Skip to main content
Open Access Publications from the University of California

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.

  • Author(s): Rockstroh, Juergen K
  • Soriano, Vicente
  • Plonski, Frank
  • Bansal, Meena
  • Fätkenheuer, Gerd
  • Small, Catherine B
  • Asmuth, David M
  • Pialoux, Gilles
  • Mukwaya, Geoffrey
  • Jagannatha, Shyla
  • Heera, Jayvant
  • Pineda, Juan A
  • et al.

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.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.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.the percentage at week 48 of subjects with Grade 3 and Grade 4 ALT abnormalities, defined as >5 ×  upper limit of normal (ULN) if baseline ALT ≤ ULN or >3.5 ×  baseline if baseline ALT>ULN in the maraviroc versus the placebo arm.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.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.

Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.

Main Content
Current View