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Caucasians Had Better HCV Viral Load Reductions Than African-Americans During First 3 Days & During Weeks 1-4 After Starting Peg/RBV
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Reported by Jules Levin
IAS-Rio July 2005
Poster WePp0304
"Early hepatitis C viral kinetics prediction of SVR in HIV/HCV co-infected patients treated with pegylated interferon-alpha 2B (PEGLFN) 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
2 STUDY POINTS
--caucasians had HCV viral load reductions by day 3 compared to African-Americans, as well as during the second phase viral load decline (weeks 1-4).
--viral load levels at day 3 predicted second phase viral load decline, which suggests viral load decline may predict SVR but not necessarily not achieving SVR; if viral load suppression is good at day 3 this gives a good indication that you will achieve SVR 6 months after stopping 48 weeks therapy. But achieving a 2 log reduction or undetectable at week 12 is still probably a better predictor of outcome. You may have a good viral response at day 3 but not achieve 2-log reduction at week 12 or an SVR, 12 weeks response is probably better predictor of failure. In sum, a good viral load reduction by day 3 should indicate you are likely to achieve SVR, but check again at week 12 for a better indication.
ABSTRACT
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-ALPHA 2b 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-ALPHA 2b 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. (ED NOTE from Jules Levin: perhaps using standard IFN daily at 5 million units during first week of therapy would prevent this rebound and increase SVR rates.
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.
1st Phase Viral Load Reduction (day 1-3)
-0.96 for Caucasians
-0.51 for African-Americans (p<.01)
2nd Phase Viral Load Reduction (weeks 1-4)
-0.52 Caucasians
-0.24 for African-Americans (p<.01)
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 5 of 22 patients (23%). 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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