BIO publishes quarterly newsletters for its members which focus on the therapeutic areas of member companies. The newsletters include updates from biotech stakeholders around Washington, including Congress, FDA, NIH, and patient organizations. The following is an excerpt from the "Focus on Allergy/Infectious Disease/Antiviral" newsletter. To find funding opportunities and learn about what Congress and the federal agencies are doing for biotechnology, please click here to read the “Focus on Allergy/Infectious Disease/Antiviral" newsletter.
Results from studies presented March 6 at the Conference on Retroviruses & Opportunistic Infections in Seattle demonstrated the importance of identifying & treating HIV-infected infants within the first year of life to prevent harm to the immune system & to enable normal neurological development.
Although immediate ART during infancy benefits HIV-infected babies, the prospect of lifelong treatment raises numerous concerns, including the risk of drug side effects and the potential for resistance to develop to available treatments. The “Children with HIV Early Antiretroviral Therapy” (CHER) trial, funded by NIAID, launched in South Africa in 2005. It tested a novel strategy of giving immediate ART to HIV-infected infants but stopping it after the period of infancy when the risks of consequences from HIV decreases. Treatment was not resumed until there was evidence of health decline. The study initially compared immediate versus delayed treatment, but the delayed treatment arm was stopped in 2007 after a data and safety monitoring board found that infants given ART beginning at an average age of 7 weeks had a significantly lower risk of death within 48 weeks compared with infants in the deferred treatment group. Based on these findings, in 2008 the WHO revised its treatment guidelines to recommend that in HIV-infected children under the age of one, ART be started immediately after HIV diagnosis, regardless of state of health.
Study results presented by Dr. Mark Cotton showed that infants could safely stop ART after 1 to 2 years and continue to fare significantly better than infants in whom the initiation of therapy was delayed until signs of illness or a weakened immune system appeared. Very few infants who received immediate ART had significant disease progression or died after treatment was stopped. Many of the infants who stopped therapy were able to remain off treatment for a long time. In follow up of the 375 study participants, 33% of infants who received 2 years of initial ART and 25% of the infants who received 1 year of initial therapy were still well and able to remain off treatment for roughly 5 years after the study officially ended.
Another presentation highlighted new results from the PREDICT study. This Phase III clinical trial among HIV-infected children in Thailand and Cambodia examined the question of when to begin ART in children who were not diagnosed with HIV during infancy and did not present for treatment until they became sick. The study, which began in 2006 & involved 299 children ages 2-12, compared beginning treatment immediately or delaying treatment until levels of CD4+ T cells fell to a certain threshold. Dr. Jintanat Ananworanich presented findings demonstrating that both study groups experienced comparably low rates of disease progression, while higher rates of drug toxicities & resistance were found in the immediate treatment group. Neurological development problems were frequent & equally prevalent in both groups.
Taken together, both the CHER and PREDICT studies illustrate the importance of identifying and treating HIV-infected infants as soon as possible.
For more information on these studies, please click here.
For more information, please click here to read the “Focus on Allergy/Infectious Disease/Antiviral” newsletter.