PMID- 29390377 OWN - NLM STAT- MEDLINE DCOM- 20180212 LR - 20240315 IS - 1536-5964 (Electronic) IS - 0025-7974 (Print) IS - 0025-7974 (Linking) VI - 96 IP - 50 DP - 2017 Dec TI - Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older. PG - e9271 LID - 10.1097/MD.0000000000009271 [doi] LID - e9271 AB - Advanced age has been a major limitation of interferon-based treatment for chronic hepatitis C virus (HCV) infection because of its poor response and tolerability. Direct-acting antiviral (DAA) drug regimens are safe and highly effective, allowing administration of treatment also in elderly. This study aims to assess the efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) with ribavirin for the treatment of patients aged >/=70 years with HCV genotype 1b compensated cirrhosis.A total of 1008 patients with HCV genotype 1b compensated cirrhosis were prospectively treated with PrOD + ribavirin for 12 weeks, between December 2015 and July 2016. Sustained virologic response 12 weeks after the end of treatment (SVR12), adverse effects (AEs), comorbidities, discontinuation, and death rates were recorded. Efficacy and safety of therapy were assessed in patients aged >/=70 years and compared with data from patients <70 years.There were 117 patients aged >/=70 years, preponderantly females (58.9%), mean age 73.3 +/- 2.8 years (range 70-82), and 37 (31.6%) were treatment-experienced. Comorbidities were reported in 60.6% of patients >/=70 years and in 39.8% of those <70 years (P < .001). SVR12 rates based on intention-to-treat and per-protocol analyses were 97.4% and 100%, respectively, in patients >/=70 years, compared to 97.8% and 99.6%, respectively, in patients <70 years (P = ns and P = ns). Severe AEs were reported in 4 (3.4%) patients >/=70 years, compared to 23 (2.6%) in those <70 years (P = ns). One death was recorded in a patient aged 79 years (0.9%) and 6 deaths (0.8%) in those <70 years (P = ns).Treatment with PrOD + ribavirin in patients 70 years of age or older with HCV genotype 1b compensated cirrhosis proved as effective, safe, and well tolerated, as it did in younger patients. CI - Copyright (c) 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved. FAU - Trifan, Anca AU - Trifan A AD - "Grigore T. Popa" University of Medicine and Pharmacy Iasi Institute of Gastroenterology and Hepatology, Iasi Gastroenterology, "Carol Davila" University of Medicine and Pharmacy Gastroenterology and Hepatology Center, Fundeni Clinical Institute, Bucharest Infectious Diseases, "Victor Babes" University of Medicine and Pharmacy Department of Infectious Diseases, "Victor Babes" Hospital for Infectious and Lung Diseases, Timisoara Gastroenterology, Oradea University of Medicine and Pharmacy Department of Gastroenterology, County Clinical Hospital, Oradea Gastroenterology, "Victor Babes" University of Medicine and Pharmacy Department of Gastroenterology and Hepatology Timisoara, The County Hospital Timisoara Infectious Diseases, "Grigore T. Popa" University of Medicine and Pharmacy "Sf. Parascheva" Infectious Diseases Clinical Hospital, Iasi Gastroenterology, Targu Mures University of Medicine and Pharmacy, Targu Mures Department of Gastroenterology, Targu Mures Emergency County Hospital Internal Medicine, Craiova University of Medicine and Pharmacy Internal Medicine Department, Emergency Clinical County Hospital Craiova Infectious Diseases, "Carol Davila" University of Medicine and Pharmacy "Matei Bals" National Institute for Infectious Diseases, Bucharest, Romania. FAU - Stanciu, Carol AU - Stanciu C FAU - Gheorghe, Liana AU - Gheorghe L FAU - Iacob, Speranta AU - Iacob S FAU - Curescu, Manuela AU - Curescu M FAU - Cijevschi Prelipcean, Cristina AU - Cijevschi Prelipcean C FAU - Stefanescu, Gabriela AU - Stefanescu G FAU - Girleanu, Irina AU - Girleanu I FAU - Chiriac, Stefan AU - Chiriac S FAU - Mihai, Catalina AU - Mihai C FAU - Brisc, Ciprian AU - Brisc C FAU - Goldis, Adrian AU - Goldis A FAU - Sporea, Ioan AU - Sporea I FAU - Miftode, Egidia AU - Miftode E FAU - Bataga, Simona AU - Bataga S FAU - Rogoveanu, Ion AU - Rogoveanu I FAU - Preda, Carmen AU - Preda C FAU - Caruntu, Florin Alexandru AU - Caruntu FA FAU - Singeap, Ana-Maria AU - Singeap AM LA - eng PT - Journal Article PL - United States TA - Medicine (Baltimore) JT - Medicine JID - 2985248R RN - 0 (Anilides) RN - 0 (Antiviral Agents) RN - 0 (Carbamates) RN - 0 (Cyclopropanes) RN - 0 (Lactams, Macrocyclic) RN - 0 (Macrocyclic Compounds) RN - 0 (Sulfonamides) RN - 2302768XJ8 (ombitasvir) RN - 49717AWG6K (Ribavirin) RN - 56HH86ZVCT (Uracil) RN - 9DLQ4CIU6V (Proline) RN - CKR7XL41N4 (2-Naphthylamine) RN - DE54EQW8T1 (dasabuvir) RN - HG18B9YRS7 (Valine) RN - O3J8G9O825 (Ritonavir) RN - OU2YM37K86 (paritaprevir) SB - IM MH - 2-Naphthylamine MH - Aged MH - Aged, 80 and over MH - Anilides/therapeutic use MH - Antiviral Agents/*therapeutic use MH - Carbamates/therapeutic use MH - Cyclopropanes MH - Drug Resistance, Viral MH - Drug Therapy, Combination MH - Female MH - Genotype MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Lactams, Macrocyclic MH - Liver Cirrhosis/*drug therapy/*virology MH - Macrocyclic Compounds/therapeutic use MH - Male MH - Proline/analogs & derivatives MH - Prospective Studies MH - Ribavirin/therapeutic use MH - Ritonavir/therapeutic use MH - Sulfonamides/therapeutic use MH - Sustained Virologic Response MH - Uracil/analogs & derivatives/therapeutic use MH - Valine PMC - PMC5815789 COIS- The authors have no funding and conflicts of interest to disclose. EDAT- 2018/02/03 06:00 MHDA- 2018/02/13 06:00 PMCR- 2017/12/15 CRDT- 2018/02/03 06:00 PHST- 2018/02/03 06:00 [entrez] PHST- 2018/02/03 06:00 [pubmed] PHST- 2018/02/13 06:00 [medline] PHST- 2017/12/15 00:00 [pmc-release] AID - 00005792-201712150-00127 [pii] AID - MD-D-17-01761 [pii] AID - 10.1097/MD.0000000000009271 [doi] PST - ppublish SO - Medicine (Baltimore). 2017 Dec;96(50):e9271. doi: 10.1097/MD.0000000000009271.