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When Are Adults in Resource-constrained Settings Most Likely to Experience an HIV-associated Illness following HAART Initiation and What Is It Related To?
Paula Braitstein*1, M Brinkhof1, M Schechter2,3, N Kumarasamy4, D Nash5, A Boulle6, E Ekong7, F Dabis8, E Balestre8, M Egger1, and the Antiretroviral Treatment in Lower Income Countries (ART-LINC) Collaboration
1Univ of Berne, Switzerland; 2Hosp Univ Clementino Fraga Filho, Rio de Janeiro, Brazil; 3Fed Univ of Rio de Janeiro, Brazil; 4YRG CARE, Chennai, India; 5Columbia Univ, Mailman Sch of Publ Hlth, New York, NY, US; 6Univ of Cape Town, Sch of Publ Hlth and Family Med, South Africa; 7Military Reference Hosp, Lagos, Nigeria; and 8INSERM 593, Univ Victor Segalen, Bordeaux, France
Background: Our objective was to examine the incidence of
any HIV-associated illness and tuberculosis (TB) during the first year
following the start of HAART among adults in resource-constrained settings.
Methods: The ART-LINC Collaboration is a multinational
network of HIV treatment programs in Africa, Brazil,
and Asia. Eligible for analysis were those
aged >16 years, previously treatment-naïve who initiated ≥3 ART drugs,
with known baseline CD4. New HIV-associated illness and TB events were examined
using random-effect survival models, adjusted for between-cohort heterogeneity.
Follow-up time was censored at time of event, death, last follow-up, or after
12 months. The following risk factors for the occurrence of HIV-associated
illness and TB events were examined: age, sex, baseline CD4, initial treatment
regimen (non-nucleoside reverse transcriptase inhibitor [NNRTI]-based vs protease inhibitor [PI]-based vs
other ≥3 drugs), and having a HIV-associated illness or TB at or
pre-HAART. Incidence rates were calculated for months 1 to 2, 3 to 6, and 7 to 12
post-HAART
Results: There were 696 new HIV-associated illness events
in 4655 patients over 12 months: 17.0/100 person-years (11.7 to 24.7), from 16
centers. Of these, 259 were TB: 5.8/100 person-years
(3.4 to 10.0). The incidence of new HIV-associated illness events in months 1
to 2, 3 to 6, and 7 to 12 were 35.1/100 person-years (23.9 to 51.6); 13.3/100 person-years
(7.1 to 24.7), and 10.2/100 person-years (6.3 to 16.7). Corresponding rates for
TB events were 13.0/100 person-years (6.0 to 28.1), 5.6/100 person-years (2.7
to 11.7), and 4.2/100 person-years (2.0 to 8.4), respectively. Male sex (p = 0.002), lower baseline CD4 count (p <0.001), HAART regimen not based on
an NNRTI or PI (p = 0.003), and a
history of an OI (p <0.001)
predicted new HIV-associated illness events, but not age (p = 0.144). Predictors of a new TB event were younger age (p = 0.001), male sex (p = 0.014), lower baseline CD4 count (p = 0.006), and a history of TB (p <0.001), but not treatment regimen
(p = 0.557). Separate analyses for
the three time periods produced similar results.
Conclusions: Although the completeness of ascertainment of HIV-associated
illness events in ART-LINC is unclear at the moment, and diagnostic criteria
differ across centers, these results indicate a considerably higher risk of new
HIV-associated illness and TB events during months 1 to 2 than later months post-HAART. The increased risk early on may be
associated with the immune reconstitution syndrome. Age, sex, baseline CD4
count, initial treatment regimen, and having a history of HIV-associated
illness or TB at baseline were important predictive factors.
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