title: Raltegravir-based therapy in a cohort of HIV/HCV co-infected individuals.
abstract: The relationship between hepatic tolerance and hepatitis C virus (HCV) co-infection has not been extensively studied in clinical practice. We assessed the efficacy and safety of raltegravir-based therapy in an Italian cohort of HIV/HCV co-infected patients. One hundred and forty patients with HIV/HCV co-infection initiating raltegravir from SCOLTA project (Surveillance Cohort Long-Term Toxicity Antiretrovirals) were examined. Of them, 43 were women, with mean age of 45.4±6.4years; 65 (46%) had undetectable HIV-RNA<50copies/mL and 75 (54%) HIV-RNA≥50copies/mL. According to CDC classification, 49 (35%) were in stage C. Based on Fib4 score at the time of starting raltegravir, patients were classified in class I in 41 cases, class II in 68 and in class III in 31 cases. Globally, the Fib4 score slightly decreased during 24months follow-up, from 2.2 to a value of 1.8. Hepatic adverse events of any grade were observed in 67 patients, of which only 2 cases (3%) had severe liver toxicity (grade 3-4). Only one patient had to discontinue the therapy because of adverse events. According to univariate analysis, being in CDC stage C represented a risk for the development of liver toxicity, with a hazard ratio (HR) of 2.27 (95% CI 1.06-4.84, P=0.033). None of the other variables considered (age, sex, years since detection of HIV and HCV-RNA detectable, years of previous HIV therapy, concomitant therapy with PI or NRTI, CD4+ cell count, Fib4, and transaminases level at baseline) resulted statistically correlated to the outcome. In conclusion, raltegravir-based regimens can be safely used in HCV infected patients; in this study, the hepatic toxicity has been found to be more frequent in patients with an advanced HIV disease (CDC stage C), independently of HIV-RNA suppression at raltegravir initiation.
authors: University of Genova (DISSAL), Infectious Diseases Clinic, IRCCS AOU San Martino-IST, Genova, Italy. Electronic address: taramasso.lucia@gmail.com.
authors: L
authors: L
authors: Taramasso
authors: Department of Clinical and Experimental Medicine, University of Sassari, Sassari, Italy.
authors: G
authors: G
authors: Madeddu
authors: Epi2004, Luigi Sacco Hospital, Milano, Italy.
authors: E
authors: E
authors: Ricci
authors: Unit of Infectious Diseases, Santa Maria Hospital, Perugia, Italy.
authors: G V
authors: GV
authors: De Socio
authors: Unit of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy.
authors: B
authors: B
authors: Menzaghi
authors: Department of Infectious Diseases, Amedeo Di Savoia Hospital, Torino, Italy.
authors: G
authors: G
authors: Orofino
authors: Department of Infectious Diseases, L. Sacco Hospital, University of Milano, Milano, Italy.
authors: S
authors: S
authors: Passerini
authors: Department of Infectious Diseases, L. Sacco Hospital, University of Milano, Milano, Italy.
authors: M
authors: M
authors: Franzetti
authors: Infectious Diseases Clinic, University Hospital Policlinico, Bari, Italy.
authors: P
authors: P
authors: Maggi
authors: Department of Infectious Diseases, Sanremo Hospital, Sanremo, Italy.
authors: C
authors: C
authors: Dentone
authors: Unit of Infectious Diseases, Careggi Hospital, Firenze, Italy.
authors: C
authors: C
authors: Martinelli
authors: Department of Clinical and Molecular Biomedicine, Division of Infectious Diseases, University of Catania, Catania, Italy.
authors: B M
authors: BM
authors: Celesia
authors: Department of Infectious Diseases, Galliera Hospital, Genova, Italy.
authors: G
authors: G
authors: Penco
authors: National Institute of Infectious Diseases "L. Spallanzani", Roma, Italy.
authors: R
authors: R
authors: Libertone
authors: Unit of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy.
authors: T
authors: T
authors: Quirino
authors: Infectious Diseases Unit, A. Manzoni Hospital, Lecco, Italy.
authors: P
authors: P
authors: Bonfanti
authors: Infectious Disease Clinic, IRCCS AOU San Martino-IST, Genova, Italy. Electronic address: antonio.dibiagio@hsanmartino.it.
authors: A
authors: A
authors: Di Biagio
mesh_terms: D000410:Alanine Transaminase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000378:metabolism; D015331:Cohort Studies; D060085:Coinfection / Q000188:drug therapy* / Q000821:virology*; D003710:Demography; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011760:Pyrrolidinones / Q000627:therapeutic use*; D012367:RNA, Viral / Q000378:metabolism; D000068898:Raltegravir Potassium
chemical_list: D011760:Pyrrolidinones; D012367:RNA, Viral; D000068898:Raltegravir Potassium; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: Efficacy; HCV; Hepatitis; Raltegravir; Safety; Tolerability