Vienna 2010: Early ARVs enhance survival in HIV-TB

Submitted by Evelyn Harvey (Evelyn) about 2 months ago

Antiretroviral drugs should be initiated after just two weeks of TB treatment in patients with HIV and TB, according to a new study. Currently, a gap of up to 8 weeks between commencement of TB treatment and initiation of HAART is advised, to reduce the risks of immune reconstitution inflammatory syndrome (IRIS) and adverse drug interactions. The findings of the CAMELIA (Cambodian early vs late introduction of antiretrovirals) were presented at AIDS 2010 on 22 July by Dr Francis Xavier Blanc, Bicetre Hopital, France.

CAMELIA researchers recruited 661 people with TB and HIV into the randomised trial, across five sites in Cambodia. All of the participants had newly diagnosed acid-fast bacillus smear positive TB. Their CD4 counts were below 200 cells/mm3 (on average 25 cells/mm3). Both pulmonary and extrapulmonary TB cases were included; some participants had both forms of TB.

The trial population was divided equally into two groups. One group received early HAART, just two weeks after initiation of TB treatment. The other group received HAART 8 weeks after the start of TB treatment, in accordance with normal guidelines. There is moderate evidence to suggest that starting TB treatment before antiretrovirals (ARVs) is always better in terms of adverse events and tolerability, so TB treatment was begun before HAART in both groups. MDR-TB rates were low, at 1-2% in both groups.

After 50 weeks, 146 participants were known to have died, 59 in the early arm and 90 in the late arm. This demonstrated that survival was significantly enhanced in the early arm (p= 0.002). At week 50, median CD4 cell gain was 114, and nearly all the participants had an undetectable viral load. Calculations of survival gave a 3-year survival probability of 82% if ARVs are given early, two weeks after TB treament starts, and 70.2% if they are given late, at 8 weeks (p =0.002).

Participants were at higher risk if they had MDR TB, combined pulmonary and extrapulmonary infection, and low (<16) BMI at baseline, regardless of when ARVs were given. IRIS was significantly more frequent in the early arm (p<0.0001), but symptoms were manageable. Only 12 (1.8%) patients were lost to follow-up.

The CAMELIA study has shown that initiation of HAART at 2 weeks, rather than 8 weeks, after the onset of TB treatment significantly improves survival in severely immunosuppressed HIV-infected adults, despite the increased incidence of IRIS. The findings could have significant implications for TB-HIV treatment programs globally.

"We calculated that if this early ART was applied in all HIV-TB cases, it would result in about 50,000 lives saved" said Dr Blanc.

Dr Blanc also noted that all the patients in the CAMELIA study were highly immunocompromised, and it is unclear whether the best timing of ARVs would be different in people with HIV-TB with higher CD4 counts.
Abstract THLBB106

Keywords: AIDS ARVs Coinfection HIV HIV-TB TB TB-HIV treatment trial Vienna 2010

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