title: Safety and efficacy of direct-acting antivirals for the treatment of chronic hepatitis C in a real-world population aged 65 years and older.
abstract: The availability of direct-acting antiviral agents (DAA) regimens has expanded the pool of patients eligible for treatment. However, data on the virologic response and tolerability of DAAs in elderly patients are lacking. We evaluated the efficacy and safety of DAAs in patients with advanced fibrosis/cirrhosis in real-life practice with the focus on those aged ≥65 years. Between January and December 2015, all consecutive patients with HCV-related advanced fibrosis/cirrhosis treated with DAA at eleven tertiary referral centres in Emilia Romagna (Italy) were enrolled. Regimen choice was based on viral genotype and stage of disease, according to guidelines. The primary end point was sustained virologic response 12 weeks after the end of treatment (SVR12). Overall, 282 of 556 (50.7%) patients evaluated were elderly, most of them with cirrhosis. Antiviral therapy was stopped prematurely in four (1.4%) patients. Two patients, both with cirrhosis, died during treatment due to worsening of liver/renal function. SVR12 was achieved by 94.7% and was comparable to that obtained in patients aged <65 (P=.074). Similar data were also reported in subgroup of patients aged ≥75 years. All patients with advanced fibrosis achieved virologic response. SVR12 was 80.8% in Child-Pugh-Turcotte (CTP)-B cirrhosis and 95.4% in CTP-A (P=.013). According to genotype, the SVR12 was achieved in 172 of 181 (95%) with genotype 1b cirrhosis and in 44 of 48 (91.7%) with genotype 2 cirrhosis. In conclusions, in a real-world setting, DAAs are safe and effective in elderly patients with HCV-related advanced fibrosis/cirrhosis, but SVR12 is lower with worsening CTP class.
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Conti
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Brillanti
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Buonfiglioli
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Vukotic
authors.affiliation: U.O. di Medicina Interna per il trattamento delle gravi insufficienze d'organo, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: M C
authors.initials: MC
authors.lastname: Morelli
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Lalanne
authors.affiliation: U.O. di Malattie Infettive, Azienda Ospedaliera S. Maria Nuova - IRCCS, Reggio Emilia, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Massari
authors.affiliation: U.O. di Medicina Interna, Ospedale di Faenza, Faenza, Italy.
authors.forename: F G
authors.initials: FG
authors.lastname: Foschi
authors.affiliation: U.O. di Gastroenterologia, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Bernabucci
authors.affiliation: U.O. di Medicina Interna, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Serio
authors.affiliation: U.O. di Gastroenterologia ed Epatologia, Ospedale "G da Saliceto", Piacenza, Italy.
authors.forename: G M
authors.initials: GM
authors.lastname: Prati
authors.affiliation: U.O. di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Negri
authors.affiliation: U.O. di Malattie Infettive, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Badia
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Caraceni
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Muratori
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Vitale
authors.affiliation: Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Porro
authors.affiliation: U.O. di Farmacia Clinica, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Morotti
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Mazzella
authors.affiliation: Centro di Ricerca per lo Studio delle Epatiti, Università di Bologna, Bologna, Italy.|Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Andreone
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007558:Italy; D008875:Middle Aged; D012189:Retrospective Studies; D000072230:Sustained Virologic Response; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents
keywords: antiviral therapy; cirrhosis; elderly; hepatitis C virus; interferon-free