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Abstract
Early hepatitis C viral kinetics prediction of SVR In HIV/Hcv co-infected patients treated with pegylated interferon-alpha 2B (PEG-LFN) and ribavirin (RBV)
Neumann A.1, Wu L.2, McLaughlin M.2, Koratich C.2, Rehm C.2, Masur H.3, Kottilil S.2, Polis M.2
1NIDDK, NIH, DHHS, Bethesda, MD, United States of America, 2LIR, NIAID, NIH, DHHS, Bethesda, MD, United States of America, 3CCMD, CC, NIH, DHHS, Bethesda, MD, United States of America
Introduction: HIV/HCV co-infected individuals have lower response to standard treatment of HCV than mono-infected patients. We studied the ability of early HCV kinetics to predict SVR to Peg-IFN and RBV in co-infected patients.
Methods: HIV patients co-infected with HCV genotype 1 (11 Caucasian; 12 African-American or AA; mean CD4 612 cells/mm3) were treated with weekly PEG-IFN-ALPHA2b 1.5 ug/kg and RBV 1200 mg qd for 48 wks. HCV–RNA was quantified by bDNA assay. Viral kinetic parameters were compared to historical controls of HCV-gen-1, mono-infected Caucasians treated with PEG-IFN-ALPHA2b 0.5 ug/kg (N=27) or 3.0 ug/kg (N=26) and RBV 800 mg qd (Buti et al, 2002)
Results: A rapid first phase viral decline was observed until day 1-3, which was different (P<0.05) between Caucasians and AA. A transient viral rebound was observed at days 3-7 in 22/23 patients, and at day 7 the mean viral decline from baseline was significantly (P<0.01) larger in Caucasians than AA. A second phase decline (weeks 1-4), was significantly (P<0.03) faster in Caucasians than in AA, and was correlated with viral load at day 3 (R=0.6, P<0.003). Viral kinetics did not significantly correlate with baseline ALT, CD4, HIV/HCV levels or age and gender. Viral kinetics in HIV/HCV co-infected Caucasians were not significantly different from historical mono-infected controls treated with Peg-IFN 0.5-1 ug/kg. SVR was achieved in 4 of 21 patients (19%). Lack of SVR could be predicted with NPV=100% by viral load >5 log cp/ml at day 28 (PPV=50%, Spec=77%) or at day 3 (PPV=67%, Spec=88%) independently of any baseline factor except genotype
Conclusions: SVR in HIV/HCV co-infected patients treated with Peg-IFN-ALPHA2b and RBV in this study can be accurately predicted at 4 weeks, or even as early as 3 days, of treatment. With the limitation of comparison across studies, HCV kinetics among HIV co-infected patients seem to be predominantly influenced by race and HCV genotype.
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