Three-year follow-up after antiviral treatment in new-onset type 1 diabetes. Results from the Diabetes Virus Detection and Intervention trial.
Objective
In the Diabetes Virus Detection and Intervention trial, antiviral treatment with pleconaril and ribavirin was shown to decrease the decline in endogenous C-peptide one year after diagnosis of type 1 diabetes in children and adolescents compared to placebo. This paper reports the results two and three years after diagnosis.
Research Design and Methods
This was a multicenter, randomized, placebo controlled (1:1) trial of 96 newly diagnosed children and adolescents aged 6-15.9 years. Antiviral treatment (pleconaril and ribavirin) or placebo was given for six months from diagnosis, and participants were followed for three years. The primary outcome was residual C-peptide secretion, assessed by 2-h mixed-meal tolerance test, reported as the area under the curve (AUC). Secondary outcomes included insulin doses and hemoglobin A1c.
Results
At the three-year follow-up, 75 participants attended. At two years, the mean ± standard deviation AUC C-peptide in the placebo group was 0.27 ± 0.33 compared to 0.34 ± 0.37 in the pleconaril and ribavirin group. After three years, the AUC had decreased to 0.17 ± 0.23 and 0.25 ± 0.34 respectively. There was no statistically significant difference between the groups. The groups were also comparable with regard to secondary endpoints.
Conclusions
The decreased reduction in C-peptide levels after antiviral treatment is no longer present after two or three years. Further investigations are needed to explore options to use antiviral treatment in the prevention and treatment of type 1 diabetes.