Study Examines Effectiveness of Efavirenz-Based Antiretroviral Therapy for HIV-Infected Children


Media Advisory: To contact Louise Kuhn, Ph.D., call Stephanie Berger at 212-305-4372 or email To contact editorial author Ram Yogev, M.D., call Julie Pesch at 312-227-4261 or email


To place an electronic embedded link to this study and editorial in your story This link to the study will be live at the embargo time: will be the link to the editorial:


Louise Kuhn, Ph.D., of Columbia University, New York, and colleagues evaluated whether HIV-infected children in South Africa who had achieved viral suppression with one treatment could transition to efavirenz-based therapy without risk of viral failure. The study appears in the November 3 issue of JAMA.


Implementation of pediatric antiretroviral treatment (ART) programs in sub-Saharan Africa has resulted in significant reductions in morbidity and mortality among children infected with human immunodeficiency virus (HIV), changing a rapidly fatal disease into a chronic condition. For infants and young children, ritonavir-boosted lopinavir-based therapy is recommended as first-line ART. In adults and older children, efavirenz is recommended as part of first-line ART. Advantages of this regimen include once-daily dosing, simplification of co-treatment for tuberculosis, preservation of ritonavir-boosted lopinavir for second-line treatment, and alignment of adult and pediatric treatment regimens. However, there have been concerns about possible reduced viral efficacy of efavirenz in children exposed to nevirapine for prevention of mother-to-child transmission.


This study, conducted at a hospital in Johannesburg, South Africa, included HIV-infected children 3 years of age or older exposed to nevirapine for prevention of mother-to-child transmission and who had plasma HIV RNA of less than 50 copies/ml during ritonavir-boosted lopinavir-based therapy. Participants were randomly assigned to switch to efavirenz-based therapy (n = 150) or continue ritonavir-boosted lopinavir-based therapy (n = 148). The children were followed up to 48 weeks after randomization.


The researchers found that switching to efavirenz-based therapy compared with continuing ritonavir-boosted lopinavir-based therapy did not result in significantly higher rates of viral rebound (i.e., HIV RNA >50 copies/mL) or viral failure (i.e., confirmed HIV RNA >1000 copies/mL). “This therapeutic approach may offer advantages in children such as these.”


“There is little guidance available as to what clinicians ought to do when confronted with a child older than 3 years who has begun treatment with ritonavir-boosted lopinavir. As a result, it has been left to individual interpretation, and there are anecdotal reports of clinicians switching to efavirenz in the absence of data to support such a practice. This study provides evidence to support the safety and efficacy of switching to efavirenz, the recommended drug for children older than 3 years, among children with viral suppression,” the authors write.

(doi:10.1001/jama.2015.13631; Available pre-embargo to the media at http:/


Editor’s Note: The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.


Editorial: Antiretroviral Therapy for Nevirapine-Exposed Children With HIV Infection


Ram Yogev, M.D., of Lurie Children’s Hospital, Chicago, comments on the findings of this study in an accompanying editorial.


“The study by Coovadia et al is an important contribution in the evolving science of how to treat perinatally HIV­infected children. Even when combination ART controls the viral load, HIV-related complications remain (e.g., cardiovascular disease), and strategies to improve patient outcomes are needed that include early treatment and chemoprophylaxis as well as research on vaccines and an effective cure.”

(doi:10.1001/jama.2015.13763; Available pre-embargo to the media at http:/


Editor’s Note: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.


# # #