AEGiS-08IAC: Rifabutin therapy for the prevention of M. avium complex (MAC) bacteremia in patients with AIDS and CD4 less than or equal to 200. The Rifabutin Study Group.

8th International AIDS Conference

Amsterdam, Netherlands — July 19-24, 1992

Rifabutin therapy for the prevention of M. avium complex (MAC) bacteremia in patients with AIDS and CD4 less than or equal to 200. The Rifabutin Study Group.

Int Conf AIDS 1992 Jul 19-24; 8:We54 (abstract no. WeB 1055)
Cameron W, Sparti P, Pietroski N, Pearce D, Eron L, Sullam P, Conant M, Bianchine J, Gupta S, Schoenfelder J, et al; Univ. of Ottawa, Ottawa General Hospital, Ontario, Canada.

OBJECTIVE: Disseminated MAC infection is one of the most common serious complications of the late stages of AIDS. This study (Adria 087027) evaluates rifabutin (RIF) prophylaxis of MAC bacteremia in AIDS.

METHODS: This Phase III randomized, double-blind, multicenter, placebo-controlled trial of RIF 300 mg/day studied 556 patients with CDC-defined AIDS and CD4 counts less than or equal to 200. All patients were on antiretroviral therapy and PCP prophylaxis. Baseline, monthly and off-study clinical and laboratory evaluations included blood cultures for mycobacteria. Study endpoints were MAC bacteremia and severe toxicity.

RESULTS: The groups were similar with regard to demographics, extent of HIV disease and antiretroviral therapy. At the to-date analysis, excluding 6 placebo (P) and 11 RIF baseline MAC's, 40/276 (14.5%) P and 26/263 (9.9%) RIF pts. developed MAC bacteremia. For the intent-to-treat analysis of MAC-free survival, the hazard ratio was 1.5 (95% confidence interval 0.95-2.39, logrank p-value = 0.077). Covariate adjustment for baseline parameters did not alter the treatment effect. Excluding urine discoloration, adverse experiences were reported in 44% of patients in both groups. RIF was associated with an increased incidence of rash. RIF did not adversely affect liver function tests. No differences were noted in total WBC, platelet and CD4 cell counts, whereas a RIF-related decrease in absolute neutrophil counts was present.

CONCLUSION: To-date analysis of this ongoing trial suggests RIF 300 mg/day may be efficacious as a prophylaxis agent against MAC bacteremia, and that it is well tolerated in persons with AIDS. These results are supportive of another study (Adria 087023) which demonstrated that RIF prevented and/or delayed the development of MAC bacteremia.

Keywords: AEGIS, Rifabutin, Acquired Immunodeficiency Syndrome, Mycobacterium avium-intracellulare Infection, Mycobacterium Infections, CD4 Lymphocyte Count, Antigens, CD4, Antibiotics, Antitubercular, Double-Blind Method, Antibiotics, Macrolide, Multicenter Studies, Tuberculosis, Human, therapy, prevention & control, drug therapy, ICA8
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WeB1055