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Study raises concerns about empiric regimen for treatment of HIV-TB coinfection
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At least eight months of rifamycin therapy with initial daily dosing may produce better outcomes among patients coinfected with HIV and tuberculosis than the currently-recommended treatment protocol, according to results of a recent meta-analysis.
Researchers conducted a meta-analysis and systematic review that involved 5,158 citations, 21 cohort studies and six randomized trials. They evaluated the duration and dosing schedule of rifamycin and use of ART in the treatment of patients who were coinfected with TB and HIV.
The risk for relapse among patients with regimens using two months of rifamycin was 3.6 (95% CI, 1.1-11.7) compared with patients using rifamycin for at least eight months.
Trends toward higher relapse rates among patients treated with six months of rifamycin compared with those treated for equal to or more than eight months were also observed. Trends toward higher relapse rates also were observed among patients not receiving ART.
“The most important and striking finding of this review is the paucity of well-designed and adequately powered randomized trials of HIV-TB coinfection treatment,” the researchers wrote.
Owing to the importance of TB and HIV as a global co-epidemic, the work in this study was commissioned by WHO to address duration of rifamycin therapy, dosage schedules (daily vs. intermittent), and the effect of ART on outcomes. This was an impressive amount of work, paring down a huge literature to 27 evaluable studies meeting the criteria for analysis.
The finding of better outcomes with at least eight months of rifamycin therapy rather than two months is not surprising. This previously led to changes in WHO recommendations, with greatest relevance to developing countries where prior standards were the use of rifampin only in the two-month intensive phase of anti-TB therapy. The finding that eight months of a rifamycin-containing regimen may be better than six months was not statistically significant, but the trend was consistent with results from a prior review of individual treatment regimens. Although the question of length of anti-TB therapy has been an issue ever since TB was recognized to be the most common opportunistic illness in HIV/AIDS patients on a global basis, it is striking that only three head-to-head randomized controlled trials have been done to address this question. Many clinicians extend therapy beyond six months based on prior studies, many of which are included in this analysis; this is not, however, common practice in resource-limited settings.
That the use of ART in patients on treatment for TB may have better outcomes is consistent with the use and benefit of ART in many other opportunistic infections in patients with AIDS. This review does not address the question of the optimal time to start ART in patients with TB, which is currently being evaluated in other trials.
As above, I agree with the conclusion of the authors that well-designed and adequately powered randomized clinical trials on treatment of TB in HIV-infected patients are needed, to provide the most accurate and definitive data, rather than retrospective analyses of cohort data (albeit with a well done and thoughtful meta-analysis) with their inherent limitations.
– David Cohn, MD
Infectious Disease News Editorial Board member –
Khan FA. Clin Infect Dis. 2010;50:1288–1299.