Sunday, March 7, 2010

Research Highlights: Study Finds Combined-Integrated Therapy for HIV and Tuberculosis Treatment Most Effective

Study Finds Combined-Integrated Therapy for HIV and Tuberculosis Treatment Most Effective
By: Caroline Melhado

A study published in the New England Journal of Medicine found that individuals who underwent combined-integrated therapy for both Tuberculosis and an HIV infection survived remarkably better than individuals who received sequential therapy. Concomitant therapy is encouraged by the World Health Organizations, however many clinicians worry about drug interactions and the pragmatics of taking so many pills for patients. This randomized study was designed to find the most opportune time for patients with both TB and HIV to start antiretroviral therapy.

The study was conducted in Durban, South Africa and included 642 patients that had a positive diagnosis of tuberculosis and an HIV infection with a CD4+ cell count < 500 per ml3. The combined-integrated therapy group included 429 patients which received a standard tuberculosis treatment, prophylaxis with trimethoprim–sulfamethoxazole, and a once daily antiretroviral treatment of didanosine, lamivudine, and efavirenz The sequential therapy group was designed to first be treated for Tuberculosis, using the same TB treatment plan, and start antiretroviral therapy upon completion of the TB regimen.

Researchers found that in the combined-integrated therapy group the incidence of death was 5.4 for every 100 person-years of observation. The sequential therapy group saw an incidence of death of 12.1 for every 100 person-years of observation. After adjustment for various confounding factors, researchers found that patients in the combined-integrated therapy group had a relative risk reduction of 54%. Two and a half years into the study the data and safety monitoring committee recommended all patients be put onto the combined-integrated therapy regimen for the remainder of the study. The combined-integrated therapy group saw nearly three times the cases of immune reconstitution inflammatory syndrome, however there were no deaths resulting from this syndrome.

Researchers concluded that antiretroviral therapy should be started during TB therapy to improve rates of survival in individuals with both an active diagnosis of TB and HIV. Even after controlling for complications resulting from drug interactions and regimen compliance, the risk ratio remains lower for combined-integrated therapy. This evidence further supports WHO’s recommendation.

NEJM Volume 362:697-706
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