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A RANDOMIZED CONTROLLED TRIAL OF PEGYLATED-INTERFERON ALPHA-2B + RIBAVIRIN VS
INTERFERON ALPHA-2B + RIBAVIRIN IN HIV CO-INFECTED PATIENTS
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S. Pol*, C. Perronne, F. Carrat, F. Banisadr, P. Morand, F. Lunel,
E. Rosenthal, *Presenting Author
ANRS HC02 - Ribavic, Paris, France
Background: HCV-related morbidity and mortality is increasing in HIV-infected
subjects and treatment of hepatitis C became a significant issue. Aim: To
compare the safety and efficacy of a 48 week-course of the standard
(IFNalpha2b: 3 MU x3/w, n=210) to the pegylated (PEG-IFNalpha2b: 1.5 mg/kg
x1/w, n=206) interferon + ribavirin combination (800mg/d, > 12 mg/kg/d).
Methods: A randomized trial in HCV-RNA-positive pts with chronic hepatitis,
CD4 > 200 and stable HIV-RNA. Results: The 416 pts (40 y, 73% M, 79% IVDU)
were given HAART in 80%; they had a mean CD4 cell count of 515 + or - 228/ml,
HIV RNA < 200 in 60% (mean viral load in others: 3.48 + or - 0.8 logs). Mean
Metavir score was A 1.8 + or - 0.7, F 2.3 + or - 1.0; 39% of pts had F3-F4. A
EOT virologic response was observed in 27% of IFN group pts and 44% of PEG
group pts (p=0.009), varying with genotypes: 19% in 1 and 4 vs 57% in 2 and
3. Treatment was discontinued in 124 pts (30%) and severe adverse events
occurred in 99 (24%) (42 IFN & 57 PEG-p=0.08). A significant decrease (p <
0.001) was observed at the early stage of treatment (W12) in Hb, lymphocytes
and more marked with PEG-IFN for neutrophils (p=0.0035) and platelets
(p=0.02). Conclusions: A 48 weeks course of PEG-IFNalpha2b + ribavirin
achieves more frequently a therapeutic virologic response than the standard
combination in co-infected patients and appears as the reference therapy.
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