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Prediction of Post-treatment Relapse Using Transcription Mediated Amplification at the End of PegIFN + Ribavirin Therapy in HIV/HCV-co-infected Patients
Beatriz Hernandez*1, A Machuca2, C Gutierrez1, N Fernandez3, C Quereda1, A Moreno1, M Perez Elias1, J Casado1, F Dronda1, and S Moreno1
1Hosp Ramon y Cajal, Madrid, Spain; 2Bayer Diagnostics, Madrid, Spain; and 3Carlos Haya Hosp, Malaga, Spain
Background: Relapse after successful end of treatment
response occurs in up to 20% of HIV infected patients treated for chronic
hepatitis C virus (HCV) infection with pegylated interferon (pegIFN) +
ribavirin (RBV). The use of the sensitive transcription-mediated amplification
(TMA) test may detect minimal residual viremia at the end of treatment and help
predict relapses.
Methods: HIV/HCV-co-infected patients treated for HCV infection with combined peg-IFN + RBV (administered for 12 months) who had
available stored samples, were selected. TMA (threshold 5 IU/mL) was done in
plasma samples collected at the end of treatment and 6 months after therapy
withdrawal (sustained virological response). Qualitative polymerase chain
reaction (PCR) (threshold 50 IU/ml) negative samples at end of treatment were
re-tested by TMA and the results were correlated with the virological outcome
after therapy withdrawal.
Results: Of the 47 patients who fulfilled the criteria
for analysis, 81% were men, median age was 39, and 77% were receiving HAART. With respect to HCV infection, the median baseline HCV RNA was
500,000 IU/mL with genotype distribution, G1 28%, G2 11%, G3 55%, and G4 6%.
Advanced liver fibrosis (F3-F4) was found in 41% of the patients. Among
patients with negative HCV RNA by PCR at end of treatment, 38 (81%) had sustained virological response and 9
(19%) were relapsers. TMA was positive in 5 of the 47 (11%) patients with
negative PCR at end of treatment. Of the 5 (80%) TMA-positive patients, 4 were
relapsers after therapy withdrawal, compared with 5 of the 42 (12%)
TMA-negative patients (p = 0.003).
Only 1 patient who was TMA positive at end of treatment had sustained virological response. The
sensitivity of the test was 44%, the specificity 97%, the positive predictive
value 80%, and the negative predictive value 88%.
Conclusions: TMA is highly specific to predict the relapse of HCV infection
in HIV/HCV-co-infected patients with negative PCR at the end of peg-IFN + RBV
therapy. TMA seems to be superior to PCR in identifying patients with sustained virological response.
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