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Safety and Antiretroviral Effectiveness of Concomitant Use of Rifampicin and Efavirenz for Antiretroviral-Naive Patients in India Who Are Coinfected With Tuberculosis and HIV-1

Patel, Atul MD*; Patel, Ketan MD*; Patel, Jagdish MD†; Shah, Nitesh MD‡; Patel, Bhupendra BSc, MT§; Rani, Shubha

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 September 2004 - Volume 37 - Issue 1 - pp 1166-1169
Brief Report: Clinical Science

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: atulptel@icenet.net).

© 2004 Lippincott Williams & Wilkins, Inc.