In the search for new treatment options for patients living with HIV with tuberculosis, researchers at the Instituto de Pesquisa Clínica Evandro Chagas [Evandro Chagas Institute for Clinical Research] (Ipec/Fiocruz), in partnership with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS), the Ministry of Health, and research centers in Brazil and in France, have tested an antiretroviral system containing the medication Raltegravir, which belongs to the class of pharmaceuticals called integrase inhibitors, by comparing it to that containing Efavirenz. The research is part of the project "Phase of randomized tests to compare the efficacy and safety of different doses of Raltegravir and Efavirenz combined with Tenofovir and Lamivudine", supported by Fiotec.

According to data from the Ministry of Health, tuberculosis is the leading cause of death among HIV-seropositive people (people living with HIV). The death rate is 20% and, like AIDS, it affects particularly developing countries, where the number of patients with both diseases is growing. Rifampicin is one of the basic components used to fight tuberculosis, although it interacts with many of the antiretrovirals used to treat infection by HIV, which can lead to difficulties in the treatment of co-infected patients.

The medication Efavirenz, in combination with the pharmaceuticals Tenofovir (TDF) and Lamivudine (3TC), composes the antiretroviral system used in the initial treatment of these patients. However, there are still no alternative systems for individuals with intolerance to Efavirenz and women in early pregnancy, the use of which is restricted due to the risk of harm to the fetus. Therefore, the proposal aims to seek alternative treatments for patients with both diseases.

The results obtained were promising: the system with the inhibitor has shown similar efficacy and safety. For Fiocruz infectologist and study coordinator in Brazil, Beatriz Grinsztejn, the results indicate the possibility of using the inhibitor as an alternative to Efavirenz. "Raltegravir has a good tolerance profile and is easy to be taken," she states. The study, which is in phase 2, involved 155 HIV-seropositive patients receiving Rifampicin-based treatment.

The applicants were divided into three groups: the first group received a standard dose of Raltegravir (400 mg twice daily), the second group received a double dose of the pharmaceutical and the third group received the usual dose of Efavirenz. All three groups participated in the tests for 48 weeks and concomitantly received the treatment for tuberculosis. According to Grinsztejn, the findings indicate the conduction of a larger phase-3 study so that the final results can be achieved. "Our expectation for the next steps is optimistic," she declares.

*Includes information from the CCS/Fiocruz