Objectives: To describe the 28-day hepatitis C virus (HCV) kinetics under Pegylated-interferon (Peg-IFN) + ribavirin (RBV) therapy in HIV/HCV co-infected patients. To evaluate the predictive value of early virological response (EVR) of achieving a sustained virological response (SVR). To investigate the baseline mutations in the interferon sensitivity determining region (ISDR)2209–2248 in the non-structural 5A protein of HCV according to genotype.
Methods: Open, prospective trial including 28 co-infected patients with directly observed treatment with Peg-IFN + RBV. We assessed the predictive values of EVR (≥ 2 log10 of HCV decay or a negative qualitative test) at days 1, 7, 28 and in week 12 of the SVR.
Results: The SVR in an intention-to-treat analysis was 28.6% (genotype 1, 1/13; genotype 3, 6/10; genotype 4, 1/5). Patients who reached SVR presented a significantly faster HCV plasma viral load reduction compared to non-responders from the first 24 h [−1.06 log10 (interquartile range, −1.7 to −0.4) versus –0.05 log10 (interquartile range, −0.4 to +0.14) respectively; P = 0.002]. The median HCV viral load at week 12 was significantly different from that at baseline in responder and transient responders but not in non-responder patients. The positive predictive value was 100% within the first month and the best negative predictive value was 92% and 88.8% at weeks 4 and 12 respectively. The only genotype 1 responder patient had eight mutations in ISDR2209–2248.
Conclusions: A very early HCV viral decay is observed in responder patients. An early virological response assessment at week 4 and 12 might be a useful tool in the clinical management of the co-infected population.
From the HIV Clinical Unit, aIrsiCaixa Foundation, and the bHepatology and Gastroenterology Department. University Hospital Germans Trias i Pujol, Universitat Autónoma de Barcelona (UAB), Barcelona, Spain.
See also pp. 1, 67, 75, 121, 131
Correspondence to C. Tural, HIV Clinical Unit, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, 08916 Badalona, Barcelona, Spain.
Received: 9 July 2003; revised: 10 August 2003; accepted: 12 August 2003.