Universität zu Köln

Rockstroh, Juergen K., Soriano, Vicente ORCID: 0000-0002-4624-5199, Plonski, Frank, Bansal, Meena, Faetkenheuer, Gerd, Small, Catherine B., Asmuth, David M., Pialoux, Gilles, Mukwaya, Geoffrey, Jagannatha, Shyla, Heera, Jayvant and Pineda, Juan A. ORCID: 0000-0002-3751-0296 (2015). Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents. HIV Clin. Trials, 16 (2). S. 72 - 81. LEEDS: MANEY PUBLISHING. ISSN 1945-5771

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Abstract

Background: One of the more clinically relevant co-morbidities in HIV-infected patients is the development of progressive liver disease due to hepatitis B virus (HBV) or hepatitis C virus (HCV). In addition, hepatotoxicity has been observed with prolonged use of antiretroviral agents. Objective: To evaluate the hepatic safety of maraviroc in combination with other antiretroviral agents in HIV-1-infected subjects co-infected with HCV and/or HBV. Methods: In this 148-week randomized, double-blind, placebo- controlled, multicentre study (NCT01327547), subjects received maraviroc twice daily (n=70) or placebo (n=67) in combination with other antiretroviral agents. Primary endpoint: the percentage at week 48 of subjects with Grade 3 and Grade 4 ALT abnormalities, defined as > 5 x upper limit of normal (ULN) if baseline ALT <= ULN or > 3.5 x baseline if baseline ALT > ULN in the maraviroc versus the placebo arm. Results: At week 48, one subject in each group had met the primary endpoint definition. No subjects met protocol-defined liver stopping criteria and there were no cases of Hy's law or treatment-related hepatobiliary serious adverse events. No significant difference in change from baseline in enhanced liver fibrosis or hepatic elastography was observed between groups. Treatment-related hepatobiliary adverse events were reported in one and two subjects receiving maraviroc and placebo, respectively; discontinuations due to treatment-related AEs occurred in four and two subjects receiving maraviroc and placebo, respectively; two deaths were reported in the placebo group. Conclusions: The use of maraviroc does not increase hepatotoxicity in HIV-1-infected subjects co-infected with HCV and/or HBV through 48 weeks of treatment.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Rockstroh, Juergen K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Soriano, Vicente UNSPECIFIED orcid.org/0000-0002-4624-5199 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 Mukwaya, Geoffrey UNSPECIFIED UNSPECIFIED UNSPECIFIED Jagannatha, Shyla UNSPECIFIED UNSPECIFIED UNSPECIFIED Heera, Jayvant UNSPECIFIED UNSPECIFIED UNSPECIFIED Pineda, Juan A. UNSPECIFIED orcid.org/0000-0002-3751-0296 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-404099
DOI:	10.1179/1528433614Z.0000000011
Journal or Publication Title:	HIV Clin. Trials
Volume:	16
Number:	2
Page Range:	S. 72 - 81
Date:	2015
Publisher:	MANEY PUBLISHING
Place of Publication:	LEEDS
ISSN:	1945-5771
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HUMAN-IMMUNODEFICIENCY-VIRUS; CLINICAL-TRIALS; CCR5; INHIBITOR; ENTRY; HEPATOTOXICITY; INFECTION; MORTALITY; MECHANISM; FIBROSIS Multiple languages Infectious Diseases; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/40409