Efficacy and Safety of Pegylated Interferon plus Ribavirin in HIV and Hepatitis C Virus–Coinfected Patients with Advanced Immunosuppression

Abstract

Background. The aim of this study was to assess the efficacy and safety of pegylated interferon (IFN) plus ribavirin (RBV) in human immunodeficiency virus (HIV) and hepatitis C virus (HCV)–coinfected patients with severe immunodeficiency in a clinical cohort. Methods. A total of 542 HIV-infected patients receiving treatment with pegylated IFN plus RBV from June 2001 through April 2007 were included in this study. The outcome variables were sustained virologic response (SVR) rate and the emergence of AIDS-defining events during HCV infection therapy. SVR rates among patients with a CD4 cell count 250 cells/mm3 at baseline were compared with those among patients with CD4 cell counts 1250 cells/mm3. The association between SVR and potential predictors was analyzed. Results. Ten (26%) of 39 individuals with a baseline CD4 cell count 250 cells/mm3 and 198 (39%) of 503 with baseline CD4 cell counts 1250 CD4 cells/mm3 achieved SVR (Pp.09). In a nested case-control study with populations matched at a 1:2 ratio, the SVR rate was 26% in the CD4 cell count 250 cells/mm3 group and 32% in the CD4 cell count 1250 cells/mm3 group (Pp.5). Baseline CD4 cell count ( 250 cells/mm3 vs 1250 cells/ mm3) was not associated with SVR in the multivariate analysis. Two (5%) individuals in the CD4 cell count 250 cells/mm3 group experienced opportunistic events during follow-up. In the CD4 cell count 250 cells/mm3 group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 16 (41%) and 12 (31%) patients, respectively. In the CD4 cell count 1250 cells/mm3 group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 29% (Pp.1) and 20% (Pp.1) of patients, respectively. Conclusions. The efficacy of pegylated IFN plus RBV in HIV-HCV–coinfected patients with advanced immunosuppression is substantial and not significantly different to that observed in the overall coinfected population. HCV therapy is generally safe in the population of coinfected patients with advanced immunosuppression.