{"id":733,"date":"2008-06-12T19:26:54","date_gmt":"2008-06-12T18:26:54","guid":{"rendered":"http:\/\/localhost\/new\/htb\/?p=733"},"modified":"2013-08-28T08:07:20","modified_gmt":"2013-08-28T08:07:20","slug":"responses-to-atazanavir-containing-haart-in-treatment-naive-children-in-south-africa","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/733","title":{"rendered":"Responses to atazanavir-containing HAART in treatment-naive children in South Africa"},"content":{"rendered":"

Polly Clayden, HIV i-Base<\/strong><\/p>\n

A poster authored by Megan Palmer and coworkers from the United States and South Africa presented findings from PACTG 1020A. This is a phase I\/II study of atazanavir (ATV) with or without ritonavir (r) with 2 NRTI (excluding tenofovir [TDF]) in HIV-positive treatment-naive children aged 91 days to 21 years.<\/strong><\/p>\n

This poster showed data from treatment-naive South African children participating in the dose-finding study, for age (<2 years, 2 to 13 years, >13 years) and formulation (powder vs capsule) groups.<\/p>\n

Each group started with a dose of 310 mg\/m2 of ATV, which was adjusted based on day 7 24-hour, intensive PK and week 4 safety data. Acceptable PK and safety dose criteria were: \u00a0AUC >\/=30 ug*hour\/mL and C24 >\/=60 ng\/mL in 4 of 5 children; no AUC <15 ug*hour\/mL; and median AUC for 5 children <\/=60 ug*hour\/mL and <\/=1 of 5 children with >\/= grade 3 adverse events, none life-threatening.<\/p>\n

Guided by these criteria, the investigators either enrolled an additional 5 children at the starting dose or the starting dose was adjusted. An optimal dose was based on >=10 evaluable children with acceptable PK and safety results.<\/p>\n

The study has enrolled 183 children to date of this evaluation; 62 from South Africa.<\/p>\n

This report showed 48-week treatment outcomes for 57 South African children receiving unboosted (n=22) and boosted (n=35) ATV. Approximately half (29\/57) of the children were girls.<\/p>\n

At baseline, the children were a median of 6 years of age (91 days to 21 years); CD4 count, 411 cells\/mm3 (24 to 2192); CD4%, 13% (1 to 35); log10 viral load, 5.0 (3.6 to 5); and mean height z-score, \u00962.09 (\u00964.56 to 0.73) and weight z-score, \u00961.98 (\u00965.80 to 0.91).<\/p>\n

The investigators reported that 35\/48 of the children (73%, 95%CI 58% to 85%) had viral load <400 copies\/mL at 48 weeks, in an intent-to-treat analysis. Weight and height z-score improved significantly at the same time point; mean change in height z-score +0.27 (p=0.04) and mean change in weight z-score +0.79 (p<0.0001).<\/p>\n

11 children discontinued ATV, of these, 5 were due to toxicity (hyperbilirubinemia, LFT increase, or QT interval changes), 1 due to death (unrelated, pneumonia), and 5 for other reasons (eg lost to follow-up, need for protocol disallowed medications).<\/p>\n

The investigators noted that RTV boosting of the capsule significantly improved PK parameters of ATV. The dose of 310 mg\/m2 for powder and 205 mg\/m2 for capsule plus RTV passed protocol defined safety parameters.<\/p>\n

They also found in this South African cohort children were severely malnourished at baseline and weight and height z-scores improved significantly.<\/p>\n

Reference:<\/p>\n

Meyers T, Rutstein R, Samson P et al. Treatment responses to atazanavir-containing HAART in a drug-naive paediatric population in South Africa. 15th CROI. February 2008. Boston, Mass, USA. Poster abstract 582.<\/p>\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base A poster authored by Megan Palmer and coworkers from the United States and South Africa presented findings from PACTG 1020A. This is a phase I\/II study of atazanavir (ATV) with or without ritonavir (r) with 2 …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,32],"tags":[62],"class_list":["post-733","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","tag-croi-2008"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/733","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=733"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/733\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=733"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=733"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}