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Efavirenz More Effective than Nevirapine for Children with HIV

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HIV positive African children and adolescents treated with efavirenz (Sustiva) were less likely to experience virological failure than those using nevirapine (Viramune), according to a large comparative study published in the May 1, 2013, Journal of the American Medical Association. Nevirapine, however, is less expensive and more widely available for children in low-income countries.

Elizabeth Lowenthal from the Children’s Hospital of Philadelphia and University of Pennsylvania Perelman School of Medicine and colleagues compared first-line treatment outcomes among children and adolescents (ages 3 to 16 years) treated with efavirenz or nevirapine, 2 non-nucleoside reverse transcriptase inhibitors (NNRTIs)recommended by the World Health Organization (WHO) for pediatric use in resource-limited settings. The analysis included more than 800 children in Botswana.

The researchers found that children taking efavirenz were half as likely as those taking nevirapine to not reach HIV RNA below 400 copies/mL within 6 months or maintain viral suppression (13.5% vs 26.4%, respectively), or to never achieve virological suppression (2.6% vs 5.2%).

Nevirapine is less expensive than efavirenz and more widely available in pediatric formulations, including convenient coformulations with other antiretroviral drugs. Efavirenz is also associated with neuro-psychiatric side effects that have not been extensively studied in children.

"With the majority of the world's children receiving nevirapine-based antiretroviral therapy, these findings may have significant public health importance," the researchers suggested.

Below is an edited excerpt from a press release issued by the Children's Hospital of Philadelphia describing the research in more detail.

First Large-Scale Study to Compare Treatments for HIV-Infected Children Finds Less-Used Regimen is More Effective for Children in Low-Resource Settings

April 30, 2013 -- Researchers from The Children’s Hospital of Philadelphia and the Perelman School of Medicine at The University of Pennsylvania, along with colleagues at the Botswana-Baylor Children's Clinical Centre of Excellence, conducted the first large-scale comparison of first-line treatments for HIV-positive children, finding that initial treatment with efavirenz was more effective than nevirapine in suppressing the virus in children ages 3 to 16. However, the less effective nevirapine is currently used much more often in countries with a high prevalence of HIV. The results of the study of more than 800 children are published today in the Journal of the American Medical Association (JAMA).

There are more than 3 million HIV-positive children in the world, and more than 90 percent of them live in sub-Saharan Africa. Currently, the World Health Organization (WHO) recommends both efavirenz and nevirapine for first-line pediatric use in resource-limited settings such as sub-Saharan Africa. Lead author Elizabeth Lowenthal, MD, MSCE of The Children’s Hospital of Philadelphia, says this study has the potential to change the standard of care in the parts of the world where most HIV-infected children live.

"Because nevirapine costs less than efavirenz and is more widely available in pediatric formulations, it is currently the more frequent choice for initial treatment in these children. However, our study suggests that efavirenz produces better outcomes," said Dr. Lowenthal.

Senior author Robert Gross, MD, MSCE, an associate professor of Infectious Diseases and Epidemiology at Penn Medicine, adds, "Given this evidence, it is very reasonable to adjust pediatric HIV treatment guidelines. However, as we move towards such changes, more work should be done to make efavirenz a more financially viable option for children on anti-retroviral therapy in these resource-limited settings."

Previous studies favoring efavirenz over nevirapine in adults have resulted in treatment guidelines for adults in many countries, including a few in resource-limited settings, to recommend the use of efavirenz over nevirapine. "In these low-resource settings, Non-Government Organizations typically work with countries’ medical programs to forecast their HIV-related drug needs and lobby companies to lower prices for bulk purchases," explained Lowenthal. "Through such programs, drugs that were once more expensive can become cost-effective."

Doctors Lowenthal and Gross applaud the work that the government of Botswana has done to both bring high-quality HIV treatment to its citizens and to facilitate the generation of knowledge to help improve treatment options. "Botswana has been extremely supportive of clinical trials and epidemiological studies, and is very forward thinking in its willingness to inform the world. For such a small country, the amount of research that comes out of Botswana on HIV and tuberculosis is tremendous, which has not only benefitted their public health, but public health for all."

5/9/13

Reference

ED Lowenthal, JH Ellenberg, E Machine, et al. Association Between Efavirenz-Based Compared With Nevirapine-Based Antiretroviral Regimens and Virological Failure in HIV-Infected Children. Journal of the American Medical Association 309(17):1803-1809. May 1, 2013.

Other Sources

Children's Hospital of Philadelphia. First Large-Scale Study to Compare Treatments for HIV-Infected Children Finds Less-Used Regimen is More Effective for Children in Low-Resource Settings. Press release. April 30, 2013.

JAMA. Antiretroviral Regimen Associated With Less Virological Failure Among HIV-Infected Children. Media advisory. April 30, 2013.