New standard of care for HIV-infected infants

In honor of World AIDS Day on December 1, we’re examining the results of a clinical trial suggesting a way to prevent illness and death in babies infected with HIV.

The World Health Organization (WHO) established World AIDS Day to give governments, national AIDS programs, faith organizations, community organizations and individuals a chance to raise awareness and focus attention on the global AIDS epidemic. (See Global Health Specialist Will Talk About World AIDS Day)

Infants infected with HIV type 1 are more likely to die than older children. Treating kids with a cocktail of antiretroviral medications can be effective initially, but long-term administration of antiretrovirals is problematic because the virus often evolves resistance and antiretroviral medications can be toxic.

Should HIV-positive infants begin treatment before clinical symptoms develop, or are the current guidelines of waiting until symptoms develop more effective?

The Children with HIV Early Antiretroviral Therapy (CHER) trial tried to answer this question. At two hospitals in South Africa (Chris Hani Baragwanath Hospital, Soweto and Tygerberg Children’s Hospital, Cape Town) physicians randomly assigned 6- to 12-week-old infants who had HIV infections but no clinical symptoms into three groups.

One group began antiretroviral therapy immediately for 40 weeks, a second group for 96 weeks, and a third group began treatment only after they displayed a clinical symptom of infection (low number of CD4-positive T cells, HIV-associated lung disease and pneumonia, kidney or heart problems, oral thrush, failure to thrive).

Antiretroviral therapy beginning at, on average, seven weeks after birth reduced mortality to 4 percent (10 babies died out of a total of 252), compared with 16 percent in babies that began treatment only after displaying symptoms (20 of 125). Disease progressed to more advanced stages in only 6 percent of infants who received early treatment (16 of 252), compared with 26 percent in the deferred therapy group (32 of 125).

Early antiretroviral treatment reduced infant mortality by 76 percent and HIV progression by 75 percent.

Immediate treatment is so effective that the CHER trial led to a new standard of care – instead of postponing treatment until signs of illness or a weakened immune system appear, WHO now “strongly” recommends starting antiretrovirals in children under age 1 immediately after HIV diagnosis, regardless of their state of health.

To learn more about the story of HIV/AIDS, check out:
http://www.hhmi.org/biointeractive/disease/lectures.html

The Howard Hughes Medical Institute (HHMI) presents four 60-minute presentations examining the story of HIV/AIDS:

• From Outbreak to Epidemic by infectious disease specialist Dr. Bisola Ojikutu
• AIDS and the HIV Life Cycle by HHMI investigator Dr. Bruce Walker
• Drugs and HIV Evolution, by Dr. Ojikutu
• Vaccines and HIV Evolution, by Dr. Walker

“Early antiretroviral therapy and mortality among HIV-infected infants” by Avy Violari, Mark F. Cotton, Diana M. Gibb, Abdel G. Babiker, Jan Steyn, Shabir A. Madhi, Patrick Jean-Philippe, James A. McIntyre, and the CHER study team appears in the November 20, 2008, New England Journal of Medicine.

CHER was supported by the National Institutes of Health; the departments of Health of the Western Cape and Gauteng, South Africa; and GlaxoSmithKline.

By : Daniel Gorelick