PMID- 25650873 OWN - NLM STAT- MEDLINE DCOM- 20160505 LR - 20150813 IS - 1478-3231 (Electronic) IS - 1478-3223 (Linking) VI - 35 IP - 9 DP - 2015 Sep TI - Triple therapy with boceprevir or telaprevir in a European cohort of cirrhotic HIV/HCV genotype 1-coinfected patients. PG - 2090-9 LID - 10.1111/liv.12799 [doi] AB - BACKGROUND & AIMS: The efficacy and safety of triple therapy combining boceprevir (BOC) or telaprevir (TVR) with pegylated interferon-alfa and ribavirin (PegIFN/RBV) has rarely been investigated in human immunodeficiency virus/hepatitis C virus (HIV/HCV) genotype 1-coinfected patients with cirrhosis. METHODS: We conducted a European (France, Italy, Germany, Netherlands) multicentre study of triple therapy in cirrhotic HIV/HCV GT1-coinfected patients. RESULTS: Fifty-nine patients (47 TVR, 12 BOC) were studied. Median CD4 cell count was 457 (293-578)/mm(3), and HIV viral load was <50 copies/ml in 93% of patients. The HCV genotype was GT1a (78%) or GT1b (13%). Previous PegIFN/RBV therapy had resulted in non-response (73%) or relapse (12%), and 15% of patients were treatment-naive. The sustained virological response rate at week 12 (SVR12) was 53% overall (57% with TVR, 36% with BOC). A baseline HCV-RNA level <800 000 IU/ml tended to be associated with SVR12 (65 vs 42%, P = 0.11). In multivariate analysis, a virological response at week 4 after BOC or TVR initiation was significantly associated with SVR12 (P = 0.040). Early discontinuation of triple therapy was frequent (n = 26, 44%), because of non-response/breakthrough (65%) or adverse events (AEs) (35%). Three patients died. Severe anaemia (<9 g/dl) occurred in 14 patients (25%), leading to RBV dose reduction (22%), erythropoietin use (56%) or blood transfusion (14%). In multivariate analysis, lack of RBV dose reduction was significantly associated with severe AEs (P = 0.006). CONCLUSIONS: More than half of HIV/HCV GT1-coinfected patients with cirrhosis achieved a SVR12. To avoid unnecessary adverse effects, therapy should be discontinued if no response is obtained at week 4. CI - (c) 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Miailhes, Patrick AU - Miailhes P AD - Department of Infectious and Tropical Diseases, Croix Rousse Hospital, Hospices Civils de Lyon, Lyon, France. FAU - Gilbert, Camille AU - Gilbert C AD - Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, ISPED, Bordeaux, France. FAU - Lacombe, Karine AU - Lacombe K AD - Sorbonne Universites, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidemiologie et de Sante Publique, Paris, France. AD - Department of Infectious and Tropical Diseases, Saint-Antoine Hospital, AP-HP, Paris, France. FAU - Arends, Joop E AU - Arends JE AD - Department of Internal Medicine and Infectious Diseases, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands. FAU - Puoti, Massimo AU - Puoti M AD - Infectious Diseases Department, AO Niguarda Ca' Granda, Milano, Italy. FAU - Rockstroh, Jurgen K AU - Rockstroh JK AD - Infectious Diseases Department, University of Bonn, Bonn, Germany. FAU - Sogni, Philippe AU - Sogni P AD - Hepatology Unit, Cochin Hospital, AP-HP, Paris, France. AD - Paris and Cochin Institute, INSERM-U1016, Paris-Descartes University, Paris, France. FAU - Fontaine, Helene AU - Fontaine H AD - Hepatology Unit, Cochin Hospital, AP-HP, Paris, France. AD - Paris and Cochin Institute, INSERM-U1016, Paris-Descartes University, Paris, France. FAU - Rosenthal, Eric AU - Rosenthal E AD - Department of Internal Medicine, CHU de Nice, Archet Hospital, University of Nice Sophia Antipolis, Nice, France. FAU - Winnock, Maria AU - Winnock M AD - Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, ISPED, Bordeaux, France. FAU - Loko, Marc-Arthur AU - Loko MA AD - Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, ISPED, Bordeaux, France. FAU - Wittkop, Linda AU - Wittkop L AD - Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, ISPED, Bordeaux, France. AD - CHU de Bordeaux, Pole de Sante Publique, Service d'Information Medicale, Bordeaux, France. FAU - Dabis, Francois AU - Dabis F AD - Centre INSERM U897-Epidemiologie-Biostatistique, INSERM, ISPED, Bordeaux, France. AD - CHU de Bordeaux, Pole de Sante Publique, Service d'Information Medicale, Bordeaux, France. FAU - Salmon, Dominique AU - Salmon D AD - Department of Internal Medicine and Infectious Diseases, Cochin Hospital, Paris Descartes University, AP-HP, Paris, France. CN - ESCMID European Study Group on Viral Hepatitis LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20150223 PL - United States TA - Liver Int JT - Liver international : official journal of the International Association for the Study of the Liver JID - 101160857 RN - 0 (Antiviral Agents) RN - 0 (Interferon-alpha) RN - 0 (Oligopeptides) RN - 0 (RNA, Viral) RN - 49717AWG6K (Ribavirin) RN - 655M5O3W0U (telaprevir) RN - 89BT58KELH (N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide) RN - 9DLQ4CIU6V (Proline) SB - IM MH - Anemia MH - Antiviral Agents/therapeutic use MH - Cohort Studies MH - Coinfection/drug therapy MH - Drug Therapy, Combination MH - Female MH - France MH - Genotype MH - Germany MH - HIV Infections/*drug therapy MH - Hepacivirus/*genetics MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Interferon-alpha/therapeutic use MH - Italy MH - Liver Cirrhosis/*complications MH - Male MH - Middle Aged MH - Multivariate Analysis MH - Oligopeptides/*therapeutic use MH - Proline/*analogs & derivatives/therapeutic use MH - RNA, Viral/blood MH - Ribavirin/therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - HIV/HCV genotype 1 coinfection OT - boceprevir OT - cirrhosis OT - telaprevir EDAT- 2015/02/05 06:00 MHDA- 2016/05/06 06:00 CRDT- 2015/02/05 06:00 PHST- 2014/08/22 00:00 [received] PHST- 2015/01/30 00:00 [accepted] PHST- 2015/02/05 06:00 [entrez] PHST- 2015/02/05 06:00 [pubmed] PHST- 2016/05/06 06:00 [medline] AID - 10.1111/liv.12799 [doi] PST - ppublish SO - Liver Int. 2015 Sep;35(9):2090-9. doi: 10.1111/liv.12799. Epub 2015 Feb 23.