AEGiS-14IAC: Preliminary results of a randomized, controlled trial of pegylated interferon alpha 2-b with ribavirin vs interferon alpha 2-b with ribavirin for treatment of chronic HCV in HIV-1 patients.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Preliminary results of a randomized, controlled trial of pegylated interferon alpha 2-b with ribavirin vs interferon alpha 2-b with ribavirin for treatment of chronic HCV in HIV-1 patients.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeB9022)

Mallolas J, Laguno M, Murillas J, Sanchez-Tapias JM, Bianchi L, Miquel R, Garcia-Gasalla M, Blanco JL, Martinez E, Milinkovic A, Leon A, Lonca M, Gatell JM
Hospital Clinic, Barcelona, Spain

BACKGROUND: Although HCV is a major morbidity in HIV infected patients, current therapies has low success and high intolerance. We evaluate the efficacy and safety of interferon (IFN) + ribavirin (RBV) vs PEG-INF + RBV in co-infected patients.

METHODS: This is a randomized, single center, open label trial. Inclusion criteria for this trial: detectable HCV RNA, ALAT higher than 1.5 fold upper normal limit, abnormal liver histology, CD4 > 250/mm³ and HIV-1 RNA < 10.000 copies/mL on stable antiretroviral therapy. Patients were randomized to INF alpha 2-b 3 MIU tiw or PEG-IFN alpha 2-b 150 mcg qwk if body weight > 75 Kg or 100 mcg qwk if < 75 Kg. Each arm received RBV 800 mg per day if < 60 Kg, 1000 mg if 60-75 Kg and 1200 mg if > 75 kg. Primary endpoint was HCV RNA undetectable at week 24. Virologic responders (VR) continued therapy until week 48 if they had HCV genotype 1 or 4 and/or HCV RNA at baseline > 800.000 UI/mL.

RESULTS: Until April 2002, 117 eligible patients were randomized and 62 of them already started therapy. Age, gender, HCV- RNA, HCV genotype, undetectable HIV-RNA, CD4, fibrosis and necroinflamatory activity score at entry were not significantly different between arms. PEG had significantly higher VR (p=0.036) among the 43 and 23 patients who reached week 12 and 24 respectively. Almost all patients in both groups developed side effects related to the therapy mainly grade 1 or 2. Total CD4 fell in both arms (- 165 in PEG vs - 161 in INF arm) at week 12 and the median HIV-1 RNA viral load was undetectable at baseline and did not change at week 12.

CONCLUSIONS: For patients co-infected with HCV and HIV, PEG IFN alpha 2b + RBV is associated with superior VR compared with INF alpha 2b + RBV. Although side effects were very frequent, the majority of them were mild or moderate. Total CD4 fell in both arms but no evidence of deleterious effect on HIV-1 control were seen. Long-term efficacy and safety will be addressed with trial completion.

Keywords: AEGIS, Ribavirin, HIV-1, Hepacivirus, Interferon Alfa-2b, Viral Load, HIV Infections, Randomized Controlled Trials, Drug Therapy, Combination, Interferon Alfa-2a, Treatment Outcome, Antigens, CD4, Greece, polyethylene glycol-interferon alfa-2b, polyethylene glycol-interferon alfa-2A, Human, therapy, immunology, drug therapy

020707
LbPeB9022