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Published on: August 11, 2008
One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis
Susan Swindells1, Ritesh Ramchandani1, Amita Gupta1
1From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).
Background:
Tuberculosis is the leading killer of patients with human immunodeficiency virus (HIV) infection. Preventive therapy is effective, but current regimens are limited by poor implementation and low completion rates.
Methods:
We conducted a randomized, open-label, phase 3 noninferiority trial comparing the efficacy and safety of a 1-month regimen of daily rifapentine plus isoniazid (1-month group) with 9 months of isoniazid alone (9-month group) in HIV-infected patients who were living in areas of high tuberculosis prevalence or who had evidence of latent tuberculosis infection. The primary end point was the first diagnosis of tuberculosis or death from tuberculosis or an unknown cause. Noninferiority would be shown if the upper limit of the 95% confidence interval for the between-group difference in the number of events per 100 person-years was less than 1.25.
Results:
A total of 3000 patients were enrolled and followed for a median of 3.3 years. Of these patients, 54% were women; the median CD4+ count was 470 cells per cubic millimeter, and half the patients were receiving antiretroviral therapy. The primary end point was reported in 32 of 1488 patients (2%) in the 1-month group and in 33 of 1498 (2%) in the 9-month group, for an incidence rate of 0.65 per 100 person-years and 0.67 per 100 person-years, respectively (rate difference in the 1-month group, -0.02 per 100 person-years; upper limit of the 95% confidence interval, 0.30). Serious adverse events occurred in 6% of the patients in the 1-month group and in 7% of those in the 9-month group (P = 0.07). The percentage of treatment completion was significantly higher in the 1-month group than in the 9-month group (97% vs. 90%, P<0.001).
Conclusions:
A 1-month regimen of rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing tuberculosis in HIV-infected patients. The percentage of patients who completed treatment was significantly higher in the 1-month group. (Funded by the National Institute of Allergy and Infectious Diseases; BRIEF TB/A5279 ClinicalTrials.gov number, NCT01404312.).
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