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SAFETY AND EFFICACY OF N-ACETYLCYSTEINE IN HOSPITALIZED PATIENTS WITH HIV-ASSOCIATED TUBERCULOSIS: AN OPEN-LABEL, RANDOMIZED, PHASE II TRIAL (RIPENACTB STUDY)
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Abstract
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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