3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

IMPACT OF SAFETY EVENTS ON SUSTAINED VIROLOGICAL RESPONSE (SVR) IN PATIENTS WITH HIV-HCV CO-INFECTION ENROLLED IN THE AIDS PEGASYS RIBAVIRIN INTERNATIONAL CO-INFECTION TRIAL (APRICOT)

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C19

Sulkowski M.¹, Pérez-Guzmán E.², Moreno S.³, Marinos G.⁴, Dieterich D.T.⁵, Clumeck N.⁶, Opravil M.^7
1Johns Hopkins University School of Medicine, Baltimore, United States of America, ²Hospital Universitario Puerta del Mar, Cádiz, Spain, ³Hospital Ramon y Cajal, Universidad de Alcala de Henares, Madrid, Spain, ⁴Prince of Wales Hospital, Sydney, Australia, ⁵Mt Sinai School of Medicine, New York, United States of America, ⁶CHU Saint-Pierre, Brussels, Belgium, ⁷University Hospital Zurich, Zurich, Switzerland

INTRODUCTION: We analyzed the impact of safety events on SVR rates in patients with HIV-HCV infection enrolled in APRICOT (NEJM 2004;351:438-50).

METHODS: HCV-treatment-naïve patients with HIV-HCV co-infection were randomized to PEGASYS® 180µg/wk plus COPEGUS® 800mg/day (RBV), PEGASYS plus placebo or interferon 3MIU tiw plus RBV for 48 wks. Events included in this analysis were treatment-related serious AEs, premature withdrawal because of AEs, laboratory abnormalities (neutrophils <0.75×10⁹/L, platelets <50×10⁹/L and/or hemoglobin <10g/dL) or depression. SVR was defined as serum HCV RNA<50 IU/mL at the end of untreated follow-up (wk72).

RESULTS: (ITT) 860 patients received ≥1 dose of study drugs. Among patients treated with PEGASYS/COPEGUS, treatment-related serious AEs and AE-related premature withdrawal were associated with the greatest reductions in SVR rates. In contrast, laboratory abnormalities and depression had minimal impact on SVR rates in this group.

CONCLUSIONS: If AEs can be prevented or treated without the need for premature withdrawal, it may be possible to improve SVR rates.

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Clinical | TuPe1.1C19 | Mark Sulkowski
Hepatitis viruses

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