Low-cost drug gaining favor for use in HIV-infected children in poor countries

A new systematic review highlights strong results from a single study at the center of mounting support for worldwide use of the low-cost drug Bactrim to help HIV-infected children in poor countries.

The reviewers surveyed medical literature on the preventive use of Bactrim -- one of several brand names for the generic medicine cotrimoxazole -- for children to ward off common infections that can be deadly to a person whose immune system is weakened by HIV.

Dr. Kate Grimwade, with the Heart of England National Health Service foundation trust in Birmingham, led the review of the drug and found "a significant mortality benefit."

Grimwade's review appears in the most recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

To be included in the Cochrane findings, a study had to be a randomized clinical trial. Grimwade's search turned up only one trial that passed that litmus test: a study of 534 HIV-positive children in Zambia.

The study found 33 percent fewer deaths in the group of children who received cotrimoxazole versus the children who were not treated with the antibiotic. The children prescribed cotrimoxazole also were hospitalized less. Those positive results held true "across the board" for children in all age groups and in different stages of HIV illness, Grimwade said.

Every medication has side effects, and the trial did uncover some adverse reactions from cotrimoxazole. Still, Grimwade said the Zambian study shows that the drug is a safe precaution against opportunistic infections in HIV-positive children.

The new review is being released as health policy makers anticipate updated recommendations on cotrimoxazole from the World Health Organization. In May 2005, the WHO gathered HIV/AIDS experts from around the world -- including Grimwade -- to pore over the scientific evidence on the preventive use of cotrimoxazole for people with HIV.

Nine months later, Grimwade said despite concerns over drawing conclusions from one study there is now much more consensus. She said, "the new WHO guidelines will likely recommend its use in both infected adults and children."

"In the latest discussions, there's no talk of further studies. It's basically accepted now," she added. The results from the single trial are so strong, Grimwade said, that many people believe that it is unethical to use a placebo in children to further investigate the preventive use of the drug.

Dr. Marco Antônio de Ávila Vitória, a medical officer with the WHO's Department of HIV/AIDS, also said preventive use of cotrimoxazole is gaining wide acceptance.

"It's a very cheap strategy," he said, "and the drug is very available, a lot more available in many areas where antiretroviral drugs are not around."

Cotrimoxazole is not a substitute for antiretroviral treatment, but the antibiotic may be a good stopgap measure until comprehensive HIV/AIDS care is available, or a way to extend the time until a patient needs anti-retroviral drugs, Vitória said.

Vitória said many discussions at the WHO summit centered on which settings would best benefit from preventive cotrimoxazole treatment given their health care infrastructure and ability to monitor and respond to possible side effects.

The WHO updated recommendations -- scheduled to be released early this year -- will provide some guidance for countries as they make their own decisions, Vitória said.

The recommendations include guidelines on monitoring toxicity and when to begin cotrimoxazole treatment given the child's age, whether the patient has symptoms of HIV disease and the strength of the patient's immune system.

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INTERVIEWS
Kate Grimwade at 44 121 424 2358 or katherine.grimwade@heartofengland.nhs.uk

Grimwade K, et al. Cotrimoxazole prophylaxis for opportunistic infections in children with HIV. The Cochrane Database of Systematic Reviews 2006, Issue 1.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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