Universität zu Köln

Rockstroh, Juergen K., Plonski, Frank, Bansal, Meena, Faetkenheuer, Gerd, Small, Catherine B., Asmuth, David M., Pialoux, Gilles, Zhang-Roper, Rebecca, Wang, Ronnie, Pineda, Juan A. ORCID: 0000-0002-3751-0296 and Heera, Jayvant (2017). 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. Antivir. Ther., 22 (3). S. 263 - 270. LONDON: INT MEDICAL PRESS LTD. ISSN 1359-6535

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Rockstroh, Juergen K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Plonski, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Bansal, Meena UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Small, Catherine B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Asmuth, David M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pialoux, Gilles UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang-Roper, Rebecca UNSPECIFIED UNSPECIFIED UNSPECIFIED Wang, Ronnie UNSPECIFIED UNSPECIFIED UNSPECIFIED Pineda, Juan A. UNSPECIFIED orcid.org/0000-0002-3751-0296 UNSPECIFIED Heera, Jayvant UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-244512
DOI:	10.3851/IMP3116
Journal or Publication Title:	Antivir. Ther.
Volume:	22
Number:	3
Page Range:	S. 263 - 270
Date:	2017
Publisher:	INT MEDICAL PRESS LTD
Place of Publication:	LONDON
ISSN:	1359-6535
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HUMAN-IMMUNODEFICIENCY-VIRUS; CLINICAL-TRIALS; CCR5; ENTRY; COMBINATION; VICRIVIROC; INHIBITOR; MECHANISM; PHASE-2 Multiple languages Infectious Diseases; Pharmacology & Pharmacy; Virology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/24451