Prezista Extends HIV Suppression in Children (CME/CE)
Children with human immunodeficiency virus (HIV) maintain viral control for 48 weeks when treated with the protease inhibitor darunavir/ritonavir (Prezista) along with an optimized background regimen, researchers reported here.
In the Darunavir in Treatment Experienced Pediatric Population (ARIEL) study, 81% of the 21 children ages 3 to 5 years were able to achieve viral suppression to undetectable limits using the 50 copies/ml assay, an increase from the 57% viral suppression rate at 24 weeks, said Avy Violari, MD, deputy executive director of the Perinatal HIV Research Unit at Chris Hani Baragwaneth Hospital, Soweto, South Africa.
"I think this is an important finding because a lot of us feel that if we do not achieve virologic suppression by 24 weeks we are not doing well," she said. But in the trial, viral suppression continued beyond 24 weeks.
She also noted that CD4-positive cell counts had increased further from baseline with continued treatment. After 24 weeks, the mean CD4-positive cell counts had increased 109 cells/mm3; by 48 weeks the mean increased was 187 cells/mm3.
Three children experienced virologic failure at week 48, two of whom had never reached viral suppression and one who had rebounded, Violari reported.
"No new safety concerns were reported compared with the known safety profile of darunavir/ritonavir," she added. In the 24-week analysis, safety issues in the pediatric cohort were similar to that seen in adults. One child discontinued treatment in the 48-week study due to Grade 2 vomiting.
Violari also noted that in 48-week study no development of resistance to darunavir was observed. Most of the adverse events in the children were associated with childhood illnesses such as head colds.
The ARIEL trial was conducted in Argentina, Brazil, India, Kenya and South Africa. The researchers enrolled children who were 3 years of age and less than 6 years of age who weighed at least 10 kg but weighed less than 20 kg. All had been on highly active antiretroviral therapy for at least a year before entering the trial. They also had to have viral loads of at least 1,000 copies/ml at baseline.
Darunavir/ritonavir was provided in either suspension or tablet form. Patients weighing 10kg to less than 15 kg received a dose of 25 mg darunavir/3 mg ritonavir per kilogram; children weighing 15 kg or more were dosed at 375/50 mg per kilogram.
Violari said 42 children were screened for inclusion in the study and 27 were included in the 24-week trial. Twenty-one of them went on to the 48-week study. The aim of the study was to develop guidelines for treatment of these children with darunavir/ritonavir.
Diana Gibb, MD, professor of epidemiology and honorary consultant in pediatrics with the Medical Research Council Clinical Trials Unit, London, who moderated the oral abstract sessions, questioned how well children tolerated the drugs, noting that taste has been an issue. "I think that among older children they tend to be switched to tablets if they dislike the suspension," she said.
Violari said about 50% of the children liked the taste of the suspensions of ritonavir and darunavir; about 20% were indifferent and 30% said they didn't like the medicine.
"This is a good study," Gibb said. "It means that there is a possibility that we can use darunavir after Kaletra (lopinavir/ritonavir) or even fill those gaps that we have with fixed dose combinations in the future."
The study was sponsored by Janssen Infectious Diseases BVBA, Beerse, Belgium, and Janssen Research & Development, Titusville, New Jersey.
Gibb had no disclosures. Violari has previously disclosed commercial relationships with Abbott.
Primary source: International AIDS Society
Source reference:
Violari A, et al "Safety and efficacy of darunavir/ritonavir in treatment-experienced pediatric patients aged 3 to <6 data-blogger-escaped-48="" data-blogger-escaped-analysis="" data-blogger-escaped-ariel="" data-blogger-escaped-ias="" data-blogger-escaped-of="" data-blogger-escaped-the="" data-blogger-escaped-trial="" data-blogger-escaped-week="" data-blogger-escaped-years:=""> 2013, Abstract MOAB0102.
