Lab Monitoring Offers Little Benefit to African HIV Efforts

DART study team supports allocation of more resources to drugs, less to monitoring

WEDNESDAY, Dec. 9 (HealthDay News) -- Antiretroviral therapy (ART) in Africa can be successfully carried out without constant laboratory monitoring, allowing limited funds to be reallocated to drugs, according to a study published online Dec. 9 in The Lancet.

A. Sarah Walker, Ph.D., of the Medical Research Council in London, and colleagues on the Development of AntiRetroviral Therapy (DART) study team randomized 3,321 HIV-infected patients at four treatment centers in Uganda and Zimbabwe to receive laboratory and clinical monitoring (LCM) or clinically-driven monitoring only (CDM). Hematology and biochemistry tests and CD4-cell counts were performed every 12 weeks.

The researchers found that the five-year survival was 87 percent in the CDM group and 90 percent in the LCM group. In the CDM group, 28 percent progressed to a WHO stage 4 event or died, compared to 21 percent in the LCM group. Overall, 19 percent of CDM group patients switched to second-line ART compared to 22 percent in the LCM group, with more switching in the LCM group in the second and third years of therapy.

"We have shown that routine laboratory monitoring for toxic effects in HIV patients receiving ART has no benefit. ART can be delivered safely with good quality clinical care, allowing treatment delivery to be decentralized. Small differences in disease progression suggest a role for CD4-cell testing from the second year on ART to guide the switch to second-line ART and should encourage accelerated development of simpler, cheaper, point-of-care CD4 tests," the authors write.

The study received funding from GlaxoSmithKline, Boehringer-Ingelheim, and Abbott Laboratories.

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