14th International AIDS Conference Barcelona, Spain — July 7-12, 2002

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. ThPeC7492

BACKGROUND: To evaluate the efficacy and safety of therapy with IFN and RBV for the treatment of chronic hepatitis (CH) C in HIV-infected patients.

METHODS: Open prospective trial between Dec-99 and Jul-01 in 26 patients coinfected with hepatitis C virus (HCV) and HIV, diagnosed of CH by means of a biopsy. We performed CD4 cells count, HIV viral load, hematology, biochemistry at baseline and weeks 8, 16, 24, 48 y 72. HCV viral load was performed at baseline and weeks 16, 24, 48 y 72. Patients were treated with IFN 3 MU 3 times a week and RBV 1-1,2 g daily for 6 months (genotype 2-3) or 12 months (genotype 1-4). 23 patients were on HAART. Primary endpoint was a sustained viral response, defined by the lack of HCV RNA in serum 6 months after the end of treatment. Results are described as intention to treat.

RESULTS: Males 22, females 4. Mean age 36,5 yo. Mean CD4 cells count: 632x10<6>/L (r:180-1186). Mean serum HIV RNA (log): 2,76 (r: 2,6-3,7). HCV genotype: 1a-1b, 13; 2b, 1; 3a, 10; 4, 2. Median baseline ALT and AST: 118 and 78 IU/ml. Adverse events: flu-like syndrome in 22, insomnia in 10, weight loss in 9. 3 patients withdrew the therapy due to flu-like syndrome. 1 patient commited suicide in week 18. RBV was withdrew in 1 patient due to severe anemia and the dose of RBV was diminished in 4 patients in week 2 due to anemia. There was no impact on the level of HIV RNA. All patients showed absolute decrease in CD4 cells count. 6 months after the end of the treatment, 7 patients (27%) exhibited undetectable HCV RNA (their genotype was: 1, 1a; 5, 3a; 1, 4). Median levels of ALT and AST of all patients decreased at the end of treatment to 37 and 34.

CONCLUSIONS: Our results show that combination therapy is effective in 50% of cases of genotype 3 by achieving sustained viral response, but only in 1 of 13 with genotype 1. There were no interferences in surrogate markers of HIV infection and in most of the cases adverese events were of no importance.

Presenting author: Santos, I.

1Servicio de Medicina Interna, Hospital Universitario de la Princesa, Servicio de Medicina Interna, Hospital Universitario de la Princesa, Diego de Leon, 62, 28006-Madrid, Spain

2Servicio de Medicina Interna, Hospital Universitario de la Princesa, Servicio de Medicina Interna, Hospital Universitario de la Princesa, Diego de Leon, 62, 28006-Madrid, Spain

3Servicio de Medicina Interna, Hospital Universitario de la Princesa, Servicio de Medicina Interna, Hospital Universitario de la Princesa, Diego de Leon, 62, 28006-Madrid, Spain

4Servicio de Medicina Interna, Hospital Universitario de la Princesa, Servicio de Medicina Interna, Hospital Universitario de la Princesa, Diego de Leon, 62, 28006-Madrid, Spain

5Servicio de Medicina Interna, Hospital Universitario de la Princesa, Servicio de Medicina Interna, Hospital Universitario de la Princesa, Diego de Leon, 62, 28006-Madrid, Spain

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ThPeC7492

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