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:
CreatorsEmailORCIDORCID Put Code
Rockstroh, Juergen K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soriano, VicenteUNSPECIFIEDorcid.org/0000-0002-4624-5199UNSPECIFIED
Plonski, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bansal, MeenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faetkenheuer, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Small, Catherine B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asmuth, David M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pialoux, GillesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mukwaya, GeoffreyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jagannatha, ShylaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heera, JayvantUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pineda, Juan A.UNSPECIFIEDorcid.org/0000-0002-3751-0296UNSPECIFIED
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:
KeywordsLanguage
HUMAN-IMMUNODEFICIENCY-VIRUS; CLINICAL-TRIALS; CCR5; INHIBITOR; ENTRY; HEPATOTOXICITY; INFECTION; MORTALITY; MECHANISM; FIBROSISMultiple languages
Infectious Diseases; Pharmacology & PharmacyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/40409

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