The STATIS trial (sponsor Inserm-ANRS) has compared two innovative strategies designed to reduce mortality in severely immunosuppressed HIV-infected adults. Coordinated by Professors François-Xavier Blanc (CHU de Nantes) and Serge Domoua (Programme PAC-CI, CHU de Treichville, Abidjan), the trial is being conducted in Cambodia, Côte d'Ivoire, Uganda, and Vietnam. The results will be presented this Monday, March 5, at the Conference on Retroviruses and Opportunistic Infections held in Boston from March 4 to 7, 2018.
Despite increased access to HIV screening and antiretroviral therapy, many HIV-infected people still enter healthcare systems very late, by which time severe immunosuppression complicates management. Mortality is high in these patients, notably because of tuberculosis, the leading cause of death in HIV-infected people. Patients who initiate antiretroviral therapy late are currently offered simple tuberculosis screening.
The STATIS trial (sponsor Inserm-ANRS) has studied the effects of intensive, systematic, and continuous screening for tuberculosis compared with systematic use of antituberculosis therapy on mortality in these patients. The first results of this study, which is conducted by Professors François-Xavier Blanc (CHU de Nantes) and Serge Domoua (Programme PAC-CI, CHU de Treichville, Abidjan) and their colleagues in Cambodia, Côte d'Ivoire, Uganda, and Vietnam, will be disclosed in an oral presentation at the Conference on Retroviruses and Opportunistic Infections (CROI 2018).
The study analyzed data from 1047 adult patients who had never received antiretroviral therapy and whose CD4+ cell count was low (<100/mm3) at inclusion. At initiation of antiretroviral therapy, these patients were randomized between two arms. In the first arm, the patients underwent tuberculosis screening comprising an Xpert MTB/RIF test and a urine lipoarabinomannan assay. Only patients who tested positive were then given antituberculosis drugs. The tests could be repeated throughout follow-up, depending on symptoms. In the second arm, all patients received systematic antituberculosis therapy.
The success rates of these two strategies, as a function of the number of deaths or of invasive bacterial infections during the first 24 weeks of follow-up, were higher than that previously reported in the literature for simple tuberculosis screening. There was no significant difference between the two strategies.
ANRS STATIS therefore shows that systematic initiation of antituberculosis treatment is no superior than intensive tuberculosis screening in reducing mortality in severely immunosuppressed HIV-infected adults when they enter the healthcare system. The study is still ongoing and new analyses will be performed for each patient after 48 weeks of follow-up. The two strategies compared in this study are particularly suited to resource-limited settings.