Second study shows no TB-free survival benefit from isoniazid prophylaxis in HIV+/− infants
WEDNESDAY, July 6 (HealthDay News) -- Novel secondary regimens to prevent tuberculosis in HIV-infected adults are no more effective than standard isoniazid for achieving tuberculosis-free survival; and isoniazid prophylaxis is not effective for improving tuberculosis-free survival in HIV-infected or uninfected children, according to two studies published in the July 7 issue of the New England Journal of Medicine.
Neil A. Martinson, M.B., B.Ch., M.P.H., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues investigated whether three new regimens for latent tuberculosis were more effective than standard isoniazid in 1,148 HIV patients with a positive tuberculin skin test, who were not receiving antiretroviral therapy. Participants were randomized to rifapentine-isoniazid treatment, rifampin-isoniazid, continuous isoniazid, or standard isoniazid treatment (control). Incidence rates of active tuberculosis or death were similar for all secondary regimens (3.1, 2.9, 2.7, and 3.6 per 100 person-years, respectively).
Shabir A. Madhi, M.D., Ph.D., from the University of the Witwatersrand in Johannesburg, South Africa, investigated isoniazid prophylaxis against tuberculosis in 548 HIV-infected infants with access to antiretroviral therapy and 804 HIV-uninfected infants. Children were vaccinated against tuberculosis within 30 days of birth and were randomly assigned to isoniazid or matching placebo for 96 weeks. In HIV-infected children, there was no significant difference in the incidence of protocol-defined tuberculosis or death; and in HIV-uninfected children, there was no significant difference in the combined incidence of tuberculosis infection, disease, or death in either group.
"Primary isoniazid prophylaxis did not improve tuberculosis-disease-free survival among HIV-infected children or tuberculosis-infection-free survival among HIV-uninfected children immunized with bacille Calmette-Guérin vaccine," Madhi and colleagues write.
One of the authors from the Martinson study disclosed a financial tie to the pharmaceutical industry. The Madhi study was funded by a grant from the Secure the Future Fund, which is sponsored by Bristol-Myers Squibb.
Abstract - Martinson
Abstract - Madhi