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Clinical utility of viral load measurements in individuals with chronic hepatitis C infection on antiviral therapy
Author(s) -
Terrault N. A.,
Pawlotsky JM.,
McHutchison J.,
Anderson F.,
Krajden M.,
Gordon S.,
Zitron I.,
Perrillo R.,
Gish R.,
Holodniy M.,
Friesenhahn M.
Publication year - 2005
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/j.1365-2893.2005.00615.x
Subject(s) - viral load , bdna test , medicine , ribavirin , viral hepatitis , hepatitis c virus , immunology , virology , antiviral therapy , virus , chronic hepatitis
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.