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

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

Publication date: Aug 07, 2019

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, well 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.

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Concepts Keywords
Acetylcysteine Parallel
Adverse Event TB
Brazilian Amazon HIV
Center Open Tuberculosis
Ethambutol Drugs
Glutathione RTT
HIV Medicine
Isoniazid Tuberculosis
Mycobacterial Health
Pulmonary Prodrugs
Pyrazinamide Rifamycin antibiotics
Rifampicin Isoniazid
Tertiary Care Center Rifampicin
Tuberculosis Pyrazinamide
Vivo Acetylcysteine
Extensively drug-resistant tuberculosis

Semantics

Type Source Name
drug DRUGBANK Acetylcysteine
disease MESH tuberculosis
pathway KEGG Tuberculosis
drug DRUGBANK Glutathione
drug DRUGBANK Rifampicin
drug DRUGBANK Isoniazid
drug DRUGBANK Pyrazinamide
drug DRUGBANK Ethambutol

Original Article

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