574   Efficacy and Tolerance of IFNα;Plus Ribavirin for Chronic Hepatitis C in HIV-Infected Patients.

M. Bochet, M. De Torres, M. A. Valantin, V. Thibault, T. Poynard, C. Katlama, and Y. Benhamou.
Hosp. Pitié-Salpêtrière, Paris, France.

Background:IFNα;plus ribavirine has been poorly studied in HIV/HCV-coinfected patients. We studied retrospectively efficacy and tolerance of IFNα;plus ribavirin for the treatment of HCV infection in HIV-infected patients.

Methods:Demographic, clinical, biological, virological and liver histology (METAVIR scoring system) findings of 56 HIV/HCV-coinfected patients (mean age, 36.5+1.5 years, 42 male and 14 female) treated with IFNα;(3 MU TIW) and ribavirin (800—1200 mg daily) for 6, 9 or 12 months were recorded. Early and sustained responses were defined as a negative HCV RNA PCR at the end of treatment and 6 months after the end of treatment, respectively. Response rate was analyzed in intent to treat.

Results:Thirty patients (54.6%) were naive of anti-HCV therapy, and 26 patients (46.4%) failed to respond to a previous course of INFα;monotherapy. Mean baseline HCV and HIV RNA, CD4 count and liver fibrosis scores were 6.9+0 .1 log₁₀copies/mL, 2.74+0.08 log₁₀copies/mL, 377+27 cells/µL and 2.8+0.1 (cirrhosis, n = 13), respectively. Thirty-five patients (62.5%) had an HCV genotype 1 infection. Fifteen patients withdrew for serious adverse events after a median period of 4.5+2.7 months of treatment, including: anemia (n = 4), depression (n = 5), asthenia (n = 5), angor (n = 1), and neuropathy (n = 1). Of the remaining 38 patients, 10, 3 and 25 patients were treated for 6, 9 and 12 months, respectively. Early response was obtained in 11 of 56 studied patients (19.6%); this rate was not different in IFNα;-pretreated (19.2%) and naive (20%) patients, p = 0.7. All early responders but 1 had a sustained response. Early and sustained responses were not influenced by previous course of IFNα;therapy, HCV genotype 1, baseline HIV RNA, CD4 count and liver fibrosis; only baseline HCV RNA (<6.47 log₁₀copies/mL) was associated with sustained response (p = 0.01, multivariate analysis). Treatment was poorly tolerated; moderate or major asthenia (n = 33) and psychiatric symptoms (n = 10) were the main observed side effects. We did not observe significant change in CD4 count or HIV RNA.

Conclusions:IFNα;plus ribavirine led to a sustained negativation of HCV RNA in 17.8% of HIV/HCV-coinfected patients. This modest efficacy was associated with a high prevalence of side effects.