Concurrent ART/TB Treatment Finally Proven to Be Beneficial
Giving ART while TB treatment was still ongoing dramatically improved survival among HIV/TB-coinfected patients in a large clinical trial in South Africa.
Initiating antiretroviral therapy (ART) together with tuberculosis (TB) therapy could reduce mortality risk among coinfected patients by 55%, according to interim findings from a large clinical trial in South Africa. Historically, ART has been delayed in many coinfected patients until after the completion of TB therapy because of concerns about drug–drug interactions, high pill burden, overlapping drug toxicities, and immune reconstitution inflammatory syndrome.
The SAPIT trial was designed to determine the optimal timing of ART initiation in conjunction with TB treatment. Enrollment took place between June 2005 and July 2008. A total of 645 coinfected patients were randomized to one of three treatment arms:
- Early integrated treatment: Patients started ART as soon as possible within the first 2 months of starting TB treatment.
- Late integrated treatment: Patients started ART as soon as possible after completing the 2-month intensive phase of TB treatment.
- Sequential treatment: Patients started ART as soon as possible after completing their TB treatment.
All patients received the same antiretroviral regimen: once-daily ddI, 3TC, and efavirenz. The average time from TB treatment initiation to ART initiation was 67 days in the integrated-treatment arms combined versus 261 days in the sequential-treatment arm.
By September 2008, 26 patients in the sequential-treatment arm had died (mortality rate, 11.6 per 100 person-years), compared with 24 in the integrated-treatment arms combined (mortality rate, 5.1 per 100 person-years), for a mortality rate ratio of 2.3. Based on these findings, the Data and Safety Monitoring Board recommended stopping the sequential-treatment arm of the study and initiating ART in this group as soon as possible. The two integrated-treatment arms will continue according to protocol, and all study participants will continue to be followed.
These findings have important implications for the management of HIV/TB coinfection. Dr. Salim Abdool Karim, principal investigator of the SAPIT trial, comments: "This trial addresses one of the biggest challenges facing AIDS treatment programs in Africa and provides compelling clinical-trial evidence that, in HIV/TB-coinfected patients with CD4 counts <500 cells/mm3, initiating ART during TB treatment significantly improves survival. The findings provide further impetus for closer linkages between TB and HIV care services. Implementing this approach as standard of care has the potential to substantially improve prognosis in HIV/TB coinfection."
— ACC Editors
Published in Journal Watch HIV/AIDS Clinical Care September 29, 2008
Important new research findings on treatment of TB-HIV co-infection [press release]. Durban, South Africa: CAPRISA — Centre for the AIDS Programme of Research in South Africa; Sep 19 , 2008. (http://www.caprisa.org/joomla/index.php/memberaccess/95-pressrelease17092008)
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