The World Health Organization has altered its guidelines after a study led by Dartmouth-Hitchcock Medical Center pediatrician Paul Palumbo found the use of a new drug combination in the treatment of pediatric HIV in Africa to be more effective than the traditional approach. Now the researchers must confront the obstacles most particularly, the cost of implementation in resource-deprived nations, Palumbo said.
The study addressed the issue of how to treat children who have contracted HIV from their mothers. The study, published this month in the New England Journal of Medicine, found that adding the drug Kaletra to the treatment was more effective in combating HIV infections in babies compared with the more conventionally used method of solely using Nevirapine.
"If a baby gets infected, and they need treatment, then there is the issue of what to actually treat them with," Palumbo said. "The featured strategy for preventing transmission from an infected mother to her baby is to give a pregnant woman a single dose of Nevirapine when she goes into labor, and then when the baby is born, give the baby Nevirapine."
This method halves the HIV transmission rate from mother to baby, he said.
Despite the popularity of this approach in Africa, there is a high probability that HIV will eventually develop resistance to Nevirapine, Palumbo said. This danger warranted investigation into whether a different drug could protect newborns against HIV infection.
All the babies in the study aged six months to three years were treated with Nevirapine prior to enrollment. The study involved giving some of the babies a dose of Kaletra and some a second dose of Nevirapine and comparing the results, Palumbo said.
In April 2009, an independent group of experts, who were dispatched to clinical trial sites every six months to gauge both the study's effectiveness and the subjects' safety, determined that the combination was more effective than the single doses. Currently, the researchers are looking at the effect of Kaletra after no initial dose of Nevirapine.
In response to the study results, the World Health Organization updated its guidelines to recommend the use of Kaletra in treating pediatric HIV patients. With the new guidelines, the next step is to bring the Kaletra-focused approach to the country level, where the health ministries of individual African nations will have to decide whether they want to follow the WHO's recommendations, Palumbo said.
Because Kaletra costs four to five times more than Nevirapine, Palumbo acknowledged that this would be a challenge for developing countries.
"At the country level they're still grappling with this," he said. "They're dealing with very limited resources."
Palumbo acknowledged the efforts of the people on the ground, including a physician, nurses, pharmacists, data managers and community leaders, who enabled the study to be put into action.
"Study teams on the ground were critical," Palumbo, who took a three-day visit to each of the 10 study sites in a total of six African nations, said. "They were very skilled, dedicated people."
Combating HIV/AIDS is one of the United Nations' Millennium Development Goals, launched in 2000 to fight global poverty. By 2015, the year the MDGs are to be attained, the goal is to have halted and begun to reverse the spread of HIV/AIDS, according to the UN website.
But Sub-Saharan Africa, where Palumbo conducted his research, remains vulnerable to the HIV/AIDS crisis, according to "The Millennium Development Goals Report 2010," published by the UN.
Of all new HIV infections in 2008, 72 percent occurred in sub-Saharan Africa, according to the report. Sub-Saharan Africa also accounted for an overwhelming majority of the 17.5 million children worldwide who lost at least one parent to AIDS in 2008.
One of the MDGs related to HIV/AIDS was to have achieved universal access to HIV/AIDS treatment by 2010 for all those who need it, according to the report.
"The rate of new infections continues to outstrip the expansion of treatment, drawing attention to the urgent need to intensify both prevention and treatment measures," the report said in assessing the failure to meet this target.
Despite the prevalence of HIV/AIDS in Africa, there remains reason for optimism, according to Donna Barry, the policy and advocacy director of Partners In Health, an international health care organization co-founded by College President Jim Yong Kim.
"We've seen some incredible success stories [with HIV/AIDS treatment]," Barry said in an interview. "Ten years ago there were none."
HIV/AIDS treatment is making far more progress than maternal and child health another one of the MDGs because so much research has been devoted to HIV/AIDS issues, according to Barry.
At the same time, however, the economic crisis has made it difficult for European donor nations to ensure the necessary funding for AIDS treatment, Barry said.
"If resources aren't there, the progress is going to be slower than any of us would like," Barry said.
