Abstract
Purpose: Although current HCV antiviral treatment algorithms reliably predict virologic nonresponders at TW12, a method to identify potential relapsers remains unclear. We sought to determine whether available clinical data could predict those patients likely to experience relapse. Methods: 52 consecutive treatment naïve chronic HCV genotype 1 patients received PEG/ribavirin therapy (weight based) for 48 weeks. Therapy was stopped in those patients who did not achieve EVR (greater than 2 log decline) at TW 12 or viral negativity at TW 24. Liver biopsies were performed within one year of therapy and were scored by an individual pathologist (Ishak). We assessed HCV RNA levels (Bayer Versant quantitative with reflex TMA qualitative) at TW 4, 8, 12, 16, 20, 24, 48 and at week 24 follow-up. We examined factors (BMI, baseline viral load, and fibrosis stage) that might affect relapse rate. We also assessed whether late virologic response (HCV RNA positive at TW 12 and negative at TW 24) or duration of viral negativity were associated with subsequent relapse. We used two sample t-tests and the Wilcoxon rank sum tests to assess significance. All data were expressed according to ITT analysis. Results: The mean age was 49 yrs (range, 33–71), 57% men; 81% Caucasian, 13% AA, 6% Asian. The SVR rate was 44% (23/52) and relapse rate was 13% (7/52). 6/52 discontinued treatment prematurely. The median baseline viral level for SVR was 1,275,000 IU and 1,490,000 IU for relapsers (p = 0.90). The mean time to viral negativity was 15.5 weeks for those patients who achieved SVR and 22.3 weeks in those who relapsed (p < 0.001). No relapser became viral negative before TW 20. There was a trend toward higher mean BMI and among relapsed compared to SVR patients. The mean BMI in patients with an SVR was 25.5 (range, 21.3–32.5), and 27.7 (range 23.7–32.7) for relapsers (p = 0.096). 7/23 (30%) of SVR patients and 2/7 (28%) of relapsers had advanced fibrosis or cirrhosis (p = 0.89). 16/52 (30%) genotype 1 patients failed to achieve EVR or viral negativity at TW 24. Conclusions: (1) The rate of virologic relapse is directly related to time to first HCV RNA negativity. (2) Relapsers have a shorter duration of viral negativity during therapy than do sustained responders on a 48-week treatment regimen. (3) These findings corroborate recent reports suggesting that extending HCV antiviral therapy from 48 to 72 weeks lowers relapse rates in the cohort of patients with a late virologic response.
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