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Viral kinetics and early prediction of non response to pegylated interferon/ribavirin in HCV genotypes 1/4 according to HIV serostatus



Viral kinetics and early prediction of non response to pegylated interferon/ribavirin in HCV genotypes 1/4 according to HIV serostatus



Abstracts of the Interscience Conference on Antimicrobial Agents & Chemotherapy 43: 495



Background: Positive serum HCV RNA after 6 months of therapy correlates with failure in HCV monoinfection. Measuring the initial viral decline during therapy may identify non-responders. In HCV/HIV patients viral kinetics and the feasibility to predict non-response are undetermined. We compared in a population of genotypes 1/4 HCV patients, according to HIV serostatus, 6th month response rates, viral kinetics, the predictive value of initial viral decline and cut-off values predicting failure. Methods: Prospective study of 84 genotype 1 or 4 (n=77 and 7) naive HCV patients after 24 weeks of weight-adjusted peg-interferon alfa-2b and ribavirin: group 1, 50 HIV (-); group 2, 34 HIV (+). HCV RNA was evaluated at day 0 and week 4 in both groups, and at week 12 in group 2, to assess viral decay and to determine the most sensitive cut-off value of viral decay at week 4 predicting 6th month failure. Results: Group 1 vs group 2: mean baseline HCV RNA, 5.6 vs 5.7 log10 (p=0.33); 6th month virological response 60% vs 38% (p=0.05). Median viral decay at week 4, -1.94 vs -0.45 log10 (p=0.04). The most sensitive cut-off values of viral decline at week 4 predicting 6th month failure, <1 log10 for group 1 (13/20, 65%; sensitivity (Se) 100%, specificity (sp) 33%, PPV 70%, NPV 100%) vs 0 log10 (no decline or increase from baseline) for group 2 (8/21, 38%; Se 100%, sp 38%, PPV 50%, NPV 100%). ROC curves areas, 0.96 (95% CI 0.91-1.0) and 0.82 (95% CI 0.68-0.98), respectively. In group 2, the cut-off value at week 12 predicting 6th month failure was <0.6 log10 (9/19, 47%; Se 100%, sp 59%, PPV 57%, NPV 100%). Conclusions: Serum HCV RNA decays at week 4 are correlated to 6th month treatment failure, regardless HIV serostatus, and allow early discontinuation in a significant proportion of non-responders (65 and 37%). Significant differences in viral dinamycs/cut-off values predicting non-response suggest a slower viral clearance in HCV/HIV coinfection.

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Accession: 036038227

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