Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study)

Izabella Picinin Safe, Marcus Vinícius Guimarães Lacerda, Vitoria Silva Printes, Adriana Ferreira Praia Marins, Amanda Lia Rebelo Rabelo, Amanda Araújo Costa, Michel Araújo Tavares, Jaquelane Silva Jesus, Alexandra Brito Souza, Francisco Beraldi-Magalhães, Cynthia Pessoa Neves, Wuelton Marcelo Monteiro (+6 others)
2020 PLoS ONE  
Despite the availability of effective antimicrobials, tuberculosis (TB) is still a serious health threat. Mortality is even higher in people living with HIV who are diagnosed with TB. New therapies are needed to shorten the time required to cure TB and decrease fatality rates in this population. N-acetylcysteine (NAC) is a glutathione precursor and has shown recently in experimental setting to present in vitro and in vivo anti-mycobacterial activity. We test the hypothesis that NAC is safe,
more » ... tolerated and secondarily efficacious as adjunctive anti-TB therapy in hospitalized individuals with HIV-associated TB. Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon. We performed a randomized, parallel group, single-center, open study trial of two arms, in hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC Group). A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively. Adverse event rates were similar in the two arms. Our findings suggest that in the more critical population of hospitalized patients with HIV-associated TB, the use of NAC was not unsafe, despite the low sample size, and a potential impact on faster negative cultures needs to be further explored in larger studies.
doi:10.1371/journal.pone.0235381 pmid:32589648 fatcat:nga5qrqgdfck5emf6jxquzqbya