Background/aims: Albinterferon alfa-2b is a novel, long-acting, fusion polypeptide that is dosed q2wk or q4wk. The predictive value of early virologic response during albinterferon alfa-2b or peginterferon alfa-2a treatment was investigated in interferon-naïve patients with genotype 1, chronic hepatitis C.
Methods: Four hundred and fifty-eight patients were randomized to: albinterferon 900 or 1200 microg q2wk, or 1200 microg q4wk, or peginterferon 180 microg qwk. HCV RNA was measured by real-time PCR. A linear exhaustive search algorithm was used to determine the best SVR prediction algorithm in the per-protocol population (n=368), with inclusion of key ITT analyses to assess impact.
Results: SVR rate: 54-67% (P=NS between arms). Rapid initial virologic response rate at week 2 (RIVR; viral decline >2 log(10)IU/mL) was 32-50% and gave rise to positive predictive value of 88-97% for SVR. No initial virologic response at week 4 (NIVR; viral decline <2 log(10)IU/mL; viral load >5.5 log(10)IU/mL) demonstrated a 100% negative predictive value for SVR. A sequential prediction algorithm based on viral kinetics at weeks 2 and 4 identified four prediction groups that reliably predicted SVR, positively or negatively, in 65-72% of patients.
Conclusions: Improved SVR prediction was obtained by integrating absolute levels and reduction of HCV RNA at treatment week 2 and 4. Patients with RIVR had a high likelihood of achieving SVR.
Trial registration: ClinicalTrials.gov NCT00115908.