Twelve weeks posttreatment follow‐up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin†

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Abstract
A sustained virologic response (SVR) in patients with chronic hepatitis C receiving pegylated interferon (PEG‐IFN) plus ribavirin is defined as undetectable serum HCV‐RNA at 24 weeks (W+24) posttreatment follow‐up. Viral load outcome in patients with virological relapse (VR) has not been explored. This study evaluated whether the assessment of serum HCV‐RNA 12 weeks (W+12) after the end of treatment was as relevant as W+24 to evaluate SVR in 573 patients who received combination PEG‐IFN and ribavirin and had a virological response at the end of treatment. Serum HCV‐RNA was measured, using a new assay based on transcription‐mediated amplification (TMA) with a lowest detection limit of 5‐10 IU/mL, at W+12 and W+24 after the end of treatment. VR was defined as reappearance of detectable HCV‐RNA at W+24 posttreatment follow‐up. The positive predictive value (PPV) of undetectable serum HCV‐RNA at W+12 was evaluated to identify patients with SVR, and the viral load outcome was measured in relapse patients. At the W+24 posttreatment follow‐up, 408 (71%) patients had an SVR, 181 (71.2%) were treated with PEG‐IFNα‐2a and ribavirin, and 227 (71.1%) were treated with PEG‐IFNα‐2b and ribavirin. At W+12, serum HCV‐RNA was undetectable in 409 patients, and 408 patients were SVR (PPV 99.7%, 95% confidence interval 99.1‐100). In relapse patients, serum HCV‐RNA levels were 5.623 ± 0.748, 4.979 ± 0.870, and 5.216 ± 0.758 log10 IU/mL at baseline, W+12, and W+24, respectively. Conclusion: Our results show that the assessment of serum HCV‐RNA 12 weeks after the end of treatment, using the highly sensitive TMA assay (PPV 99.7%), is as relevant as after 24 weeks to predict SVR and make decisions on the management of treated patients, suggesting a new definition for SVR. (HEPATOLOGY 2010.)

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