RT Journal Article
T1 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
A1 Rockstroh, Juergen K.
A1 Plonski, Frank
A1 Bansal, Meena
A1 Faetkenheuer, Gerd
A1 Small, Catherine B.
A1 Asmuth, David M.
A1 Pialoux, Gilles
A1 Zhang-Roper, Rebecca
A1 Wang, Ronnie
A1 Pineda, Juan A.
A1 Heera, Jayvant
K1 Human-immunodeficiency-virus
K1 Clinical-trials
K1 Ccr5
K1 Entry
K1 Combination
K1 Vicriviroc
K1 Inhibitor
K1 Mechanism
K1 Phase-2
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.
PB Int medical press ltd
SN 1359-6535
YR 2017
FD 2017-01-01
LK http://hdl.handle.net/10668/19340
UL http://hdl.handle.net/10668/19340
LA en
DS RISalud
RD Apr 10, 2025