title: Nelfinavir in HIV-HCV coinfected patients: a 24-month follow-up in a cohort of 82 patients.
abstract: This retrospective and longitudinal study evaluated the long-term hepatic tolerance of a nelfinavir (NFV)-antiretroviral combined regimen in 82 patients of the HCV-HIV Cohort of CISIH-Sud of Marseilles. Follow-up data (liver enzyme levels, CD4 cell count, HIV viral load, and metabolic parameters) of patients treated with NFV on inclusion or during the follow-up of the cohort were analyzed under treatment over 24 months. Comparisons were performed with X2 or Kruskal-Wallis tests. At baseline (n = 82), the median exposure to NFV was 4.1 months; 58 patients received NFV combined with NRTI and 24 with NNRTI. The median CD4 cell count was 337/mm3 [interquartile range (IR): 216-480) and 39.7% had an undetectable HIV RNA level. Qualitative HCV PCR was positive in 91% of the patients and 19/51 patients with liver biopsy were F3-F4. Median alanine and aspartate aminotransferase (ALAT, ASAT), gamma-glutamyltransferase (GT), and alkaline phosphatase (ALP) were 46 UI/liter (IR: 36-76), 55 UI/liter (IR: 32-97), 97 UI/liter (IR: 50-194), and 88 UI/liter (IR: 72-104), respectively, with 76% of the patients with ALAT/ASAT grade <2. Median follow-up was 23 months (IR: 13.8-37). No significant difference was observed in the distribution of ALAT, ASAT, GT, and ALP as well as of ALAT/ASAT grades over the 24-month study period. Patients treated with NFV + NNRTI had significantly higher GT and ALP levels at baseline with no significant increase during follow-up. Cholesterol, triglyceride, and glycemia distributions remained stable over time. In conclusion, this study showed a good hepatic and metabolic tolerance of a long-term NFV-combined regimen in HIV-HCV coinfected patients.
authors.affiliation: CISIH-SUD, Clinical Research Department, Hôpital Sainte-Marguerite CHU, Marseille, France., INSERM U379, Marseille, France. isabelle.poisot@mail.ap-hm.fr
authors.forename: I
authors.initials: I
authors.lastname: Poizot-Martin
authors.forename: C
authors.initials: C
authors.lastname: Marimoutou
authors.forename: M P
authors.initials: MP
authors.lastname: Drogoul-Vey
authors.forename: F
authors.initials: F
authors.lastname: Vion-Dury
authors.forename: V
authors.initials: V
authors.lastname: Frixon-Marin
authors.forename: S
authors.initials: S
authors.lastname: Benhaim
authors.forename: P
authors.initials: P
authors.lastname: Poggi
authors.forename: J A
authors.initials: JA
authors.lastname: Gastaut
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D019888:Nelfinavir / Q000008:administration & dosage / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D018894:Reverse Transcriptase Inhibitors; D019888:Nelfinavir