Objective: To study the safety and antiretroviral effectiveness of concomitant use of rifampicin and efavirenz for antiretroviral-naïve 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 ≤200/μL 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/μL (range, 5–200/μL), 225/μL (range, 26–528/μL), 251/μL (range, 65–775/μL), and 275/μL (range, 61–611/μL), respectively, and in group B, these values were 118/μL (range, 2–200/μL), 244/μL (range, 38–881/μL), 294/μL (range, 23–1322/μL), and 295/μL (range, 26–991/μL), respectively. The overall increase in CD4 cell count was greater in group A than in group B at 9 months (190 vs. 176/μL, 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.
From the *Chief Division of Infectious Disease, Sterling Hospital, Ahmedabad, India; †Adit Diagnostic Center, Ahmedabad, India; ‡Sterling Hospital, Ahmedabad, India; §Shashwat Diagnostic, B.V. Patel PERD Center, Ahmedabad, India; and ∥B.V. Patél PERD Center, Ahmedabad, India.
Received for publication October 25, 2003;
accepted June 4, 2004.
Presented in part at the 10th Conference on Retroviruses and Opportunistic Infections, Boston, February 10–14, 2003 (oral abstract 138).
Reprints: Atul Patel, Division of Infectious Disease, Sterling Hospital, Off Gurukul Road, Ahmedabad, India (e-mail: firstname.lastname@example.org).