PMID- 28163136
OWN - NLM
STAT- MEDLINE
DCOM- 20170315
LR  - 20170315
IS  - 1872-7913 (Electronic)
IS  - 0924-8579 (Linking)
VI  - 49
IP  - 3
DP  - 2017 Mar
TI  - Safety and effectiveness of a 12-week course of sofosbuvir and 
      simeprevir +/- ribavirin in HCV-infected patients with or without HIV infection: a 
      multicentre observational study.
PG  - 296-301
LID - S0924-8579(17)30033-X [pii]
LID - 10.1016/j.ijantimicag.2016.11.030 [doi]
AB  - The combination of sofosbuvir and simeprevir +/- ribavirin (SOF + SMV +/- RBV) for 
      hepatitis C virus (HCV) treatment has been associated with high rates of 
      sustained virological response (SVR). Few data are available regarding this 
      regimen in HIV/HCV co-infected patients. This study evaluated the effectiveness 
      and safety of a 12-week course of SOF + SMV +/- RBV in a cohort of HCV monoinfected 
      and HIV/HCV co-infected individuals. HCV-infected patients, with or without HIV 
      infection, receiving a 12-week course of SOF + SMV +/- RBV in four Italian centres 
      from February to October 2015, were included in this retrospective observational 
      study. Clinical and biochemical data were retrieved for all patients. A total of 
      88 individuals were evaluated: 29 (33.0%) HIV/HCV co-infected and 59 (67.0%) 
      monoinfected. Most patients were males with HCV genotype 1b (62.5%) and 1a (25%) 
      infection. RBV was used in 41 HCV monoinfected and 6 HIV/HCV co-infected 
      patients. Cirrhosis was found in 67 patients (76.1%). The most common adverse 
      events (AEs) were rash and/or pruritus (23.9%), fatigue (13.6%) and anaemia 
      (9.1%). Serious AEs occurred in three patients (3.4%). No treatment 
      discontinuations were observed. RBV use was associated with multiple AEs 
      (P = 0.02). An overall SVR12 of 93.2% was achieved; 96.6% in HCV monoinfected and 
      86.2% in HIV/HCV co-infected individuals, without significance both in univariate 
      (P = 0.09) and multivariate analyses (P = 0.12). A baseline platelet count >/=90 
      000/mm(3) was associated with higher rates of SVR (P = 0.005). A 12-week course 
      of SOF + SMV +/- RBV was associated with good safety and high SVR12 rate both in 
      HCV monoinfected and HIV-HCV co-infected individuals.
CI  - Copyright (c) 2017 Elsevier B.V. and International Society of Chemotherapy. All 
      rights reserved.
FAU - Bruno, Giuseppe
AU  - Bruno G
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy. Electronic address: giusbruno85@gmail.com.
FAU - Saracino, Annalisa
AU  - Saracino A
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
FAU - Fabrizio, Claudia
AU  - Fabrizio C
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
FAU - Scudeller, Luigia
AU  - Scudeller L
AD  - Scientific Direction, Clinical Epidemiology Unit, IRCCS San Matteo Foundation, 
      Pavia, Italy.
FAU - Milano, Eugenio
AU  - Milano E
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
FAU - Dell'Acqua, Raffaele
AU  - Dell'Acqua R
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
FAU - Ladisa, Nicoletta
AU  - Ladisa N
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
FAU - Fasano, Massimo
AU  - Fasano M
AD  - Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
FAU - Minniti, Salvatore
AU  - Minniti S
AD  - Infectious Diseases Unit, 'A. Perrino' Hospital, ASL Brindisi, Brindisi, Italy.
FAU - Buccoliero, Giovanni
AU  - Buccoliero G
AD  - Oncohaematologic Department, Infectious Diseases, 'San G. Moscati' Hospital, ASL 
      Taranto, Taranto, Italy.
FAU - Tartaglia, Alessandra
AU  - Tartaglia A
AD  - Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
FAU - Giammario, Adele
AU  - Giammario A
AD  - Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
FAU - Milella, Michele
AU  - Milella M
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
FAU - Angarano, Gioacchino
AU  - Angarano G
AD  - Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 
      Bari, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20170202
PL  - Netherlands
TA  - Int J Antimicrob Agents
JT  - International journal of antimicrobial agents
JID - 9111860
RN  - 0 (Antiviral Agents)
RN  - 0 (Protease Inhibitors)
RN  - 49717AWG6K (Ribavirin)
RN  - 9WS5RD66HZ (Simeprevir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/*administration & dosage/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - HIV Infections/complications
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Protease Inhibitors
MH  - Retrospective Studies
MH  - Ribavirin/administration & dosage/adverse effects
MH  - Simeprevir/*administration & dosage/*adverse effects
MH  - Sofosbuvir/*administration & dosage/*adverse effects
MH  - Sustained Virologic Response
MH  - Treatment Outcome
OTO - NOTNLM
OT  - HIV/HCV co-infection
OT  - SVR
OT  - Simeprevir
OT  - Sofosbuvir
OT  - Sustained virological response
EDAT- 2017/02/07 06:00
MHDA- 2017/03/16 06:00
CRDT- 2017/02/07 06:00
PHST- 2016/09/16 00:00 [received]
PHST- 2016/11/03 00:00 [revised]
PHST- 2016/11/25 00:00 [accepted]
PHST- 2017/02/07 06:00 [pubmed]
PHST- 2017/03/16 06:00 [medline]
PHST- 2017/02/07 06:00 [entrez]
AID - S0924-8579(17)30033-X [pii]
AID - 10.1016/j.ijantimicag.2016.11.030 [doi]
PST - ppublish
SO  - Int J Antimicrob Agents. 2017 Mar;49(3):296-301. doi: 
      10.1016/j.ijantimicag.2016.11.030. Epub 2017 Feb 2.