Safety and antiretroviral effectiveness of concomitant use of rifampicin and efavirenz for anti retroviral-naive patients in India who are coinfected with tuberculosis and HIV-1

Objective: To study the safety and antiretroviral effectiveness of concomitant use of rifampicin and efavirenz for antiretroviral-naive patients in India who are coinfected with tuberculosis (TB) and HIV-1. Design and Methods: The study was an observational longitudinal cohort investigation. HIV-1-infected patients with CD4 cell counts of less than or equal to200/muL who attended the Infectious Disease Clinic of Sterling Hospital (Ahmedabad, India) from June 2001 to December 2002 were recruited for the study. Patients were divided in 2 groups: group A, patients with active TB (n = 126); and group B, patients without TB (n = 129). Group A patients were given efavirenz with 2 nucleoside reverse transcriptase inhibitors along with rifampicin-containing anti-TB treatment. Group B patients were treated for presenting opportunistic infections and started therapy with efavirenz plus 2 nucleoside reverse transcriptase inhibitors. The nucleoside reverse transcriptase inhibitors were either zidovudine and lamivudine (n = 30) or stavudine and lamivudine (n = 225). Patients self-funded their investigations and medications (antiretroviral, anti-TB, and other opportunistic infection-related agents). Indian generic medications were used. Results: Efavirenz-based highly active antiretroviral therapy with rifampicin for HIV/TB-coinfected patients resulted in an immunologic response that was comparable with that of the group not receiving rifampicin. Median CD4 cell counts at baseline, 3 months, 6 months, and 9 months in group A were 84/muL (range, 5-200/muL), 225/muL (range, 26-528/muL), 251/muL (range, 65-775/muL), and 275/muL (range, 61-611/muL), respectively, and in group 13, these values were 118/muL (range, 2-200/muL), 244/muL (range, 38-881/muL), 294/muL (range, 23-1322/muL), and 295/muL (range, 26-991/muL), respectively. The overall increase in CD4 cell count was greater in group A than in group B at 9 months (190 vs. 176/muL, respectively). Patients in both groups tolerated the therapy well; the adverse effects profile was comparable except that group A patients had a higher incidence of hepatitis than group B patients (13.49% vs. 0, respectively; P < 0.0001). Conclusion: Clinical and immunologic benefits are comparable for patients receiving efavirenz-based antiretroviral therapy with or without rifampicin.