ARTs safe without routine lab tests, Lancet study finds

Dec 10 2009

A Lancet study published online Tuesday validates the safety of administering first-line antiretroviral therapy (ART) to patients with HIV without routine toxicity and efficacy lab tests, "[b]ut tests of immune-system function might still be a good idea to monitor the progression of the disease and guide the second year of treatment," HealthDay/U.S. News & World Report reports. Patients in Africa "often receive [HIV] drug treatment ... without routine laboratory monitoring," according to the article.

For the Development of Anti-Retroviral Therapy in Africa (DART) study, researchers examined the benefits of routine testing for side effects experienced by patients on ART and measured the efficacy of the drugs. The researchers divided more than 3,000 HIV-positive adults from Uganda and Zimbabwe into two groups - one group received monitoring in a doctor's office and laboratory; the other only received monitoring in the doctor's office (12/9).

"The results of one group of patients were given to doctors routinely after each three-monthly test," the BBC reports, adding that "for a second group the results of toxicity tests were only passed on to doctors if they gave cause for concern - and this hardly ever happened."

The news service continues: "The results show that 90% of people whose results were routinely passed to a doctor were alive after five years compared to 87% in the group whose results were only passed over if abnormal." There were no differences in side effects between the two groups, according to the BBC (12/9).

However, the authors did note that "CD4-cell count monitoring has a small but significant benefit in terms of disease progression and mortality, probably owing to slightly earlier switching to second-line ART," according to HealthDay/U.S. News & World Report (12/9).

The BBC adds: "For health policymakers in Africa, DART provides evidence that more people could be treated for the same amount of money by not using routine laboratory tests," said Diana Gibb, of the Medical Research Council, who was involved with the study. "This would substantially reduce the number of people dying with serious disease due to HIV infection" (12/9).

Health-e also examines the results of the DART trial and features comments by Francois Venter, president of the Southern Africa HIV Clinicians Society, and HIV/AIDS advocate Gregg Gonsalves (Thom, 12/9).

"DART results have major implications for ART programmes in Africa at a time when there is uncertainty about long-term funding and sustainability and when most people still cannot access treatment," the study authors conclude. "With less need to provide routine monitoring, particularly for toxicity, funding can be focused on drug procurement, strengthening of diagnostic laboratory services, and training and supervision for health-care workers to foster quality clinical monitoring, to support scale-up of ART rollout to rural Africa where 60% of the HIV-infected population live" (Lancet, 12/9).

A Lancet comment also examines the results of the DART trial (Phillips/van Oosterhout, 12/9).