Abstract:
SUMMARY:Both absolute viral load and log decline in viral load from baseline were found clinically useful in predicting sustained virological response and lack of sustained virological response (non-sustained virological response, NSVR) to treatment. We assessed the clinical utility of hepatitis C virus (HCV) RNA quantitation and changes in viral load using the VERSANT HCV RNA 3.0 Assay (bDNA) in 351 HCV-infected individuals treated with interferon plus ribavirin. We show that viral load decision thresholds provided negative predictive values (NPVs) of >95% at week 4 using a 100 000 IU/mL cut-off and at weeks 8 and 12 using 10 000 IU/mL cut-offs. A 2-log decline from baseline provided NPVs >95% at weeks 8 and 12. Combinations of absolute viral loads and changes in viral load from baseline did not enhance the performance of the decision rules for predicting NSVR. The positive predictive values (PPVs) at weeks 8 and 12 were 59.1 and 67.3%. This study highlights the critical importance of viral quantitation in gauging therapeutic response in patients with chronic HCV infection on antiviral therapy. Early changes in viral load, measured as absolute viral loads or change in viral load from baseline, are highly predictive of NSVR at 8 and 12 weeks. PPVs are modest but these data may provide encouragement to patients who are in the early phases of treatment when side effects are frequent. Additionally, we demonstrated the need for cautious interpretation of stopping rules when the values are at or near the decision thresholds.
journal_name
J Viral Hepatjournal_title
Journal of viral hepatitisauthors
Terrault NA,Pawlotsky JM,McHutchison J,Anderson F,Krajden M,Gordon S,Zitron I,Perrillo R,Gish R,Holodniy M,Friesenhahn Mdoi
10.1111/j.1365-2893.2005.00615.xsubject
Has Abstractpub_date
2005-09-01 00:00:00pages
465-72issue
5eissn
1352-0504issn
1365-2893pii
JVH615journal_volume
12pub_type
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journal_title:Journal of viral hepatitis
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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