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Rapid Virological Response at Week 4 Predicts Sustained Response to Pegylated Interferon + Ribavirin among HIV/HCV-co-Infected Patients
José A. Mira*1, B Valera-Bestard2, A Arizcorreta-Yarza3, M González-Serrano4, A Rivero5, I Santos6, S Vergara1, A Gutierrez-Valencia2, J Girón-González3, J Pineda1, and Grupo Andaluz para el Estudio de las Enfermedades Infecciosas (GAEI)
1Hosp Univ de Valme, Seville, Spain; 2Hosp Univ Virgen del Rocío, Sevilla, Spain; 3Hosp Univ Puerta del Mar, Cadiz, Spain; 4Hosp Univ Virgen de la Victoria, Malaga, Spain; 5Hosp Univ Reina Sofia, Cordoba, Spain; and 6Hosp Univ de la Princesa, Madrid, Spain
Background: The clinical applicability of
the early viral kinetic at
week 4 in predicting sustained
virological response of pegylated interferon (pegIFN) + ribavirin (RBV) in
HIV/HCV-co-infected patients is unclear. For this reason, we undertook this study, whose objective was to
assess if rapid virological response at week 4 of therapy could predict sustained
virological response among HIV-infected patients with chronic hepatitis C
treated with the combination of pegIFN + RBV.
Methods: All HIV/HCV-co-infected patients who received
pegIFN + RBV from June 2000 to February 2006 at 6 university hospitals in Spain
and in whom a HCV viral load determination has been carried out at week 4 of
therapy were included in the study. The positive predictive value and the
negative predictive value of rapid virological response (undetectable serum HCV
RNA) for sustained virological response were calculated in the overall
population and after categorizing the patients according to HCV genotype,
baseline HCV RNA level, liver fibrosis stage, type of pegIFN and daily RBV
dosage. Receiver operating characteristic curves were used to determine the
best cut-off of HCV RNA decrease to predict treatment failure.
Results: A total of 101 HIV/HCV-co-infected
patients were included in this study. Rapid virological response and sustained
virological response were observed in 37 (37%) and in 49 (48%) individuals,
respectively. Of 64 patients without rapid virological response, 51 did not
show sustained virological response (negative predictive value 80%), whereas of
37 individuals with rapid virological response, 36 finally achieved sustained
virological response (positive predictive value 97%). Among the 16 patients
with HCV genotype 3 who were treated for 24 weeks, the positive predictive
value of rapid virological response was 100%. When the data were grouped by
other features, the positive predictive value did not differ significantly from
the values found in the overall population and the negative predictive value varied
from 42% to 85%. The highest negative predictive value (96%) was reached by using
a cut-off level of HCV RNA decrease of 0.6 log10. By applying this
cut-off level, treatment could have been discontinued in 24 (24%) of
patients.
Conclusions: An undetectable serum HCV RNA
determination at week 4 of treatment with pegIFN + RBV is a reliable predictor
of sustained virological response in HIV/HCV-co-infected patients. In addition,
a decay of HCV RNA <0.6 logs10 at this point of treatment could
identify an appreciable proportion of individuals who will fail to achieve sustained
virological response. The use of these cutoff points may lead us to predict
reliably the rapid virological response after 4 weeks of therapy in as many as
60% of patients, which could contribute to save unnecessary adverse effects and
money and to improve the management of these individuals.
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