PMID- 27440554
OWN - NLM
STAT- MEDLINE
DCOM- 20170426
LR  - 20220410
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 41
IP  - 5
DP  - 2016 Oct
TI  - Safety of interferon-free therapies for chronic hepatitis C: a network 
      meta-analysis.
PG  - 478-85
LID - 10.1111/jcpt.12426 [doi]
AB  - WHAT IS KNOWN AND OBJECTIVE: Interferon-free (IFN-free) therapies for hepatitis C 
      virus (HCV) have been developed to provide more effective, tolerable and safer 
      therapeutic strategies. To date, no network meta-analysis (NMA) evaluating the 
      safety profile of these regimens has been performed. This systematic review and 
      NMA aimed to evaluate safety outcomes of IFN-free treatment options for chronic 
      hepatitis C. METHODS: A systematic review was performed according to PRISMA and 
      Cochrane recommendations. A literature search was conducted in PubMed/Medline, 
      Scopus, Cochrane Library, International Pharmaceutical Abstracts and Web of 
      Science electronic databases and included only randomized clinical trials that 
      provided safety outcomes of interest of evaluated second-generation direct-acting 
      antivirals: incidence of any adverse events (AEs) and serious AE. NMA allowed 
      estimating probability for the relative safety of the interventions. A 
      consistency model was used to draw conclusions about relative safety of 
      treatments, presented as odds ratio (OR) and corresponding 95% credible interval 
      (CrI). RESULTS: Fifty-one clinical trials were included (13 089 participants). 
      Most participants had hepatitis C genotype 1 virus (76%) and were treated for 
      12 weeks. Two NMAs were built to investigate the incidence of AEs and serious 
      AEs, comparing 13 and 10 IFN-free treatment options, respectively. For the 
      outcome incidence of AEs, few significant differences were observed, which were 
      explained by the presence of RBV. Elbasvir with grazoprevir and placebo were both 
      safer than ombitasvir in combination with paritaprevir, ritonavir, daclatasvir 
      plus RBV [ORs with 95% Crl of 4.09 (1.17-14.09) and 2.40 (1.19-4.77), 
      respectively] and sofosbuvir with RBV [ORs with 95% Crl of 0.22 (0.07-0.72) and 
      2.69 (1.53-4.80), respectively]. Furthermore, elbasvir with grazoprevir was safer 
      than sofosbuvir used with velpatasvir and RBV [OR 0.19 (95% CrI 0.03-0.98)]; 
      ombitasvir in combination with paritaprevir, ritonavir, daclatasvir was safer 
      than the same therapy but combined with RBV [OR 2.14 (95% CrI 1.09-4.44)]; and 
      sofosbuvir used with velpatasvir was safer than sofosbuvir with RBV [OR 2.07 (95% 
      CrI 1.13-3.79)]. Elbasvir with grazoprevir (50%) followed by placebo (28%) had 
      the highest probabilities of less AEs. No significant differences were observed 
      for serious AE outcomes. WHAT IS NEW AND CONCLUSION: This meta-analysis included 
      a large number of therapies. Small differences were observed in any AEs, but not 
      in serious AEs.
CI  - (c) 2016 John Wiley & Sons Ltd.
FAU - Ferreira, V L
AU  - Ferreira VL
AD  - Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, 
      Universidade Federal do Parana, Curitiba, Brazil.
FAU - Assis Jarek, N A
AU  - Assis Jarek NA
AD  - Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, 
      Universidade Federal do Parana, Curitiba, Brazil.
FAU - Tonin, F S
AU  - Tonin FS
AD  - Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, 
      Universidade Federal do Parana, Curitiba, Brazil.
FAU - Borba, H H L
AU  - Borba HH
AD  - Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, 
      Universidade Federal do Parana, Curitiba, Brazil.
FAU - Wiens, A
AU  - Wiens A
AD  - Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, 
      Universidade Federal do Parana, Curitiba, Brazil.
FAU - Pontarolo, R
AU  - Pontarolo R
AD  - Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, 
      Universidade Federal do Parana, Curitiba, Brazil.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20160721
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 0 (Antiviral Agents)
RN  - 9008-11-1 (Interferons)
SB  - IM
MH  - Antiviral Agents/*adverse effects/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Hepacivirus/drug effects
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Interferons/therapeutic use
MH  - Network Meta-Analysis
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - hepatitis C
OT  - interferon-free
OT  - meta-analysis
OT  - network
OT  - safety
EDAT- 2016/07/22 06:00
MHDA- 2017/04/27 06:00
CRDT- 2016/07/22 06:00
PHST- 2016/05/30 00:00 [received]
PHST- 2016/06/27 00:00 [accepted]
PHST- 2016/07/22 06:00 [entrez]
PHST- 2016/07/22 06:00 [pubmed]
PHST- 2017/04/27 06:00 [medline]
AID - 10.1111/jcpt.12426 [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2016 Oct;41(5):478-85. doi: 10.1111/jcpt.12426. Epub 2016 Jul 
      21.