[LbOr16] RIBAVIC trial (ANRS HC02): a controlled randomized trial of pegylated-interferon alfa-2b plus ribavirin vs interferon alfa-2b plus ribavirin for the initial treatment of chronic hepatitis C in HIV co-infected patients : Preliminary results

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] RIBAVIC trial (ANRS HC02): a controlled randomized trial of pegylated-interferon alfa-2b plus ribavirin vs interferon alfa-2b plus ribavirin for the initial treatment of chronic hepatitis C in HIV co-infected patients : Preliminary results

[AUTHOR(S):] Christian Perronne, Fabrice Carrat, Firouze Bani Sadr, Thidaravy Hor, Patrice Morand, Francoise Lunel, Eric Rosenthal, Stanislas Pol, Patrice Cacoub, For the ANRS HC02 Study group¹

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. LbOR16

BACKGROUND: HCV morbidity and mortality is increasing in HIV-infected patients. We compared the safety, tolerability, and efficacy of a 48 week-course of the standard (IFNa2b: 3 MIU x3/w, n=210) to the pegylated (PEG-IFNa2b: 1.5 µg/kg x1/w, n=206) interferon + ribavirin combination (800mg/d, = 12 mg/kg/d).

METHODS: A randomized, multicenter, parallel-group, open-label trial. Inclusion criteria were: HCV-RNA positive and abnormal liver histology , CD4 > 200/ml, stable HIV-RNA, stable HAART or off HAART. Primary endpoint was the virologic response rate (loss of detectable serum HCV RNA) at week 72.

RESULTS: The 416 patients (40 y, 73% male, 79% IVDU) were given HAART in 80%; they had a mean CD4 cell count of 515 ± 228/ml, HIV RNA < 200 cp in 60% (mean viral load in others: 3.48 ± 0.8 logs) and belonged to the CDC class A, B & C in 56, 28 & 16% respectively. The mean pre-treatment Metavir score was A 1.8 ± 0.7, F 2.3 ± 1.0, 39% of pts had F3-F4 of which 16% had sustained normal ALT. Baseline variables at entry were not different between groups. In tested serum samples, a virologic response at W48 was observed in 27% of IFN group pts (n=118) and 44% of PEG group pts (n=110)- p=0.009. The response rate varied with genotypes 1 and 4 (19%) vs 2 and 3 (57%), but not with the Metavir score or the adjusted ribavirin dose for bodyweight. Treatment discontinuation have been reported in 124 pts (30%) and severe adverse events in 99 (24%)(42 IFN & 57 PEG). A significant decrease (p<0.001) was observed at the early stage of treatment (W12) in Hb (IFN: -1.5g/dl; PEG :-1.8g/dl; p=0.04), neutrophils (IFN: -693;PEG: -1298; p=0.0035), lymphocytes (IFN: -317; PEG: -542; p=0.12; including -44 CD4 and -69 CD4, p=0.21) and platelets (IFN: -16.000; PEG: -33 000; p=0.02).

CONCLUSIONS: PEG-IFNa2b + ribavirin is associated with a superior HCV virologic response and a quite similar adverse-event profile at the end of treatment. Long term response will be further evaluated.

Presenting author: Christian Perronne

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1ANRS, Paris, France.

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