AEGiS-13IAC: Long term efficacy and safety of combination therapy with interferon alpha 2b and ribavirin for chronic hepatitis C in HIV-infected patients.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Long term efficacy and safety of combination therapy with interferon alpha 2b and ribavirin for chronic hepatitis C in HIV-infected patients.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrB656)

Landau A, Batisse D, Piketty C, Duong Van Huyen JP, Bloch F, Pialoux G, Belec L, Jian R, Weiss L, Kazatchkine MD
A. Landau, Hopital Broussais, 96, rue Didot, 75674 Paris Cedex 14, France, Tel.: +33 14 395 83 03, Fax: +33 14 395 95 24, E-mail: alain.landau@brs.ap-hop-paris.fr

BACKGROUND: to evaluate the long term efficacy and safety of a combination therapy of interferon-alpha 2b (IFN) and ribavirin for the treatment of chronic hepatitis C in coinfected HIV-seropositive patients.

METHODS: Sixty patients coinfected with HCV and HIV were enrolled in an open prospective trial.They were treated with IFN 3MU/tiw, in combination with ribavirin (500mg twice a day)for 6 or 12 months according to initial liver histology Knodell score.Tolerance and efficacy were monitored at weeks 12,24,36,48 and six months after the end of treatment. The primary endpoint was a complete end of treatment virological response (ETR), as defined by the lack of detectable HCV RNA in plasma. The second endpoint was a sustained virological response (SVR)6 months after the end of treatment.Intent-to-treat methodology was employed for all analyses.

RESULTS: At baseline patients exhibiting a mean CD4 cell count of 443±229 (x106/L)and alanine aminotransferase and aspartate aminotransferase were 117±74 and 105±64, respectively. The total Knodell score was 10.7±2.5, with 24(41%) patients exhibiting histological evidence of active cirrhosis.Nine(15%)patients discontinued the treatment prematurely based on adverse events. No impact on the course of HIV infection was observed.Twenty four patients (41%) exhibited ETR response and 16 (27%) a SVR. The number of CD4 T cells and HCV viremia at baseline were associated with a SVR (p > 0.05 and p > 0.01 respectively). HCV genotype 3a was predictive of a SVR (p > 0.02)

CONCLUSIONS: Ours results indicate that combination therapy with IFN and ribavirin is associated with 41% ETR and 27% SVR and may thus provide effective means of therapy in HIV-HCV coinfected patients.

Keywords: AEGIS, Ribavirin, Interferon Alfa-2b, Hepatitis C, Chronic, HIV Infections, Hepacivirus, CD4 Lymphocyte Count, Combined Modality Therapy, HIV Seropositivity, Treatment Outcome, Liver, Human
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ThOrB656