Hepatic Safety of High-Dose Rifampicin for Tuberculosis Treatment in TB/HIV Co-infected Patients: A Randomized Clinical Trial

High-dose Rifampicin regimens have been shown to be more effective for tuberculosis (TB) treatment in TB/HIV co-infected patients. This study assessed the hepatic safety of a high-dose Rifampicin regimen among TB/HIV co-infected patients. 811 TB/HIV co-infected patients, antiretroviral treatment (ART) naive, at least 18 years old with a CD4 T-cell count between 50 and 350 cells/mm(3) were enrolled. Patients with multidrug-resistant tuberculosis were excluded. Patients had received first-line antituberculosis treatment followed by ART after two weeks (arm A) or two months (arm B). In arm C, they received antituberculosis treatment with a high dose of Rifampicin (15 mg/kg/day instead of 10 mg/kg/day) during the TB intensive phase of treatment and ART after two months. The patients performed transaminases (ALT, AST), gamma-glutamyl transpeptidase (gamma-GT), alkaline phosphatase (ALP), and total bilirubin blood tests. The study outcomes were an elevation of ALT at least 5 times the Upper Limit of Normal (Primary outcome), an isolated elevation grade 4 of AST, gamma-GT, ALP, and/or total bilirubin (Secondary outcomes). The patients included were 53.97% men and 2.44% co-infected hepatitis B or C virus. There were no significant differences between ALT, AST, gamma-GT, ALP, and total bilirubin between the standard regimens (Arms A and B) and high dose Rifampicin regimen (Arm C). This study showed that a high-dose Rifampicin regimen for TB treatment in TB/HIV co-infected patients was as safe as that of a standard regimen.