A Shorter, Effective Treatment for TB in HIV-Positive Patients

Richard Chaisson, MD

A groundbreaking study has shown that a one-month course of antibiotics is at least as effective and safe as the commonly recommended nine-month course of antibiotics in preventing the development of tuberculosis in people with HIV.

The study compared a daily, month-long regimen of the antibiotics rifapentine and isoniazid (1HP) with the standard nine-month regimen of daily isoniazid (9H). The study followed 3000 participants, who were recruited between 2012-2014, and included an average of 3 years of follow-up.

All participants either lived in a country with high TB burden or tested positive for latent TB infection. At the start of the study, about half of participants were taking antiretroviral medication. Patients included adults and adolescents aged 13 years or older from 45 countries.

Globally, tuberculosis (TB) is most common serious opportunistic infection in people living with HIV. According to the World Health Organization (WHO), in 2016 TB caused 40% of the deaths among people with HIV, even though the disease is treatable and preventable.

“More than 1000 people with HIV die of tuberculosis every day,” said Richard Chaisson, MD, a study author who presented the findings at the Conference on Retroviruses and Opportunistic Infections in March. “1HP could contribute to improvements in global tuberculosis control.”

Overall, TB incidence was lower than expected in both arms of the study, with 32 of the 1HP participants and 33 of the 9H participants developing active TB.

Previous research has shown that people living with HIV who have TB should receive treatment for both conditions simultaneously. Results from this study support that recommendation. In both 1HP and 9H groups, participants who were not on antiretroviral therapy at the start of the study and those who had positive skin or blood TB tests showed higher rates of active TB.

Both antibiotic regimens were safe, with fewer adverse events occurring in the 1HP arm of the study. The results showed slightly higher hematologic toxicity in the 1HP group and higher liver and neurologic toxicity in the 9H group.

Treatment adherence was significantly higher in the shorter regimen. Of patients assigned to the short 1HP arm, 97% completed the full antibiotic course, compared to 90% of participants in the nine-month arm. Given the effectiveness of both treatment regimens, the difference in adherence is especially important.

“These results have the potential to dramatically change clinical practice by offering people living with HIV who are at risk of developing active tuberculosis an additional, shorter-duration prevention option that is safe, effective and more convenient,” said NIAID Director Anthony S. Fauci, M.D. in a statement. “This study also will inform future research on prevention of tuberculosis disease among HIV-negative people at risk for developing active tuberculosis.”

The study is not yet published, however, the abstract, “One Month of Rifapentine/Isoniazid to Prevent TB in People with HIV: Brief-TB/A5279,” is available from the Conference on Retroviruses and Opportunistic Infections.