Routine Laboratory Monitoring Not Essential for Implementation of First-Line ART in Africa

Summary and Comment |
January 11, 2010

Routine Laboratory Monitoring Not Essential for Implementation of First-Line ART in Africa

  1. Salim S. Abdool Karim, MD, PhD

The DART study showed similar outcomes between patients on antiretroviral therapy who received laboratory tests only as clinically indicated and those who underwent routine monitoring.

  1. Salim S. Abdool Karim, MD, PhD

With drastic reductions in the price of antiretroviral drugs, laboratory tests have become one of the largest contributors to the cost of providing antiretroviral therapy (ART) in resource-constrained settings. This expense, coupled with the lack of laboratory facilities, has resulted in patients on ART being managed without routine laboratory monitoring.

To evaluate the consequences of this approach, investigators conducted an open, noninferiority trial (DART) among 3321 symptomatic HIV-infected adults initiating ART in Uganda and Zimbabwe (median CD4 count, 65 cells/mm3). Patients were randomized to clinical monitoring with or without additional routine toxicity and CD4-cell–count monitoring.

Five-year survival was similar between the groups — 90% with routine laboratory monitoring and 87% without — despite a significant difference in the combined rate of deaths and new WHO stage 4 events (5.2 vs. 6.9 per 100 person-years). During the first 2 years, routine laboratory monitoring was associated with more switches to second-line therapy, but by the end of the study, the two groups had similar proportions of patients who had switched (22% with routine monitoring and 19% without). The proportion of patients with serious adverse events was also similar between groups (16% and 17%).

Comment

This report shows that clinical monitoring, with laboratory tests performed only as indicated, is an effective strategy for managing patients on first-line ART and allays concerns that patients being treated in Africa are receiving substandard care. These data are reassuring, given that many of the countries with the greatest AIDS burdens do not have the necessary laboratory infrastructure to perform routine testing in their ongoing ART rollout programs.

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