 4 or 6 and none had HIV; they could have compensated cirrhosis. The primary endpoint was SVR12 in the immediate EBR/GZR arm.