This investigator-initiated, open-label randomized trial was conducted in Vietnam between 2008 and 2010. One hundred and five treatment-na茂ve HCV genotype 6 patients were randomized to either 48-week (N = 70) or 24-week (N = 35) duration of pegylated interferon (PEG-IFN) alfa-2a 180 mcg/week and ribavirin (RBV) 15 mg/kg/day; 92 patients completed the study (63 in the 48-week and 29 in the 24-week group, respectively). Primary outcome was sustained virological response (SVR) as intention-to-treat analysis.
There was no statistical difference in SVR between 48-week and 24-week treated groups (71%vs. 60%, respectively; p = 0.24). In the 48-week and 24-week treatment groups, 81%and 80%of cases achieved rapid virological response (RVR) (p = 0.86), and 86%and 80%achieved complete early virological response (p = 0.45). Among those patients with RVR, SVR was in 86%(48-weeks), and 75%(24-weeks) of cases, whereas following non-RVR, only 8%of cases had an SVR with 48-week treatment duration.
Overall, RVR was achieved in the majority of genotype 6 patients and, in those patients, similar and high rates of SVR were noted following 24-week and 48-week therapy. This observation, however, needs validation in a larger study to demonstrate non-inferiority of the shorter duration therapy. In non-RVR patients, even 48-week therapy achieved low SVR rates.