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Viral rebound, failure similar in children with HIV switched from Kaletra to Sustiva
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Switching from Kaletra–based ART to Sustiva-based ART in South African children with HIV and exposed to nevirapine did not significantly increase rates of viral rebound or viral failure in a recent study.
“There are several potential advantages of switching to [Sustiva, Bristol-Myers Squibb (efavirenz)], including preserving [Kaletra, AbbVie (ritonavir-boosted lopinavir)] for second-line treatment, harmonizing pediatric and adult treatment guidelines, and reducing the cost of national programs,” Louise Kuhn, PhD, an epidemiologist at the Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, and colleagues wrote
The researchers studied a cohort of 300 HIV-infected children aged older than 3 years who were prenatally exposed to nevirapine and receiving ritonavir-boosted lopinavir. A group of 150 children randomly were switched to efavirenz, while 148 children continued receiving ritonavir-boosted lopinavir. Follow-up testing was done at 48 weeks after the initial treatments.
Data showed that viral rebound was not increased by switching to efavirenz-based therapy, with a Kaplan-Meier probability of 0.176 after 48 weeks in the intervention group vs. 0.284 in the control group (P < .001). The probability of viral failure also was not increased (0.02 vs. 0.027; P < .001).
Kuhn and colleagues rejected the null hypothesis that efavirenz-based ART was inferior to ritonavir-boosted lopinavir–based ART (P < .001). The researchers also wrote that the intervention group had a more robust CD4 cell response rate compared with controls.
According to the study, while efavirenz-based ART is safe and well-tolerated, clinical awareness is needed. Twenty-six percent of the children in the intervention group reported having nightmares and trouble sleeping after 4 weeks of treatment. Two children in the intervention cohort also developed seizure disorders while receiving efavirenz.
“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,” Kuhn and colleagues wrote. “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.”
In a related editorial, Ram Yogev, MD, a professor of pediatric infectious diseases at the Lurie Children’s Hospital, Chicago, supported Kuhn and colleagues’ research, while highlighting some of the concerns raised by their findings.
“The current WHO dosing recommendation for efavirenz may result in a higher proportion of children with excessive blood levels, which may lead to increased toxicity,” Yogev wrote. “The possible role of other factors affecting the pharmacokinetics and pharmacodynamics of efavirenz, such as nutritional status and developmental physiology … needs to be investigated further to assess appropriate dose selection that will minimize both toxicity (ie, overdosing) and development of viral resistance (ie, underdosing).” – by David Costill
Disclosure: The researchers report no relevant financial disclosures.
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