PMID- 27924779
OWN - NLM
STAT- MEDLINE
DCOM- 20180326
LR  - 20181202
IS  - 2040-2058 (Electronic)
IS  - 1359-6535 (Linking)
VI  - 22
IP  - 3
DP  - 2017
TI  - Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B 
      virus: 144-week results from a randomized, placebo-controlled trial.
PG  - 263-269
LID - 10.3851/IMP3116 [doi]
AB  - BACKGROUND: In the primary 48-week analysis of a hepatic safety trial in patients 
      with HIV-1 coinfected with HBV and/or HCV, maraviroc-containing treatment 
      regimens were not associated with increased hepatotoxicity. METHODS: In this 
      randomized, double-blind, placebo-controlled, multicentre study, patients 
      received maraviroc twice daily (n=70) or placebo (n=67) with concomitant 
      antiretroviral therapy for 144 weeks (Clinicaltrials.gov identifier, 
      NCT01327547). The primary end point was the proportion of patients with 
      protocol-defined Grade 3/4 alanine aminotransferase (ALT) abnormalities through 
      week 48. Key secondary end points included 144-week analysis of Grade 3/4 ALT 
      abnormalities and liver fibrosis by enhanced liver fibrosis (ELF) testing, 
      hepatic elastography and an optional biopsy substudy. RESULTS: Through 144 weeks 
      of treatment, two (maraviroc) and three (placebo) patients met the 
      protocol-defined Grade 3/4 ALT end point. Similar to the 48-week results, there 
      were no statistically significant differences between groups in change from 
      baseline in ELF or hepatic elastography. However, decreased elastography scores 
      were noted in the maraviroc group. Blinded pathologist review suggested that 2 of 
      11 paired biopsies (both on maraviroc) showed signs of decreased fibrosis. One 
      (maraviroc) and two (placebo) patients experienced treatment-related 
      hepatobiliary adverse events (AEs). Five patients in the maraviroc group 
      discontinued because of treatment-related AEs versus three in the placebo group. 
      One death in the maraviroc group and two deaths in the placebo group were 
      reported. CONCLUSIONS: Use of maraviroc did not increase hepatotoxicity in this 
      population through 144 weeks. Further investigation regarding possible beneficial 
      effects of maraviroc on liver fibrosis may be warranted.
FAU - Rockstroh, Juergen K
AU  - Rockstroh JK
AD  - Department of Medicine I, University of Bonn, Bonn, Germany.
FAU - Plonski, Frank
AU  - Plonski F
AD  - Global Clinical Development, Pfizer Inc., Collegeville, PA, USA.
FAU - Bansal, Meena
AU  - Bansal M
AD  - Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, 
      NY, USA.
FAU - Fatkenheuer, Gerd
AU  - Fatkenheuer G
AD  - Department I of Internal Medicine, University Hospital Cologne, Cologne, Germany.
FAU - Small, Catherine B
AU  - Small CB
AD  - Department of Medicine, Division of Infectious Diseases, Weill Cornell Medical 
      College, New York, NY, USA.
AD  - Department of Medicine, Division of Infectious Diseases, New York Medical 
      College, Valhalla, NY, USA.
FAU - Asmuth, David M
AU  - Asmuth DM
AD  - Department of Internal Medicine, University of California Davis Medical Center, 
      Sacramento, CA, USA.
FAU - Pialoux, Gilles
AU  - Pialoux G
AD  - Maladies Infectieuses et Tropicales, Hopital Tenon, Paris, France.
FAU - Zhang-Roper, Rebecca
AU  - Zhang-Roper R
AD  - Safety Evaluation and Risk Management, GlaxoSmithKline, London, UK.
FAU - Wang, Ronnie
AU  - Wang R
AD  - Clinical Sciences, Pfizer Inc., Groton, CT, USA.
FAU - Pineda, Juan A
AU  - Pineda JA
AD  - Unit of Infectious Diseases, Hospital Universitario de Valme, Instituto de 
      Investigacion Biomedica de Sevilla (IBIS), Seville, Spain.
FAU - Heera, Jayvant
AU  - Heera J
AD  - Clinical Sciences, Pfizer Inc., Groton, CT, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01327547
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161207
PL  - England
TA  - Antivir Ther
JT  - Antiviral therapy
JID - 9815705
RN  - 0 (Cyclohexanes)
RN  - 0 (HIV Fusion Inhibitors)
RN  - 0 (Triazoles)
RN  - MD6P741W8A (Maraviroc)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antiretroviral Therapy, Highly Active/adverse effects
MH  - *Coinfection
MH  - Cyclohexanes/*adverse effects/therapeutic use
MH  - Female
MH  - HIV Fusion Inhibitors/*adverse effects/therapeutic use
MH  - HIV Infections/*drug therapy/metabolism
MH  - *Hepatitis B/virology
MH  - *Hepatitis C/virology
MH  - Humans
MH  - Liver/*drug effects/metabolism/pathology/virology
MH  - Liver Function Tests
MH  - Male
MH  - Maraviroc
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Triazoles/*adverse effects/therapeutic use
MH  - Viral Load
EDAT- 2016/12/08 06:00
MHDA- 2018/03/27 06:00
CRDT- 2016/12/08 06:00
PHST- 2016/11/20 00:00 [accepted]
PHST- 2016/12/08 06:00 [pubmed]
PHST- 2018/03/27 06:00 [medline]
PHST- 2016/12/08 06:00 [entrez]
AID - 10.3851/IMP3116 [doi]
PST - ppublish
SO  - Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.