Journal of Viral Hepatitis
Volume 12 Issue 5 Page 465 - September 2005
doi:10.1111/j.1365-2893.2005.00615.x


Clinical utility of viral load measurements in individuals with chronic
hepatitis C infection on antiviral therapy
N. A. Terrault1, J-M. Pawlotsky2, J. McHutchison3, F. Anderson4, M.
Krajden4,5, S. Gordon6, I. Zitron6, R. Perrillo7, R. Gish8, M.
Holodniy9,
and M. Friesenhahn10
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.





Sandra Tara Balduf (Ane)

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