946     A Comparison of Risk of Treatment Limiting Adverse Events in HCV-co-infected vs Non-co-infected persons with HIV in EuroSIDA JD Lundgren*1, J Rockstroh2, V Soriano3, B Ledergerber4, O Kirk1, E Vinogradova5, P Reiss6, C Katlama7, A Blaxhult8, A Mocroft9, and EuroSIDA Study Group 1Copenhagen HIV Prgm, Hvidovre Univ Hosp, Denmark; 2Univ of Bonn, Germany; 3Hosp Carlos III, Madrid, Spain; 4Zurich Univ Hosp, Switzerland; 5St. Petersburg AIDS Centre, St. Petersburg, Russia; 6Academic Med Ctr, Univ of Amsterdam, The Netherlands; 7Hosp Pitie-Salpetriere, Paris, France; 8Karolinska Hospital, Stockholm, Sweden; and 9Royal Free and Univ Coll Med Sch, London, UK

Background:  Liver damage associated with hepatitis C virus (HCV) may impede the likelihood of experiencing treatment-limiting adverse events from ART. Little information to address this concern is available from randomized clinical trials because patients with HCV co-infection are often excluded. To address this issue, treatment-limiting adverse effects were compared between patients with or without HCV in the EuroSIDA study.

Methods:  EuroSIDA is a prospective observational study. Persons were followed who stopped ART due to toxicities or patient or physician choice, and who had taken 2 nucleoside reverse transcription inhibitors (NRTI) since December 1998 (zidovudine [ZDV]/lamivudine [3TC], didanosine [ddI]/stavudine [d4T], d4T/3TC, other) with a third drug (abacavir [ABC], nelfinavir [NFV], indinavir [IDV], lopinavir/ritonavir [LPV/r], nevirapine [NVP], efavirenz [EFV], or other dual protease inhibitor [PI]-containing regimen) and with known HCV serostatus were studied for the incidence of stopping any ARV due to treatment-limiting adverse events. Incidence rate ratios (IRR) were derived from Poisson regression models.

Results:  Of the 4259 patients, 28% were HCV⁺. During 10,453 patient-years, 1727 patients stopped a nucleoside due to adverse events and 2011 stopped a third drug for this reason. In univariate analyses, the treatment-limiting adverse event rate (per 100 patient-years) was higher in HCV⁺ patients than HCV^–ve patients both for NRTI (18.4 vs 15.7; IRR 1.17; 95% CI 1.06 to 1.29) and for the third drug (22.9 vs 19.1; IRR 1.20; 95% CI 1.10 to 1.31). After adjustment for CD4 count, gender, exposure group, time since starting HAART, time on HAART, region, treatment regimen, there were no specific drugs for which there was a particularly marked negative effect of HCV infection on incidence of treatment-limiting adverse events (test for interaction p > 0.05).  

Conclusions:  HCV⁺ patients had a somewhat increased risk of treatment-limiting adverse events than those HCV^–ve, but no specific drugs had a particularly marked negative effect of HCV infection on incidence of adverse events. The presence of HCV should not necessarily influence the choice among ART.

Keywords: Hepatitis C virus; Treatment limiting adverse events; Antiretroviral treatment